Peri-implantitisNCT07471386
Adjunctive Keratinized Mucosa Augmentation in Peri-Implantitis
A study testing Submucosal debridman + saline irrigation and Free gingival graft surgery in people with Peri-implantitis and Soft Tissue Augmentation at Dental Implants, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to increase the width and thickness of peri-implant keratinized mucosa (KM) by transferring a properly dimensioned free gingival graft (FGG) from the palatal donor site and to evaluate its effect as an adjunctive approach to non-surgical peri-implantitis therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Peri-implantitis, Soft Tissue Augmentation at Dental Implants
- What is being tested?
- Submucosal debridman + saline irrigation and Free gingival graft surgery
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2026to 1 Jun 2027
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Non-smoker
- Systemically healthy
- Keratinized mucosa witdh < 2 mm
Who cannot join
- İntake of medications that impede periodontal tissue health and healing
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gazi University Faculty of Dentistry
Ankara
About this study
Official title: Impact of Keratinized Mucosa Augmentation as an Adjunct to Non-Surgical Therapy in the Management of Peri-Implantitis
This study aims to increase the width and thickness of peri-implant keratinized mucosa (KM) by transferring a properly dimensioned free gingival graft (FGG) from the palatal donor site and to evaluate its effect as an adjunctive approach to non-surgical peri-implantitis therapy. The procedure is indicated for patients diagnosed with peri-implantitis who present with an inadequate KM (midbuccal KM height < 2 mm). One month after non-surgical therapy, patients in the test group will undergo keratinized mucosa augmentation using an FGG, while patients in the control group will continue with supportive periodontal therapy and regular follow-up visits. The primary outcome measure of the study is the change in probing depth (PD) at 12 months following peri-implantitis treatment.
Read the detailed description
Background and Case Definition
Peri-implantitis is a disease that typically develops from peri-implant mucositis, an inflammatory condition affecting the soft tissues surrounding dental implants. If left untreated, peri-implant mucositis may progress to peri-implantitis, leading to loss of supporting hard and soft tissues. Clinical signs of peri-implantitis include bleeding on probing (BoP), erythema of the peri-implant mucosa, suppuration, and increased probing depths (PD ≥ 5 mm). The presence of peri-implant bone loss on radiographic examination is a key diagnostic criterion for peri-implantitis.
Although increased width and thickness of keratinized mucosa have been suggested to support peri-implant tissue stability, their role in maintaining peri-implant health and improving the response to peri-implantitis therapy remains controversial. Given the ongoing debate regarding the role of keratinized mucosa dimensions in modulating the response to non-surgical peri-implantitis therapy, further clinical evidence is warranted.
The hypothesis of this study is that adjunctive keratinized mucosa augmentation following non-surgical peri-implantitis therapy results in improved clinical outcomes compared to non-surgical treatment alone. Therefore, the aim of this study was to investigate whether adjunctive keratinized mucosa augmentation improves clinical and radiographic outcomes compared to non-surgical peri-implantitis therapy alone.
Study Population Inclusion Criteria
Systemically healthy adults (≥18 years of age)
Implant-supported restorations in function for at least one year prior to enrollment
Exclusion Criteria
Systemic conditions potentially affecting wound healing or treatment outcomes (e.g., uncontrolled diabetes, active cancer therapy)
Use of medications within the previous three months that could influence healing or inflammation (e.g., anticoagulants, antiplatelet agents, antibiotics, corticosteroids)
Pregnancy or lactation
Smoking ≥10 cigarettes/day
Untreated periodontitis
Malpositioned implants
Previous soft tissue grafting procedures at the implant site
Treatment Protocol
All patients will receive initial non-surgical peri-implantitis therapy, including mechanical debridement of the implant surface using titanium curettes and resin ultrasonic tips, along with saline irrigation for surface decontamination. Oral hygiene instructions will be reinforced in all patients.
In the test group, a free gingival graft procedure will be performed 4-6 weeks after completion of non-surgical therapy to increase the width and thickness of keratinized mucosa.
In the control group, no surgical intervention will be performed following non-surgical therapy, and patients will continue with supportive peri-implant care.
Clinical Parameters
All clinical parameters will be recorded by a calibrated examiner at predefined evaluation time points.
- Plaque Index (PI) Plaque accumulation will be assessed using the Plaque Index described by O'Leary et al. (1972). The presence or absence of plaque will be recorded at six sites per implant (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual). The plaque index will be expressed as a percentage of sites with visible plaque relative to the total number of assessed sites.
- Probing Depth (PD) Probing pocket depth will be measured using a William's periodontal probe, positioned parallel to the long axis of the implant. Measurements will be obtained at six sites per implant (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual). The mean value of the six measurements will be calculated and used as the representative PPD value for each implant.
- Bleeding on Probing (BoP) Bleeding on probing will be assessed according to the criteria proposed by Ainamo and Bay (1975). Following gentle probing of the peri-implant sulcus, bleeding will be recorded as present (+) or absent (-) at six sites per implant. BoP will be expressed as the percentage of bleeding-positive sites.
- Width of Keratinized Mucosa (Mid-Buccal) The width of keratinized mucosa will be measured in millimeters at the mid-buccal aspect of each implant. Measurements will be taken from the peri-implant soft tissue margin to the mucogingival junction, encompassing both the free and attached keratinized mucosa.
- Thickness of Keratinized Mucosa (Mid-Buccal) Keratinized mucosa thickness will be assessed using a K-type endodontic file with a silicone stopper. The file will be gently inserted perpendicular to the mucosal surface at the mid-buccal aspect until bone contact is reached. The penetration depth will then be measured using a digital caliper.
- Vestibular Depth (Mid-Buccal) Vestibular depth will be measured at the mid-buccal aspect of the implant site as the vertical distance from the mucogingival junction to the deepest point of the vestibule. This measurement aims to assess changes in vestibular morphology potentially associated with soft tissue augmentation procedures.
- Mucosal Recession (MR)
Peri-implant mucosal recession will be measured as the linear distance (in millimeters) from a fixed reference point on the implant-supported restoration (e.g., the crown margin or implant shoulder) to the most coronal level of the peri-implant soft tissue margin at the mid-buccal aspect. Positive values will indicate apical displacement of the mucosal margin.
- Being tested
- Submucosal debridman + saline irrigation, Free gingival graft surgery
- Keywords
- Peri-implantitis, Free gingival graft, Inflamation, Soft tissue deficiency
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Submucosal debridman + saline irrigationOther
Participants diagnosed with peri-implantitis and presenting with insufficient keratinized mucosa (width and thickness <2 mm) will first receive non-surgical peri-implant therapy. Mechanical debridement of the peri-implant surfaces will be performed using titanium curettes and implant-specific ultrasonic tips in order to remove bacterial biofilm without damaging the implant surface. Additionally, sterile saline solution will be used for submucosal irrigation after mechanical debridement. Patients will receive individualized oral hygiene instructions, including proper brushing techniques, and be suitable for implant-supported restorations.
Participants in this group will not receive any surgical or soft tissue grafting procedures.
Free gingival graft surgeryProcedure or surgery
Participants diagnosed with peri-implantitis and presenting with insufficient keratinized mucosa (width and thickness <2 mm) will first receive non-surgical peri-implant therapy. Mechanical debridement of the peri-implant surfaces will be performed using titanium curettes and implant-specific ultrasonic tips in order to remove bacterial biofilm without damaging the implant surface. Additionally, sterile saline solution will be used for submucosal irrigation after mechanical debridement. Patients will receive individualized oral hygiene instructions, including proper brushing techniques, and be suitable for implant-supported restorations.
In this group, a free gingival graft (FGG) will be harvested from the palatal donor site under local anesthesia after completion of non-surgical therapy and resolution of acute inflammation.FGG will be stabilized using interrupted or continuous sutures.
Participants will be followed for clinical and radiographic evaluations.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Non-surgical treatment of peri-implantitis alone Receives: Other: Submucosal debridman + saline irrigation |
| Test Group | Active comparator | Non-surgical treatment of perı-implantitis + Free gingival graft procedure Receives: Procedure: Free gingival graft surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PPD
Measured: Following at 12. months post-treatment
Secondary outcomes (4)
Bleeding on Probing
Measured: Following at 12. months post-treatment
Plaque index
Measured: Following at 12. months post-treatment
Keratinized mucosa width
Measured: Following at 12. months post-treatment
Keratinized mucosa thickness
Measured: Following at 12. months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start1 Mar 2026
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-implantitisStudies 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
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sıla Çağrı İşler, Gazi University
- Investigators
- Sila Cagri Isler, Prof Dr, Study director, Gazi University Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07471386
- Sponsor's protocol ID
- 2024-KAEK-07/063
- Status last verified
- Jan 2026
- First submitted
- 10 Mar 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Keratinized Mucosa Augmentation as an Adjunct to Non-Surgical Therapy in the Management of Peri-Implantitis
- ClinicalTrials.gov ID
- NCT07471386
- Acronym / sponsor ID
- 2024-KAEK-07/063
- Keywords
- Peri-implantitis, Free gingival graft, Inflamation, Soft tissue deficiency
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 13 Mar 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.
This study aims to increase the width and thickness of peri-implant keratinized mucosa (KM) by transferring a properly dimensioned free gingival graft (FGG) from the palatal donor site and to evaluate its effect as an adjunctive approach to non-surgical peri-implantitis therapy. The procedure is indicated for patients diagnosed with peri-implantitis who present with an inadequate KM (midbuccal KM height < 2 mm). One month after non-surgical therapy, patients in the test group will undergo keratinized mucosa augmentation using an FGG, while patients in the control group will continue with supportive periodontal therapy and regular follow-up visits. The primary outcome measure of the study is the change in probing depth (PD) at 12 months following peri-implantitis treatment.
Detailed description
Background and Case Definition
Peri-implantitis is a disease that typically develops from peri-implant mucositis, an inflammatory condition affecting the soft tissues surrounding dental implants. If left untreated, peri-implant mucositis may progress to peri-implantitis, leading to loss of supporting hard and soft tissues. Clinical signs of peri-implantitis include bleeding on probing (BoP), erythema of the peri-implant mucosa, suppuration, and increased probing depths (PD ≥ 5 mm). The presence of peri-implant bone loss on radiographic examination is a key diagnostic criterion for peri-implantitis.
Although increased width and thickness of keratinized mucosa have been suggested to support peri-implant tissue stability, their role in maintaining peri-implant health and improving the response to peri-implantitis therapy remains controversial. Given the ongoing debate regarding the role of keratinized mucosa dimensions in modulating the response to non-surgical peri-implantitis therapy, further clinical evidence is warranted.
The hypothesis of this study is that adjunctive keratinized mucosa augmentation following non-surgical peri-implantitis therapy results in improved clinical outcomes compared to non-surgical treatment alone. Therefore, the aim of this study was to investigate whether adjunctive keratinized mucosa augmentation improves clinical and radiographic outcomes compared to non-surgical peri-implantitis therapy alone.
Study Population Inclusion Criteria
Systemically healthy adults (≥18 years of age)
Implant-supported restorations in function for at least one year prior to enrollment
Exclusion Criteria
Systemic conditions potentially affecting wound healing or treatment outcomes (e.g., uncontrolled diabetes, active cancer therapy)
Use of medications within the previous three months that could influence healing or inflammation (e.g., anticoagulants, antiplatelet agents, antibiotics, corticosteroids)
Pregnancy or lactation
Smoking ≥10 cigarettes/day
Untreated periodontitis
Malpositioned implants
Previous soft tissue grafting procedures at the implant site
Treatment Protocol
All patients will receive initial non-surgical peri-implantitis therapy, including mechanical debridement of the implant surface using titanium curettes and resin ultrasonic tips, along with saline irrigation for surface decontamination. Oral hygiene instructions will be reinforced in all patients.
In the test group, a free gingival graft procedure will be performed 4-6 weeks after completion of non-surgical therapy to increase the width and thickness of keratinized mucosa.
In the control group, no surgical intervention will be performed following non-surgical therapy, and patients will continue with supportive peri-implant care.
Clinical Parameters
All clinical parameters will be recorded by a calibrated examiner at predefined evaluation time points.
- Plaque Index (PI) Plaque accumulation will be assessed using the Plaque Index described by O'Leary et al. (1972). The presence or absence of plaque will be recorded at six sites per implant (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual). The plaque index will be expressed as a percentage of sites with visible plaque relative to the total number of assessed sites.
- Probing Depth (PD) Probing pocket depth will be measured using a William's periodontal probe, positioned parallel to the long axis of the implant. Measurements will be obtained at six sites per implant (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual). The mean value of the six measurements will be calculated and used as the representative PPD value for each implant.
- Bleeding on Probing (BoP) Bleeding on probing will be assessed according to the criteria proposed by Ainamo and Bay (1975). Following gentle probing of the peri-implant sulcus, bleeding will be recorded as present (+) or absent (-) at six sites per implant. BoP will be expressed as the percentage of bleeding-positive sites.
- Width of Keratinized Mucosa (Mid-Buccal) The width of keratinized mucosa will be measured in millimeters at the mid-buccal aspect of each implant. Measurements will be taken from the peri-implant soft tissue margin to the mucogingival junction, encompassing both the free and attached keratinized mucosa.
- Thickness of Keratinized Mucosa (Mid-Buccal) Keratinized mucosa thickness will be assessed using a K-type endodontic file with a silicone stopper. The file will be gently inserted perpendicular to the mucosal surface at the mid-buccal aspect until bone contact is reached. The penetration depth will then be measured using a digital caliper.
- Vestibular Depth (Mid-Buccal) Vestibular depth will be measured at the mid-buccal aspect of the implant site as the vertical distance from the mucogingival junction to the deepest point of the vestibule. This measurement aims to assess changes in vestibular morphology potentially associated with soft tissue augmentation procedures.
- Mucosal Recession (MR)
Peri-implant mucosal recession will be measured as the linear distance (in millimeters) from a fixed reference point on the implant-supported restoration (e.g., the crown margin or implant shoulder) to the most coronal level of the peri-implant soft tissue margin at the mid-buccal aspect. Positive values will indicate apical displacement of the mucosal margin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Submucosal debridman + saline irrigationNon-surgical treatment of peri-implantitis alone |
| Test Group | Active comparator | Procedure: Free gingival graft surgeryNon-surgical treatment of perı-implantitis + Free gingival graft procedure |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Non-smoker
- Systemically healthy
- Keratinized mucosa witdh < 2 mm
Key exclusion criteria (2 listed)
- İntake of medications that impede periodontal tissue health and healing
- Pregnancy or lactation
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 |
|---|---|---|
| Submucosal debridman + saline irrigationParticipants diagnosed with peri-implantitis and presenting with insufficient keratinized mucosa (width and thickness <2 mm) will first receive non-surgical peri-implant therapy. Mechanical debridement of the peri-implant surfaces will be performed using titanium curettes and implant-specific ultrasonic tips in order to remove bacterial biofilm without damaging the implant surface. Additionally, sterile saline solution will be used for submucosal irrigation after mechanical debridement. Patients will receive individualized oral hygiene instructions, including proper brushing techniques, and be suitable for implant-supported restorations. Participants in this group will not receive any surgical or soft tissue grafting procedures. | Other | Control group |
| Free gingival graft surgeryParticipants diagnosed with peri-implantitis and presenting with insufficient keratinized mucosa (width and thickness <2 mm) will first receive non-surgical peri-implant therapy. Mechanical debridement of the peri-implant surfaces will be performed using titanium curettes and implant-specific ultrasonic tips in order to remove bacterial biofilm without damaging the implant surface. Additionally, sterile saline solution will be used for submucosal irrigation after mechanical debridement. Patients will receive individualized oral hygiene instructions, including proper brushing techniques, and be suitable for implant-supported restorations. In this group, a free gingival graft (FGG) will be harvested from the palatal donor site under local anesthesia after completion of non-surgical therapy and resolution of acute inflammation.FGG will be stabilized using interrupted or continuous sutures. Participants will be followed for clinical and radiographic evaluations. | Procedure or surgery | Test Group |
Primary outcome
Change in PPD
Time frame: Following at 12. months post-treatment
4 secondary outcomes
Bleeding on Probing
Time frame: Following at 12. months post-treatment
Plaque index
Time frame: Following at 12. months post-treatment
Keratinized mucosa width
Time frame: Following at 12. months post-treatment
Keratinized mucosa thickness
Time frame: Following at 12. months post-treatment
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 13 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Sila Cagri Isler, Prof Dr study director
Gazi University Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Submucosal debridman + saline irrigation and Free gingival graft surgery in people with Peri-implantitis and Soft Tissue Augmentation at Dental Implants, run by Gazi University at 1 site in Turkey (Türkiye).
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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 13 Mar 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 Turkey (Türkiye). 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 Sila Cagri Isler, Prof. Dr. (+905069966074, silaisler@gazi.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PPD (time frame: Following at 12. months post-treatment). 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 13 Mar 2026.