NCT06253910

Brief Summary

Attached gingiva, a crucial component of the keratinized tissue, plays a vital role in preserving periodontal health. The free gingival graft (FGG) and modified apically repositioned flap (MARF) techniques are frequently used for addressing issues related to insufficient attached gingiva. The aim of this study was to compare the efficiency of the FGG and the MARF increasing the zone of attached gingiva in 2-year posttreatment.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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 Start

First participant enrolled

February 15, 2019

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 12, 2024

Completed
Last Updated

February 13, 2024

Status Verified

February 1, 2024

Enrollment Period

3.8 years

First QC Date

February 2, 2024

Last Update Submit

February 10, 2024

Conditions

Keywords

attached gingivafree gingival graft

Outcome Measures

Primary Outcomes (2)

  • Attached gingiva width

    The width of the attached gingiva was calculated by measuring the distance from the crest of the gingival margin to the mucogingival junction and then subtracting the probing depth of the gingival sulcus from this distance on the particular tooth.

    Baseline, third month, first year and second years.

  • Keratinized tissue width

    The width of the keratinized tissue was calculated by measuring the distance from the crest of the gingival margin to the mucogingival junction

    Baseline, third month, first year and second years.

Secondary Outcomes (1)

  • Pocket probing depth

    Baseline, third month, first year and second years.

Study Arms (3)

Patient selection

OTHER

A total of 15 (female) patients, between 31 and 70 years, who were systemically and periodontally healthy and applied to the periodontology clinic for treatment, were included in our study. Criteria for inclusion in the study are having ≥15 permanent teeth excluding third molars, not using any orthodontic appliance, not being pregnant or breastfeeding, not having any uncontrolled chronic and/or auto-immune disease, and not smoking.

Other: Patients selection

MARF and FGG tehcniques

OTHER

Free gingival graft for the treatment of a total of 21 teeth with gingival recession in the lower jaw incisors area, no bone dehiscence, and the amount of attached gingiva being at least 0.5 mm and at most 1.5 mm and modified apically positioned flap methods were randomly selected (coin toss) and applied by a single investigator (MY). Surgical methods were performed on a minimum of 1 and a maximum of 2 teeth in the treated areas.

Other: Patients selection

Post-surgical evalution and periodontal measurements

OTHER

Clinical periodontal parameters (plaque index (PI), pocket probing depth (PPD), bleeding on probing (BOP), gingival recession (GR) and clinical attachment level (CAL)) were recorded and evaluated at baseline, third months, first and second years. Periodontal measurements (keratinized tissue width (KTW), attached gingiva width (AGW)) recorded and evaluated at baseline, third months, first and second years.

Other: Recall visits

Interventions

Patient selection were selected according to selected criteria.

MARF and FGG tehcniquesPatient selection

Following the operations, periodontal measurements were measured at the baseline, third month, first and second years.

Post-surgical evalution and periodontal measurements

Eligibility Criteria

Age34 Years - 58 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • having ≥15 permanent teeth excluding third molars,
  • not using any orthodontic appliance,
  • not being pregnant or breastfeeding,
  • not having any uncontrolled chronic and/or auto-immune disease,
  • not smoking.

You may not qualify if:

  • having chronic and/or auto-immune disease
  • smoking.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University, School of Dentistry

Istanbul, Fatih, 34083, Turkey (Türkiye)

Location

Related Publications (2)

  • Carnio J, Camargo PM, Klokkevold PR, Pirih FQ. The Modified Apically Repositioned Flap Technique: A Long-Term (4 to 16 Years) Retrospective Study. Int J Periodontics Restorative Dent. 2018 July/August;38(4):519-524. doi: 10.11607/prd.3028. Epub 2017 Dec 15.

    PMID: 29244886BACKGROUND
  • Carnio J, Carnio AT, Pirih FQ, Cordero MG, Camargo PM. The Modified Apically Repositioned Flap Technique and Its Potential to Create Attached Gingiva in Areas with No Keratinized Tissue: A Long-Term (1 to 11 Years) Retrospective Case Series Study. Int J Periodontics Restorative Dent. 2020 Jan/Feb;40(1):103-109. doi: 10.11607/prd.4241.

    PMID: 31815979BACKGROUND

Related Links

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
double (Participant, Investigator)
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Prof Dr

Study Record Dates

First Submitted

February 2, 2024

First Posted

February 12, 2024

Study Start

February 15, 2019

Primary Completion

November 22, 2022

Study Completion

December 1, 2023

Last Updated

February 13, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

IPD will not be shared

Locations