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

NCT06603467 | Active Not Recruiting DMC

• 1 other identifier: #R-OMPDR-2-24-3097
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Gingival Recessions

Keywords

gingival recessions

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Recession depth

  6 months

• gingival thickness

  6 months

• recession width

  6 months

Study Arms (2)

group 1

ACTIVE COMPARATOR

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

Procedure: non-guided de-epithelialized free gingival graft harvested

group 2

ACTIVE COMPARATOR

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

Procedure: guided de-epithelialized free gingival graft harvested

Interventions

non-guided de-epithelialized free gingival graft harvested PROCEDURE

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

group 1

guided de-epithelialized free gingival graft harvested PROCEDURE

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

group 2

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculty of Dentistry,Tanta university

Tanta, Tanta, 020240, Egypt

Location

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Officials

• bassem nabil elfahl, lecturer in periodontology

  Faculty of Dentistry, Tanta university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer in periodontology

Study Record Dates

• First Submitted: September 16, 2024
• First Posted: September 19, 2024
• Study Start: April 15, 2024
• Primary Completion: September 15, 2024
• Study Completion: October 15, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)