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Local Delivery of Silk Fibroin and Chlorhexidine

Sponsor
Krishnadevaraya College of Dental Sciences & Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06050863
Collaborator
(none)
15
Enrollment
3
Arms
8
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: silk fibroin
  • Drug: Chlorhexidin
  • Biological: combination of silk fibroin and chlorhexidine
 Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
15 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Probing pocket Depth (PPD) [3 months]

      measured using a UNC-15 probe (university of North Carolina-15 periodontal probe- Hu-Friedy, Chicago, IL, USA

    2. 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

    1. Plaque Index [3 months]

      measured on the tooth surface using a probe

    2. Gingival index [3 month]

      measured on the tooth surface using a probe

    3. Modified Sulcus Bleeding Index [3 months]

      measured on the tooth surface using a probe

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Krishnadevaraya College of Dental Sciences & Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Krishnadevaraya College of Dental Sciences & Hospital
    ClinicalTrials.gov Identifier:
    NCT06050863
    Other Study ID Numbers:
    • 02_D012_126027
    First Posted:
    Sep 22, 2023
    Last Update Posted:
    Sep 22, 2023
    Last Verified:
    Sep 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Periodontal Pocket
    Chlorhexidine
    Chlorhexidine gluconate

    Study Results

    No Results Posted as of Sep 22, 2023