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The Effect of Free Gingival Graft on Root Closure

Primary Purpose

Gingival Recession, Lack of Keratinized Gingiva

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Free gingival graft placed apically
Free gingival graft placed coronally
Sponsored by
Berceste Guler
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession focused on measuring free gingival grafts, creeping attachment, root closure, gingival recession

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 18-99 years old The patient does not have any systemic disease Presence of at least one tooth with gingival recession in the mandibular anterior region Excessive dentin sensitivity and impaired esthetics associated with recession Identification of the enamel-cementum boundary in the shrinkage region The tooth is alive and there are no irregularities, grooves, caries and restorations in the area to be treated. No periodontal surgical treatment in the relevant areas in the last 24 months Presence of adequate keratinized and attached gingiva in the donor area Exclusion Criteria: Being outside the specified age range Any contraindication for systematic periodontal surgery Failure to define the enamel-cementum boundary in the withdrawal region Presence of caries, restoration, root concavity in the area to be treated Patients who smoke more than 10 cigarettes per day Patients who use drugs that suppress the immune system or impair recovery Patients using drugs that impair bleeding Insufficient keratinized and attached gingiva in the donor area

Sites / Locations

  • Kütahya Health Sciences University Faculty of Dentistry, Department of PeriodontologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Free gingival grafts to be placed apical to the gingival recession.

Free gingival grafts to be placed coronal to the gingival recession.

Arm Description

It is the application of free gingival graft to the apical part of the recession area of mandibular anterior teeth with gingival recession and keratinized gingival height deficiency.

It is the application of free gingival graft to the coronal part of the recession area of mandibular anterior teeth with gingival recession and keratinized gingival height deficiency.

Outcomes

Primary Outcome Measures

1. Percent closure of the gingival recession
It is calculated by dividing the pre- and post-surgical values of the exposed root surface.

Secondary Outcome Measures

2. Keratinized mucosa width change
It is the pre- and post-surgical variation of the distance from the free gingival margin to the mucogingival junction line.
3. Keratinized mucosa width thickness change
It is the pre- and post-surgical variation of the distance measured between the gingival surface and hard tissue with a standard periodontal probe inserted perpendicular to the keratinized gingiva.
4. Vestibular sulcus depth change
It is the pre- and post-surgical variation of the distance measured from the gingival margin to the base of the sulcus.

Full Information

First Posted
October 28, 2022
Last Updated
November 8, 2022
Sponsor
Berceste Guler
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1. Study Identification

Unique Protocol Identification Number
NCT05604391
Brief Title
The Effect of Free Gingival Graft on Root Closure
Official Title
The Effect of Two Different Graft Positioning Techniques on Creeping Attachment in Free Gingival Graft Operations
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Berceste Guler

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
Free gingival graft is a mucogingival surgical technique applied to increase keratinized gingival width and reduce gingival recession. Free gingival graft is one of the most widely used approaches in root closure treatments and in increasing the height of the keratinized gingiva. Evaluation of the effect of the amount of creeping attachment on the root surface caused by the free gingival grafts placed coronally and apical to the mucogingival line on the gingival recession in the mandibular anterior region with keratinized gingival deficiency with gingival recession. Forty patients with gingival recession and insufficient keratinized gingival height will be randomly divided into 2 main groups as free gingival grafts to be placed coronal and apical to the gingival recession.
Detailed Description
Free gingival graft is a mucogingival surgical technique applied to increase keratinized gingival width and reduce gingival recession. Free gingival graft is one of the most widely used approaches in root closure treatments and in increasing the height of the keratinized gingiva. The "creeping attachment" phenomenon draws attention in the long-term success of root closure treatment in areas with gingival recession. "Creeping attachment" is defined as the coronal movement of the gingiva in the area where free gingival graft or connective tissue is applied in the postoperative period. The mean root closure rate with the creeping attachment is approximately 1 mm and can be detected 1 to 36 days after graft surgery. In the literature, clinical studies that measured a creeping attachment value between 0.12 and 3.5 mm in a 2-year period in free gingival grafts applied to the marginal gingival level have been reported. Systemically healthy and non-smoking patients older than 18 years of age who applied to Kütahya Health Sciences University, Faculty of Dentistry, Department of Periodontology and had gingival recession in mandibular anterior teeth and keratinized gingival deficiency will be included in the study. Systemic and dental anamnesis will be taken from the patient before the operation and clinical measurements will be recorded. Patients will be divided into 2 main groups as free gingival grafts to be placed coronal and apical to the gingival recession. They will be written as Group I and Group II in sealed envelopes and apical and coronal positioning groups will be chosen randomly. The operation date will be given after the patient is given oral hygiene training and 4 weeks after receiving Phase I routine periodontal treatment. The data to be obtained preoperatively and postoperatively are as follows: Clinical measurements Plaque index (Löe&Silness): It is obtained by measuring with a periodontal probe from 4 regions of a tooth (mesial, distal, buccal and lingual). Gingival index (Silness&Löe): It is obtained by measuring with a periodontal probe from 4 regions of a tooth (mesial, distal, buccal and lingual). Attachment loss: It is the value of the distance between a tooth and the free gingiva based on the enamel-cementum boundary measured using a periodontal sonde. Bleeding index on probing (Ainamo & Bay): In this index, probing is performed by gently walking around the pocket. As a result of probing, the evaluation is made by looking at the presence or absence of bleeding in the gingiva. A positive value is given if bleeding occurs within 10-15 seconds after probing in the mesial, distal, buccal and lingual gingival parts of all teeth. The ratio of the bleeding area to the examined area is expressed as %. Pocket depth: It is the vertical distance measured between a standard periodontal probe and the base of the periodontal sulcus and the gingival margin. Keratinized gingival height: It is the distance from the free gingival margin to the mucogingival junction line. Keratinized gingival thickness: It is the distance measured between the gingival surface and hard tissue with a standard periodontal probe inserted perpendicular to the keratinized gingiva. Gingival recession depth: It is obtained by measuring the distance between the gingival margin in the midbuccal region and the enamel-cementum boundary. Gingival recession width: It is the mesio-distal width of the recession from the midpoint of the distance between the enamel cementum border and the gingival margin. Gingival phenotype: Visibility of the periodontal tube in the sulcus Vestibular sulcus depth: It is the distance measured from the gingival margin to the base of the sulcus. Sample Selection: Taking the effect size of 0.08 for the significance value in the G Power analysis program as a reference to a previously presented study, 40 teeth were planned to be taken for α= 0.05 and 80% power. Statistical Analysis method: All analyzes will be done with SPSS software. Intra-group temporal evaluations in test and control groups will be evaluated using Pairedsample -T or Wilcoxon test according to normal distribution values. For intergroup comparisons, according to the normal distribution of data, Student-t test will be analyzed in parametric within-group evaluations and Mann Withney U test in nonparametrics. The normal distribution of the data will be evaluated with the Kolmogorov-Smirnov test. The significance value will be taken as 0.05. Relationships between variables will be evaluated with Logistic Regression Analysis or Multivariate Regression Analysis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession, Lack of Keratinized Gingiva
Keywords
free gingival grafts, creeping attachment, root closure, gingival recession

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Method clinical trial Free gingival graft application has been a routine and successful treatment option since the 1960s. Positioning methods are applied on or apical gingival recession. The aim of this study is to evaluate the effect of two different free gingival graft positioning techniques on the creeping attachment.
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Free gingival grafts to be placed apical to the gingival recession.
Arm Type
Active Comparator
Arm Description
It is the application of free gingival graft to the apical part of the recession area of mandibular anterior teeth with gingival recession and keratinized gingival height deficiency.
Arm Title
Free gingival grafts to be placed coronal to the gingival recession.
Arm Type
Active Comparator
Arm Description
It is the application of free gingival graft to the coronal part of the recession area of mandibular anterior teeth with gingival recession and keratinized gingival height deficiency.
Intervention Type
Procedure
Intervention Name(s)
Free gingival graft placed apically
Intervention Description
For free gingival graft operation, the recipient area will be prepared with a half-thickness flap. A graft with a thickness of approximately 1.5 mm and a width and height of the recipient bed will be obtained from the palatal region in accordance with the recipient bed, and it will be sutured by placing it in the apical region of the gingival recession according to the randomly selected positioning technique.
Intervention Type
Procedure
Intervention Name(s)
Free gingival graft placed coronally
Intervention Description
For free gingival graft operation, the recipient area will be prepared with a half-thickness flap. A graft with a thickness of approximately 1.5 mm and a width and height of the recipient bed will be obtained from the palatal region in accordance with the recipient bed, and it will be sutured by placing the coronal region of the gingival recession according to the randomly selected positioning technique.
Primary Outcome Measure Information:
Title
1. Percent closure of the gingival recession
Description
It is calculated by dividing the pre- and post-surgical values of the exposed root surface.
Time Frame
Postoperatively 1th month, Postoperatively 3th month, Postoperatively 6th month, Postoperatively 12th month
Secondary Outcome Measure Information:
Title
2. Keratinized mucosa width change
Description
It is the pre- and post-surgical variation of the distance from the free gingival margin to the mucogingival junction line.
Time Frame
Postoperatively 1th month, Postoperatively 3th month, Postoperatively 6th month, Postoperatively 12th month
Title
3. Keratinized mucosa width thickness change
Description
It is the pre- and post-surgical variation of the distance measured between the gingival surface and hard tissue with a standard periodontal probe inserted perpendicular to the keratinized gingiva.
Time Frame
Postoperatively 1th month, Postoperatively 3th month, Postoperatively 6th month, Postoperatively 12th month
Title
4. Vestibular sulcus depth change
Description
It is the pre- and post-surgical variation of the distance measured from the gingival margin to the base of the sulcus.
Time Frame
Postoperatively 1th month, Postoperatively 3th month, Postoperatively 6th month, Postoperatively 12th month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18-99 years old The patient does not have any systemic disease Presence of at least one tooth with gingival recession in the mandibular anterior region Excessive dentin sensitivity and impaired esthetics associated with recession Identification of the enamel-cementum boundary in the shrinkage region The tooth is alive and there are no irregularities, grooves, caries and restorations in the area to be treated. No periodontal surgical treatment in the relevant areas in the last 24 months Presence of adequate keratinized and attached gingiva in the donor area Exclusion Criteria: Being outside the specified age range Any contraindication for systematic periodontal surgery Failure to define the enamel-cementum boundary in the withdrawal region Presence of caries, restoration, root concavity in the area to be treated Patients who smoke more than 10 cigarettes per day Patients who use drugs that suppress the immune system or impair recovery Patients using drugs that impair bleeding Insufficient keratinized and attached gingiva in the donor area
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Berceste Güler
Phone
+05059359207
Email
berceste.guler@ksbu.edu.tr
First Name & Middle Initial & Last Name or Official Title & Degree
Seyma Eken
Phone
05518489820
Email
seyma.eken@ksbu.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Berceste Güler
Organizational Affiliation
Kütahya Health Sciences University
Official's Role
Study Director
Facility Information:
Facility Name
Kütahya Health Sciences University Faculty of Dentistry, Department of Periodontology
City
Kütahya
ZIP/Postal Code
43100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Berceste Güler

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
ndividual participant data can be shared if the principal investigator is contacted
IPD Sharing Time Frame
Following acceptance of manuscript
IPD Sharing Access Criteria
Individual participant data can be shared if the principal investigator is contacted
Citations:
PubMed Identifier
6936409
Citation
Dorfman HS, Kennedy JE, Bird WC. Longitudinal evaluation of free autogenous gingival grafts. J Clin Periodontol. 1980 Aug;7(4):316-24. doi: 10.1111/j.1600-051x.1980.tb01974.x.
Results Reference
background
PubMed Identifier
19722789
Citation
Agudio G, Nieri M, Rotundo R, Franceschi D, Cortellini P, Pini Prato GP. Periodontal conditions of sites treated with gingival-augmentation surgery compared to untreated contralateral homologous sites: a 10- to 27-year long-term study. J Periodontol. 2009 Sep;80(9):1399-405. doi: 10.1902/jop.2009.090122.
Results Reference
background
PubMed Identifier
282425
Citation
Bell LA, Valluzzo TA, Garnick JJ, Pennel BM. The presence of "creeping attachment" in human gingiva. J Periodontol. 1978 Oct;49(10):513-7. doi: 10.1902/jop.1978.49.10.513.
Results Reference
background
PubMed Identifier
1067400
Citation
Matter J, Cimasoni G. Creeping attachment after free gingival grafts. J Periodontol. 1976 Oct;47(10):574-9. doi: 10.1902/jop.1976.47.10.574.
Results Reference
background
PubMed Identifier
31473705
Citation
Gul SS, Zardawi FM, Sha AM, Rauf AM. Assessment of Creeping Attachment after Free Gingival Graft in Treatment of Isolated Gingival Recession. J Int Acad Periodontol. 2019 Jul 1;21(3):125-131.
Results Reference
background

Learn more about this trial

The Effect of Free Gingival Graft on Root Closure

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