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COMPLETED
NCT07647120
NA

Comparison of Freeze-Dried Amniotic and Collagen Membranes for Soft Tissue Healing After Grafted Implant Surgery

Sponsor: RAJAS DENTAL COLLEGE AND HOSPITAL

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to learn whether Freeze-Dried Amniotic Membrane (FD-AM) or Collagen Membrane (CM) provides better soft tissue healing after Stage I dental implant surgery with particulate bone grafting in adults requiring implant treatment in bilateral posterior maxillary edentulous sites. It will also evaluate postoperative pain associated with the two membrane types. The main questions it aims to answer are: Does FD-AM result in improved early soft tissue healing compared with CM as assessed by the Early Healing Score (EHS)? Does FD-AM reduce postoperative pain compared with CM as assessed by the Visual Analogue Scale (VAS)? Researchers will compare FD-AM and CM placed over grafted implant sites to determine whether one membrane provides superior healing outcomes and patient comfort. Participants will: Undergo Stage I implant surgery with particulate bone grafting. Receive FD-AM at one implant site and CM at the contralateral implant site according to the study randomization protocol. Attend follow-up visits for assessment of soft tissue healing and postoperative pain. Complete questionnaires related to pain and healing outcomes during the postoperative period.

Official title: Comparison of Freeze-Dried Amniotic Membrane (FD-AM) and Collagen Membrane (CM) in Soft Tissue Healing After Stage 1 Implant Surgery With Particulate Grafting: An In Vivo Study

Key Details

Gender

All

Age Range

25 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2025-06-19

Completion Date

2026-02-18

Last Updated

2026-06-15

Healthy Volunteers

No

Interventions

DEVICE

Freeze-Dried Amniotic Membrane (FD-AM)

Freeze-Dried Amniotic Membrane (FD-AM) was placed over the particulate bone grafted implant site following Stage I implant surgery. The membrane was trimmed and adapted to cover the grafted area, serving as a barrier membrane for guided bone regeneration and promoting soft tissue healing during the postoperative period.

DEVICE

Collagen Membrane (CM)

Collagen Membrane (CM) was placed over the particulate bone grafted implant site following Stage I implant surgery. The membrane was trimmed and adapted to cover the grafted area, serving as a barrier membrane for guided bone regeneration and supporting soft tissue healing during the postoperative period.

Locations (1)

Rajas Dental College and Hospital

Kavalkinaru, Tamil Nadu, India