Effect of Free Gingival Grafting on Peri-implant Health

Peri-implant Mucositis Clinical Trial

Official title:

The Influence of Soft Tissue Phenotype Modification Following Free Gingival Grafting on the Treatment of Peri-implant Mucositis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06392256
• Other study ID #: E-21071282-050.99-630224
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: August 15, 2024

Study information

• Verified date: May 2024
• Source: Gazi University
• Contact: Assoc Prof Dr
• Phone: +905069966074
• Email: silaisler[@]gazi.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this randomized-controlled 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, in addition to non-surgical mechanical therapy of PM, affect the complete disease resolution? - Does the presence of KMW < 2 mm around the implants exhibit similar outcomes compared to the sites with sufficient KMW (i.e., ≥ 2 mm) for professional mechanical plaque removal? Patients who apply to the Department of Periodontology, Faculty of Dentistry, Gazi University, are systemically healthy, have implant-supported fixed 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. As a positive control group, those who apply to the same department, have implants in function as noted during routine annual maintenance appointments, and are diagnosed as healthy will be selected.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: August 15, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

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) along with increased peri-implant probing depth (PPD) in comparison to previous examinations 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 fixed restorations installed at least one year prior to their enrollment,
• Patients who have full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) = 20%. Peri-implant Health
• Adult (>18 years old), systemically healthy patients,
• Patients with healthy implants, defined as the absence of bleeding on probing (BoP) or suppuration (SoP), or at most the presence of a single bleeding spot around the implant, no increase in peri-implant probing depth (PPD) compared to previous examinations, and no bone loss beyond crestal bone level changes resulting from initial bone remodeling (Berglundh et al., 2018),
• Presence of buccal peri-implant KMW = 2 mm around the healthy implant site.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Inflammation
• Mucositis
• Peri-implant Mucositis
• Soft Tissue Inflammation

Intervention

Procedure:
• Non surgical therapy
Non-surgical submarginal instrumentation using titanium curettes with saline irrigation will be done once in the treatment session.
• Free gingival Grafting
In the PM-NS-FGG group, soft tissue augmentation using a free gingival graft will be performed.

Locations

Country	Name	City	State
Turkey	Gazi University Faculty of Dentistry	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

References & Publications (8)

Berglundh 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. — View Citation

Clementini M, Fabrizi S, Discepoli N, Minoli M, De Sanctis M. Evaluation of the adjunctive use of Er:YAG laser or erythritol powder air-polishing in the treatment of peri-implant mucositis: A randomized clinical trial. Clin Oral Implants Res. 2023 Nov;34(11):1267-1277. doi: 10.1111/clr.14167. Epub 2023 Sep 1. — View Citation

Galarraga-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. — View Citation

Herrera D, Berglundh T, Schwarz F, Chapple I, Jepsen S, Sculean A, Kebschull M, Papapanou PN, Tonetti MS, Sanz M; EFP workshop participants and methodological consultant. Prevention and treatment of peri-implant diseases-The EFP S3 level clinical practice guideline. J Clin Periodontol. 2023 Jun;50 Suppl 26:4-76. doi: 10.1111/jcpe.13823. Epub 2023 Jun 4. — View Citation

Rakic 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. 2023 Dec 2. doi: 10.1002/JPER.23-0507. Online ahead of print. — View Citation

Ramanauskaite A, Obreja K, Muller KM, Schliephake C, Wieland J, Begic A, Dahmer I, Parvini P, Schwarz F. Three-dimensional changes of a porcine collagen matrix and free gingival grafts for soft tissue augmentation to increase the width of keratinized tissue around dental implants: a randomized controlled clinical study. Int J Implant Dent. 2023 Jun 16;9(1):13. doi: 10.1186/s40729-023-00482-2. Erratum In: Int J Implant Dent. 2023 Jun 28;9(1):19. — View Citation

Schwarz 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in bleeding on probing (BoP)	Change in BoP around the implants between baseline (before the treatment) and 6 months after the treatment (%)	6 months after the treatment
Secondary	Percentage of complete disease resolution (%)	Total absence of BoP around the implants	6 months after the treatment
Secondary	Probing pocket depth (PPD) changes	The change in PPD around the implants between baseline (before the treatment) and 6 months after the treatment (mm)	6 months after the treatment
Secondary	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	6 months after the treatment
Secondary	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)	6 months after the treatment
Secondary	3D linear measurement of KMW	Measurement by substraction the vertical extension of KMW in region of interest at baseline and 6 months after the treatment	6 months after the treatment
Secondary	3D linear measurement of KMT	Measurement by substraction the horizontal extension of KMT in region of interest at baseline and 6 months after the treatment	6 months after the treatment