Clinical trial NCT06101524: Volumetric Changes in Free Gingival Graft Procedures Taken With Different Techniques
Official title: Digital Evaluation of Volumetric Changes of Free Gingival Graft and Gingival Unit Graft With Indirect Method
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ndirectly Measuring the Difference Between the Free Gingival Graft and the Free Gingival Unit Via a Scanner
Keywords: Free gingival greft
Free gingival unit
Scanner
Lead sponsor: Kahramanmaras Sutcu Imam University
Sponsor class: OTHER
First posted: 2023-10-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The primary aim of this study is to evaluate the clinical results of free gingival graft and gingival unit graft by indirect method.

To evaluate the 6-month results linearly and volumetrically using an intraoral scanner (TRİOS, 3Shape, Copenhagen, Denmark) (using measurements and on a plaster model).

Detailed description: Deficiency of keratinized tissue includes mucogingival problems among different clinical entities. (Silva et al., 2010) There is no consensus on the minimum amount of attached gingiva required to maintain the health of the gums. However, there are many clinical situations that demonstrate the necessity of keratinized tissue. (Cevallos et al., 2020) (Agarwal et al., 2015) For example, if the attached gingiva is thin, it becomes difficult to perform adequate oral hygiene procedures and plaque. Inflammation and attachment loss are observed due to accumulation. (Gümüş and Buduneli, 2014) (Raoofi et al., 2019) Keratinized tissue width expresses the distance between the coronal margin of the gingival sulcus and the mucogingival line. It is considered to be the main factor in the management and protection of tissue health around natural teeth. (Agudio et al., 2019) Gingival recession refers to the apical displacement of the soft tissue margin from the cemento-enamel border. Oral hygiene and plaque with tooth sensitivity, root caries, unaesthetic appearance as well as loss of periodontal attachment causes retention. (Arzouman et al., n.d.) (Chambrone and Tatakis, 2015) In the treatment of gingival recession Many techniques have been described: Subepithelial connective tissue graft, stemmed grafts (coronally, laterally), free gingival graft (FGG), gingival unit graft (GUG). (Cevallos et al., 2020)(Sriwil et al., 2020). Although significant results are observed, there are different success rates between techniques. (Sriwil et al., 2020) FGG is used not only to cover the root surface but also to increase the width of keratinized tissue. It was first proposed by Nabers for this purpose. (Mörmann et al., 1981) Currently, the FGG's incompatible aesthetic and crude. It has many limitations due to its appearance. (Sriwil et al., 2020)

Due to the limitations of the FGG, there was a need for a new perspective on such phenomena. The vascular characteristics of the graft are important in terms of rapid capillary anastomosis with impaired vascularity of the recipient site. (Sriwil et al., 2020) Gingival sulcus, where thin blood vessels form a network and capillaries show numerous anastomoses is the place. (Jenabian et al., 2016) The vascular plexus of the gingiva, in terms of horizontal anastomoses feeding the marginal zone marginal and interdental tissues to benefit from better blood perfusion of the recipient area can be used, thus increasing the chances of survival of the graft. (Sriwil et al., 2020) (Yıldırım, 2015) The supracrestal part of the gingiva, which includes the marginal and papillary tissues, is included in the soft tissue graft taken to nourish the avascular root surface.

Studies have shown that the marginal, attached, and interdental gingival regions have significantly different vascular distributions. (Sriwil et al., 2020)

Due to these advantages of marginal and interdental tissues, the technique defined as Gingival Unit Graft (GUG) containing marginal and interdental papilla has emerged as an alternative approach to FGG. (Yıldırım, 2015) Kuru and Yıldırım, in their randomized controlled study comparing FGG and GUG in terms of keratinized tissue gain and root surface coverage, reported that DÜG gave better clinical results. (Dry oath Yıldırım, 2013)

G Power 3.1 (University Kiel, Germany) program was used to calculate the effect size. Effect size Free Gingival Graft in the study of Sriwil, Fakher (1) and an effect size of 2.12 d cohen was determined to be sufficient for significance. It was found that a total of 20 samples, at least 10 for each study group, was sufficient with a type 1 error of 0.05 and 99% power.

Free Gingival Graft was applied to 10 patients with keratinized mucosa deficiency, and Gingival Unit Graft was applied to 10 patients. Volumetric changes in the gingiva were measured both clinically and by scanner at the beginning and 6th months.

Eligibility criteria: Inclusion Criteria:

* Patients who are systemically healty,

Exclusion Criteria:

-

Primary outcomes:
measure: Keratinized gingival width
timeFrame: İnitial and postoperative 6 months
measure: Average gingival thickness change (mm)
timeFrame: İnitial and postoperative 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kahramanmaraş
country: Turkey
facility: Kahramanmaraş Sütçü İmam University
Study officials:
affiliation: Kahramanmaras Sutcu Imam University
name: Eda Çetin Özdemir
role: STUDY_CHAIR
References:
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citation: Arzouman A, Deas DE, Mills MP, Huynh-Ba G, Prihoda TJ, Mealey BL. Impact of different surgical protocols on dimensional changes of free soft tissue autografts: A randomized controlled trial. J Periodontol. 2021 Jan;92(1):45-53. doi: 10.1002/JPER.20-0033. Epub 2020 Oct 16.
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citation: Cevallos CAR, de Resende DRB, Damante CA, Sant'Ana ACP, de Rezende MLR, Greghi SLA, Zangrando MSR. Free gingival graft and acellular dermal matrix for gingival augmentation: a 15-year clinical study. Clin Oral Investig. 2020 Mar;24(3):1197-1203. doi: 10.1007/s00784-019-02983-0. Epub 2019 Jul 12.
citation: De Bruyckere T, Cabeza RG, Eghbali A, Younes F, Cleymaet R, Cosyn J. A randomized controlled study comparing guided bone regeneration with connective tissue graft to reestablish buccal convexity at implant sites: A 1-year volumetric analysis. Clin Implant Dent Relat Res. 2020 Aug;22(4):468-476. doi: 10.1111/cid.12934. Epub 2020 Jul 19.