Guided Versus Non-Guided Harvesting Technique of Soft Tissue Graft in Cairo Recession Type I Sites

NCT ID: NCT06603467

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-15
• Study Completion Date: 2024-10-15

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 &the 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 & 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 3& 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 & 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) & 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 0.05.

Conditions

Gingival Recessions

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

group 1

gingival recession will be covered with de-epithelialized free gingival graft harvested without guide

Group Type: ACTIVE_COMPARATOR

non-guided de-epithelialized free gingival graft harvested

Intervention Type: PROCEDURE

gingival recession will be covered with de-epithelialized free gingival graft harvested without guide

group 2

gingival recession will be covered with de-epithelialized free gingival graft harvested with guide

Group Type: ACTIVE_COMPARATOR

guided de-epithelialized free gingival graft harvested

Intervention Type: PROCEDURE

gingival recession will be covered with de-epithelialized free gingival graft harvested with digital guide

Interventions

non-guided de-epithelialized free gingival graft harvested

gingival recession will be covered with de-epithelialized free gingival graft harvested without guide

Intervention Type: PROCEDURE

guided de-epithelialized free gingival graft harvested

gingival recession will be covered with de-epithelialized free gingival graft harvested with digital guide

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Gingival recession sited classifies as Cairo type I
• must have a general health showing no contraindications for oral surgery,
• must be at least 20 years old.
• patients also had to have good oral hygiene before the treatment

Exclusion Criteria

• signs or symptoms of bruxism or clenching i
• patients suffering from uncontrolled systemic conditions
• smoker
• pregnant or lactating

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

safinaz saleh mohamed saeed

lecturer in periodontology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

bassem nabil elfahl, lecturer in periodontology

Role: PRINCIPAL_INVESTIGATOR

Faculty of Dentistry, Tanta university

Locations

Faculty of Dentistry,Tanta university

Tanta, Tanta, Egypt

Countries

Egypt

Other Identifiers

#R-OMPDR-2-24-3097

Identifier Type: -

Identifier Source: org_study_id