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

Primary Purpose

Gingival Recession, Localized

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Mucogingival surgery
Sponsored by
Göteborg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession, Localized

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Free Gingival Graft

Modified Free Gingival Graft

Arm Description

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

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

Outcomes

Primary Outcome Measures

mean mid-facial recession coverage (mRC)
mRC measured as a percentage

Secondary Outcome Measures

Keratinized tissue (KT) gain
KT gain measured in mm

Full Information

First Posted
January 16, 2021
Last Updated
May 8, 2022
Sponsor
Göteborg University
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1. Study Identification

Unique Protocol Identification Number
NCT04718545
Brief Title
Effectiveness of Modified-free Gingival Graft for Treatment of Localized Gingival Recession Defects
Official Title
Treatment of Localized Gingival Recession Defects at Lower Mandibular Incisors Using a Modified-free Gingival Graft: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
March 10, 2021 (Actual)
Primary Completion Date
May 5, 2022 (Actual)
Study Completion Date
May 5, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Göteborg University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession, Localized

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Free Gingival Graft
Arm Type
Active Comparator
Arm Description
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
Arm Title
Modified Free Gingival Graft
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Mucogingival surgery
Intervention Description
The gingival recession at mandibular incisor site will be covered by a gingival graft harvested from the palate.
Primary Outcome Measure Information:
Title
mean mid-facial recession coverage (mRC)
Description
mRC measured as a percentage
Time Frame
up to 1 year
Secondary Outcome Measure Information:
Title
Keratinized tissue (KT) gain
Description
KT gain measured in mm
Time Frame
6 months and 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tord Berglundh, DDS, PhD
Organizational Affiliation
Goteborg University
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Periodontology, Institute of Odontology, Sahlgrenska Academy, University of Gothenburg
City
Gothenburg
ZIP/Postal Code
40530
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24640999
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 Suppl 15:S36-43. doi: 10.1111/jcpe.12219.
Results Reference
result
PubMed Identifier
28758301
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.
Results Reference
result
PubMed Identifier
29926948
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.
Results Reference
result
PubMed Identifier
24802283
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. 2014 Aug;41(8):806-13. doi: 10.1111/jcpe.12269. Epub 2014 Jun 5.
Results Reference
result
PubMed Identifier
6358084
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. No abstract available.
Results Reference
result
PubMed Identifier
24641000
Citation
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.
Results Reference
result

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

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