Effectiveness of Meshed Free Gingival Graft for Widening of Keratinized Tissues
Widening of Keratinized Tissues With an Expanded Meshed Free Gingival Graft: a Multi-center Randomized Controlled Trial.
1 other identifier
interventional
30
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 7, 2023
CompletedFirst Posted
Study publicly available on registry
September 14, 2023
CompletedStudy Start
First participant enrolled
January 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2026
August 21, 2025
October 1, 2024
2.4 years
September 7, 2023
August 20, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Changes of Keratinized Mucosa Thickness (KMT)
up to 1 year
Patient Morbidity
up to 2 weeks
Patient Satisfaction
up to 1 year
Study Arms (2)
Free Gingival Graft
ACTIVE COMPARATORA mucogingival surgery where a conventional free gingival graft harvested from the palate is placed on a recipient site prepared to increase the width of KM at implant sites.
Meshed Free Gingival Graft
EXPERIMENTALA mucogingival surgery where a meshed free gingival graft harvested from the palate is placed on a recipient site prepared to increase the width of KM at implant sites.
Interventions
Implant site with insufficient dimensions of KM will be covered by a conventional free gingival graft.
Implant site with insufficient dimensions of KM will be covered by a expanded meshed free gingival graft.
Eligibility Criteria
You may qualify if:
- ≥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%.
You may not qualify if:
- pregnancy or lactation,
- tobacco smoking,
- uncontrolled medical condition,
- medication that can affect gingival conditions.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
ConfiDent ® Dental Surgery Clinic, Dubai Palm Jumeirah
Dubai, Dubai, 0000, United Arab Emirates
Related Publications (7)
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.
PMID: 29926484BACKGROUNDSanz 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 1 of the DGI/SEPA/Osteology Workshop. Clin Oral Implants Res. 2022 Jun;33 Suppl 23:47-55. doi: 10.1111/clr.13956.
PMID: 35763021BACKGROUNDLim 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/s00784-017-2320-y. Epub 2017 Dec 23.
PMID: 29275490BACKGROUNDTavelli 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: 10.1002/JPER.19-0716. Epub 2020 Aug 9.
PMID: 32710810BACKGROUNDSingh 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.
PMID: 28153583BACKGROUNDDe 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. 2024 Sep;14(3):157-164. doi: 10.1002/cap.10264. Epub 2023 Aug 16.
PMID: 37551510BACKGROUNDThoma 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. doi: 10.1111/clr.13114.
PMID: 29498129BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jan Derks
Goteborg University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 7, 2023
First Posted
September 14, 2023
Study Start
January 1, 2024
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
August 1, 2026
Last Updated
August 21, 2025
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share