Local Delivery of Silk Fibroin and Chlorhexidine

Phase 1

Not yet recruiting

• Conditions: Periodontal Pocket
• Interventions: Biological: silk fibroin; Biological: combination of silk fibroin and chlorhexidine; Drug: Chlorhexidin

• Registration Number: NCT06050863
• Lead Sponsor: Krishnadevaraya College of Dental Sciences & Hospital

Brief Summary

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

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.

1. Group I (SRP+ Silk Fibroin)

2. Group II (SRP+ Chlorhexidine)

3. 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.

Study Timeline

• Status Verified: 2023-09
• Study First Submitted: 2023-09-16
• Study First Submitted QC: 2023-09-16
• Last Update Submitted: 2023-09-16
• Study First Posted: 2023-09-22
• Last Update Posted: 2023-09-22
• Study Start: 2023-11
• Primary Completion: 2024-06
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

1. Patient with age between 30-50 years.
2. Patients with stage I/ II with Grade A/ B periodontitis according to 2017 World workshop classification of periodontal disease will be considered.
3. Patients with localized periodontal pockets.
4. Patients willing to participate in the study.

Exclusion Criteria

1. Patients with known systemic diseases.
2. Non complaint patients.
3. Patients who received any surgical or nonsurgical therapy 6 months before the start of the study.
4. Pregnant or lactating females.
5. Use of systemic antibiotics in the past 6 months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I - Silk Fibroin	silk fibroin	test group 1 is treated with silk fibroin
Group III - Combination of Fibroin and Chlorhexidine	combination of silk fibroin and chlorhexidine	test group 3 is treated with combination of silk fibroin and chlorhexidine
Group II -Chlorhexidine	Chlorhexidin	test group 2 is treated with chlorhexidine

Primary Outcome Measures

Name	Time	Method
Probing pocket Depth (PPD)	3 months	measured using a UNC-15 probe (university of North Carolina-15 periodontal probe- Hu-Friedy, Chicago, IL, USA
Relative attachment level (RAL)	3 months	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)

Secondary Outcome Measures

Name	Time	Method
Plaque Index	3 months	measured on the tooth surface using a probe
Gingival index	3 month	measured on the tooth surface using a probe
Modified Sulcus Bleeding Index	3 months	measured on the tooth surface using a probe