Effect of Modified Free Gingival Graft and Conventional Free Gingival Graft on Gingival Recession
NCT ID: NCT06737120
Last Updated: 2024-12-17
Study Results
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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NOT_YET_RECRUITING
NA
60 participants
INTERVENTIONAL
2024-12-30
2025-07-30
Brief Summary
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Will gingival recession completely close in modified free gingival grafting areas? Will there be a significant increase in the amount of keratinized gingiva in modified free gingival grafting participants compared to traditional free gingival grafting participants? Participants will visit our clinic in the 1st, 3rd and 6th months. Necessary clinical parameter measurements will be made by the clinician.
Detailed Description
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The study was designed as a randomised controlled clinical trial in which 30 patients underwent free gingival grafting (FGG) operation and 30 patients underwent modified free gingival grafting operation (mod-FG). Clinical parameters of the patients were planned to be measured 1 week before, 1 month, 3 months and 6 months after the operation.
The following clinical measurements will be taken by a single investigator at baseline (1 week before surgery) and at 1, 3, 6 and 12 months after surgery:
* Gingival Recession Depth: The distance from the enamel-cementum border to the gingival margin will be measured with an accuracy of 0.1 mm.
* Recession width: The horizontal distance from the widest part of the recession at the enamel-cementum junction to the mesial and distal starting borders, measured with an accuracy of 0.1 mm.
* Keratised Tissue Height: The distance from the gingival margin to the mucogingival junction will be measured with an accuracy of 0.1 mm.
* Papil width: The length of the horizontal line connecting the zenith points of two neighbouring teeth, measured with an accuracy of 0.1 mm.
* Papil height: The length of the vertical distance from the papillary apex to the line passing through the zenith points of the teeth, measured with an accuracy of 0.1 mm.
* Tissue thickness: It will be measured 2 mm apical to the gingival margin in the mid-buccal region under topical anaesthesia with a root canal instrument fitted with a rubber stopper and the distance between the tip of the root canal instrument and the rubber stopper will be measured with a digital caliper.
* Pocket Depth: The distance between the base of the pocket and the free gingival margin will be measured with the help of a periodontal Williams probe at six points for each tooth and the pocket depth will be recorded.
After the initial examination, each person will be given individual oral hygiene instructions and will receive professional dental cleaning, root planing and polishing with a low abrasive polishing paste and a rubber band. Surgical treatment will be planned after adequate personal plaque control has been achieved.
The included participants will be randomly allocated into two groups: conventional free gingival graft (FGG, control) or modified free gingival graft (ModFGG, test). Random allocation will be done in a 1:1 ratio based on a computer-generated number list. Under local anaesthesia, the exposed root surfaces will be cleaned with Gracey curettes and rinsed thoroughly with saline. One of the following two procedures will be performed according to group allocation.
The primary outcome will be the reduction in gingival recession. Sample size calculation will be performed using a 5% significance level and 95% power, assuming that the critical difference in gingival recession reduction between the groups at the end of 12 months is 1.7 mm and the standard deviation is 1.2 mm.
Statistical analysis will be performed using the Statistical Package for the Social Sciences (SPSS) version 23 (IBM Corp., Armonk, NY). Data will be expressed as mean and standard deviation. Data normality will be assessed using the Kolmogorov-Smirnov test. Differences between parameter means in intra-group comparisons of SDG and modSDG groups will be evaluated using One-way ANOVA (Bonferroni post-hoc) test. Differences between the 2 groups in terms of gingival recession, changes in keratinized tissue height and probing depth, and percentage root coverage will be evaluated by regression analysis using time point and group distribution as main and interaction terms. Results will be expressed as predicted values and 95% confidence intervals. p\<0.05 will be considered statistically significant.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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modified free gingival graft
A connective tissue pedicle flap will be applied before a free gingival graft is placed in the recipient area.
Mod-fgg
Following an intrasulcular incision, 2 mm long horizontal incisions will be made on each side at the level of the gum line. From these incisions, divergent vertical release incisions will be made extending towards the alveolar mucosa. To prepare the recipient area, a thin partial thickness flap will be lifted and then removed. A foil template will be obtained by measuring the dimensions of the resulting area.
A horizontal incision will be made apical to the exposed root area of the target teeth at a distance corresponding to the height of the exposed root surface. Starting from the endpoints of this incision, two more slightly divergent incisions will be made in the coronal direction. Thus, a connective tissue pedicle flap will be formed and carefully separated from the periosteum. The pedicle graft will be turned over the exposed root surface and fixed with bioabsorbable sutures. The palatal graft will be sutured to cover the connective tissue.
traditional free gingival graft
Fgg
The surgical procedures to be performed in this group will be the same as in the modified free gingival graft group, but no connective tissue pedicle flap will be performed.
Interventions
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Mod-fgg
Following an intrasulcular incision, 2 mm long horizontal incisions will be made on each side at the level of the gum line. From these incisions, divergent vertical release incisions will be made extending towards the alveolar mucosa. To prepare the recipient area, a thin partial thickness flap will be lifted and then removed. A foil template will be obtained by measuring the dimensions of the resulting area.
A horizontal incision will be made apical to the exposed root area of the target teeth at a distance corresponding to the height of the exposed root surface. Starting from the endpoints of this incision, two more slightly divergent incisions will be made in the coronal direction. Thus, a connective tissue pedicle flap will be formed and carefully separated from the periosteum. The pedicle graft will be turned over the exposed root surface and fixed with bioabsorbable sutures. The palatal graft will be sutured to cover the connective tissue.
Fgg
The surgical procedures to be performed in this group will be the same as in the modified free gingival graft group, but no connective tissue pedicle flap will be performed.
Eligibility Criteria
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Inclusion Criteria
* Not smoking.
* Individuals aged 18 years and over.
* Shallow vestibule (≤5 mm).
* The periodontal pocket depth of the tooth/teeth to be treated should be ≤3 mm and the degree of tooth mobility should be ≤1.
* There should be no cervical composite restoration and no caries-free lesions on the teeth to be treated.
* Presence of Cairo Type 1 class gingival recession on the buccal surface of at most 2 of the mandibular incisors.
Exclusion Criteria
* untreated periodontal disease
* parafunctional habits
* poor oral hygiene (persistent whole mouth plaque index \> 20%)
* iodine allergy
* excessive dental crowding or misalignment of teeth.
18 Years
65 Years
ALL
Yes
Sponsors
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AYSE HUMEYRA ORUC
OTHER
Responsible Party
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AYSE HUMEYRA ORUC
research assistant
Locations
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Necmettin Erbakan University
Konya, , Turkey (Türkiye)
Countries
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Central Contacts
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References
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Camargo PM, Melnick PR, Kenney EB. The use of free gingival grafts for aesthetic purposes. Periodontol 2000. 2001;27:72-96. doi: 10.1034/j.1600-0757.2001.027001072.x. No abstract available.
Carcuac O, Trullenque-Eriksson A, Derks J. Modified free gingival graft technique for treatment of gingival recession defects at mandibular incisors: A randomized clinical trial. J Periodontol. 2023 Jun;94(6):722-730. doi: 10.1002/JPER.22-0581. Epub 2023 Jan 30.
Other Identifiers
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ModifiedFreeGingivalGraft
Identifier Type: -
Identifier Source: org_study_id