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Apical Flap Repositioning vs. Mucosa Excision With Free Gingival Grafts for Peri-Implant Keratinized Mucosa Augmentation

NCT07772414 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2026-08-19

No results posted yet for this study

Summary

The goal of this clinical trial is to learn which surgical technique works better to increase the amount of firm gum tissue (called keratinized mucosa) around dental implants in adults.

The main question it aims to answer is:

-Does repositioning the gum flap upward with stitches lead to a greater gain in firm gum tissue width at 6 months compared to simply removing the extra gum tissue, when both techniques are combined with a free gum graft?

Researchers will compare two techniques used during the second stage of implant surgery to see which one produces a greater gain in firm gum tissue around the implant.

Participants will:

* Receive a free gum graft (a small piece of tissue taken from the roof of the mouth) placed around their dental implant during a routine surgical visit
* Be randomly assigned to one of the two surgical techniques
* Have digital scans of their mouth taken at 5 timepoints over 6 months
* Complete a pain diary and answer questions about their experience during the first week after surgery
* Attend follow-up visits at 6 weeks, 3 months, and 6 months after surgery

Conditions

  • Keratinized Mucosa Deficiency
  • Peri-implant Soft Tissue
  • Dental Implants

Interventions

PROCEDURE

Free gingival graft with apical flap repositioning

Autologous free gingival graft harvested from the palate and placed at the recipient site. The vestibular mucosal flap is repositioned apically and sutured to the periosteum during second-stage implant surgery.

PROCEDURE

Free gingival graft with vestibular mucosa excision

Autologous free gingival graft harvested from the palate and placed at the recipient site. The vestibular mucous tissue is excised during second-stage implant surgery.

Sponsors & Collaborators

  • Universidad Complutense de Madrid

    collaborator OTHER

  • University of Barcelona

    lead OTHER

Principal Investigators

  • Octavi Camps Font · University of Barcelona

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2028-09-30
Completion
2029-03-30

Countries

  • Spain

Study Locations

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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 NCT07772414 on ClinicalTrials.gov