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

NCT ID: NCT06604676

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 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 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

Detailed Description

50 sites will be included. All investigations will be carried out in accordance with the 1975 Helsinki Declaration, as revised in 2013 for ethical approval. All participants will provide written informed consent after receiving explanations on study objectives and procedures. Primary outcomes will be patient- and operator-centered outcomes. Patient- and operator-centered outcomes will be assessed through visual analogue scale (VAS), 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. Secondary outcomes will be time-efficiency by assessing workflow duration and number of appointments needed to complete the procedure. The treatment phases will include digital analysis of landmarks and design, of the guide and surgical phase (free gingival graft harvesting ). Time will be recorded in minutes. All the parameters will be recorded in the clinical chart by the same two operators not involved in the treatment after each phase was completed. The planned duration for the research will be 6 months.

Conditions

Gingival Recession

Study Design

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

Study Groups

guided soft tissue grafting technique

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

Group Type: ACTIVE_COMPARATOR

guided soft tissue grafting

Intervention Type: 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

non-guided soft tissue grafting technique

the graft was taken with the scalpel without guide

Group Type: ACTIVE_COMPARATOR

non-guided soft tissue grafting technique

Intervention Type: PROCEDURE

the graft was taken with traditional technique without guide

Interventions

guided soft tissue grafting

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

Intervention Type: PROCEDURE

non-guided soft tissue grafting technique

the graft was taken with traditional technique without guide

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• signs or symptoms of bruxism or clenching
• if they were suffering from uncontrolled systemic conditions

• 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 of periodontics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

bassem nabil elfahl, assistant professor

Role: PRINCIPAL_INVESTIGATOR

faculty of dentistry,tanta university

Locations

Faculty of Dentistry ,Tanta University

Tanta, Tanta, Egypt

Countries

Egypt

Other Identifiers

#R-OMPDR-2-24-3096

Identifier Type: -

Identifier Source: org_study_id