Patient and Operator Centered Outcomes Concerning Connective Tissue Graft Should Be Considered to Choose Adequately Which Protocol to Use

NCT06604676 | Active Not Recruiting DMC

• 1 other identifier: #R-OMPDR-2-24-3096
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate patient and operator centered outcomes after connective tissue graft harvesting with a fully digital workflow and compare this approach with a conventional one. The main questions it aims to answer are:

• Does it differ in patient- and operator-centered outcomes between the conventional and digital workflow?
• What is the difference in time efficiency between conventional and digital protocols? Researchers will compare digital guided versus conventional technique to choose adequately which protocol to use. Participants will:
• Receive periodontal surgery to treat gingival recession site
• Visit the clinic after 2 weeks for suture removal \& filling the survey
• The time will be recorded during the surgery

Conditions

Gingival Recession

Outcome Measures

Primary Outcomes (2)

• Patient- and operator-centered outcomes will be assessed through visual analogue scale (VAS)

  Primary outcome will be patient- and operator-centered outcome. Patient- and operator-centered outcome will be assessed through visual analogue scale (VAS).

  6 months

• The questionnaires containing self-developed questions about each phase of the treatment

  The questionnaires containing self-developed questions about each phase of the treatment which will be administered at the end of each phase. The questionnaires will be administered as part of a survey which aimed to obtain information about the dental practices.

  6 months

Secondary Outcomes (2)

• The time-efficiency by assessing workflow duration

  6 months

• The number of appointments needed to complete the procedure

  6 months

Study Arms (2)

guided soft tissue grafting technique

ACTIVE COMPARATOR

aguide was fabricated for harvesting the graft and patient and operater centered outcomes is recorded

Procedure: guided soft tissue grafting

non-guided soft tissue grafting technique

ACTIVE COMPARATOR

the graft was taken with the scalpel without guide

Procedure: non-guided soft tissue grafting technique

Interventions

guided soft tissue grafting PROCEDURE

guided soft tissue grafting techniquea special digital guide was fabricated for one intervention non-guided soft tissue grafting technique receive the traditional technique without guide

guided soft tissue grafting technique

non-guided soft tissue grafting technique PROCEDURE

the graft was taken with traditional technique without guide

non-guided soft tissue grafting technique

Eligibility Criteria

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

You may qualify if:

• area need soft tissue augmentation around teeth either coronal or apical to recession
• 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
• if they were suffering from uncontrolled systemic conditions

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculty of Dentistry ,Tanta University

Tanta, Tanta, 02040, 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, assistant professor

  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 of periodontics

Study Record Dates

• First Submitted: September 13, 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)