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

Gingival Recession, Localized Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04718545
• Other study ID #: OCarcuac-modFGG
• Status: Completed
• Phase: N/A
• Start date: March 10, 2021
• Est. completion date: May 5, 2022

Study information

• Verified date: May 2022
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 5, 2022
• Est. primary completion date: May 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Gingival Recession
• Gingival Recession, Localized

Intervention

Procedure:
• Mucogingival surgery
The gingival recession at mandibular incisor site will be covered by a gingival graft harvested from the palate.

Locations

Country	Name	City	State
Sweden	Department of Periodontology, Institute of Odontology, Sahlgrenska Academy, University of Gothenburg	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
Göteborg University

Country where clinical trial is conducted

Sweden, 

References & Publications (6)

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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 Sup — View Citation

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. 201 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean mid-facial recession coverage (mRC)	mRC measured as a percentage	up to 1 year
Secondary	Keratinized tissue (KT) gain	KT gain measured in mm	6 months and 1 year