Clinical Trial

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

Study acronym: FDAM-CM
Completed
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.
Trial Details
NCT Number NCT07647120
Lead Sponsor RAJAS DENTAL COLLEGE AND HOSPITAL
Conditions Peri-implant Soft Tissue Healing
Enrollment 10 participants
Start Date 2025-06-19
Primary Completion 2026-01-27 (estimated)
Study Completion 2026-02-18 (estimated)
Updated on ClinicalTrials.gov 2026-06-15