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

Guided Versus Non-Guided Harvesting Technique of Soft Tissue Graft in Cairo Recession Type I Sites: a Randomized Clinical Trial

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

Study Overview

• Status: Active, not recruiting
• Conditions: Gingival Recessions
• Intervention / Treatment: Procedure: non-guided de-epithelialized free gingival graft harvested; Procedure: guided de-epithelialized free gingival graft harvested

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Tanta, Egypt, 020240
    • Faculty of Dentistry,Tanta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: group 1; gingival recession will be covered with de-epithelialized free gingival graft harvested without guide	Procedure: non-guided de-epithelialized free gingival graft harvested; gingival recession will be covered with de-epithelialized free gingival graft harvested without guide
Active Comparator: group 2; gingival recession will be covered with de-epithelialized free gingival graft harvested with guide	Procedure: guided de-epithelialized free gingival graft harvested; gingival recession will be covered with de-epithelialized free gingival graft harvested with digital guide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early Wound Healing Score (EHS) EHS	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	6 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recession depth	Regarding soft tissue coverage, Gingival recession depth (GRD) from cementoenamel junction to Free gingival margin will be measured at baseline, 3 and 6 months after surgery.	6 months
gingival thickness	leach 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	6 months
recession width	measured at cementoenamel junction from mesial to distal line angel at baseline , 3 months & 6 months	6 months

Collaborators and Investigators

• Sponsor: Tanta University
• Investigators: Principal Investigator: bassem nabil elfahl, lecturer in periodontology, Faculty of Dentistry, Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2024
• Primary Completion (Estimated): September 15, 2024
• Study Completion (Estimated): October 15, 2024

Study Registration Dates

• First Submitted: September 16, 2024
• First Submitted That Met QC Criteria: September 17, 2024
• First Posted (Estimated): September 19, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 17, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: gingival recessions
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontal Atrophy; Gingival Recession
• Other Study ID Numbers: #R-OMPDR-2-24-3097

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No