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Completed

NCT Number: NCT04718545

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

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Periodontology, Institute of Odontology, Sahlgrenska Academy, University of Gothenburg

Gothenburg, 40530, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Mucogingival surgery

Procedure

The gingival recession at mandibular incisor site will be covered by a gingival graft harvested from the palate.

Primary outcomes

  1. Mean Mid-facial Recession Coverage (mRC)

    Time frame: up to 1 year

    mRC measured as a percentage

Secondary outcomes

  1. Keratinized Tissue (KT) Gain

    Time frame: up to 1 year

    KT gain measured in mm

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Registry information

Official study title

Treatment of Localized Gingival Recession Defects at Lower Mandibular Incisors Using a Modified-free Gingival Graft: a Randomized Clinical Trial

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 22, 2021
Registry last updated
Apr 15, 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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