NCT06030947

Brief Summary

The objective of this project is to evaluate 1-year outcomes of treatment of MAGRD using a modified coronally advanced tunnel technique (MCAT) with either conventional CTG (control group) or micro-CTG (test group).

Trial Health

77
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
3mo left

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress84%
Mar 2025Aug 2026

First Submitted

Initial submission to the registry

September 3, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 11, 2023

Completed
1.5 years until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Expected
Last Updated

March 13, 2025

Status Verified

March 1, 2025

Enrollment Period

10 months

First QC Date

September 3, 2023

Last Update Submit

March 11, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Mean mid-facial recession coverage (mRC)

    Percentage of the exposed tooth root covered after surgical intervention

    up to 1 year

Secondary Outcomes (5)

  • Complete Root Coverage (CRC)

    up to 1 year

  • Changes of Keratinized Tissue Width (KTW)

    up to 1 year

  • Changes of Gingival Thickness (GT)

    up to 1 year

  • Patient Morbidity

    up to 2 weeks

  • Patient Satisfaction

    up to 1 year

Study Arms (2)

Connective Tissue Graft

ACTIVE COMPARATOR

A mucogingival surgery where a conventional connective tissue graft harvested from the palate is placed on a recipient site prepared for modified coronally advanced tunnel and sutured to cover multiple adjacent gingival recession defects.

Procedure: Coronally Advanced Flap combined with a Connective Tissue Graft

Micro Connective Tissue Graft

EXPERIMENTAL

A mucogingival surgery where multiple micro connective tissue graft harvested from the palate are placed on a recipient site prepared for modified coronally advanced tunnel and sutured to cover multiple adjacent gingival recession defects.

Procedure: Coronally Advanced Flap combined with micro Connective Tissue GraftDevice: Division of the Connective Tissue Graft into multiple micro Connective Tissue Grafts

Interventions

Multiple adjacent gingival recession defects will be covered by coronally advanced flap combined with a connective tissue graft harvested from the palate.

Connective Tissue Graft

Multiple adjacent gingival recession defects will be covered by coronally advanced flap combined with multiple micro connective tissue graft harvested from the palate.

Micro Connective Tissue Graft

The harvested connective tissue graft is divided in multiple micro connective tissue grafts with a scalpel blade before being placed on the recipient site.

Micro Connective Tissue Graft

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • age ≥18 years,
  • systemically healthy,
  • presenting with a minimum of 4 and a maximum of 6 adjacent RT1/RT2 recessions, located in the maxilla or mandible with an apico-coronal extension (i.e. recession depth) of ≥2 mm,
  • Full-Mouth Plaque Score (FMPS) \<20%,
  • Full-Mouth Bleeding Score (FMBS) \<20%.

You may not qualify if:

  • pregnancy or lactation,
  • tobacco smoking,
  • uncontrolled medical condition,
  • medication that can affect gingival conditions.
  • thick phenotype,
  • severe tooth malpositioning,
  • uncorrected trauma from toothbrushing,
  • a previous history of root coverage procedures
  • the presence of furcation defects.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Confident Dubai Palm

Dubai, 0000, United Arab Emirates

RECRUITING

Related Publications (6)

  • Consensus report. Mucogingival therapy. Ann Periodontol. 1996 Nov;1(1):702-6. doi: 10.1902/annals.1996.1.1.702. No abstract available.

  • 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.

  • 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.

  • Graziani F, Gennai S, Roldan S, Discepoli N, Buti J, Madianos P, Herrera D. Efficacy of periodontal plastic procedures in the treatment of multiple gingival recessions. J Clin Periodontol. 2014 Apr;41 Suppl 15:S63-76. doi: 10.1111/jcpe.12172.

  • Ronco V, Dard M. A novel suturing approach for tissue displacement within minimally invasive periodontal plastic surgery. Clin Case Rep. 2016 Jul 23;4(8):831-7. doi: 10.1002/ccr3.582. eCollection 2016 Aug.

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Study Officials

  • Jan Derks, DDS, PhD

    Goteborg University

    STUDY CHAIR

Central Study Contacts

Olivier Carcuac, DDS, PhD

CONTACT

Jan Derks, DDS, PhD

CONTACT

Study Design

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

Study Record Dates

First Submitted

September 3, 2023

First Posted

September 11, 2023

Study Start

March 1, 2025

Primary Completion

January 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

March 13, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations