Effectiveness of Meshed Free Gingival Graft for Widening of Keratinized Tissues

Gingiva Atrophy Clinical Trial

Official title:

Widening of Keratinized Tissues With an Expanded Meshed Free Gingival Graft: a Multi-center Randomized Controlled Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06037694
• Other study ID #: OCarcuac-meshFGG
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: August 1, 2025

Study information

• Verified date: February 2024
• Source: Göteborg University
• Contact: Olivier Carcuac, DDS, PhD
• Phone: 556275575
• Email: olivier.carcuac[@]gu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The overall objective of this project is to evaluate, over a period of 1 year, the outcomes of either conventional free gingival graft (FGG) or mesh-FGG to increase the width of keratinized mucosa (KM) at implant sites.

Description:

The importance of the width of keratinized mucosa (KM) at implant sites remains a subject of ongoing debate. Reduced dimensions of KM (width <2 mm) are associated with mucosal recession, biofilm accumulation, soft-tissue inflammation, marginal bone loss, peri-implantitis and patient discomfort. Surgical options to increase the width of KM include an apically positioned flap, either alone or in combination with an autogenous graft or a xenogeneic collagen matrix. The free gingival graft (FGG) is a well-established technique with a history of successful clinical use. The harvesting procedure for autogenous graft from the palatal mucosa, however, is usually associated with significant patient morbidity, especially when there is a need to graft extensive mucosal areas. To overcome this problem, various graft modifications have been proposed to limit the need for large-area autografts. Examples include the accordion technique, the strip gingival autograft technique, and a vertical modification of the strip gingival graft. The expanded mesh graft, another graft modification, has been used in the field of plastic surgery, especially in the treatment of large burn wounds. Recently, De Greef, Carcuac, De Mars et al. proposed this technique to be used in periodontal plastic surgery, more specifically, in the widening of KM at implant sites by means of a meshed free gingival graft (mesh-FGG). In this case series, initially inadequate width of KM in edentulous areas could be successfully increased prior to implant installation, without the need for any extensive autograft harvesting. Data from trials comparing mesh-FGG to conventional FGG and assessing the long-term efficacy of this novel technique, however, are missing. The investigators hypothesize that the mesh-FGG technique will demonstrate similar clinical results (non-inferiority: increase in KM width) but improved patient-reported outcomes (superiority: post-surgical morbidity) compared to the FGG.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• =18 years of age,
• systemically healthy,
• presence of =2 adjacent implants in both sides of the mandibles showing <2 mm of KM on the buccal aspects,
• subjects have to present with discomfort from brushing and/or difficulties in maintaining proper home care due to inadequate dimension of KM
• Full-Mouth Plaque Score (FMPS) <20%,
• Full-Mouth Bleeding Score (FMBS) <20%.

Exclusion Criteria:

• pregnancy or lactation,
• tobacco smoking,
• uncontrolled medical condition,
• medication that can affect gingival conditions.

Related Conditions & MeSH terms

• Gingiva Atrophy
• Gingival Recession

Intervention

Procedure:
• Conventional Free Gingival Graft
Implant site with insufficient dimensions of KM will be covered by a conventional free gingival graft.
• 'Mesh Free Gingival Graft
Implant site with insufficient dimensions of KM will be covered by a expanded meshed free gingival graft.

Locations

Country	Name	City	State
United Arab Emirates	ConfiDent ® Dental Surgery Clinic, Dubai Palm Jumeirah	Dubai

Sponsors (1)

Lead Sponsor	Collaborator
Göteborg University

Country where clinical trial is conducted

United Arab Emirates, 

References & Publications (7)

De Greef A, Carcuac O, De Mars G, Stankov V, Cortasse B, Giordani G, Van Dooren E. The expanded mesh free gingival graft: A novel approach to increase the width of keratinized mucosa. Clin Adv Periodontics. 2023 Aug 8. doi: 10.1002/cap.10264. Online ahead — View Citation

Lim HC, An SC, Lee DW. A retrospective comparison of three modalities for vestibuloplasty in the posterior mandible: apically positioned flap only vs. free gingival graft vs. collagen matrix. Clin Oral Investig. 2018 Jun;22(5):2121-2128. doi: 10.1007/s007 — View Citation

Sanz M, Schwarz F, Herrera D, McClain P, Figuero E, Molina A, Monje A, Montero E, Pascual A, Ramanauskaite A, Renouard F, Sader R, Schiegnitz E, Urban I, Heitz-Mayfield L. Importance of keratinized mucosa around dental implants: Consensus report of group — View Citation

Schwarz F, Derks J, Monje A, Wang HL. Peri-implantitis. J Clin Periodontol. 2018 Jun;45 Suppl 20:S246-S266. doi: 10.1111/jcpe.12954. — View Citation

Singh M, Nuutila K, Collins KC, Huang A. Evolution of skin grafting for treatment of burns: Reverdin pinch grafting to Tanner mesh grafting and beyond. Burns. 2017 Sep;43(6):1149-1154. doi: 10.1016/j.burns.2017.01.015. Epub 2017 Jan 30. — View Citation

Tavelli L, Barootchi S, Avila-Ortiz G, Urban IA, Giannobile WV, Wang HL. Peri-implant soft tissue phenotype modification and its impact on peri-implant health: A systematic review and network meta-analysis. J Periodontol. 2021 Jan;92(1):21-44. doi: 10.100 — View Citation

Thoma DS, Naenni N, Figuero E, Hammerle CHF, Schwarz F, Jung RE, Sanz-Sanchez I. Effects of soft tissue augmentation procedures on peri-implant health or disease: A systematic review and meta-analysis. Clin Oral Implants Res. 2018 Mar;29 Suppl 15:32-49. d — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of Keratinized Mucosa width (KMW)	Measured as the distance from the muco-gingival-junction to the occlusal portion of the mucosa	up to 1 year
Secondary	Changes of Keratinized Mucosa Thickness (KMT)	measured by a therapeutic probe with a rubber stop	up to 1 year
Secondary	Patient Morbidity	Measured with Visual Analogue Scale (VAS), which consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be')	up to 2 weeks
Secondary	Patient Satisfaction	Measured with Visual Analogue Scale (VAS), which consists of a 10cm line, with two end points representing 0 ('not satisfied') and 10 ('satisfied as much as it could possibly be')	up to 1 year