European Journal of General Dentistry

ORIGINAL ARTICLE
Year
: 2014  |  Volume : 3  |  Issue : 1  |  Page : 39--45

Clinical evaluation of the efficacy of two commercially available controlled-release drugs-chlorhexidine gel (CHLO-SITE) TM and tetracycline fibers (periodontal plus AB) TM as an adjunct to scaling root planning in the treatment of chronic periodontitis


Harpreet Singh Grover, Amit Bhardwaj, Himanshu Dadlani, Anil Yadav, Yaswin Singh 
 Department of Periodontics, SGT Dental College, Hospital and Research Institute, Budhera, Gurgaon, Haryana, India

Correspondence Address:
Amit Bhardwaj
Department of Periodontics, SGT Dental College, Hospital and Research Institute, Budhera, Gurgaon, Haryana
India

Abstract

Background: Selective removal or inhibition of pathogenic microbes with locally delivered antimicrobials, combined with scaling and root planning (SRP) is an effective approach for the management of chronic periodontitis. Aim: Evaluation of the efficacy of two commercially available controlled release drugs - tetracycline fibers (periodontal plus AB TM ) and chlorhexidine gel (CHLO-SITE TM ) as an adjunct to SRP in the treatment of chronic periodontitis. Materials and Methods: Twenty systemically healthy patients in the age group of 30-50 years suffering from generalized chronic periodontitis were selected. Three experimental sites were chosen that had probing depth 5-8 mm in maxillary and mandibular posterior segment. First site receiving tetracycline fibers, other chlorhexidine gel and one site was taken as control after SRP. Plaque score, bleeding score, probing pocket depth (PPD), and relative attachment level (RAL) gain were recorded on baseline, 1 month and at the end of 3 months. Results and Conclusion: In all groups, there was statistically highly significant reduction in all the clinical parameters that is plaque score, bleeding score, PPD, and RAL gain were seen at different time intervals. Inter-comparison shows that tetracycline fibers and chlorhexidine gel are equally efficacious for treatment of chronic periodontitis, but more efficient than SRP alone.



How to cite this article:
Grover HS, Bhardwaj A, Dadlani H, Yadav A, Singh Y. Clinical evaluation of the efficacy of two commercially available controlled-release drugs-chlorhexidine gel (CHLO-SITE) TM and tetracycline fibers (periodontal plus AB) TM as an adjunct to scaling root planning in the treatment of chronic periodontitis.Eur J Gen Dent 2014;3:39-45


How to cite this URL:
Grover HS, Bhardwaj A, Dadlani H, Yadav A, Singh Y. Clinical evaluation of the efficacy of two commercially available controlled-release drugs-chlorhexidine gel (CHLO-SITE) TM and tetracycline fibers (periodontal plus AB) TM as an adjunct to scaling root planning in the treatment of chronic periodontitis. Eur J Gen Dent [serial online] 2014 [cited 2019 Jun 25 ];3:39-45
Available from: http://www.ejgd.org/text.asp?2014/3/1/39/126209


Full Text

 Introduction



Periodontal diseases are a group of inflammatory microbial-induced infections involving the supporting tissues of the teeth: The gingiva, periodontal ligament, and alveolar bone. [1] Chronic periodontitis results in a progressive loss of attachment and formation of a periodontal pocket. The process of periodontal pocket formation represents the pathologic sequelae of microbial and inflammatory mediated degradation of collagenous connective tissue and alveolar bone. [2] Therefore, an objective of periodontal treatment is to suppress or eliminate putative subgingival periodontal pathogens. [1]

The treatment offered to the patient by the clinician may be non-surgical, surgical or a combination of both. Non-surgical therapy includes both mechanical and chemotherapeutic approaches to minimize or eliminate the microbial biofilm. [3]

Thorough scaling and root planning (SRP) is required in order to prevent the recolonization of the subgingival area by periodontopathogens. However, mechanical therapy may fail to eliminate the pathogenic bacteria completely because of their location within the gingival tissues or in areas inaccessible to periodontal instrumentation.

The use of several antimicrobial agents started gaining prominence as chemical aids prevent early microbial recolonization ensuring, the best chance for clinical improvements. These chemical agents gain access into the periodontal pocket through both systemic and local route of delivery. Since, systemic use of antibiotics may cause several side-effects, contemporary research is now focused on the role of topical/local antimicrobial agents in the treatment of periodontitis. [2]

Local antimicrobial therapy can be subclassified as "sustained release device" delivering the drug for less than 24 h and "controlled delivery device," releasing the agent over an extended period of time.

Goodson (1979) first proposed the concept of controlled delivery in the treatment of periodontitis. [4] The effectiveness of this form of therapy is that, it reaches the base of periodontal pocket and is maintained for an adequate time for the antimicrobial effect to occur. Periodontal pocket provides a natural reservoir bathed by gingival crevicular fluid that is easily accessible for the insertion of a delivery device.

Various agents have been used to prevent further progression of periodontal disease either as monotherapy or as an adjunct to SRP. These include tetracycline, doxycycline, minocycline, chlorhexidine; metronidazole, simvastatin, and alendronate have been administered in pure forms by their incorporation in mouthwashes, chewing gums, dentifrices, acrylic strips, hollow fibers, fibrillar collagen, films, ointments, gels etc.

In the present study, an attempt was made to evaluate the efficacy of two commercially available controlled release drugs - tetracycline fibers (periodontal plus AB TM ) and chlorhexidine gel (CHLO-SITE TM ) as an adjunct to SRP in the treatment of chronic periodontitis.

 Materials and Methods



Twenty systemically healthy patients suffering from generalized chronic periodontitis were selected among the patients visiting the Department of Periodontics, SGT Dental College, Hospital and research institute, Gurgaon (Haryana). Patients did not receive any surgical or non-surgical periodontal therapy in past 6 months and were not on any antibiotic therapy since past 6 months. Written informed consent was taken from each patient who participated in the study and ethical clearance was obtained from the Institutional Committee. For each subject, three experimental sites were chosen that had probing depth 5-8 mm in either maxillary or mandibular molars randomly.

Clinical parameters of all the selected sites were recorded and then SRP was carried out. Plaque score was brought down to zero and the same was confirmed by using a disclosing solution (Alpha Plac TM ) [Figure 1]{Figure 1}

Root planning of selected teeth was carried out and selected sites were divided into three groups randomly:

Group A (Test): Tetracycline fibers (periodontal plus AB TM ) were inserted into the periodontal pocket until pocket was filled. COE-PAK TM was then applied for 10 days [Figure 2].{Figure 2}

Group B (Test): Chlorhexidine gel (CHLO-SITE TM ) was applied directly from the syringe into the pocket. COE-PAK TM was then applied for 10 days [Figure 3].{Figure 3}

Group C (Control): SRP was done.

Recording of various clinical parameters was carried out on day 0 (baseline) and subsequently at the end of 1 month and 3 months. The course of the study was of 3 months duration. The statistical analysis for periodontal parameters was carried out by using the paired t-test for comparison at two different time interval between the probing pocket depth (PPD) and relative attachment level (RAL). The periodontal parameters, plaque index (PI), and sulcus bleeding index (SBI) were assessed by using the Wilcoxon signed rank sum test between different time periods in the same group and Mann-Whitney U test for comparison of PI and SBI between different groups in different time periods.

Clinical parameters

PI (Silness and Loe, 1964) (PI)PPD (using UNC 15 periodontal probe) (PPD)SBI (Muhlemann and Son, 1971) (SBI)RAL (Measurement using the customized acrylic stent) (RAL) [Figure 4].{Figure 4}

Materials

Tetracycline fibers (periodontal plus AB TM )

Tetracycline fibers (Periodontal Plus AB TM ) product contains 25 mg pure fibrillar collagen containing approximately 2 mg of evenly impregnated tetracycline hydrochloride in each individual vial. Periodontal Plus AB TM fibers are available in a box containing four individually packed and separable sterile product packs (vials).

Chlorhexidine gel (CHLO-SITE TM gel)

CHLO-SITE TM gel is a xanthan based 1.5% chlorhexidine gel containing 0.5% fast releasing Chlorhexidine gluconate and 1% in form of slow releasing chlorhexidine dihydrochloride. Xanthan is an optimum substrate for formation of a stable gel that is easily extruded from 0.5 ml syringe needle.

 Results



Intragroup comparison in tetracycline group reveals highly significant reduction in PI and SBI at baseline to 1 month and baseline to 3 month interval. In case of PPD and RAL, highly significant reduction in baseline to 1 month interval and baseline to 3 month interval and significant reduction in 1 month to 3 month interval was found [Table 1].{Table 1}

Intragroup comparison in chlorhexidine group reveals significant reduction in PI and highly significant in SBI at baseline to 1 month and baseline to 3 month interval. In case of PPD and RAL, highly significant reduction in the entire time intervals [Table 2].{Table 2}

Intragroup comparison in control group reveals significant reduction in PI and SBI at baseline to 1 month and baseline to 3 month interval. In case of PPD and RAL, highly significant reduction in all time intervals was found [Table 3].{Table 3}

Intergroup comparison of PI reveals no significant difference between tetracycline and chlorhexidine group at all-time intervals. At baseline, no significant difference was found between tetracycline and control, and chlorhexidine and control group, but significant difference was found at 1 month and 3 month interval [Table 4].{Table 4}

Intergroup comparison of SBI reveals no significant difference between tetracycline and chlorhexidine group at all-time intervals. At baseline, no significant difference was found between tetracycline and control, and chlorhexidine and control group, but significant difference was found at 1 month and 3 month interval [Table 5].{Table 5}

Intergroup comparison of PPD reveals no significant difference between tetracycline and chlorhexidine group at all-time intervals. At baseline, no significant difference was found between tetracycline and control, and chlorhexidine and control group, but significant difference was found at 1 month and 3 month interval [Table 6].{Table 6}

Intergroup comparison of RAL reveals no significant difference between tetracycline and chlorhexidine group at all-time intervals. At baseline, no significant difference was found between tetracycline and control, and chlorhexidine and control group, but significant difference was found at 1 month and 3 month interval [Table 7].{Table 7}

 Discussion



A periodontal disease essentially comprises a group of oral infections, whose primary etiological factor is dental plaque, which results in an inflammatory lesion in the supporting tissues. Removal of the cause (and its effects) is the primary aim of both non-surgical and surgical treatment regimens. The major non-surgical therapeutic approach involves mechanical SRP. Local delivery of antimicrobial agents is becoming more prevalent since it leads to higher concentration of the drug at the intended site of action using a lower dose, with an associated reduction in side effects relative to systemic administration. Local route of drug delivery provides direct access to the systemic circulation through the jugular vein bypassing the first pass hepatic metabolism leading to high bioavailability. [5]

In the present study, clinical parameters were recorded at 1 month as the bacterial flora is supposedly said to return to pre-treatment patterns after 3-6 weeks of SRP. [6] The 3 month interval was chosen because the effects of locally delivered chlorhexidine and tetracycline have been shown to be evident for 11 weeks after administration and also 3 months corresponds to typical recall interval for patients after periodontal treatment. [7]

Intragroup comparison

Tetracycline fibers

Reduction in PI score was statistically significant in tetracycline group. Reduction in supragingival plaque score in tetracycline fiber group could be attributed to chemical control of subgingival plaque by tetracycline fibers which could also have an inhibitory effect on supragingival plaque. [8]

Reduction in SBI score was statistically significant in the tetracycline group. The results are in accordance with studies conducted by Soares et al., (2009). [9] Reduction in bleeding is due to resolution of gingival inflammation after SRP and well-known antimicrobial effect of tetracycline. [10]

Reduction in PPD and RAL score was statistically significant in tetracycline group. Similar reduction in PPD was recorded by Friesen et al., (2002) [11] Perinetti et al., (2004). [12] The improved gingival health may have contributed to the observed reduction of PPD, presumably by decreasing the edematous swelling of the marginal gingiva and/or by decreasing the penetrability of tissue by the probe as a result of an increase of collagen content. [13] These findings are in contrast with the result of Drisko et al., (1995) [14] who observed no difference

Chlorhexidine gel

Reduction in PI score was statistically significant in chlorhexidine group. Lower PI scores observed in the present study may be the result of antiplaque and antibacterial role of chlorhexidine, which may have leaked out from the pockets and better oral hygiene practiced by the patients. [15] Similar observations were made by Vaidya et al., (2011). [3] The results were however in contrast to the studies conducted by Azmak et al., (2002). [16]

Reduction in SBI score was statistically significant in chlorhexidine group. Similar findings were noted by Rusu et al., (2005). [17] Cationic chlorhexidine molecule is rapidly attracted by the negatively charged bacterial cell surface. After adsorption, the integrity of the bacterial cell membrane is altered, which results in a reversible leakage of bacterial low molecular-weight components at low dosage (bacteriostatic) or more severe membrane damage at higher dosage (bactericidal). [2]

Reduction in PPD and RAL score was statistically significant in chlorhexidine group. Similar findings were recorded by Vinholis et al., (2001). [18] The reduction in the PPD can be attributed to the bactericidal concentrations achieved after administration of chlorhexidine gel at the selected sites. [15] These results were in accordance with the studies conducted by Vaidya et al., (2011). [3]

Control

Reduction in PI score was statistically significant in control group. This change may be due to removal of bacterial deposits; moreover, improved plaque control by patients may have led to favorable subgingival microbial changes (Bollen and Quirynen 1996). [19] Similar observations were made by Checchi et al., (1997). [20]

Reduction in SBI score was statistically significant in control group. In the present study, reduction in bleeding is due to resolution of gingival inflammation after removal of bacterial deposits by SRP. [10],[19] Similar results were observed by Haffajee et al., (1997). [21]

Reduction in PPD and RAL score was statistically significant in the control group. It is suspected that either a continued reorganization of the connective tissue permitting less probe penetration or coronally creeping attachment is responsible for this occurrence of changes. [22] Similar observations were made by Srivastava et al., (2009). [2]

Intergroup comparison

PI

No significant difference in PI reduction was seen in between tetracycline fibers and chlorhexidine gel at baseline, 1 month and 3 months. Findings are in accordance with Unsal et al., (1994) [10] who evaluated the effect of subgingivally placed 2% chlorhexidine gel and 10% tetracycline paste in periodontal pockets along with the SRP.

Significant reduction in PI reduction was seen in the tetracycline group and the control group at 1 month and 3 months. This reduction in supragingival plaque score could be attributed to chemical control of subgingival plaque by tetracycline fibers, which could also have an inhibitory effect on supragingival plaque. [23] Similar observations were made by Friesen et al., (2002). [11]

Significant reduction in PI reduction was seen in chlorhexidine group and control group at 1 month and 3 months. Chlorhexidine from CHLO-SITE TM is released at a rapid and consistent rate during the 1 st day, with concentration greater than 100 g/ml. This action continues for an average of 6-9 days, with total release rate equal to 85% of the total amount of chlorhexidine contained in CHLO-SITE TM gel. After the 9 th day, the presence of chlorhexidine dihydrochloride assures a constant concentration, which is efficient and microbiologically active, for an additional week. [3] These results were in accordance with the results observed by Verma et al., (2012). [15] The results were in contrast with those observed by Vinholis et al., (2001). [18]

SBI

No significant difference in SBI reduction was seen in between tetracycline fibers and chlorhexidine gel at baseline, 1 month and 3 months. In the present study, reduction in SBI score in both the groups is due to resolution of gingival inflammation after SRP. [10]

Significant reduction in SBI was seen in tetracycline group and control group at 1 month and 3 months. Tetracycline offers better substantivity and good binding and/or penetration into root surfaces. [23] The results were in accordance with results observed by Sadaf et al., (2012). [24]

Significant reduction in SBI was seen in chlorhexidine group and control group at 1 month and 3 months. This difference may be due to antiplaque and antibacterial role of chlorhexidine, which leaked out of the periodontal pockets, which thereby reduced the gingival inflammation, resulting in reduced SBI. [15] The results were in contrast with the studies conducted by Azmak et al., (2002). [16]

PPD

No significant difference in PPD reduction was seen in between tetracycline fibers and chlorhexidine gel at baseline, 1 month and 3 months. Reduction in PPD in both groups is due to resolution of gingival inflammation after SRP and to well-known antimicrobial effects of both locally delivered drugs. [15]

Significant reduction in PPD was seen in tetracycline group and control group at 1 month and 3 months. Similar observations were made by Banodkar and Rao (2011). [25] The benefits of tetracycline include not only bactericidal and bacteriostatic activity in periodontal disease, but also adsorption to dental surface and capacity to increase fibroblast attachment to root surface. These results were in contrast with the results observed by Wilson et al., (1998). [26]

Significant reduction in PPD was seen in chlorhexidine group and control group at 1 month and 3 months. Higher improvement can be attributed to chlorhexidine, which is known to inhibit microbial proteases from potent periodontal pathogens. Chlorhexidine reduces PGE 2 , which might be a causative factor for improvement of clinical parameters. [27] Similar results were observed by Vinholis et al., (2001). [18]

RAL

No significant difference in reduction in RAL at baseline, 1 month and 3 months in tetracycline group and chlorhexidine group was seen.

Highly significant difference in reduction in RAL at 1 month and 3 months in tetracycline group and control group was observed. PPD might change from time to time even in untreated periodontal disease because of changes in gingival margin, while changes in level of attachment can be caused only by gain or loss of attachment and thus provide a better indication of the degree of periodontal destruction. [9] The findings were similar to Goodson et al., (1991). [28]

Highly significant difference in reduction in RAL at 1 month and 3 months in chlorhexidine group and control group was observed. Similar results were observed by Vinholis et al., (2001). [18] The results were however in contrast to the studies conducted by Azmak et al., (2002). [16]

 Conclusion



The results of the study shows that both local drug delivery agents with respect to SRP are equally competent and efficient in management of periodontal pockets and both materials were having good biological acceptability and were well-tolerated by all the patients during the course of the study. Within the limits of our study, it can be concluded that local delivery of tetracycline fibers and chlorhexidine gel is a safe and efficacious method along with SRP in the management of periodontal disease. However, further studies are advised with larger sample size, longer follow-up duration and confirmation with the microbiological analysis to overcome the drawbacks of the present study.

References

1Shankraiah M, Nagesh C, Venkatesh JS, Narsu LM, Setty SR. Local drug delivery system of chitosan strips containing sparfloxacin for periodontal disease. Pharmacologyonline 2011;1:237-47.
2Srivastava R, Verma PK, Tandon P, Kumar R, Gupta KK, Srivastava A. Chlorhexidine chip and tetracycline fibers as adjunct to scaling and root planning - A clinical study. Braz J Oral Sci 2009;8:201-5.
3Vaidya P, Thomas M, Dixit A. Treatment of chronic periodontitis using chlorhexidine gel as an adjunct to scaling and root planning: A clinical study. J Indian Dent Assoc 2011;5:966-8.
4Divya PV, Nandakumar K. Local drug delivery-Periocol in periodontics. Trends Biomater Artif Organs 2006;19:74-80.
5Chaturvedi TP, Srivastava R, Srivastava AK, Gupta V, Verma PK. Evaluation of metronidazole nanofibers in patients with chronic periodontitis: A clinical study. Int J Pharma Investig 2012;2:213-7.
6Ryan ME. Nonsurgical approaches for treatment of periodontal diseases. Dent Clin N Am 2005;49:611-36.
7Stabholz A, Sela MN, Friedman M, Golomb G, Soskolne A. Clinical and microbiological effects of sustained release chlorhexidine in periodontal pockets. J Clin Periodontol 1986;13:783-8.
8Jeong SN, Han SB, Lee SW, Magnusson I. Effects of tetracycline-containing gel and a mixture of tetracycline and citric acid-containing gel on non-surgical periodontal therapy. J Periodontol 1994;65:840-7.
9Soares PB, de Menezes HH, Naves MM, Taga EM, de Magalhães D. Effect of absorbent tetracycline-loaded membrane used in the reduction of periodontal pockets: An in vivo study. Braz Dent J 2009;20:414-8.
10Unsal E, Akkaya M, Walsh TF. Influence of a single application of subgingival chlorhexidine gel or tetracycline paste on the clinical parameters of adult periodontitis patients. J Clin Periodontol 1994;21:351-5.
11Friesen LR, Williams KB, Krause LS, Killoy WJ. Controlled local delivery of tetracycline with polymer strips in the treatment of periodontitis. J Periodontol 2002;73:13-9.
12Perinetti G, Paolantonio M, Cordella C, D'Ercole S, Serra E, Piccolomini R. Clinical and microbiological effects of subgingival administration of two active gels on persistent pockets of chronic periodontitis patients. J Clin Periodontol 2004;31:273-81.
13Sachdeva S, Agarwal V. Evaluation of commercially available biodegradable tetracycline fiber therapy in chronic periodontitis. J Indian Soc Periodontol 2011;15:130-4.
14Drisko CL, Cobb CM, Killoy WJ, Michalowicz BS, Pihlstrom BL, Lowenguth RA, et al. Evaluation of periodontal treatments using controlled-release tetracycline fibers: Clinical response. J Periodontol 1995;66:692-9.
15Verma A, Sanghi S, Grover D, Aggarwal S, Gupta R, Pandit N. Effect of insertion of xanthan-based chlorhexidine gel in the maintenance phase following the treatment of chronic periodontitis. J Indian Soc Periodontol 2012;16:381-5.
16Azmak N, Atilla G, Luoto H, Sorsa T. The effect of subgingival controlled-release delivery of chlorhexidine chip on clinical parameters and matrix metalloproteinase-8 levels in gingival crevicular fluid. J Periodontol 2002;73:608-15.
17Rusu D, Stratul SL, Necker A, Benta A. Non-surgical periodontal therapy using a novel chlorhexidine based gel: A split mouth study. Int Poster J Dent Oral Med 2005;7:286-90.
18Vinholis AH, Figueiredo LC, Marcantonio Júnior E, Marcantonio RA, Salvador SL, Goissis G. Subgingival utilization of a 1% chlorhexidine collagen gel for the treatment of periodontal pockets. A clinical and microbiological study. Braz Dent J 2001;12:209-13.
19Bollen CM, Quirynen M. Microbiological response to mechanical treatment in combination with adjunctive therapy. A review of the literature. J Periodontol 1996;67:1143-58.
20Checchi L, Forteleoni G, Pelliccioni GA, Loriga G. Plaque removal with variable instrumentation. J Clin Periodontol 1997;24:715-7.
21Haffajee AD, Cugini MA, Dibart S, Smith C, Kent RL Jr, Socransky SS. The effect of SRP on the clinical and microbiological parameters of periodontal diseases. J Clin Periodontol 1997;24:324-34.
22Kaldahl WB, Kalkwarf KL, Patil KD, Dyer JK, Bates RE Jr. Evaluation of four modalities of periodontal therapy. Mean probing depth, probing attachment level and recession changes. J Periodontol 1988;59:783-93.
23Gill JS, Bharti V, Gupta H, Gill S. Non-surgical management of chronic periodontitis with two local drug delivery agents-A comparative study. J Clin Exp Dent 2011;3:e424-9.
24Sadaf N, Anoop B, Dakshina B, Shweta B. Evaluation of efficacy of tetracycline fibers in conjunction with scaling and root planing in patients with chronic periodontitis. J Indian Soc Periodontol 2012;16:392-7.
25Banodkar AB, Rao J. A comparative study of periodontal treatment using tetracycline impregnated collagen fibers as compared to scaling and root planing alone-A clinical and microbiological study. J Indian Dent Assoc 2011;5:1044-6.
26Wilson TG Jr, McGuire MK, Greenstein G, Nunn M. Tetracycline fibers plus scaling and root planing versus scaling and root planing alone: Similar results after 5 years. J Periodontol 1997;68:1029-32.
27Mizrak T, Güncü GN, Caglayan F, Balci TA, Aktar GS, Ipek F. Effect of a controlled-release chlorhexidine chip on clinical and microbiological parameters and prostaglandin E2 levels in gingival crevicular fluid. J Periodontol 2006;77:437-43.
28Goodson JM, Cugini MA, Kent RL, Armitage GC, Cobb CM, Fine D, et al. Multicenter evaluation of tetracycline fiber therapy: II. Clinical response. J Periodontal Res 1991;26:371-9.