- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05604391
The Effect of Free Gingival Graft on Root Closure
The Effect of Two Different Graft Positioning Techniques on Creeping Attachment in Free Gingival Graft Operations
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Berceste Güler
- Phone Number: +05059359207
- Email: berceste.guler@ksbu.edu.tr
Study Contact Backup
- Name: Seyma Eken
- Phone Number: 05518489820
- Email: seyma.eken@ksbu.edu.tr
Study Locations
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-
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Kütahya, Turkey, 43100
- Recruiting
- Kütahya Health Sciences University Faculty of Dentistry, Department of Periodontology
-
Contact:
- Berceste Güler
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Free gingival grafts to be placed apical to the gingival recession.
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.
|
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.
|
Active Comparator: Free gingival grafts to be placed coronal to the gingival recession.
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
1. Percent closure of the gingival recession
Time Frame: Postoperatively 1th month, Postoperatively 3th month, Postoperatively 6th month, Postoperatively 12th month
|
It is calculated by dividing the pre- and post-surgical values of the exposed root surface.
|
Postoperatively 1th month, Postoperatively 3th month, Postoperatively 6th month, Postoperatively 12th month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
2. Keratinized mucosa width change
Time Frame: Postoperatively 1th month, Postoperatively 3th month, Postoperatively 6th month, Postoperatively 12th month
|
It is the pre- and post-surgical variation of the distance from the free gingival margin to the mucogingival junction line.
|
Postoperatively 1th month, Postoperatively 3th month, Postoperatively 6th month, Postoperatively 12th month
|
3. Keratinized mucosa width thickness change
Time Frame: Postoperatively 1th month, Postoperatively 3th month, Postoperatively 6th month, Postoperatively 12th month
|
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.
|
Postoperatively 1th month, Postoperatively 3th month, Postoperatively 6th month, Postoperatively 12th month
|
4. Vestibular sulcus depth change
Time Frame: Postoperatively 1th month, Postoperatively 3th month, Postoperatively 6th month, Postoperatively 12th month
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It is the pre- and post-surgical variation of the distance measured from the gingival margin to the base of the sulcus.
|
Postoperatively 1th month, Postoperatively 3th month, Postoperatively 6th month, Postoperatively 12th month
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Berceste Güler, Kutahya Health Sciences University
Publications and helpful links
General Publications
- 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.
- 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.
- Bell LA, Valluzzo TA, Garnick JJ, Pennel BM. The presence of "creeping attachment" in human gingiva. J Periodontol. 1978 Oct;49(10):513-7.
- Matter J, Cimasoni G. Creeping attachment after free gingival grafts. J Periodontol. 1976 Oct;47(10):574-9.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-02/09
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Clinical Study Report (CSR)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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