Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06404762
Status:
RECRUITING
Last Update Posted:
2024-05-08
First Post:
2024-05-05
Brief Title:
Tuberosity Versus Palatal Connective Tissue Graft on the Treatment of Single Maxillary Recession-type Defects
Sponsor:
Gazi University
Organization:
Gazi University
Study Overview
Official Title:
Comparison of Subepithelial Connective Tissue Grafts Harvested from the Maxillary Tuberosity or Lateral Palate in the Treatment of Single Maxillary Recession-type Defects
Status:
RECRUITING
Status Verified Date:
2024-05
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:
The goal of this randomized clinical study is to assess the root coverage outcomes and patient morbidity following the treatment of single maxillary recession-type defects using a coronally advanced flap CAF combined with a subepithelial connective tissue graft SCTG harvested from the maxillary tuberosity MT versus lateral palate LP The secondary objective is to evaluate the histological characteristics of graft compositions harvested from the different regions MT versus LP
Therefore the following questions related to the study are raised
Do SCTGs harvested from MT tSCTG and LP pSCTG exhibit similar root coverage outcomes in the treatment of single maxillary recession-type defects using CAF
What are the histological characteristics of tSCTG and pSCTG
A total of 30 patients who have been referred to the Gazi University Department of Periodontology will be randomly assigned to receive tSCTG or pSCTG in combination with CAF Clinical measurements will be recorded at baseline 1 3 6 and 12 months after surgeries Immediately after interventions a questionnaire evaluating post-operative pain discomfort sensitivity and bleeding will be given to the patients The amount of non-steroid anti-inflammatory drugs used will be recorded at 1 2 3 7 14 and 28 days after surgery Descriptive morphologic analysis of the grafts will be assessed in terms of the presence of inflammatory cells connective tissue cellularity vascularization adipose tissue and collagen structure
Therefore the following questions related to the study are raised
Do SCTGs harvested from MT tSCTG and LP pSCTG exhibit similar root coverage outcomes in the treatment of single maxillary recession-type defects using CAF
What are the histological characteristics of tSCTG and pSCTG
A total of 30 patients who have been referred to the Gazi University Department of Periodontology will be randomly assigned to receive tSCTG or pSCTG in combination with CAF Clinical measurements will be recorded at baseline 1 3 6 and 12 months after surgeries Immediately after interventions a questionnaire evaluating post-operative pain discomfort sensitivity and bleeding will be given to the patients The amount of non-steroid anti-inflammatory drugs used will be recorded at 1 2 3 7 14 and 28 days after surgery Descriptive morphologic analysis of the grafts will be assessed in terms of the presence of inflammatory cells connective tissue cellularity vascularization adipose tissue and collagen structure
Detailed Description:
The treatment of gingival recessions using the coronally advanced flap CAF in combination with palatal subepithelial connective tissue graft pSCTG is highly predictable and frequently accepted in periodontal plastic-aesthetic surgeries However due to its limitations and disadvantages clinicians often use grafts harvested from different autogenous areas or multiple non-autogenous materials as an alternative
CAF combined with pSCTG is considered the gold standard for root coverage procedures However factors such as the density of vascular structures a close approximation to nerves and postoperative morbidity remain concerning for clinicians using palatal connective tissue grafts Because of this researchers have sought different techniques for palatal connective tissue harvesting andor different autogenous donor areas The maxillary tuberosity region has been found to have a denser lamina propria and is farther from nervevascular bundles
Despite differences in harvesting techniques literature has presented similar root coverage outcomes lesser post-operative bleeding and pain for SCTGs harvested from the maxillary tuberosity tSCTG compared to pSCTG groups Decreased post-operative pain after tSCTG harvesting could be explained by higher amounts of connective tissue present in the donor area after harvesting and avoiding trauma created by food consumption and tongue movements in the region Clinical data also showed an increased amount of keratinized tissue and its stability after augmentation favoring tSCTG Considering structural differences literature has shown that tSCTG provides more thickness a more abundant lamina propria and denser collagen compared to pSCTG However due to the size of the harvested tSCTG not being as abundant as pSCTG it can be assumed that the augmented areas were limited to multiple recessions or defects
CAF combined with pSCTG is considered the gold standard for root coverage procedures However factors such as the density of vascular structures a close approximation to nerves and postoperative morbidity remain concerning for clinicians using palatal connective tissue grafts Because of this researchers have sought different techniques for palatal connective tissue harvesting andor different autogenous donor areas The maxillary tuberosity region has been found to have a denser lamina propria and is farther from nervevascular bundles
Despite differences in harvesting techniques literature has presented similar root coverage outcomes lesser post-operative bleeding and pain for SCTGs harvested from the maxillary tuberosity tSCTG compared to pSCTG groups Decreased post-operative pain after tSCTG harvesting could be explained by higher amounts of connective tissue present in the donor area after harvesting and avoiding trauma created by food consumption and tongue movements in the region Clinical data also showed an increased amount of keratinized tissue and its stability after augmentation favoring tSCTG Considering structural differences literature has shown that tSCTG provides more thickness a more abundant lamina propria and denser collagen compared to pSCTG However due to the size of the harvested tSCTG not being as abundant as pSCTG it can be assumed that the augmented areas were limited to multiple recessions or defects
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