NCT04718545

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

March 10, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2022

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

April 15, 2025

Completed
Last Updated

April 15, 2025

Status Verified

April 1, 2025

Enrollment Period

1.2 years

First QC Date

January 16, 2021

Results QC Date

October 15, 2024

Last Update Submit

April 14, 2025

Conditions

Gingival Recession, Localized

Outcome Measures

Primary Outcomes (1)

  • Mean Mid-facial Recession Coverage (mRC)

    mRC measured as a percentage

    up to 1 year

Secondary Outcomes (1)

  • Keratinized Tissue (KT) Gain

    up to 1 year

Study Arms (2)

Free Gingival Graft

ACTIVE COMPARATOR

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

Modified Free Gingival Graft

EXPERIMENTAL

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

Interventions

Mucogingival surgeryPROCEDURE

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

Free Gingival GraftModified Free Gingival Graft

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnancy
  • Smoking
  • Alcoholism
  • Para-functional habits
  • Poor oral hygiene
  • Excessive crowding or misalignment of teeth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Gothenburg, 40530, Sweden

Location

Related Publications (6)

  • 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.

    PMID: 24640999RESULT

  • 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.

    PMID: 28758301RESULT

  • 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.

    PMID: 29926948RESULT

  • 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.

    PMID: 24802283RESULT

  • 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.

    PMID: 6358084RESULT

  • 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.

    PMID: 24641000RESULT

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Results Point of Contact

Title
Dr Olivier Carcuac
Organization
Goteborg University
olivier.carcuac@gu.se
317863124

Study Officials

  • Tord Berglundh, DDS, PhD

    Goteborg University

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2021

First Posted

January 22, 2021

Study Start

March 10, 2021

Primary Completion

May 5, 2022

Study Completion

May 5, 2022

Last Updated

April 15, 2025

Results First Posted

April 15, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)