An interventional study of Mucogingival surgery in Gingival Recession, Localized, sponsored by Göteborg University. Completed at 1 site in Sweden. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2025-04-15.
Sponsored by Göteborg University · Not applicable, Interventional, and Treatment
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.
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.
402 studies on the registry are indexed under Gingival Recession; 98 are open to participants now.
This study's enrollment of 30 is close to the median of 30 across 368 interventional studies indexed under Gingival Recession.
Browse Gingival Recession studies →Göteborg University is the lead sponsor of 265 studies on the registry; 46 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Procedure: 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
Procedure: Mucogingival surgery
The gingival recession at mandibular incisor site will be covered by a gingival graft harvested from the palate.
Mean Mid-facial Recession Coverage (mRC)
mRC measured as a percentage
Time frame: up to 1 year
Keratinized Tissue (KT) Gain
KT gain measured in mm
Time frame: up to 1 year
| Milestone | Free Gingival Graft | Modified Free Gingival Graft |
|---|---|---|
| Started | 15 | 15 |
| Completed | 15 | 15 |
| Not completed | 0 | 0 |
mRC measured as a percentage
| percentage | Free Gingival Graft | Modified Free Gingival Graft |
|---|---|---|
| Mean Mid-facial Recession Coverage (mRC) | 60.7 (56.0 to 65.3) | 91.8 (87.1 to 96.4) |
KT gain measured in mm
| mm | Free Gingival Graft | Modified Free Gingival Graft |
|---|---|---|
| Keratinized Tissue (KT) Gain | 2.2 ± 0.9 | 4.2 ± 0.8 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Free Gingival Graft | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Modified Free Gingival Graft | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Age, Categorical(Participants) | Free Gingival Graft | Modified Free Gingival Graft | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 15 | 15 | 30 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Free Gingival Graft | Modified Free Gingival Graft | Total |
|---|---|---|---|
| Mean | 36.7 ± 10.9 | 35.8 ± 10.0 | 36.2 ± 10.3 |
| Sex: Female, Male(Participants) | Free Gingival Graft | Modified Free Gingival Graft | Total |
|---|---|---|---|
| Female | 6 | 9 | 15 |
| Male | 9 | 6 | 15 |
| Race and Ethnicity Not Collected(Participants) | Free Gingival Graft | Modified Free Gingival Graft | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(Participants) | Free Gingival Graft | Modified Free Gingival Graft | Total |
|---|---|---|---|
| United Arab Emirates | 15 | 15 | 30 |
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Göteborg University