Keratinized Mucosa DeficiencyFGGIFNCT07772414
Apical Flap Repositioning vs. Mucosa Excision With Free Gingival Grafts for Peri-Implant Keratinized Mucosa Augmentation
A study testing Free gingival graft with apical flap repositioning and Free gingival graft with vestibular mucosa excision in people with Keratinized Mucosa Deficiency and Peri-implant Soft Tissue, run by University of Barcelona at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Keratinized Mucosa Deficiency, Peri-implant Soft Tissue, Dental Implants
- What is being tested?
- Free gingival graft with apical flap repositioning and Free gingival graft with vestibular mucosa excision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 30 Sep 2026to 30 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Prof. Dr. contact
Spain1 site
Hospital Odontològic Universitat de Barcelona, L'Hospitalet de Llobregat,
Barcelona, Barcelona, 08907
Octavi Camps Font DDS MS PhD, +34 934 024 269, ocamps@ub.edu
About this study
Official title: Multicenter Randomized Clinical Trial Comparing Apical Flap Repositioning Versus Vestibular Mucosa Excision Associated With Free Gingival Grafts for Peri-Implant Keratinized Mucosa Augmentation
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:
Read more
-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
Read the detailed description
This superiority multicenter randomized clinical trial is coordinated by the Universitat de Barcelona (UB) and includes the Universidad Complutense de Madrid (UCM) as a collaborating center.
Participant selection Adults with osseointegrated implants in the posterior maxilla or mandible presenting keratinized mucosa width of 2 mm or less and/or vestibular depth less than 4 mm will be screened for eligibility. Participants must be in periodontal and peri-implant health and have a plaque index of 15% or less.
Randomization Eligible participants will be randomly assigned (1:1) to one of two treatment groups using an Interactive Web Response System (IWRS) provided by Sealed Envelope Ltd. Randomization will take place intraoperatively, once the partial-thickness mucosal flap has been prepared.
Interventions
Group 1 (Control): Free gingival graft with apical repositioning and suturing of the vestibular mucosal flap to the periosteum Group 2 (Experimental): Free gingival graft with excision of the vestibular mucous tissue
Outcome assessment Soft tissue changes will be assessed at 5 timepoints (T0, Tim, T6w, T3m, T6m) using intraoral scans (TRIOS 3®, 3Shape) analyzed with Geomagic Control X® software through three-dimensional digital superimposition. Clinical measurements will also be performed using a calibrated periodontal probe and a customized thermoplastic stent to standardize the measurement point across visits.
Participants will complete a pain diary during the first 7 postoperative days recording pain intensity (100 mm visual analogue scale), analgesic consumption, and days with limited activity.
Sample size A total of 46 participants (23 per group) are required, accounting for a minimum clinically relevant difference of 1 mm in KTW gain, a standard deviation of 1.3 mm, 80% statistical power, 5% significance level, an intraclass correlation coefficient of 0.30 for multiple implants per patient, and a 15% dropout rate.
Statistical analysis The primary outcome will be analyzed in the intention-to-treat population using a generalized linear mixed model (GLMM), with patient as a random effect, adjusted for baseline KTW and study center.
- Being tested
- Free gingival graft with apical flap repositioning, Free gingival graft with vestibular mucosa excision
- Keywords
- Free gingival graft, Keratinized mucosa, Peri-implant mucosa, Second-stage implant surgery, Apical flap repositioning, Vestibuloplasty, Soft tissue augmentation, Intraoral scanner
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Free gingival graft with apical flap repositioningProcedure or surgery
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.
Free gingival graft with vestibular mucosa excisionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Free gingival graft with vestibular mucosa excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline (T0) to 6 months (T6m)
Secondary outcomes (13)
Clinical gain in peri-implant keratinized tissue width (KTW)
Absolute change in KTW, measured clinically with a calibrated periodontal probe using a customized thermoplastic stent.
Measured: Baseline (T0) to 6 months (T6m)
Change in graft height
Change in graft height, measured in millimeters (mm), between immediate postoperative and 6 months, assessed by 3D digital superimposition.
Measured: Immediate postoperative (Tim), 6 weeks (T6w), 3 months (T3m), 6 months (T6m)
Change in graft width
Change in graft width, measured in millimeters (mm), between immediate postoperative and 6 months, assessed by 3D digital superimposition.
Measured: Immediate postoperative (Tim), 6 weeks (T6w), 3 months (T3m), 6 months (T6m)
Graft area contraction
Percentage of graft area reduction between immediate postoperative and 6 months, assessed by 3D digital superimposition.
Measured: Immediate postoperative (Tim) to 6 months (T6m)
Change in graft volume
Change in graft volume, measured in cubic millimeters (mm³), between immediate postoperative and 6 months, assessed by 3D digital superimposition.
Measured: Immediate postoperative (Tim), 6 weeks (T6w), 3 months (T3m), 6 months (T6m)
Vestibular depth
Change in vestibular depth from baseline to 6 months, assessed both digitally and clinically.
Measured: Baseline (T0) to 6 months (T6m)
Surgical time
Time in minutes from anesthesia administration to placement of the last suture.
Measured: Intraoperative (Tim)
Adverse events
Incidence and nature of postoperative adverse events related to the free gingival graft procedure.
Measured: Immediate postoperative (Tim) to 6 months (T6m)
Clinician-perceived surgical difficulty
Degree of surgical difficulty perceived by the clinician at the end of the procedure, evaluated using a 100 mm visual analogue scale (0 = no difficulty, 100 = maximum imaginable difficulty).
Measured: Intraoperative (Tim)
Postoperative pain
Pain intensity recorded at the end of the procedure and at 2, 6, 12 and 24 hours, and daily for 7 days, using a 100 mm visual analogue scale (0 = no pain, 100 = worst imaginable pain).
Measured: Up to 7 days postoperat
Analgesic consumption
Number of doses of ibuprofen 600 mg and paracetamol 1 g consumed during the first 7 postoperative days.
Measured: Up to 7 days postoperative
Patient global satisfaction
Overall satisfaction with the intervention evaluated at 7 days postoperative using a 100 mm visual analogue scale (0 = completely dissatisfied, 100 = completely satisfied).
Measured: 7 days postoperative
Days with limitation of daily activity
Number of days with total or partial limitation of usual daily activity during the first 7 postoperative days.
Measured: Up to 7 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start30 Sep 2026 (estimated)
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Keratinized Mucosa DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two parallel groups with 1:1 allocation ratio. Each participant is assigned to one treatment group only and followed for 6 months.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Complutense de Madrid
- Responsible party
- Principal investigator, Octavi Camps-Font, University of Barcelona
- Investigators
- Octavi Camps Font, Study director, University of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07772414
- Sponsor's protocol ID
- 26/2026
- Acronym
- FGGIF
- Status last verified
- Sep 2026
- First submitted
- 3 Aug 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomized Clinical Trial Comparing Apical Flap Repositioning Versus Vestibular Mucosa Excision Associated With Free Gingival Grafts for Peri-Implant Keratinized Mucosa Augmentation
- ClinicalTrials.gov ID
- NCT07772414
- Acronym / sponsor ID
- FGGIF / 26/2026
- Keywords
- Free gingival graft, Keratinized mucosa, Peri-implant mucosa, Second-stage implant surgery, Apical flap repositioning, Vestibuloplasty, Soft tissue augmentation, Intraoral scanner
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of BarcelonaUniversity, hospital or other
- Collaborators
- Universidad Complutense de Madrid
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Mar 2029 (estimated)
- First posted
- 19 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This superiority multicenter randomized clinical trial is coordinated by the Universitat de Barcelona (UB) and includes the Universidad Complutense de Madrid (UCM) as a collaborating center.
Participant selection Adults with osseointegrated implants in the posterior maxilla or mandible presenting keratinized mucosa width of 2 mm or less and/or vestibular depth less than 4 mm will be screened for eligibility. Participants must be in periodontal and peri-implant health and have a plaque index of 15% or less.
Randomization Eligible participants will be randomly assigned (1:1) to one of two treatment groups using an Interactive Web Response System (IWRS) provided by Sealed Envelope Ltd. Randomization will take place intraoperatively, once the partial-thickness mucosal flap has been prepared.
Interventions
Group 1 (Control): Free gingival graft with apical repositioning and suturing of the vestibular mucosal flap to the periosteum Group 2 (Experimental): Free gingival graft with excision of the vestibular mucous tissue
Outcome assessment Soft tissue changes will be assessed at 5 timepoints (T0, Tim, T6w, T3m, T6m) using intraoral scans (TRIOS 3®, 3Shape) analyzed with Geomagic Control X® software through three-dimensional digital superimposition. Clinical measurements will also be performed using a calibrated periodontal probe and a customized thermoplastic stent to standardize the measurement point across visits.
Participants will complete a pain diary during the first 7 postoperative days recording pain intensity (100 mm visual analogue scale), analgesic consumption, and days with limited activity.
Sample size A total of 46 participants (23 per group) are required, accounting for a minimum clinically relevant difference of 1 mm in KTW gain, a standard deviation of 1.3 mm, 80% statistical power, 5% significance level, an intraclass correlation coefficient of 0.30 for multiple implants per patient, and a 15% dropout rate.
Statistical analysis The primary outcome will be analyzed in the intention-to-treat population using a generalized linear mixed model (GLMM), with patient as a random effect, adjusted for baseline KTW and study center.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two parallel groups with 1:1 allocation ratio. Each participant is assigned to one treatment group only and followed for 6 months.
| Arm | Type | Receives |
|---|---|---|
| Apical Flap Repositioning | Active comparator | Procedure: Free gingival graft with apical flap repositioningFree gingival graft with apical repositioning and suturing of the vestibular mucosal flap to the periosteum during second-stage implant surgery. |
| Vestibular Mucosa Excision | Experimental | Procedure: Free gingival graft with vestibular mucosa excisionFree gingival graft with excision of the vestibular mucous tissue during second-stage implant surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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%.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Free gingival graft with apical flap repositioningAutologous 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 or surgery | Apical Flap Repositioning |
| Free gingival graft with vestibular mucosa excisionAutologous free gingival graft harvested from the palate and placed at the recipient site. The vestibular mucous tissue is excised during second-stage implant surgery. | Procedure or surgery | Vestibular Mucosa Excision |
Primary outcome
Peri-implant keratinized tissue width (KTW) gain
Time frame: Baseline (T0) to 6 months (T6m)
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).
13 secondary outcomes
Clinical gain in peri-implant keratinized tissue width (KTW)
Time frame: Baseline (T0) to 6 months (T6m)
Change in graft height
Time frame: Immediate postoperative (Tim), 6 weeks (T6w), 3 months (T3m), 6 months (T6m)
Change in graft width
Time frame: Immediate postoperative (Tim), 6 weeks (T6w), 3 months (T3m), 6 months (T6m)
Graft area contraction
Time frame: Immediate postoperative (Tim) to 6 months (T6m)
Change in graft volume
Time frame: Immediate postoperative (Tim), 6 weeks (T6w), 3 months (T3m), 6 months (T6m)
Vestibular depth
Time frame: Baseline (T0) to 6 months (T6m)
Surgical time
Time frame: Intraoperative (Tim)
Adverse events
Time frame: Immediate postoperative (Tim) to 6 months (T6m)
Clinician-perceived surgical difficulty
Time frame: Intraoperative (Tim)
Postoperative pain
Time frame: Up to 7 days postoperat
Analgesic consumption
Time frame: Up to 7 days postoperative
Patient global satisfaction
Time frame: 7 days postoperative
Days with limitation of daily activity
Time frame: Up to 7 days postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Hospital Odontològic Universitat de BarcelonaLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Keratinized Mucosa Deficiency
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Adjunctive Keratinized Mucosa Augmentation in Peri-Implantitis
Peri-implantitis, Soft Tissue Augmentation at Dental Implants
Recruiting
Non-Submerged De-Epithelialized Free Gingival Graft Versus Conventional Free Gingival Graft
Deficient Keratinized Mucosa
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Prof. Dr. contact
Octavi Camps Font study director
University of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Free gingival graft with apical flap repositioning and Free gingival graft with vestibular mucosa excision in people with Keratinized Mucosa Deficiency and Peri-implant Soft Tissue, run by University of Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Octavi Camps-Font, DDS MS PhD (+34 934 024 269, ocamps@ub.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peri-implant keratinized tissue width (KTW) gain (time frame: Baseline (T0) to 6 months (T6m)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.