Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06365983
Status:
RECRUITING
Last Update Posted:
2024-04-15
First Post:
2024-04-10
Brief Title:
Comparison of Free Gingival Graft and Linear Incision for Connective Tissue
Sponsor:
Federal University of Rio Grande do Sul
Organization:
Federal University of Rio Grande do Sul
Study Overview
Official Title:
Comparison of Free Gingival Graft and Linear Incision Techniques to Obtain Connective Tissue Graft in the Treatment of Multiple Gingival Recessions a 12-month Non-inferiority Randomized Trial
Status:
RECRUITING
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:
A randomized controlled non-inferiority trial will be conducted with 24 individuals aged 18 or older who are periodontally healthy and require root coverage in bilateral multiple RT1-type recessions involving at least two teeth on each side of the mouth The number of teeth to be covered must be equal on both sides to avoid imbalance in patient-centered comparisons
Patients included in the study will undergo the bilateral multiple root coverage technique with coronally repositioned flap Zucchelli and De Sanctis in both groups The donor areas for connective tissue will be the hard palate region with grafts harvested using the linear technique on one side and the free de-epithelialized gingival graft technique on the other side
Each patient will undergo a preparatory phase for study inclusion consisting of supragingival scaling polishing and oral hygiene instructions at least 3 weeks before study inclusion Patients will be instructed on personalized and proper use of toothbrush dental floss andor interdental brush
All surgical procedures in both groups will be performed by the same operator CCO Randomization will determine the side to be operated on first The other side will be operated on after 30 days or until the patient reports complete absence of symptoms in the area of the first surgery to avoid confusion in patient-centered outcomes regarding pain and satisfaction with the techniques
Outcomes evaluated at 3 6 9 and 12 months include gingival recession depth probing depth visible plaque bleeding on probing width of keratinized tissue three-dimensional tissue assessment from intraoral scanning and quality of life related Linear and logistic generalized estimating equation models considering the longitudinal nature of the study will be used for data analysis
INCLUSION CRITERIA Patients aged 18 or older requiring root coverage in bilateral multiple recessions involving at least two teeth on each side of the mouth will be included The number of teeth to be covered must be equal on both sides to avoid imbalance in patient-centered comparisons Recessions should be RT1 type according to the 2017 Workshop on the Classification of Periodontal Conditions and Diseases Jepsen et al 2018 and without non-carious cervical lesions
EXCLUSION CRITERIA
Individuals will not be considered eligible if they
Present any form of immunological compromise
Have diseases or systemic conditions contraindicating surgical procedures or affecting periodontal healing pattern such as diabetes and autoimmune diseases
Present active periodontitis defined by presence of 10 subgingival bleeding and probing depth and clinical attachment loss proximal 4mm Tonetti et al 2018
Are current or ex-smokers
Have allergies to ibuprofen and chlorhexidine digluconate
Research Objective
PRIMARY OBJECTIVE The overall objective of this study is to compare free gingival graft and subepithelial connective tissue graft in outcomes related to multiple recession coverage
SECONDARY OBJECTIVE
Compare the two grafts in terms of clinical outcomes of root coverage Compare the two grafts in terms of digital outcomes of root coverage obtained in scanning and tomography Compare the two grafts in terms of patient-centered outcomes
Patients included in the study will undergo the bilateral multiple root coverage technique with coronally repositioned flap Zucchelli and De Sanctis in both groups The donor areas for connective tissue will be the hard palate region with grafts harvested using the linear technique on one side and the free de-epithelialized gingival graft technique on the other side
Each patient will undergo a preparatory phase for study inclusion consisting of supragingival scaling polishing and oral hygiene instructions at least 3 weeks before study inclusion Patients will be instructed on personalized and proper use of toothbrush dental floss andor interdental brush
All surgical procedures in both groups will be performed by the same operator CCO Randomization will determine the side to be operated on first The other side will be operated on after 30 days or until the patient reports complete absence of symptoms in the area of the first surgery to avoid confusion in patient-centered outcomes regarding pain and satisfaction with the techniques
Outcomes evaluated at 3 6 9 and 12 months include gingival recession depth probing depth visible plaque bleeding on probing width of keratinized tissue three-dimensional tissue assessment from intraoral scanning and quality of life related Linear and logistic generalized estimating equation models considering the longitudinal nature of the study will be used for data analysis
INCLUSION CRITERIA Patients aged 18 or older requiring root coverage in bilateral multiple recessions involving at least two teeth on each side of the mouth will be included The number of teeth to be covered must be equal on both sides to avoid imbalance in patient-centered comparisons Recessions should be RT1 type according to the 2017 Workshop on the Classification of Periodontal Conditions and Diseases Jepsen et al 2018 and without non-carious cervical lesions
EXCLUSION CRITERIA
Individuals will not be considered eligible if they
Present any form of immunological compromise
Have diseases or systemic conditions contraindicating surgical procedures or affecting periodontal healing pattern such as diabetes and autoimmune diseases
Present active periodontitis defined by presence of 10 subgingival bleeding and probing depth and clinical attachment loss proximal 4mm Tonetti et al 2018
Are current or ex-smokers
Have allergies to ibuprofen and chlorhexidine digluconate
Research Objective
PRIMARY OBJECTIVE The overall objective of this study is to compare free gingival graft and subepithelial connective tissue graft in outcomes related to multiple recession coverage
SECONDARY OBJECTIVE
Compare the two grafts in terms of clinical outcomes of root coverage Compare the two grafts in terms of digital outcomes of root coverage obtained in scanning and tomography Compare the two grafts in terms of patient-centered outcomes
Detailed Description:
None
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