Comparison of Free Gingival Graft and Modified Apical Repositioning Flap Techniques

NCT ID: NCT06253910

Last Updated: 2024-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-15

Study Completion Date

2023-12-01

Brief Summary

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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.

Detailed Description

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The study included 15 participants who were both systemically and periodontally healthy, and these participants had a total of 21 teeth (10 for SDG and 11 for MARF). All included teeth had an attached gingiva width ranging from 0.5 mm to 1.5 mm and showed no signs of bone dehiscence. SDG and MARF methods were selected randomly (coin-to-coin). Clinical parameters recorded at baseline, third month, at first and second years were plaque index (PI), pocket probing depth (PPD), keratinized tissue width (KTW), attached gingiva width (AGW), bleeding on probing (BOP), gingival recession (GR) and clinical attachment level (CAL).

Conditions

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Periodontal Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators
double (Participant, Investigator)

Study Groups

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Patient selection

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.

Group Type OTHER

Patients selection

Intervention Type OTHER

Patient selection were selected according to selected criteria.

MARF and FGG tehcniques

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.

Group Type OTHER

Patients selection

Intervention Type OTHER

Patient selection were selected according to selected criteria.

Post-surgical evalution and periodontal measurements

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.

Group Type OTHER

Recall visits

Intervention Type OTHER

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

Interventions

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Patients selection

Patient selection were selected according to selected criteria.

Intervention Type OTHER

Recall visits

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* having chronic and/or auto-immune disease
* smoking.
Minimum Eligible Age

34 Years

Maximum Eligible Age

58 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Istanbul Medipol University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Nur Balci, DDs, PhD

Associate Prof Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Istanbul Medipol University, School of Dentistry

Istanbul, Fatih, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 29244886 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31815979 (View on PubMed)

Related Links

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Other Identifiers

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79

Identifier Type: -

Identifier Source: org_study_id

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