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NCT Number: NCT06037694

Effectiveness of Meshed Free Gingival Graft for Widening of Keratinized Tissues

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ConfiDent ® Dental Surgery Clinic, Dubai Palm Jumeirah

Dubai, 0000, United Arab Emirates

Location status: Recruiting

Location contact

Olivier Carcuac, DDS, PhD

CONTACT

[email protected]

0097556275575

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

conventional free gingival graft

Procedure

Implant site with insufficient dimensions of KM will be covered by a conventional free gingival graft.

'Mesh Free Gingival Graft

Procedure

Implant site with insufficient dimensions of KM will be covered by a expanded meshed free gingival graft.

Primary outcomes

  1. Changes of Keratinized Mucosa width (KMW)

    Time frame: up to 1 year

    Measured as the distance from the muco-gingival-junction to the occlusal portion of the mucosa

Secondary outcomes

  1. Changes of Keratinized Mucosa Thickness (KMT)

    Time frame: up to 1 year

    measured by a therapeutic probe with a rubber stop

  2. Patient Morbidity

    Time frame: up to 2 weeks

    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')

  3. Patient Satisfaction

    Time frame: up to 1 year

    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')

Study contacts

Contact information is provided by the study sponsor or research team.

Jan Derks, DDS, PhD

CONTACT

[email protected]

317863124 ext. 0046

Olivier Carcuac, DDS, PhD

CONTACT

[email protected]

556275575 ext. 00971

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 14, 2023
Registry last updated
Aug 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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