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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06050863
Other study ID # 02_D012_126027
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received
Last updated
Start date November 2023
Est. completion date July 2024

Study information

Verified date September 2023
Source Krishnadevaraya College of Dental Sciences & Hospital
Contact DR .Prabhuji MLV, MDS
Phone 9448057407
Email prabhujimlv@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 15
Est. completion date July 2024
Est. primary completion date June 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years to 50 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
silk fibroin
silk fibroin extracted from bombyx mori silk worm is processed in laboratory to form silk fibroin films
Drug:
Chlorhexidin
chlorhexidine is used
Biological:
combination of silk fibroin and chlorhexidine
combination of silk fibroin and chlorhexidine is used

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Krishnadevaraya College of Dental Sciences & Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Probing pocket Depth (PPD) measured using a UNC-15 probe (university of North Carolina-15 periodontal probe- Hu-Friedy, Chicago, IL, USA 3 months
Primary 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 Plaque Index measured on the tooth surface using a probe 3 months
Secondary Gingival index measured on the tooth surface using a probe 3 month
Secondary Modified Sulcus Bleeding Index measured on the tooth surface using a probe 3 months
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