Peri-implant MucositisNCT06392256
Effect of Free Gingival Grafting on Peri-implant Health
A study testing Non surgical therapy and Free gingival Grafting in people with Peri-implant Mucositis and Soft Tissue Inflammation, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this randomized clinical study is to investigate the impact of soft tissue phenotype modification following free gingival grafting (FGG) in addition to the non-surgical mechanical therapy of peri-implant mucositis (PM) with keratinized mucosa width (KMW) < 2 mm over a 6-month follow-up period. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Peri-implant Mucositis, Soft Tissue Inflammation
- What is being tested?
- Non surgical therapy and Free gingival Grafting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2023to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Peri-implant Mucositis
- Adult (>18 years old), systemically healthy patients,
- Presence of at least one implant affected by peri-implant mucositis characterized by the presence of bleeding on probing and/or suppuration (BoP/SoP) and the absence of bone loss beyond crestal bone level changes that occur as a result of initial bone remodeling,
- Presence of buccal peri-implant keratinized mucosa width (KMW) < 2 mm around the implants diagnosed with peri-implant mucositis,
- Patients who have implant-supported restorations installed at least one year prior to their enrollment.
Who cannot join
- Systemic diseases that could influence the outcomes of dental and surgical treatments such as uncontrolled diabetes (HbA1c > 7), active treatment phase for cancer, autoimmune diseases, osteoporosis, medications such as steroids, bisphosphonates, selective serotonin reuptake inhibitors (SSRIs), proton pump inhibitors (PPIs), and antihypertensives,
- Consumption of anti-coagulants, anti-aggregation agents, antibiotics, or corticosteroid medications during the past three months,
- Pregnancy or lactation,
- History of soft tissue grafting at the respective implant sites,
- Current untreated periodontal diseases,
- Smokers (≥ 10 cigarettes per day),
- Malpositioned implants.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi University Faculty of Dentistry
Ankara, 06490
About this study
Official title: The Influence of Soft Tissue Phenotype Modification Following Free Gingival Grafting on the Treatment of Peri-implant Mucositis
The goal of this randomized clinical study is to investigate the impact of soft tissue phenotype modification following free gingival grafting (FGG) in addition to the non-surgical mechanical therapy of peri-implant mucositis (PM) with keratinized mucosa width (KMW) < 2 mm over a 6-month follow-up period. Therefore, the following questions related to the study are raised:
- Does soft tissue modification following free gingival grafting around the implants with KMW < 2 mm, in addition to non-surgical mechanical therapy of PM, affect the change in bleeding on probing and the rate of complete disease resolution?
Patients who apply to the Department of Periodontology, Faculty of Dentistry, Gazi University, are systemically healthy, have implant-supported restorations installed at least one year prior to their enrollment, and are diagnosed with PM on these implants will be selected for the study. Patients with KMW < 2 mm at the respective implant sites will be treated with non-surgical mechanical treatment combined with soft tissue augmentation with FGG or non-surgical mechanical treatment alone.
Read the detailed description
The primary goal of treating peri-implant mucositis (PM) is to disturb the dental implant biofilm and resolve inflammatory conditions. This aims to achieve treatment success or complete disease resolution, preventing its progression to peri-implantitis. Indeed, regardless of the non-surgical mechanical/physical instrumentation approaches and despite noticeable clinical improvements, none of the existing procedures would result in complete disease resolution [i.e., absence of bleeding on probing (BOP)] in peri-implant mucositis. Taking this into account, the execution of interventions targeted at managing modifiable risk factors plays a pivotal role in maintaining peri-implant health.
Despite the increasing evidence documenting that implant sites exhibiting either a lacking or a reduced keratinized mucosa (KM) of ≤2 mm demonstrate difficulties in eliminating bacterial biofilm, leading to inflammation around the soft tissue, the requirement for a minimum peri-implant KM width (KMW) to avoid peri-implant diseases has been a highly debated topic. Indeed, KM augmentation at implant sites with a reduced KMW has been reported to be associated with statistically significant lower plaque and gingival scores as well as peri-implant probing depths (PPD) when compared with non-augmented sites. However, there is no study evaluating primarily the effect of KM augmentation on maintaining peri-implant health and preventing peri-implant diseases.
Therefore, the aim of this study is to investigate the impact of soft tissue phenotype modification following free gingival grafting in addition to the non-surgical submarginal instrumentation of peri-implant mucositis over a 6-month follow-up period.
- Conditions
- Peri-implant Mucositis, Soft Tissue Inflammation
- Being tested
- Non surgical therapy, Free gingival Grafting
- Keywords
- Peri-implant Mucositis, Keratinized Mucosa, Non-surgical Therapy, Free Gingival Graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non surgical therapyProcedure or surgery
Non-surgical submarginal instrumentation using titanium curettes with saline irrigation will be done once in the treatment session.
Free gingival GraftingProcedure or surgery
In the PM-NS-FGG group, soft tissue augmentation using a free gingival graft will be performed.
| Study group | Role | What they receive |
|---|---|---|
| PM-NS: Peri-implant mucositis-Non-surgical therapy | Active comparator | Professional mechanical plaque removal and submarginal instrumentation using titanium curettes will be performed in the non-surgical treatment of peri-implant mucositis with KMW < 2 mm. Receives: Procedure: Non surgical therapy |
| PM-NS-FGG: Peri-implant mucositis-Non-surgical therapy-Free Gingival Grafting | Experimental | Professional mechanical plaque removal and submarginal instrumentation using titanium curettes will be performed in the non-surgical treatment of peri-implant mucositis with KMW < 2 mm. Free gingival grafting will be done one month after the non-surgical treatment. Receives: Procedure: Non surgical therapy; Procedure: Free gingival Grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding on probing (BoP) - BoP extent
The number of BoP around the implants
Measured: 3 and 6 months after the treatment
Secondary outcomes (5)
Percentage of complete disease resolution (%)
The absence of BoP at more than one site per implant and deepest PPD≤5 mm.
Measured: 3 and 6 months after the treatment
Probing pocket depth (PPD)
The distance between the bottom of the pocket and mucosal margin around the implants
Measured: 3 and 6 months after the treatment
Keratinized mucosa width (KMW)
The distance between the peri-implant mucosal margin and the mucogingival junction and recorded to the nearest millimeter using a UNC periodontal probe
Measured: 3 and 6 months after the treatment
Keratinized mucosa thickness (KMT)
KTT will be measured 1 mm below the mucosal margin inserting an endodontic reamer to the soft tissue, and measuring the distance between the tip of the reamer and the stopper through a digital caliper. Mucosal thickness was also categorized as thick (≥2 mm) and thin (<2 mm)
Measured: 3 and 6 months after the treatment
Peri-implant soft-tissue dehiscence [PISTD]
The distance between the apical margin of the crown to the peri-implant mucosal margin, including exposure of the prosthetic abutment, with or without the exposure of the implant-treated surface
Measured: 3 and 6 months after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start1 May 2023
- Primary completion1 Nov 2024
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Peri-implant MucositisStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 43 participants (actual)
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, Asso Prof, Study director, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06392256
- Sponsor's protocol ID
- E-21071282-050.99-630224
- Status last verified
- Apr 2025
- First submitted
- 26 Apr 2024
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Verket A, Koldsland OC, Bunaes D, Lie SA, Romandini M. Non-surgical therapy of peri-implant mucositis-Mechanical/physical approaches: A systematic review. J Clin Periodontol. 2023 Jun;50 Suppl 26:135-145. doi: 10.1111/jcpe.13789. Epub 2023 Feb 28.
PubMed 36802083Rakic M, Tatic Z, Radovanovic S, Petkovic-Curcin A, Vojvodic D, Monje A. Resolution of peri-implant mucositis following standard treatment: A prospective split-mouth study. J Periodontol. 2024 Sep;95(9):842-852. doi: 10.1002/JPER.23-0507. Epub 2023 Dec 2.
PubMed 38041803Galarraga-Vinueza ME, Tavelli L. Soft tissue features of peri-implant diseases and related treatment. Clin Implant Dent Relat Res. 2023 Aug;25(4):661-681. doi: 10.1111/cid.13156. Epub 2022 Nov 29.
PubMed 36444772Schwarz F, Sager M, Golubovic V, Iglhaut G, Becker K. Horizontal mucosal thickness at implant sites as it correlates with the integrity and thickness of the buccal bone plate. Clin Oral Implants Res. 2016 Oct;27(10):1305-1309. doi: 10.1111/clr.12747. Epub 2016 Feb 10.
PubMed 26864237Berglundh T, Armitage G, Araujo MG, Avila-Ortiz G, Blanco J, Camargo PM, Chen S, Cochran D, Derks J, Figuero E, Hammerle CHF, Heitz-Mayfield LJA, Huynh-Ba G, Iacono V, Koo KT, Lambert F, McCauley L, Quirynen M, Renvert S, Salvi GE, Schwarz F, Tarnow D, Tomasi C, Wang HL, Zitzmann N. Peri-implant diseases and conditions: Consensus report of workgroup 4 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Clin Periodontol. 2018 Jun;45 Suppl 20:S286-S291. doi: 10.1111/jcpe.12957.
PubMed 29926491
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Soft Tissue Phenotype Modification Following Free Gingival Grafting on the Treatment of Peri-implant Mucositis
- ClinicalTrials.gov ID
- NCT06392256
- Acronym / sponsor ID
- E-21071282-050.99-630224
- Conditions
- Peri-implant Mucositis, Soft Tissue Inflammation
- Keywords
- Peri-implant Mucositis, Keratinized Mucosa, Non-surgical Therapy, Free Gingival Graft
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 30 Apr 2024 (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 randomized clinical study is to investigate the impact of soft tissue phenotype modification following free gingival grafting (FGG) in addition to the non-surgical mechanical therapy of peri-implant mucositis (PM) with keratinized mucosa width (KMW) < 2 mm over a 6-month follow-up period. Therefore, the following questions related to the study are raised:
- Does soft tissue modification following free gingival grafting around the implants with KMW < 2 mm, in addition to non-surgical mechanical therapy of PM, affect the change in bleeding on probing and the rate of complete disease resolution?
Patients who apply to the Department of Periodontology, Faculty of Dentistry, Gazi University, are systemically healthy, have implant-supported restorations installed at least one year prior to their enrollment, and are diagnosed with PM on these implants will be selected for the study. Patients with KMW < 2 mm at the respective implant sites will be treated with non-surgical mechanical treatment combined with soft tissue augmentation with FGG or non-surgical mechanical treatment alone.
Detailed description
The primary goal of treating peri-implant mucositis (PM) is to disturb the dental implant biofilm and resolve inflammatory conditions. This aims to achieve treatment success or complete disease resolution, preventing its progression to peri-implantitis. Indeed, regardless of the non-surgical mechanical/physical instrumentation approaches and despite noticeable clinical improvements, none of the existing procedures would result in complete disease resolution [i.e., absence of bleeding on probing (BOP)] in peri-implant mucositis. Taking this into account, the execution of interventions targeted at managing modifiable risk factors plays a pivotal role in maintaining peri-implant health.
Despite the increasing evidence documenting that implant sites exhibiting either a lacking or a reduced keratinized mucosa (KM) of ≤2 mm demonstrate difficulties in eliminating bacterial biofilm, leading to inflammation around the soft tissue, the requirement for a minimum peri-implant KM width (KMW) to avoid peri-implant diseases has been a highly debated topic. Indeed, KM augmentation at implant sites with a reduced KMW has been reported to be associated with statistically significant lower plaque and gingival scores as well as peri-implant probing depths (PPD) when compared with non-augmented sites. However, there is no study evaluating primarily the effect of KM augmentation on maintaining peri-implant health and preventing peri-implant diseases.
Therefore, the aim of this study is to investigate the impact of soft tissue phenotype modification following free gingival grafting in addition to the non-surgical submarginal instrumentation of peri-implant mucositis over a 6-month follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PM-NS: Peri-implant mucositis-Non-surgical therapy | Active comparator | Procedure: Non surgical therapyProfessional mechanical plaque removal and submarginal instrumentation using titanium curettes will be performed in the non-surgical treatment of peri-implant mucositis with KMW < 2 mm. |
| PM-NS-FGG: Peri-implant mucositis-Non-surgical therapy-Free Gingival Grafting | Experimental | Procedure: Non surgical therapy, Procedure: Free gingival GraftingProfessional mechanical plaque removal and submarginal instrumentation using titanium curettes will be performed in the non-surgical treatment of peri-implant mucositis with KMW < 2 mm. Free gingival grafting will be done one month after the non-surgical treatment. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Peri-implant Mucositis
- Adult (>18 years old), systemically healthy patients,
- Presence of at least one implant affected by peri-implant mucositis characterized by the presence of bleeding on probing and/or suppuration (BoP/SoP) and the absence of bone loss beyond crestal bone level changes that occur as a result of initial bone remodeling,
- Presence of buccal peri-implant keratinized mucosa width (KMW) < 2 mm around the implants diagnosed with peri-implant mucositis,
- Patients who have implant-supported restorations installed at least one year prior to their enrollment.
Key exclusion criteria (7 listed)
- Systemic diseases that could influence the outcomes of dental and surgical treatments such as uncontrolled diabetes (HbA1c > 7), active treatment phase for cancer, autoimmune diseases, osteoporosis, medications such as steroids, bisphosphonates, selective serotonin reuptake inhibitors (SSRIs), proton pump inhibitors (PPIs), and antihypertensives,
- Consumption of anti-coagulants, anti-aggregation agents, antibiotics, or corticosteroid medications during the past three months,
- Pregnancy or lactation,
- History of soft tissue grafting at the respective implant sites,
- Current untreated periodontal diseases,
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 |
|---|---|---|
| Non surgical therapyNon-surgical submarginal instrumentation using titanium curettes with saline irrigation will be done once in the treatment session. | Procedure or surgery | PM-NS-FGG: Peri-implant mucositis-Non-surgical therapy-Free Gingival Grafting, PM-NS: Peri-implant mucositis-Non-surgical therapy |
| Free gingival GraftingIn the PM-NS-FGG group, soft tissue augmentation using a free gingival graft will be performed. | Procedure or surgery | PM-NS-FGG: Peri-implant mucositis-Non-surgical therapy-Free Gingival Grafting |
Primary outcome
Bleeding on probing (BoP) - BoP extent
Time frame: 3 and 6 months after the treatment
The number of BoP around the implants
5 secondary outcomes
Percentage of complete disease resolution (%)
Time frame: 3 and 6 months after the treatment
Probing pocket depth (PPD)
Time frame: 3 and 6 months after the treatment
Keratinized mucosa width (KMW)
Time frame: 3 and 6 months after the treatment
Keratinized mucosa thickness (KMT)
Time frame: 3 and 6 months after the treatment
Peri-implant soft-tissue dehiscence [PISTD]
Time frame: 3 and 6 months after the treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Background: PubMed 36802083Verket A, Koldsland OC, Bunaes D, Lie SA, Romandini M. Non-surgical therapy of peri-implant mucositis-Mechanical/physical approaches: A systematic review. J Clin Periodontol. 2023 Jun;50 Suppl 26:135-145. doi: 10.1111/jcpe.13789. Epub 2023 Feb 28.
- Background: PubMed 38041803Rakic M, Tatic Z, Radovanovic S, Petkovic-Curcin A, Vojvodic D, Monje A. Resolution of peri-implant mucositis following standard treatment: A prospective split-mouth study. J Periodontol. 2024 Sep;95(9):842-852. doi: 10.1002/JPER.23-0507. Epub 2023 Dec 2.
- Background: PubMed 36444772Galarraga-Vinueza ME, Tavelli L. Soft tissue features of peri-implant diseases and related treatment. Clin Implant Dent Relat Res. 2023 Aug;25(4):661-681. doi: 10.1111/cid.13156. Epub 2022 Nov 29.
- Background: PubMed 26864237Schwarz F, Sager M, Golubovic V, Iglhaut G, Becker K. Horizontal mucosal thickness at implant sites as it correlates with the integrity and thickness of the buccal bone plate. Clin Oral Implants Res. 2016 Oct;27(10):1305-1309. doi: 10.1111/clr.12747. Epub 2016 Feb 10.
- Background: PubMed 29926491Berglundh T, Armitage G, Araujo MG, Avila-Ortiz G, Blanco J, Camargo PM, Chen S, Cochran D, Derks J, Figuero E, Hammerle CHF, Heitz-Mayfield LJA, Huynh-Ba G, Iacono V, Koo KT, Lambert F, McCauley L, Quirynen M, Renvert S, Salvi GE, Schwarz F, Tarnow D, Tomasi C, Wang HL, Zitzmann N. Peri-implant diseases and conditions: Consensus report of workgroup 4 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Clin Periodontol. 2018 Jun;45 Suppl 20:S286-S291. doi: 10.1111/jcpe.12957.
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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. This study is not recruiting at the moment.
Sila Cagri Isler, Asso Prof study director
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non surgical therapy and Free gingival Grafting in people with Peri-implant Mucositis and Soft Tissue Inflammation, 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 5 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: finished, as of the sponsor's last update on 16 Apr 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bleeding on probing (BoP) - BoP extent (time frame: 3 and 6 months after the treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06392256, which also lists 5 linked publications.
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 16 Apr 2025.