Local Delivery of Silk Fibroin and Chlorhexidine
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
1 other identifier
interventional
15
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Nov 2023
Shorter than P25 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 16, 2023
CompletedFirst Posted
Study publicly available on registry
September 22, 2023
CompletedStudy Start
First participant enrolled
November 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2024
CompletedSeptember 22, 2023
September 1, 2023
7 months
September 16, 2023
September 16, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Probing pocket Depth (PPD)
measured using a UNC-15 probe (university of North Carolina-15 periodontal probe- Hu-Friedy, Chicago, IL, USA
3 months
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 Outcomes (3)
Plaque Index
3 months
Gingival index
3 month
Modified Sulcus Bleeding Index
3 months
Study Arms (3)
Group I - Silk Fibroin
EXPERIMENTALtest group 1 is treated with silk fibroin
Group II -Chlorhexidine
ACTIVE COMPARATORtest group 2 is treated with chlorhexidine
Group III - Combination of Fibroin and Chlorhexidine
EXPERIMENTALtest group 3 is treated with combination of silk fibroin and chlorhexidine
Interventions
silk fibroin extracted from bombyx mori silk worm is processed in laboratory to form silk fibroin films
combination of silk fibroin and chlorhexidine is used
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 16, 2023
First Posted
September 22, 2023
Study Start
November 1, 2023
Primary Completion
June 1, 2024
Study Completion
July 1, 2024
Last Updated
September 22, 2023
Record last verified: 2023-09