Local Delivery of Silk Fibroin and Chlorhexidine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-30

Study Completion Date

2024-07-31

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.

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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.

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.

Conditions

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Periodontal Pocket

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group I - Silk Fibroin

test group 1 is treated with silk fibroin

Group Type EXPERIMENTAL

silk fibroin

Intervention Type BIOLOGICAL

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

Group II -Chlorhexidine

test group 2 is treated with chlorhexidine

Group Type ACTIVE_COMPARATOR

Chlorhexidin

Intervention Type DRUG

chlorhexidine is used

Group III - Combination of Fibroin and Chlorhexidine

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

Group Type EXPERIMENTAL

combination of silk fibroin and chlorhexidine

Intervention Type BIOLOGICAL

combination of silk fibroin and chlorhexidine is used

Interventions

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silk fibroin

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

Intervention Type BIOLOGICAL

Chlorhexidin

chlorhexidine is used

Intervention Type DRUG

combination of silk fibroin and chlorhexidine

combination of silk fibroin and chlorhexidine is used

Intervention Type BIOLOGICAL

Other Intervention Names

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chlorhexidine

Eligibility Criteria

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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.

Minimum Eligible Age

30 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes