NCT07647120

Brief 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 Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

June 19, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 27, 2026

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 18, 2026

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 15, 2026

Completed
Last Updated

June 15, 2026

Status Verified

June 1, 2026

Enrollment Period

7 months

First QC Date

June 6, 2026

Last Update Submit

June 10, 2026

Conditions

Peri-implant Soft Tissue Healing

Keywords

Freeze-dried amniotic membraneCollagen membraneDental implantsEarly Healing ScoreVisual Analog ScaleAmniotic MembraneCollagen Barrier Membrane

Outcome Measures

Primary Outcomes (1)

  • Early Healing Score

    Assessment and comparison of soft tissue healing around bone-grafted implant sites covered with Freeze-Dried Amniotic Membrane (FD-AM) and Collagen Membrane (CM) following Stage I implant surgery using the Early Healing Score (EHS). The EHS evaluates wound healing based on three clinical parameters: Clinical Signs of Re-epithelialization (CSR): 0 = visible distance between incision margins; 3 = incision margins in contact; 6 = merged incision margins. Clinical Signs of Haemostasis (CSH): 0 = bleeding at incision margins; 1 = presence of fibrin ; 2 = absence of fibrin. Clinical Signs of Inflammation (CSI): 0 = redness involving \>50% of incision length and/or pronounced swelling; 1 = redness involving \<50% of incision length; 2 = absence of redness along incision length. The EHS is calculated as the sum of CSR, CSH, and CSI scores , where 0 represents the poorest healing and 10 represents ideal wound healing. Higher scores indicate better soft tissue healing outcomes.

    1 week and 2 weeks

Secondary Outcomes (1)

  • Postoperative Pain Assessment Using Visual Analogue Scale (VAS)

    1 week and 2 weeks

Study Arms (2)

Freeze-Dried Amniotic Membrane (FD-AM) Group

EXPERIMENTAL

Participants underwent Stage I implant surgery with particulate bone grafting at the implant site. Following graft placement, a Freeze-Dried Amniotic Membrane (FD-AM) was adapted and placed over the grafted area to facilitate guided bone regeneration and enhance soft tissue healing. Postoperative healing was evaluated using the Early Healing Score (EHS) and Visual Analogue Scale (VAS).

Device: Freeze-Dried Amniotic Membrane (FD-AM)

Collagen Membrane (CM) Group

EXPERIMENTAL

Participants underwent Stage I implant surgery with particulate bone grafting at the implant site. Following graft placement, a Collagen Membrane (CM) was adapted and placed over the grafted area to facilitate guided bone regeneration and support soft tissue healing. Postoperative healing was evaluated using the Early Healing Score (EHS) and Visual Analogue Scale (VAS).

Device: Collagen Membrane (CM)

Interventions

Freeze-Dried Amniotic Membrane (FD-AM)DEVICE

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.

Also known as: Amniotic Membrane FD-AM
Freeze-Dried Amniotic Membrane (FD-AM) Group
Collagen Membrane (CM)DEVICE

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.

Also known as: Collagen Barrier Membrane CM
Collagen Membrane (CM) Group

Eligibility Criteria

Age25 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Adults aged 25-55 years.
  • Male and female participants.
  • Bilateral posterior maxillary edentulous area in the premolar region (Bedrossian Zone 2 classification).
  • Patients with teeth requiring extraction and eligible for immediate implant placement in the bilateral posterior maxillary region.
  • Patients with ridge defects classified as Siebert Class II or Class III and eligible for delayed implant placement in the bilateral posterior maxillary region.

You may not qualify if:

  • Current smokers.
  • History of systemic diseases affecting bone turnover, including hyperthyroidism (T4 outside 5.0-12.0 μg/dL or T3 outside 80-220 ng/dL), Type I diabetes mellitus (HbA1c \> 6%), Cushing's disease, or hyperlipidemia.
  • Pregnant women.
  • Lactating mothers.
  • Presence of periodontal disease.
  • Known allergy to study materials or medications.
  • Blood-borne infectious diseases, including HIV or HBsAg positivity.
  • Vitamin D level \< 30 ng/mL.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rajas Dental College and Hospital

Kavalkinaru, Tamil Nadu, 627105, India

Location

Related Publications (2)

  • Velez I, Parker WB, Siegel MA, Hernandez M. Cryopreserved amniotic membrane for modulation of periodontal soft tissue healing: a pilot study. J Periodontol. 2010 Dec;81(12):1797-804. doi: 10.1902/jop.2010.100060. Epub 2010 Jul 14.

    PMID: 20629549BACKGROUND

  • Agrawal E, Chopra R, Gupta SJ, Sharma N, Khan F, Gupta N. Comparative evaluation of the efficacy of amniotic membrane with collagen membrane along with demineralized freeze-dried bone allograft in the treatment of periodontal intrabony defects - A clinico-radiographic study. J Indian Soc Periodontol. 2022 Sep-Oct;26(5):458-464. doi: 10.4103/jisp.jisp_305_21. Epub 2022 Sep 1.

    PMID: 36339389BACKGROUND

Related Links

Study Officials

  • Alex M Muruppel, MDS

    RAJAS DENTAL COLLEGE AND HOSPITAL

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Soft tissue healing was assessed by a blinded independent examiner who was unaware of the allocation of Freeze-Dried Amniotic Membrane and Collagen Membrane at the implant sites.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: This study employed a randomized split-mouth crossover design in which each participant contributed two bilateral posterior implant sites. Following implant placement and particulate bone grafting, one site received Freeze-Dried Amniotic Membrane (FD-AM) and the contralateral site received Collagen Membrane (CM) according to a simple coin-toss randomization protocol. This design allowed each participant to serve as their own control, minimizing inter-individual variability and enabling direct comparison of soft tissue healing and postoperative pain outcomes between the two membrane types.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2026

First Posted

June 15, 2026

Study Start

June 19, 2025

Primary Completion

January 27, 2026

Study Completion

February 18, 2026

Last Updated

June 15, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Individual Participant Data (IPD) will not be shared because the study was conducted as part of an academic postgraduate research project, and no formal data-sharing plan was established. Participant confidentiality and privacy will be maintained in accordance with institutional ethics requirements.

Locations

IN(1)