Evaluation of Cross-linked Collagen Membrane With and Without Silk Fibroin Around Immediate Dental Implants
Comparative Evaluation of Cross-linked Collagen Membrane With and Without Silk Fibroin Around Immediate Dental Implants -Randomized Controlled Trial.
1 other identifier
interventional
20
1 country
1
Brief Summary
Comparative evaluation of cross-linked collagen membrane with and without silk fibroin around Immediate Dental Implants -Randomized controlled trial.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2024
1 active site
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
July 19, 2024
CompletedFirst Posted
Study publicly available on registry
August 13, 2024
CompletedStudy Start
First participant enrolled
September 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2025
CompletedAugust 13, 2024
August 1, 2024
11 months
July 19, 2024
August 12, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess wound healing, gingival thickness and keratinized tissue width
Gingival tissue thickness assessment will be done at the site of implant placement 1.5 mm below the gingival margin of adjacent tooth. Local anaesthesia will be administered before the procedure and an Endodontic K-file with silicone disc stop will be used to measure. The depth will be measured with UNC-15 probe. Apico-coronal width of keratinized tissue is measured as the distance from the mucogingival junction to the gingival margin, with the mucogingival junction determined using Schiller's Potassium Iodide Solution.
pre implant placement , 6 weeks , 12 weeks
Secondary Outcomes (1)
Radiovisiography with grid
pre implant placement , 6 weeks , 12 weeks
Study Arms (2)
10 will receive cross -linked collagen with silk fibroin membrane around immediate implant.
EXPERIMENTALLocal anesthesia is given. Atraumatic extraction is done. Osteotomy is done. Immediate implant is placed along with crosslinked collagen with silk fibroin membrane. Suture is done.
10 will receive cross linked collagen membrane around immediate implant
ACTIVE COMPARATORLocal anesthesia is given. Atraumatic extraction is done. Osteotomy is done. Immediate implant is placed along with crosslinked collagen membrane. Suture is done.
Interventions
A mucoperiosteal flap will be raised and atraumatic extraction will be done. An immediate implant with collagen with silk fibroin membrane (experimental group) will be placed according to the standard protocol. An immediate implant with collagen membrane ( comparative group) will be placed according to the standard protocol . The surgical wound closure will be coapted with mattress and single interrupted sutures
A mucoperiosteal flap will be raised and atraumatic extraction will be done. An immediate implant with collagen with silk fibroin membrane (experimental group) will be placed according to the standard protocol.
Eligibility Criteria
You may qualify if:
- Systemically healthy patients in the age group of 18 to 55years.
- Patients undergoing immediate implant placement with gingival thickness ≤ 1mm
- Stage II /Stage III and Grade B Periodontitis patients.
- Radiographic assessment using Radiovisiography (RVG) with grid.
You may not qualify if:
- Patients having allergies with collagen and silk products.
- Medical conditions contraindicating surgical interventions.
- Known smokers and alcoholic.
- Acute infections at the site of extraction. Ex Abscess.
- Patients who have undergone radiotherapy or chemotherapy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Krishnadevaraya college of dental sciences
Bangalore, Karnataka, 562157, India
Related Publications (1)
Pripatnanont P, Chankum C, Meesane J, Thonglam J. Physical and biological performances of a semi-resorbable barrier membrane based on silk fibroin-glycerol-fish collagen material for guided bone regeneration. J Biomater Appl. 2021 Nov;36(5):930-942. doi: 10.1177/08853282211025781. Epub 2021 Jun 21.
PMID: 34152233BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 19, 2024
First Posted
August 13, 2024
Study Start
September 1, 2024
Primary Completion
August 1, 2025
Study Completion
August 1, 2025
Last Updated
August 13, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share
Individual Participant Data will not be shared with other researchers.