Local Delivery of Silk Fibroin and Chlorhexidine

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Periodontal Pocket
• Intervention / Treatment: Biological: silk fibroin; Drug: Chlorhexidin; Biological: combination of silk fibroin and 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 Type: Interventional
• Enrollment (Estimated): 15
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: DR .Prabhuji MLV, MDS; Phone Number: 91 9448057407; Email: prabhujimlv@gmail.com
• Study Contact Backup: Name: DR. Aishwarya s, MDS; Phone Number: 91 9686404461; Email: draishwarya1996@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Krishnadevaraya College of Dental Sciences & Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: September 16, 2023
• First Submitted That Met QC Criteria: September 16, 2023
• First Posted (Actual): September 22, 2023

Study Record Updates

• Last Update Posted (Actual): September 22, 2023
• Last Update Submitted That Met QC Criteria: September 16, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Periodontal Pocket; Anti-Infective Agents, Local; Anti-Infective Agents; Dermatologic Agents; Disinfectants; Chlorhexidine; Chlorhexidine gluconate
• Other Study ID Numbers: 02_D012_126027

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No