Local Delivery of Silk Fibroin and Chlorhexidine

Periodontal Pocket Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06050863
• Other study ID #: 02_D012_126027
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: November 2023
• Est. completion date: July 2024

Study information

• Verified date: September 2023
• Source: Krishnadevaraya College of Dental Sciences & Hospital
• Contact: DR .Prabhuji MLV, MDS
• Phone: 9448057407
• Email: prabhujimlv[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: July 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Periodontal Pocket

Intervention

Biological:
• silk fibroin
silk fibroin extracted from bombyx mori silk worm is processed in laboratory to form silk fibroin films

Drug:
• Chlorhexidin
chlorhexidine is used

Biological:
• combination of silk fibroin and chlorhexidine
combination of silk fibroin and chlorhexidine is used

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Krishnadevaraya College of Dental Sciences & Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Probing pocket Depth (PPD)	measured using a UNC-15 probe (university of North Carolina-15 periodontal probe- Hu-Friedy, Chicago, IL, USA	3 months
Primary	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	Plaque Index	measured on the tooth surface using a probe	3 months
Secondary	Gingival index	measured on the tooth surface using a probe	3 month
Secondary	Modified Sulcus Bleeding Index	measured on the tooth surface using a probe	3 months