Local Delivery of Silk Fibroin and Chlorhexidine

Krishnadevaraya College of Dental Sciences & Hospital

Status and phase: Not yet enrolling; Phase 1

Conditions: Periodontal Pocket

Treatments: Biological: silk fibroin; Biological: combination of silk fibroin and chlorhexidine; Drug: Chlorhexidin

Study type: Interventional

Funder types: Other

Identifiers

NCT06050863

02_D012_126027

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 estimated patients

Sex: All

Ages: 30 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 3 patient groups

Group I - Silk Fibroin

Experimental group

Description:

test group 1 is treated with silk fibroin

Treatment:

Biological: silk fibroin

Group II -Chlorhexidine

Active Comparator group

Description:

test group 2 is treated with chlorhexidine

Treatment:

Drug: Chlorhexidin

Group III - Combination of Fibroin and Chlorhexidine

Experimental group

Description:

test group 3 is treated with combination of silk fibroin and chlorhexidine

Treatment:

Biological: combination of silk fibroin and chlorhexidine