Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06603467
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-09-16
Brief Title:
Guided Versus Non-Guided Harvesting Technique of Soft Tissue Graft in Cairo Recession Type I Sites
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Guided Versus Non-Guided Harvesting Technique of Soft Tissue Graft in Cairo Recession Type I Sites a Randomized Clinical Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
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:
RCT
Brief Summary:
The goal of this clinical trial is to compare the healing pattern in the palate following harvesting of deepithelialized free gingival graft by two different harvesting techniques and to compare the recession coverage at the recipient sites
The main questions it aims to answer are
Does the harvesting technique will affect the healing pattern ampthe recipient site coverage in the treatment of gingival recession
Participants will
Receive in the recession sites in group 1 deepithelialized free gingival graft harvested without guide amp group 2 will be covered with graft harvested with guide
Visit the clinic twenty-four hours after surgery and weekly visits for 1 month early wound healing at the sites of harvesting will be assessed
The recession coverage will be assessed at 3amp 6 months after surgery
The main questions it aims to answer are
Does the harvesting technique will affect the healing pattern ampthe recipient site coverage in the treatment of gingival recession
Participants will
Receive in the recession sites in group 1 deepithelialized free gingival graft harvested without guide amp group 2 will be covered with graft harvested with guide
Visit the clinic twenty-four hours after surgery and weekly visits for 1 month early wound healing at the sites of harvesting will be assessed
The recession coverage will be assessed at 3amp 6 months after surgery
Detailed Description:
Background Over the last few years deepithelialized free gingival graft has become a gold standard treatment modality for increasing the width of keratinized gingiva root coverage alveolar ridge deficiencies management of peri-implant tissue abnormalities and papillary loss The procedure of harvesting the graft from the palate is often associated with the noteworthy challenge of procurement of the largest volume of tissue possible while minimizing associated trauma to anatomical structure also special designs of the graft may be required To meet these requirements and overcome the challenges an innovative digitally designed guide for harvesting the graft is designed to allow ideally designed graft with minimal trauma to the tissue
Aim To compare the healing pattern in palate following harvesting of deepithelialized free gingival graft by two different harvesting techniques and to compare the recession coverage at the recipient sites
Methodology Twenty recession sites with RT1 Cairo classification will be recruited for this study Sites were randomly divided into 2 treatment groups as follows group 1 10 sites will be covered with deepithelialized free gingival graft harvested without guide ampamp group 2 10 sites will be covered with CTG harvested with guide Sites in both groups will be covered with laterally or coronally positioned flap Twenty-four hours after surgery and weekly visits for 1 month early wound healing at the sites of harvesting will be assessed using the Early Wound Healing Score EHS EHS This score assessed clinical signs of re-epithelialization CSR clinical signs of hemostasis CSH and clinical signs of inflammation CSI Since complete wound epithelialization was the main outcome the CSR score was weighted to be 60 of the total final score Accordingly a score of 0 3 or 6 points was possible for the assessment of CSR whereas scores of 0 1 or 2 points were possible for CSH and CSI Higher values indicated better healing Accordingly the score for ideal early wound healing was 10 Regarding soft tissue coverage Gingival recession depth GRD ampamp Gingival recession width GRW will be measured at baseline 3 and 6 months after surgery Also each group will be subjected to intraoral scanning at baseline 3 and 6 months after surgery to measure gingival thickness and level by superimposition of scanning files of different intervals to monitor the changes by software
Statistical analysis will be done using IBM SPSS Statistics for Windows version 23 IBM Corp Armonk NY USA Intergroup analysis was done using Mann-Whitney test and intra-group analysis will be done using Kruskal-Wallis test for all the study parameters Statistical significance will set at a p-value of less than 005
Aim To compare the healing pattern in palate following harvesting of deepithelialized free gingival graft by two different harvesting techniques and to compare the recession coverage at the recipient sites
Methodology Twenty recession sites with RT1 Cairo classification will be recruited for this study Sites were randomly divided into 2 treatment groups as follows group 1 10 sites will be covered with deepithelialized free gingival graft harvested without guide ampamp group 2 10 sites will be covered with CTG harvested with guide Sites in both groups will be covered with laterally or coronally positioned flap Twenty-four hours after surgery and weekly visits for 1 month early wound healing at the sites of harvesting will be assessed using the Early Wound Healing Score EHS EHS This score assessed clinical signs of re-epithelialization CSR clinical signs of hemostasis CSH and clinical signs of inflammation CSI Since complete wound epithelialization was the main outcome the CSR score was weighted to be 60 of the total final score Accordingly a score of 0 3 or 6 points was possible for the assessment of CSR whereas scores of 0 1 or 2 points were possible for CSH and CSI Higher values indicated better healing Accordingly the score for ideal early wound healing was 10 Regarding soft tissue coverage Gingival recession depth GRD ampamp Gingival recession width GRW will be measured at baseline 3 and 6 months after surgery Also each group will be subjected to intraoral scanning at baseline 3 and 6 months after surgery to measure gingival thickness and level by superimposition of scanning files of different intervals to monitor the changes by software
Statistical analysis will be done using IBM SPSS Statistics for Windows version 23 IBM Corp Armonk NY USA Intergroup analysis was done using Mann-Whitney test and intra-group analysis will be done using Kruskal-Wallis test for all the study parameters Statistical significance will set at a p-value of less than 005
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