NCT07772414

Brief 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

Trial Health

63
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Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
30mo left

Started Sep 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet 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

First Submitted

Initial submission to the registry

August 3, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 19, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

September 30, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2029

Last Updated

September 29, 2026

Status Verified

September 1, 2026

Enrollment Period

2 years

First QC Date

August 3, 2026

Last Update Submit

September 26, 2026

Conditions

Keratinized Mucosa DeficiencyPeri-implant Soft TissueDental Implants

Keywords

Free gingival graftKeratinized mucosaPeri-implant mucosaSecond-stage implant surgeryApical flap repositioningVestibuloplastySoft tissue augmentationIntraoral scanner

Outcome Measures

Primary Outcomes (1)

  • Peri-implant keratinized tissue width (KTW) gain

    Absolute change in KTW, measured digitally as the linear distance between the mucosal margin and the mucogingival junction on the vestibular aspect of the implant, using Geomagic Control X® software on intraoral scan models (TRIOS 3®, 3Shape).

    Baseline (T0) to 6 months (T6m)

Secondary Outcomes (13)

  • Clinical gain in peri-implant keratinized tissue width (KTW)

    Baseline (T0) to 6 months (T6m)

  • Change in graft height

    Immediate postoperative (Tim), 6 weeks (T6w), 3 months (T3m), 6 months (T6m)

  • Change in graft width

    Immediate postoperative (Tim), 6 weeks (T6w), 3 months (T3m), 6 months (T6m)

  • Graft area contraction

    Immediate postoperative (Tim) to 6 months (T6m)

  • Change in graft volume

    Immediate postoperative (Tim), 6 weeks (T6w), 3 months (T3m), 6 months (T6m)

  • +8 more secondary outcomes

Study Arms (2)

Apical Flap Repositioning

ACTIVE COMPARATOR

Free gingival graft with apical repositioning and suturing of the vestibular mucosal flap to the periosteum during second-stage implant surgery.

Procedure: Free gingival graft with apical flap repositioning

Vestibular Mucosa Excision

EXPERIMENTAL

Free gingival graft with excision of the vestibular mucous tissue during second-stage implant surgery.

Procedure: Free gingival graft with vestibular mucosa excision

Interventions

Free gingival graft with apical flap repositioningPROCEDURE

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.

Apical Flap Repositioning
Free gingival graft with vestibular mucosa excisionPROCEDURE

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.

Vestibular Mucosa Excision

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men or women aged 18 years or older who voluntarily agree to sign the informed consent form before any study-related procedure is performed.
  • Single or multiple edentulous spaces (≤3 units) located in the posterior maxilla or mandible, presenting osseointegrated implants in first-stage surgery with a -healing period of more than 8 weeks.
  • ASA classification I or II.
  • Periodontal and peri-implant health.
  • O'Leary plaque index ≤15%.
  • Keratinized mucosa width ≤2 mm and/or vestibular depth \<4 mm at at least one site.
  • Commitment to attend all follow-up visits over 6 months.

You may not qualify if:

  • Systemic diseases that may interfere with performing FGG (free gingival graft), including but not limited to: poorly controlled diabetes mellitus (HbA1c \> 8% or per clinical judgment), immunodeficiencies or immunosuppressive treatment, uncontrolled hematological diseases or coagulation disorders, anticoagulant or antiplatelet treatment that cannot be adjusted according to standard clinical practice, active neoplasms under treatment, severe renal or hepatic insufficiency, decompensated cardiovascular diseases, and any other medical condition that, in the investigator's judgment, could compromise participant safety or proper tissue healing.
  • Any contraindication to oral surgical procedures.
  • Periodontal and peri-implant health as defined by the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions.
  • Patients who smoke tobacco or equivalent products, as well as former smokers with an abstinence period ≤12 months.
  • History of substance abuse (drugs or alcohol) or any other factor (e.g., severe psychiatric illness) that, in the investigator's opinion, could interfere with the patient's ability to cooperate and comply with the study.
  • Patients who have participated in a clinical trial within the last 30 days.
  • Pregnant or breastfeeding women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Odontològic Universitat de Barcelona, L'Hospitalet de Llobregat,

Barcelona, Barcelona, 08907, Spain

Location

Related Links

Study Officials

  • Octavi Camps Font

    University of Barcelona

    STUDY DIRECTOR

Central Study Contacts

Octavi Camps-Font, DDS MS PhD

CONTACT

+34 934 024 269ocamps@ub.edu

Prof. Dr.

CONTACT

ocamps@ub.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Although full masking is not feasible due to the surgical nature of the interventions, the digital analysis of intraoral scan models will be performed by a single calibrated evaluator who will be blinded to group allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two parallel groups with 1:1 allocation ratio. Each participant is assigned to one treatment group only and followed for 6 months.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 3, 2026

First Posted

August 19, 2026

Study Start

September 30, 2026

Primary Completion (Estimated)

September 30, 2028

Study Completion (Estimated)

March 30, 2029

Last Updated

September 29, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)