Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06504329
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-01
Brief Title:
Recession Coverage Using Modified Coronally Advanced TunnelMCAT
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Recession Coverage Using Modified Coronally Advanced Tunnel With Connective Tissue Graft and With or Without Enamel Matrix Derivative Randomized Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MCAT
Brief Summary:
In our study patients with Miller Class I and II gingival recession will be divided into three groups to undergo the modified coronally advanced tunnel MCAT technique using connective tissue grafts enamel matrix derivatives or a combination of connective tissue grafts and enamel matrix derivatives The short- and long-term success of these groups will be evaluated There are limited studies on the MCAT technique in the literature and our objectives and anticipated outcomes upon completion of the project are as follows
1 Evaluation of the success of the MCAT technique in root coverage
2 Evaluation of the aesthetic outcomes of the MCAT technique
3 Evaluation of the impact of the MCAT technique on postoperative patient comfort and morbidity
4 Assessment of the effect of enamel matrix derivative Emdogain application on treatment outcomes
5 Assessment of the effect of connective tissue graft on treatment outcomes
6 Investigation of the additional benefits of combining connective tissue grafts with enamel matrix derivatives
7 Evaluation of the long-term outcomes of gingival recession treatment
By focusing on these goals the investigators aim to provide comprehensive insights into the efficacy and benefits of the MCAT technique and its variations in treating gingival recession
1 Evaluation of the success of the MCAT technique in root coverage
2 Evaluation of the aesthetic outcomes of the MCAT technique
3 Evaluation of the impact of the MCAT technique on postoperative patient comfort and morbidity
4 Assessment of the effect of enamel matrix derivative Emdogain application on treatment outcomes
5 Assessment of the effect of connective tissue graft on treatment outcomes
6 Investigation of the additional benefits of combining connective tissue grafts with enamel matrix derivatives
7 Evaluation of the long-term outcomes of gingival recession treatment
By focusing on these goals the investigators aim to provide comprehensive insights into the efficacy and benefits of the MCAT technique and its variations in treating gingival recession
Detailed Description:
This study is planned to be conducted with 60 individuals aged between 18 and 45 who have presented to the Department of Periodontology at Necmettin Erbakan University Faculty of Dentistry for various reasons Routine initial periodontal examinations and Phase 1 periodontal treatments will be performed on individuals exhibiting gingival recession and associated sensitivity Standard mucogingival surgical procedures are routinely applied in our faculty to these individuals
In our study the short- and long-term outcomes of the MCAT technique a mucogingival approach will be evaluated The study will consist of the following three groups
Group 1 Modified coronally advanced tunnel MCAT subepithelial connective tissue graft n20 Group 2 Modified coronally advanced tunnel MCAT enamel matrix derivativen20 Group 3 Modified coronally advanced tunnel MCAT subepithelial connective tissue graft enamel matrix derivativen20
Our study is designed as a randomized controlled clinical trial Measurements will include gingival thickness the amount of root coverage and keratinized gingiva parameters recorded using a Williams probe Hu-Friedy and rounded to the nearest millimeter
For gingival recession plaque index and gingival index will be obtained from three points mesial distal and midpoints The plaque index will be calculated according to the criteria defined by Silness and Loe while the gingival index will be assessed based on the criteria defined by Loe and Silness Gingival thickness will be measured 3 mm below the gingival margin under topical anesthesia using an endodontic reamer with a stopper
Patients will be asked to complete a chart rating their subjective pain burning sensation and discomfort in the surgical area on a visual analogue scale VAS ranging from 0 none to 100 very severe on postoperative days 3 and 7 The clinician will remove the sutures two weeks after surgery and will complete the wound healing index for each tooth individually according to Huangs criteria
This study aims to provide comprehensive insights into the effectiveness and benefits of the MCAT technique and its variations in treating gingival recession
In our study the short- and long-term outcomes of the MCAT technique a mucogingival approach will be evaluated The study will consist of the following three groups
Group 1 Modified coronally advanced tunnel MCAT subepithelial connective tissue graft n20 Group 2 Modified coronally advanced tunnel MCAT enamel matrix derivativen20 Group 3 Modified coronally advanced tunnel MCAT subepithelial connective tissue graft enamel matrix derivativen20
Our study is designed as a randomized controlled clinical trial Measurements will include gingival thickness the amount of root coverage and keratinized gingiva parameters recorded using a Williams probe Hu-Friedy and rounded to the nearest millimeter
For gingival recession plaque index and gingival index will be obtained from three points mesial distal and midpoints The plaque index will be calculated according to the criteria defined by Silness and Loe while the gingival index will be assessed based on the criteria defined by Loe and Silness Gingival thickness will be measured 3 mm below the gingival margin under topical anesthesia using an endodontic reamer with a stopper
Patients will be asked to complete a chart rating their subjective pain burning sensation and discomfort in the surgical area on a visual analogue scale VAS ranging from 0 none to 100 very severe on postoperative days 3 and 7 The clinician will remove the sutures two weeks after surgery and will complete the wound healing index for each tooth individually according to Huangs criteria
This study aims to provide comprehensive insights into the effectiveness and benefits of the MCAT technique and its variations in treating gingival recession
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None