Local Delivery of Silk Fibroin and Chlorhexidine

Study Overview
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Brief Summary
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The current study is a prospective randomised split mouth study to evaluate the effect of Silk fibroin as drug delivery system while simultaneously assessing the efficacy of silk fibroin in comparison to chlorhexidine.

Detailed Description
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Fifteen healthy individuals satisfying the inclusion and exclusion criteria were recruited for the study. A detailed, thorough medical and dental history was obtained and each patient was subjected to comprehensive clinical and radiological examination. All patients were informed about the nature of the study, procedure involved, potential benefits and risks associated with procedure and written informed consent were obtained from all patients.All the patients underwent scaling and root planing. Following randomization, the site will be assigned to one of the three study groups. Group I (SRP+ Silk Fibroin) Group II (SRP+ Chlorhexidine) Group III (SRP+ Combination of Fibroin and Chlorhexidine) Periodotal pack was placed and patient was recalled after 21days, 1 month and 3 month for the follow up.

Official Title
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A Comparative Evaluation of Subgingivally Delivered Chlorhexidine, Silk Fibroin and Combination of Fibroin and Chlorhexidine as Local Drug Delivery in Periodontitis - A Randomized Control Trial

Conditions
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Periodontal Pocket

Intervention / Treatment
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* Biological: silk fibroin
* Drug: Chlorhexidin
* Biological: combination of silk fibroin and chlorhexidine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with age between 30-50 years. Patients with stage I/ II with Grade A/ B periodontitis according to 2017 World workshop classification of periodontal disease will be considered. Patients with localized periodontal pockets. Patients willing to participate in the study. Exclusion Criteria: Patients with known systemic diseases. Non complaint patients. Patients who received any surgical or nonsurgical therapy 6 months before the start of the study. Pregnant or lactating females. Use of systemic antibiotics in the past 6 months.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I - Silk Fibroin<br>test group 1 is treated with silk fibroin | Biological: silk fibroin<br>* silk fibroin extracted from bombyx mori silk worm is processed in laboratory to form silk fibroin films<br>|
| Active Comparator: Group II -Chlorhexidine<br>test group 2 is treated with chlorhexidine | Drug: Chlorhexidin<br>* chlorhexidine is used<br>* Other names: chlorhexidine;|
| Experimental: Group III - Combination of Fibroin and Chlorhexidine<br>test group 3 is treated with combination of silk fibroin and chlorhexidine | Biological: combination of silk fibroin and chlorhexidine<br>* combination of silk fibroin and chlorhexidine is used<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probing pocket Depth (PPD) | measured using a UNC-15 probe (university of North Carolina-15 periodontal probe- Hu-Friedy, Chicago, IL, USA | 3 months | 
| Relative attachment level (RAL) | measured by placing the acrylic stent on the selected teeth using UNC-15 probe (university of North Carolina-15 periodontal probe- Hu-Friedy, Chicago, IL, USA) | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plaque Index | measured on the tooth surface using a probe | 3 months | 
| Gingival index | measured on the tooth surface using a probe | 3 month | 
| Modified Sulcus Bleeding Index | measured on the tooth surface using a probe | 3 months |