MedTrace Logo

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

NCT07647120 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-06-15

No results posted yet for this study

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.

Conditions

  • Peri-implant Soft Tissue Healing

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.

Sponsors & Collaborators

  • RAJAS DENTAL COLLEGE AND HOSPITAL

    lead OTHER

Principal Investigators

  • Alex M Muruppel, MDS · RAJAS DENTAL COLLEGE AND HOSPITAL

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
25 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-19
Primary Completion
2026-01-27
Completion
2026-02-18

Countries

  • India

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07647120 on ClinicalTrials.gov