NCT07573020

Brief Summary

To evaluate soft tissue augmentation using acellular dermal matrix (ADM) over immediately placed dental implants in anterior maxilla.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2025

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

April 1, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 1, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 7, 2026

Completed
Last Updated

May 7, 2026

Status Verified

May 1, 2026

Enrollment Period

8 months

First QC Date

May 1, 2026

Last Update Submit

May 1, 2026

Conditions

Immediate Dental Implant PlacementDental ImplantAcellular Dermal MatrixPolytetrafluoroethyleneSoft Tissue Augmentation at Dental Implants

Keywords

Acellular Dermal MatrixImmediate Dental ImplantsSoft-tissue augmentationTissue Phenotyped-PTFE

Outcome Measures

Primary Outcomes (1)

  • Peri-implant soft-tissue phenotype

    A standardized periodontal probe was used to clinically measure the keratinized mucosal width, supracrestal tissue height, and mucosal thickness. They were measured in millimeters (mm)

    Six months following implant placement

Study Arms (2)

Control Group

EXPERIMENTAL

Immediately placed dental implants with high-density polytetrafluorethylene membrane coverage

Procedure: Polytetrafluoroethylene coverage

Test Group

EXPERIMENTAL

Immediately placed dental implants with acellular dermal matrix allograft coverage

Procedure: Acellular Dermal Matrix

Interventions

Polytetrafluoroethylene coveragePROCEDURE

The socket with immediately placed dental implant was covered with a d-PTFE membrane cut to fit the surgical site

Control Group
Acellular Dermal MatrixPROCEDURE

The socket with immediately placed dental implant was covered with ADM that was inserted into facial and palatal split thickness pouches.

Test Group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with non-restorable maxillary anterior tooth/teeth.
  • Good oral hygiene.
  • Patients' cooperation and fully capable to comply with the study protocol.
  • Age ranges from 18 to 45 years.
  • Free from history of parafunctional habits e.g. clenching and bruxism
  • Sufficient inter- arch space.

You may not qualify if:

  • Any local pathological condition that contraindicates implant placement.
  • Pregnancy.
  • Medication that affects bone healing.
  • Psychological problems.
  • Patient had undergone radiation therapy to the head and neck area in the past 12 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry - Mansoura University

Al Mansurah, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2026

First Posted

May 7, 2026

Study Start

April 1, 2025

Primary Completion

December 1, 2025

Study Completion

March 1, 2026

Last Updated

May 7, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)