NCT07327047

Brief Summary

The aim of this interventional study is to evaluate the best method to place the autogenous soft tissue grafts for primary closure over immediately-placed dental implants. \- Primary hypothesis, there is no differences between the two techniques of placement.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

November 1, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 26, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 8, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

5 months

First QC Date

December 26, 2025

Last Update Submit

April 20, 2026

Conditions

Marginal Bone LossSoft Tissue Augmentation at Dental Implants

Keywords

Implantology, Buccal Fat Pad, Immediate Implant, Palatal Gingival Graft, Socket Seal, Soft tissue graft, Posterior Maxilla

Outcome Measures

Primary Outcomes (1)

  • Marginal Bone Loss

    Marginal Bone Loss around immediately-placed dental implants will be measured in millimeters on cross-sectional view of CBCT

    6 months postoperative

Secondary Outcomes (1)

  • Soft Tissue Healing

    At insertion of the prosthetic part (T0) After 2-month post-insertion of the prosthetic part

Study Arms (2)

Free autogenous soft tissue graft that will be placed without split thickness flaps

OTHER

Included 10 immediately-placed dental implants with free autogenous soft tissue graft that were placed without split thickness flaps.

Procedure: Free autogenous soft tissue grafts

Free autogenous soft tissue graft that will be placed within the prepared split thickness flaps

OTHER

Included 10 immediately-placed dental implants with free autogenous soft tissue graft that were placed within the prepared split thickness flaps

Procedure: Free autogenous soft tissue grafts

Interventions

Free autogenous soft tissue graftsPROCEDURE

Free autogenous soft tissue grafts (Buccal Pad Fat and Palatal Gingival Graft) that will be placed over immediately-placed dental implants

Free autogenous soft tissue graft that will be placed within the prepared split thickness flapsFree autogenous soft tissue graft that will be placed without split thickness flaps

Eligibility Criteria

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

You may qualify if:

  • Good oral hygiene.
  • Medically free from systemic diseases that actually contraindicate implant surgery.
  • Patient cooperation.
  • The presence of the intact walls of the socket after tooth extraction.

You may not qualify if:

  • General contraindications for dental and/or surgical treatments.
  • Concurrent or previous radiotherapy of head area.
  • Smoking.
  • Pregnancy.
  • Patients refused the procedure.

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
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 26, 2025

First Posted

January 8, 2026

Study Start

November 1, 2025

Primary Completion

April 1, 2026

Study Completion

May 1, 2026

Last Updated

April 23, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)