Effectiveness of Modified-free Gingival Graft for Treatment of Localized Gingival Recession Defects

Not Applicable

Completed

• Conditions: Gingival Recession, Localized
• Interventions: Procedure: Mucogingival surgery

• Registration Number: NCT04718545
• Lead Sponsor: Göteborg University

Brief Summary

The aim of the present study is to evaluate, whether use of the modified free gingival graft (mod-FGG) technique improves treatment outcomes after surgical root coverage at mandibular incisors with gingival recession defects.

Detailed Description

Gingival recession defects (GRD), defined as displacement of the gingival margin apical to the cemento-enamel junction, are frequent clinical findings in the general population.

The major indications for root coverage procedures are improved esthetics, reduction of root hypersensitivity and the increase of the dimensions of keratinized tissue in order to facilitate infection control and prevent further progression of gingival recession defects. Numerous surgical techniques for root coverage have been suggested, with different degrees of success as assessed by the proportion of complete root coverage. The scientific evidence has revealed that mandibular incisors were associated with the least favourable outcomes when compared to other teeth. The lower success rate and lower predictability of root coverage procedures at lower incisors, teeth with the highest frequency of GRDs, may be related to the unfavorable anatomic conditions including marginal frenum attachment, high muscle pull and a shallow vestibule. These features are frequently encountered in the anterior area of the mandible, while they are rare in the maxillary anterior region.

The so-called "Free Gingival Graft" (FGG) was shown to be the most effective procedure for gingival augmentation at sites with minimal amount of keratinized tissue. Great variability in terms of proportion of root coverage (range: 11% to 87%; mean: 63%) has been reported when applying this technique, however. One of the challenges may be the inadequate blood supply to the portion of the FGG placed on the exposed root surface. A modified version of the FGG technique (mod-FGG) has been proposed, aiming to improve the vascularity of the recipient site over the denuded root surface. However, there is to date no scientific evidence whether the mod-FGG provides better clinical results than the conventional FGG.

The hypothesis of the study is that the mod-FGG will improve predictability and treatment outcomes for root coverage at mandibular incisors.

Study Timeline

• Study First Submitted: 2021-01-16
• Study First Submitted QC: 2021-01-20
• Study First Posted: 2021-01-22
• Study Start: 2021-03-10
• Primary Completion: 2022-05-05
• Study Completion: 2022-05-05
• Results First Submitted: 2024-10-15
• Status Verified: 2025-04
• Results First Submitted QC: 2025-04-14
• Last Update Submitted: 2025-04-14
• Results First Posted: 2025-04-15
• Last Update Posted: 2025-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Age ≥ 18 years
• Periodontally and systemically healthy
• Full-mouth plaque score and full-mouth bleeding score ≤ 20% (measured at four sites per tooth)
• Thin phenotype
• Probing pocket depth (PPD) ≤3 mm
• Absence of excessive tooth mobility
• Absence of cervical composite restorations or non-carious cervical lesions
• Shallow vestibule

Exclusion Criteria

• Pregnancy
• Smoking
• Alcoholism
• Para-functional habits
• Poor oral hygiene
• Excessive crowding or misalignment of teeth

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Free Gingival Graft	Mucogingival surgery	A mucogingival surgery where a gingival graft harvested from the palate is placed on a conventionally prepared recipient site and sutured to cover the mucosal recession
Modified Free Gingival Graft	Mucogingival surgery	A mucogingival surgery where a gingival graft harvested from the palate is placed on a modified recipient site and sutured to cover the mucosal recession

Primary Outcome Measures

Name	Time	Method
Mean Mid-facial Recession Coverage (mRC)	up to 1 year	mRC measured as a percentage

Secondary Outcome Measures

Name	Time	Method
Keratinized Tissue (KT) Gain	up to 1 year	KT gain measured in mm

Trial Locations

Locations (1)

Department of Periodontology, Institute of Odontology, Sahlgrenska Academy, University of Gothenburg; 🇸🇪 Gothenburg, Sweden