Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06373783
Status:
COMPLETED
Last Update Posted:
2024-04-23
First Post:
2024-04-04
Brief Title:
Ultrasonographic Evaluation of the Connective Tissue Grafts Obtained With Two Different Methods in Root Coverage
Sponsor:
Pamukkale University
Organization:
Pamukkale University
Study Overview
Official Title:
Ultrasonographic Evaluation of the Efficacy of Subepithelial Connective Tissue Grafts Versus De-epithelized Gingival Graft in Root Coverage With Coronally Advanced Flap Technique
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Gingival recession is a clinical problem that increases with age and affects patient comfort It is defined as the displacement of the gingival margin to a more apical position of the cementum-enamel border of the tooth
Coronally advanced flap CAF or tunnel technique TUN with subepithelial connective tissue procedures have been reported to be the most predictable methods of single gingival recession treatments The ultimate goal of these plastic periodontal surgical procedures is to close the exposed root surface and achieve optimum aesthetic results The main indications for root coverage RC procedures are aesthetic concern root hypersensitivity prevention of cervical abrasion and root caries improvement of restorative results and facilitation of plaque control The use of a subepithelial connective tissue graft SCGT combined with a coronally positioned flap is considered the gold standard by many authors for single gingival recession treatments
De-epithelialization of free gingival grafts DGG has been proposed especially when palatal tissue thickness is insufficient 25 mm and larger graft size in the apico-coronal or mesio-distal directions is required In this technique the graft of the required width and length is separated from the lateral side of the palate and then the 03-05 mm thick epithelial layer of the resulting graft is cut from the connective tissue layer
Ultrasonography USG is based on the principle of recording data obtained as a result of ultrasound waves sent with the help of a probe hitting and reflecting on substances of different densities This technique is widely used in medical practice In dentistry the USG method is used to measure the alveolar bone level and the dimensions of the periodontium to evaluate the gingival thickness It also has functions to evaluate color power and color speed as well as blood flow
The study hypothesizes that combining SCGT and DGG with a coronally positioned flap could yield different clinical outcomes in patients with a single buccal gingival recession This study aims to compare the clinical success of connective tissue grafts obtained by two different surgical methods in covering the root surface with ultrasonography USG
Coronally advanced flap CAF or tunnel technique TUN with subepithelial connective tissue procedures have been reported to be the most predictable methods of single gingival recession treatments The ultimate goal of these plastic periodontal surgical procedures is to close the exposed root surface and achieve optimum aesthetic results The main indications for root coverage RC procedures are aesthetic concern root hypersensitivity prevention of cervical abrasion and root caries improvement of restorative results and facilitation of plaque control The use of a subepithelial connective tissue graft SCGT combined with a coronally positioned flap is considered the gold standard by many authors for single gingival recession treatments
De-epithelialization of free gingival grafts DGG has been proposed especially when palatal tissue thickness is insufficient 25 mm and larger graft size in the apico-coronal or mesio-distal directions is required In this technique the graft of the required width and length is separated from the lateral side of the palate and then the 03-05 mm thick epithelial layer of the resulting graft is cut from the connective tissue layer
Ultrasonography USG is based on the principle of recording data obtained as a result of ultrasound waves sent with the help of a probe hitting and reflecting on substances of different densities This technique is widely used in medical practice In dentistry the USG method is used to measure the alveolar bone level and the dimensions of the periodontium to evaluate the gingival thickness It also has functions to evaluate color power and color speed as well as blood flow
The study hypothesizes that combining SCGT and DGG with a coronally positioned flap could yield different clinical outcomes in patients with a single buccal gingival recession This study aims to compare the clinical success of connective tissue grafts obtained by two different surgical methods in covering the root surface with ultrasonography USG
Detailed Description:
The study was planned as a randomized controlled study Patients with single Miller class 1 or 2 gingival recession who need root coverage surgery in the Department of Periodontology were included in the study In combination with Zuchellis coronally positioned flap technique gingival recession in the upper jaw premolar region was treated using a de-epithelialized gingival graft or a subepithelial gingival graft The subepithelial connective tissue graft was obtained in each patient using the single incision technique from the region between the mesial of the canine and the mesial of the first molar in the palate Connective tissue dimensions were approximately 10 X 5 X 2 mm Finally the incision line was sutured with 50 synthetic nonabsorbable sterile monofilament suture The de-epithelized gingival graft was taken in a rectangular shape from the area located on the palatal side of the maxillary canine and the first molar tooth and then it was de-epithelized with the help of a scalpel After the graft was stabilized to the recipient area with a 5-0 resorbable sterile monofilament suture The flap was repositioned and sutured with 50 synthetic nonabsorbable sterile monofilament suture
Clinical measurements probing depth PD clinical attachment level CAL gingival recession depth and width keratinized tissue width and height were taken on the day of surgery the 3rd days the 14th days the 1st month the 3rd months and the 6th months
Patients were evaluated using an ultrasonography device MyLabtm Seven Esaote Genoa Italy at the Department of Oral and Maxillofacial Radiology
USG measurements were performed on days 0 3 14 30 90 and 180 for buccal tissue thickness and tissue vascularization by an oral and maxillofacial radiologist with at least six years of experience A 6-8 MHZ intraoral probe was used in intraoral USG examinations Steril gel was applied to the intraoral probe and covered with stretch film Then it was placed directly on the buccal mucosal surface Mucosal thickness was evaluated using the B-mode of the device and vascularization was evaluated using the color Doppler and pulsed wave Doppler modes of the device mean pulsatility index PI values of each patient were calculated and considered for statistical analysis
The power analysis of the study was performed for sample size calculation In the power analysis when α 005 β 040 1-β 080 the number of regions to be included in the study was determined as 20 for each group The sample size was calculated with a statistical program
The data obtained from the study is the 22 version of SPSS SPSS Inc Chicago IL descriptive analysis means and standard deviations were calculated for all clinical effects and USG measurements Repeated measures analysis of variance was used for intragroup comparisons before and after treatment The normality of data distributions of the groups was measured with the Kolmogorov-Smirnov test In the comparison of groups an independent groups t-test was used if the data distributions were normal and Mann Whitney U test was used if the data distribution was not normal The significance value was taken as p005m GPower Universitat Dusseldorf Germany
Clinical measurements probing depth PD clinical attachment level CAL gingival recession depth and width keratinized tissue width and height were taken on the day of surgery the 3rd days the 14th days the 1st month the 3rd months and the 6th months
Patients were evaluated using an ultrasonography device MyLabtm Seven Esaote Genoa Italy at the Department of Oral and Maxillofacial Radiology
USG measurements were performed on days 0 3 14 30 90 and 180 for buccal tissue thickness and tissue vascularization by an oral and maxillofacial radiologist with at least six years of experience A 6-8 MHZ intraoral probe was used in intraoral USG examinations Steril gel was applied to the intraoral probe and covered with stretch film Then it was placed directly on the buccal mucosal surface Mucosal thickness was evaluated using the B-mode of the device and vascularization was evaluated using the color Doppler and pulsed wave Doppler modes of the device mean pulsatility index PI values of each patient were calculated and considered for statistical analysis
The power analysis of the study was performed for sample size calculation In the power analysis when α 005 β 040 1-β 080 the number of regions to be included in the study was determined as 20 for each group The sample size was calculated with a statistical program
The data obtained from the study is the 22 version of SPSS SPSS Inc Chicago IL descriptive analysis means and standard deviations were calculated for all clinical effects and USG measurements Repeated measures analysis of variance was used for intragroup comparisons before and after treatment The normality of data distributions of the groups was measured with the Kolmogorov-Smirnov test In the comparison of groups an independent groups t-test was used if the data distributions were normal and Mann Whitney U test was used if the data distribution was not normal The significance value was taken as p005m GPower Universitat Dusseldorf Germany
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None