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Local Delivery of Silk Fibroin and Chlorhexidine

Primary Purpose

Periodontal Pocket

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
silk fibroin
Chlorhexidin
combination of silk fibroin and chlorhexidine
Sponsored by
Krishnadevaraya College of Dental Sciences & Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontal Pocket

Eligibility Criteria

30 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Patient with age between 30-50 years. Patients with stage I/ II with Grade A/ B periodontitis according to 2017 World workshop classification of periodontal disease will be considered. Patients with localized periodontal pockets. Patients willing to participate in the study. Exclusion Criteria: Patients with known systemic diseases. Non complaint patients. Patients who received any surgical or nonsurgical therapy 6 months before the start of the study. Pregnant or lactating females. Use of systemic antibiotics in the past 6 months.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Experimental

    Arm Label

    Group I - Silk Fibroin

    Group II -Chlorhexidine

    Group III - Combination of Fibroin and Chlorhexidine

    Arm Description

    test group 1 is treated with silk fibroin

    test group 2 is treated with chlorhexidine

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

    Outcomes

    Primary Outcome Measures

    Probing pocket Depth (PPD)
    measured using a UNC-15 probe (university of North Carolina-15 periodontal probe- Hu-Friedy, Chicago, IL, USA
    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)

    Secondary Outcome Measures

    Plaque Index
    measured on the tooth surface using a probe
    Gingival index
    measured on the tooth surface using a probe
    Modified Sulcus Bleeding Index
    measured on the tooth surface using a probe

    Full Information

    First Posted
    September 16, 2023
    Last Updated
    September 16, 2023
    Sponsor
    Krishnadevaraya College of Dental Sciences & Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06050863
    Brief Title
    Local Delivery of Silk Fibroin and Chlorhexidine
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 2023 (Anticipated)
    Primary Completion Date
    June 2024 (Anticipated)
    Study Completion Date
    July 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Krishnadevaraya College of Dental Sciences & Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.
    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. Group I (SRP+ Silk Fibroin) Group II (SRP+ Chlorhexidine) 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Periodontal Pocket

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    15 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group I - Silk Fibroin
    Arm Type
    Experimental
    Arm Description
    test group 1 is treated with silk fibroin
    Arm Title
    Group II -Chlorhexidine
    Arm Type
    Active Comparator
    Arm Description
    test group 2 is treated with chlorhexidine
    Arm Title
    Group III - Combination of Fibroin and Chlorhexidine
    Arm Type
    Experimental
    Arm Description
    test group 3 is treated with combination of silk fibroin and chlorhexidine
    Intervention Type
    Biological
    Intervention Name(s)
    silk fibroin
    Intervention Description
    silk fibroin extracted from bombyx mori silk worm is processed in laboratory to form silk fibroin films
    Intervention Type
    Drug
    Intervention Name(s)
    Chlorhexidin
    Other Intervention Name(s)
    chlorhexidine
    Intervention Description
    chlorhexidine is used
    Intervention Type
    Biological
    Intervention Name(s)
    combination of silk fibroin and chlorhexidine
    Intervention Description
    combination of silk fibroin and chlorhexidine is used
    Primary Outcome Measure Information:
    Title
    Probing pocket Depth (PPD)
    Description
    measured using a UNC-15 probe (university of North Carolina-15 periodontal probe- Hu-Friedy, Chicago, IL, USA
    Time Frame
    3 months
    Title
    Relative attachment level (RAL)
    Description
    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)
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Plaque Index
    Description
    measured on the tooth surface using a probe
    Time Frame
    3 months
    Title
    Gingival index
    Description
    measured on the tooth surface using a probe
    Time Frame
    3 month
    Title
    Modified Sulcus Bleeding Index
    Description
    measured on the tooth surface using a probe
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patient with age between 30-50 years. Patients with stage I/ II with Grade A/ B periodontitis according to 2017 World workshop classification of periodontal disease will be considered. Patients with localized periodontal pockets. Patients willing to participate in the study. Exclusion Criteria: Patients with known systemic diseases. Non complaint patients. Patients who received any surgical or nonsurgical therapy 6 months before the start of the study. Pregnant or lactating females. Use of systemic antibiotics in the past 6 months.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    DR .Prabhuji MLV, MDS
    Phone
    9448057407
    Ext
    91
    Email
    prabhujimlv@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    DR. Aishwarya s, MDS
    Phone
    9686404461
    Ext
    91
    Email
    draishwarya1996@gmail.com

    12. IPD Sharing Statement

    Learn more about this trial

    Local Delivery of Silk Fibroin and Chlorhexidine

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