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

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

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.

Study Overview

• Status: Completed
• Conditions: Gingival Recession, Localized
• Intervention / Treatment: Procedure: Mucogingival surgery

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Gothenburg, Sweden, 40530
    • Department of Periodontology, Institute of Odontology, Sahlgrenska Academy, University of Gothenburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Free Gingival Graft; 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; The gingival recession at mandibular incisor site will be covered by a gingival graft harvested from the palate.
Experimental: Modified Free Gingival Graft; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Mid-facial Recession Coverage (mRC)	mRC measured as a percentage	up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Keratinized Tissue (KT) Gain	KT gain measured in mm	up to 1 year

Collaborators and Investigators

• Sponsor: Göteborg University
• Investigators: Study Chair: Tord Berglundh, DDS, PhD, Göteborg University

Publications and helpful links

General Publications

• Cairo F, Nieri M, Pagliaro U. Efficacy of periodontal plastic surgery procedures in the treatment of localized facial gingival recessions. A systematic review. J Clin Periodontol. 2014 Apr;41 Suppl 15:S44-62. doi: 10.1111/jcpe.12182.
• Cairo F. Periodontal plastic surgery of gingival recessions at single and multiple teeth. Periodontol 2000. 2017 Oct;75(1):296-316. doi: 10.1111/prd.12186.
• Tonetti MS, Jepsen S; Working Group 2 of the European Workshop on Periodontology. Clinical efficacy of periodontal plastic surgery procedures: consensus report of Group 2 of the 10th European Workshop on Periodontology. J Clin Periodontol. 2014 Apr;41 Suppl 15:S36-43. doi: 10.1111/jcpe.12219.
• Cortellini P, Bissada NF. Mucogingival conditions in the natural dentition: Narrative review, case definitions, and diagnostic considerations. J Periodontol. 2018 Jun;89 Suppl 1:S204-S213. doi: 10.1002/JPER.16-0671.
• Zucchelli G, Marzadori M, Mounssif I, Mazzotti C, Stefanini M. Coronally advanced flap + connective tissue graft techniques for the treatment of deep gingival recession in the lower incisors. A controlled randomized clinical trial. J Clin Periodontol. 2014 Aug;41(8):806-13. doi: 10.1111/jcpe.12269. Epub 2014 Jun 5.
• Holbrook T, Ochsenbein C. Complete coverage of the denuded root surface with a one-stage gingival graft. Int J Periodontics Restorative Dent. 1983;3(3):8-27. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2021
• Primary Completion (Actual): May 5, 2022
• Study Completion (Actual): May 5, 2022

Study Registration Dates

• First Submitted: January 16, 2021
• First Submitted That Met QC Criteria: January 20, 2021
• First Posted (Actual): January 22, 2021

Study Record Updates

• Last Update Posted (Actual): April 15, 2025
• Last Update Submitted That Met QC Criteria: April 14, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Gingival Diseases; Gingival Recession
• Other Study ID Numbers: OCarcuac-modFGG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No