Evaluation of efficacy of tetracycline fibers in conjunction with scaling and root planing in patients with chronic periodontitis.

AIM: The objective of this study was to compare the efficacy of scaling and root planing (SRP) alone versus tetracycline fiber therapy used adjunctively with SRP in the treatment of chronic periodontitis sites in maintenance patients.
MATERIALS AND METHODS: A total of 30 patients with a diagnosis of chronic periodontitis (60 localized chronic periodontitis sites) in the age group of 35 to 55 were selected. None of these patients had received any surgical or non-surgical periodontal therapy and had sites of periodontal pockets measuring 4-7 mm clinically and demonstrated radiographic evidence of moderate bone loss. Two non-adjacent sites in separate quadrants were selected in each patient for monitoring based on criteria that the sites had localized chronic periodontitis. Plaque index (PI) (sillness and loe) and Gingival-bleeding index (GI) (loe and sillness) were measured at baseline and 15(th), 30(th), 60(th), and 90(th)day. Clinical pocket depth (PD) and microbial analysis (MA) were analyzed at baseline and 90(th) day.
RESULTS: At 0 and 3 months adjunctive tetracycline fiber therapy was significantly better in reducing PI, GBI, (P<0.001) than S and RP alone. In comparison, the reduction in the PD was non-significant at 0 and 3 months (P<0.001). The microbial analysis showed significant reduction in Porphyromonas gingivalis and Prevotella intermedia though there was no significant reduction in the Actinobacillus actinomycetemcomitans.
CONCLUSION: Overall, these results indicate that fiber therapy significantly enhanced the effectiveness of SRP in the management of chronic periodontitis.

INTRODUCTION

Periodontitis is one of the most prevalent diseases affecting nearly one third of the adult population. Periodontitis is characterized by loss of connective tissue attachment to the tooth and pathological migration of the junctional epithelium apically, which leads to pocket formation, tooth mobility, and finally loss of tooth. There are different types of periodontitis but the most common is adult periodontitis. There is enough evidence supporting the microbial etiology of periodontal disease.[1] The pathogenic bacteria that cause periodontitis are mainly gram-negative anaerobic or microaerophillic bacteria and the main organisms implicated are Actinobacillus actinomycetemcomitans, Porphyromonas gingivalis, and Prevotella intermedia.[2]

Eliminating these infections, thereby preventing disease progression, is a primary goal of periodontal therapy.[3] Studies have revealed that most forms of periodontal diseases are treated predictably by conventional non-surgical therapy like plaque control, scaling and root planing (SRP) and health can be maintained for a long period of time with proper maintenance care programs.[4] Although this recognized and accepted approach provides long-term stability for many patients, recurrence of disease in individual sites is not uncommon, even in well-maintained patient due to poor oral hygiene and bacterial infection. Local and systemic antimicrobial agents are used as adjunct to mechanical therapy. To overcome the shortcomings of systemic antimicrobials, various local drug delivery systems with chemotherapeutic agents have been introduced and are being used to deliver these agents to the base of the pocket, thus minimizing the adverse impact on non-oral body sites.[5]

The potential benefits of local drug delivery include better patient compliance, improved drug access to the site of disease and lower drug dosage. Commonly used methods for local drug delivery are sub-gingival irrigation and controlled release of drug.[1] The antimicrobial agents used as local drug delivery agents include tetracycline, ofloxacin, clindamycin, chlorhexidine, etc.[5] Tetracycline as well its derivatives doxycycline and minocycline are the most commonly used antimicrobial agents in the treatment of periodontal infections.[6]

These local drug delivery devices have been used either alone or as adjunct with SRP. These antimicrobial agents are aimed directly into the site of infection, and therapeutic levels can be established and maintained for days to weeks using this approach.[5] The total effectiveness of these antimicrobial agents is probably due to a decrease in gingival inflammation by modulating the inflammatory responses and suppression of the pathogenic microbiota.[5]

The use of these medications may improve periodontal maintenance results and help to extend the intervals between patients visit. Several studies have demonstrated a suppression of the pathogenic subgingival micro-biota during and after tetracycline administration associated with clinical inprovement.[789] Tetracycline also binds to the root surfaces and can be released in active form over extended periods of time.[10] The sublethal concentration of tetracycline reduces adherence and coaggregation properties of a number of disease associated bacteria including P. gingivalis and P. intermedia. Keeping in mind the effectiveness of tetracycline as a local drug delivery system, tetracycline impregnated collagen fibers (25 g of pure fibrillar collagen) have been used in this study to evaluate the efficacy of tetracycline fibers clinically and microbiologically in chronic periodontitis patients.

MATERIALS AND METHODS

A total of 30 patients were randomly selected from the OPD of Periodontics, Santosh Dental College, Ghaziabad (U.P.), with a diagnosis of chronic periodontitis.

Patients qualified for the study if they had two non-adjacent sites located in separate quadrants that required periodontal treatment, in the age group of 35-55 and had not received any surgical or non-surgical periodontal therapy. The sites must have pockets measuring 4-7 mm clinically and demonstrated radiographic evidence of moderate alveolar bone loss.

The patients were excluded from the study if they met any of the following criteria: (1) who were pregnant; (2) had a history of taking antibiotics or using anti bacterial mouth rinses for past 6 months; (3) patients with known hypersensitivity to Tetracycline; (4) had teeth with furcation involvement; (5) patients with a history of smoking, and drug or alcohol abuse.

Subjects participating in the study volunteered following a detailed verbal description of the procedure and by signing consent forms.

Clinical methods

A total of 30 patients i.e. 60 sites from the patients were selected and grouped into two categories: control and test. The control group (30 sites) was treated with SRP without using tetracycline-impregnated collagen fibers (Control Site).

The test group (30 sites) was treated by SRP plus tetracycline-impregnated fibers (Test Site).

All the patients were subjected to SRP at the baseline measurement. Prior to SRP each selected site was subjected to assessment of the following parameters; (1) plaque index; (2) gingival bleeding index; (3) clinical pocket depth; (4) microbial analysis. After recording the clinical parameters at each site, in selected patients at baseline, microbiological samples were collected from pre-selected sites belonging to both the groups. Thorough SRP was done at both the sites using ultra sonic scalers. In one of the contra lateral sites commercially available tetracycline impregnated collagen fibers was administered after SRP [Figure 1].

Figure 1

Insertion of tetracycline fibers into the periodontal pocket

For sites also receiving fiber therapy, fibers containing tetracycline were placed in the periodontal pocket surrounding the tooth. Fibers were placed until the pocket was entirely filled to the gingival margin.

Patients were instructed to avoid brushing the fiber-treated teeth and eating crusty foods until fibers and adhesive were removed. At approximately 4 days following placement, the patients were checked for fiber retention and any adverse reaction. Verbal instructions were given to avoid manipulating the study teeth.

At each visit (Baseline, 15th, 30th, 60thand 90th day), the clinical parameters were assessed. A single trained and calibrated examiner who was blinded to treatment method obtained all readings. Microbiological samples were collected at baseline and 90 thday from both the sites of the patients.

Clinical parameters were assessed sequentially. The assessment of plaque was done on the basis of thickness of plaque at the gingival margin area of the sites using plaque index (Sillness and Loe 1964). Gingival index (Loe and Sillness, 1963) was recorded for each site.

Pocket depth was measured with the help of pressure sensitive Hawe Click Probe (Second-Generation Probe) and the distance between the base of the pocket and gingival margin was measured [Figures 2 and 3]. The probe was inserted parallel to the long axis of the tooth and walked circumferentially around each tooth to detect the areas of deepest penetration. As the resistance to further penetration was noticed, readings were recorded to the nearest millimeter.

Figure 2

Post-treatment clinical probing depth at the test site

Figure 3

Pre-treatment clinical probing depth at the test site

For the collection of subgingival samples the site was isolated using cotton rolls. Sterile absorbable paper points (size 45–75) were used for the collection of plaque samples and were immediately transferred to thioglycolate broth and were sent to microbiological lab for processing. The microorganisms processed were A. actinomycetemcomitans, P. gingivalis, and P. intermedia.

RESULTS

A total of 30 patients enrolled at the baseline completed the evaluation.

A total number of 60 sites from 30 patients [Table 1] with periodontal pockets measuring (4-7 mm) in contra lateral quadrants were selected. The selected sites were divided into the Control Group (C) treated by SRP alone and the Test Group (T) which received SRP and treatment with commercially available tetracycline-impregnated collagen fibers.

Table 1

Clinical probing depth (in mm)

At the selected sites the following clinical parameters were assessed at baseline, 15thday, 30th day, 60th day, and 90th day.

Gingival index (Loe and Sillness, 1963)[11]

Plaque index (Sillness and Loe, 1964)

Microbiological Examination was done at Baseline and on 90 thday.

A comparison of Plaque Index, Gingival Index, and Microbiological Examination was evaluated from baseline to 90th day. The mean plaque score on 0 day was 2.9±0.18 and on 90th day was 2.37±0.45 for the Control group (C). The mean Plaque index at baseline was 2.93±0.15 and on the 90th day was 1.65±0.60 for the Test group. The mean difference of plaque scores between 0 and 90th days was 0.53±0.43. With ′t′ value of 6.7 which was statistically highly significant (P<0.001) and percentage reduction was 22.1%. The mean difference of plaque score between 0 and 90th day was 1.28±0.56 with ′t′ value of 12.5 which was statistically highly significant (P<0.001) and percentage reduction was 44% [Figure 4].

Figure 4

Percentage reduction in mean plaque index scores

The mean reduction of the Plaque Index from 0 to 90th day was 0.725±0.09 for the Control Group and 0.72±0.09 for the Test Group. On comparison of reduction of Plaque score between Control Group (C) and Test Group (T), the mean reduction in the test group was statistically highly significant.

The mean Gingival Score on 0thday was 2.9±0.15 and on 90th day 2.33±0.54 for the Control Group. The mean Gingival Index score at baseline was 2.91±0.17 and on 90th day was 1.37±0.80 for the Test Group. The mean difference of Gingival Score between 0 and 90th day was 0.53±0.52 with ′t′ value of 6.056 which was statistically highly significant (P<0.001). The percentage reduction was 20%. The mean reduction of gingival index score between 0 and 90th day was 1.54±10.82 with t value of 10.82 which was statistically highly significant (P<0.01). The percentage reduction was 53% [Figure 5]. The mean reduction of the Gingival Index from 0 to 90th day was 0.56±0.51 for the control group and the Test Group was 1.54±0.77, the difference was statistically highly significant (P<0.001). The mean reduction in the test group was statistically highly significant as compared to the control group. The mean probing depth on 0 day was 5.1±0.84 and on 90thday was 2.7±0.62. The mean probing depth on 0 day was 5.4±0.85 and on 90th day was 2.8±0.66. The mean difference of probing pocket depth for the Control group from 0 to 90th day was 2.33±0.88 and the percentage of reduction was 45.7% which was statistically highly significant (P<0.001).

Figure 5

Percentage reduction in mean gingival index scores

The mean difference of probing pocket depth for the Test Group from

0 to 90th day was 2.63±0.96 and the percentage of reduction was 48% [Figure 6] which was statistically highly significant (P<0.001).

Figure 6

Percentage reduction in clinical probing depths

Mean reduction in probing pocket depth between 0 and 90th day was 2.33±0.88 for the Control Group and 2.63±0.96 for the Test Group which was statistically non-significant.

The microbiological assessment [Table 2] was done for the following organisms:

Table 2

Microbiological prevalence

Actinobacillus actinomycetemcomitans

Porphyromonas gingivalis

Prevotella intermedia

Actinobacillus actinomycetemcomitans

On Bacteriological examination in Control and Test Group on 0th day and on the 90th day results showed that 07 (23.3%) subjects of the Control Group showed presence of the organism, and it was reduced to only 03 (10%) subjects on 90th day follow up. The percentage of reduction was 13.3% which was statistically not significant [Figure 7]. While in the Test Group, 07 (23.3%) subjects showed the presence of A. actinomycetemcomitans, and this was reduced to (01) 3.3% at the end of the 90th day. The percentage of reduction shown was 20% which was statistically significant (P<0.01). The comparison between Control and Test Group did not show any statistically significant reduction.

Figure 7

Percentage reduction in A. actinomycetemcomitans

Porphyromonas gingivalis

On Bacteriological examination in Control and Test Group on 0th day and on the 90th day results showed that 24 (80%) subjects of the Control Group showed the presence of the organism, it was reduced to 15 (50%) on 90th day follow up. The percentage of reduction was 30% which was statistically not significant.

While in the Test Group, 24 (80%) subjects showed the presence of organism, this was reduced to 07 (23.3%) at the end of the 90 thday. The percentage reduction shown was 56.7% [Figure 8] which was statistically significant (P<0.01). The comparison between Control and Test Group showed statistically significant reduction.

Figure 8

Percentage reduction in porphyromonas gingivalis

Prevotella intermedia

On Bacteriological examination in Control and Test Group on 0th day and on the 90th day results showed 22 (73.3%) subjects of the Control Group showed the presence of the organism, and it was reduced to 14 (46.6%) on 90th day. The percentage of reduction was 26.7% which was statistically significant (P<0.05) while in the Test Group 22 (73.3%) subjects showed the presence of the organism, it was reduced to 06 (20%) at the end of the 90th day. The percentage of reduction shown was 53.3% [Figure 9] which was statistically highly significant (P<0.01). The comparison between Control and Test Group showed statistically significant reduction.

Figure 9

Percentage reduction in prevotella intermedia

DISCUSSION

Periodontal diseases represent a group of localized microbial-induced infections involving the gingival and supporting tissues of the teeth. Adult periodontitis results in progressive loss of attachment and formation of periodontal pockets. There is considerable evidence implicating facultative and anaerobic bacteria as a primary cause of periodontal disease.[12] The control of prevalence and progression of periodontal disease requires a reduction of subgingival microbial plaque mass or at least a suppression of periodontopathic bacteria. systemic administration of antimicrobial agents required frequent dosing which is associated with the risk of developing resistant organisms and super infection as well as adverse effects such as gastrointestinal disturbances.[13] Pitcher et al.[14] observed that mouth rinses and agents used during supragingival irrigation do not predictably reach beyond 5 mm into the periodontal pocket. For antimicrobial agents to be effective, the concentration of the drug should be adequate at the site and also there should be prolonged drug microbial contact. In order to overcome the drawbacks associated with systemic and conventional mode of therapy, local drug delivery systems were developed,[15] which were used in this study.

A local delivery device consists of a drug reservoir and a limiting element that controls the rate of medicament release. The goal is to maintain effective concentrations of therapeutic agents at the site of action for longer period, despite drug loss from crevicular fluid clearance. Local delivery devices can be divided into two classes according to the duration of medicament release i.e., Sustained-release delivery devices and Controlled-release delivery devices.[16] Sustained-release formulations are designed to provide drug delivery for less than 24 h.[16] On the other hand controlled delivery systems should have duration of drug release that exceeds 1 day. The controlled-release local delivery systems that have been used and are currently under investigation may be classified as either reservoir without a rate controlling system or with a rate controlling system as reported by Kornman et al.[17]

Most widely used local drug delivery system reports in periodontal literature are of Tetracycline as reported by Goodson15] Metronidazole by Addy et al.[18] Chlorhexidine by Addy et al.[18] and Ofloxacin by Hoffler et al.[19] In the present study, collagen-impregnated tetracycline fibers was used which was found to be advantageous among other drugs.

Tetracyclines are superior to other antibiotics as they are the only class of antibiotics which has the ability for retention to the tooth cementum and soft tissues. They are the only antibiotics, which can achieve higher levels of gingival fluid concentrations than serum levels.[20] Tetracycline has also been to inhibit collagenase activity, collagen degradation and bone resorption as reported by Golub et al.[21] The substantivity of tetracyclines have proved to be effective against gram-positive and gram-negative anaerobic microflora associated with chronic adult periodontitis. They exert their antimicrobial effect by inhibiting protein synthesis.

Maiden et al.[22] reported that in vitro testing has shown probable periodontal pathogens including P. gingivalis, Fusobacterium nucleatum, P. intermedia, Eikenella corrodens, Wolinella recta, and A. actinomycetemcomitans are susceptible to local Tetracycline concentrations achieved in periodontal pocket with a controlled release device. Therefore, tetracycline is suitable to local delivery and as adjuncts to mechanical therapy in management of periodontal disease.

Fiber therapy was tested as an adjunct to an accepted mechanical procedure for treating periodontitis in maintenance patients i.e., SRP, to evaluate its ability to enhance current dental clinic practice procedures. The patients in this study, as in typical periodontal practice, were maintenance patients on 3 to 4 months recall program. Patients were monitored for clinical signs of disease evidenced by plaque, recurrent bleeding and increased probing depth. This study demonstrated that overall tetracycline fiber therapy significantly enhanced the clinical benefits obtained by SRP in chronic periodontitis patients. These results were seen for each of the key clinical parameters used to evaluate periodontitis. The benefits of SRP alone were also consistent with the results seen in other studies of periodontal disease population.[23] The mean reduction in clinical probing depth from 0-90 thday was 45.7% in the control group and 48% in the test group. The mean reduction in the probing depth when statistically analyzed for the control and test group was statistically not-significant. Perhaps the duration of this clinical study, the numbers of patients were too small to find any significant result. A. actinomycetemcomitans was isolated from 23% (on day zero) and 10% (on 90thday) in control whereas in the test group the percentage dropped from 23 to 3 on day 90, which was statistically significant. Similar rates in the reduction of P. gingivalis and P. intermedia were observed. According to the findings of Goodson et al.,[24] statistical analysis revealed significant reduction of all subgingival microbial species including P. gingivalis, P. intermedia, and A. actinomycetemcomitans. However, detection of low numbers of A. actinomycetemcomitans organism precluded statistically significant differences.

On the basis of the clinical findings from this study, tetracycline fiber therapy enhances the benefits of SRP in the treatment of chronic periodontitis. The adjunctive benefit of the fiber was maintained for 3 months following therapy without additional fiber treatment. In this study, the majority of improvement in the groups treated could be ascribed to SRP. SRP and locally delivered tetracycline therapy are completely different treatment modalities that work by different mechanisms. Tetracycline does not remove any calculus deposits, scaling removes some of the bacteria but provides no bactericidal activity. Therefore, neither is the ideal control of the other. Locally delivered tetracycline therapy has a specific purpose, to control localized infection, whereas scaling is utilized to remove calculus and other deposits.

Hence, a combination of scaling and local drug delivery results in added benefits in the control of periodontal disease. Together with frequent monitoring, which includes a comprehensive periodontal examination, tetracycline fiber therapy can provide dental professionals an additional means to maintain significantly improved clinical health in periodontal diseases.