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

Not Applicable

Active, not recruiting

• Conditions: Gingival Recession
• Interventions: Procedure: guided soft tissue grafting; Procedure: non-guided soft tissue grafting technique

• Registration Number: NCT06604676
• Lead Sponsor: Tanta University

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.

Study Timeline

• Study Start: 2024-04-15
• Status Verified: 2024-09
• Study First Submitted: 2024-09-13
• Primary Completion: 2024-09-15
• Study First Submitted QC: 2024-09-18
• Last Update Submitted: 2024-09-18
• Study First Posted: 2024-09-19
• Last Update Posted: 2024-09-19
• Study Completion: 2024-10-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
guided soft tissue grafting technique	guided soft tissue grafting	aguide was fabricated for harvesting the graft and patient and operater centered outcomes is recorded
non-guided soft tissue grafting technique	non-guided soft tissue grafting technique	the graft was taken with the scalpel without guide

Primary Outcome Measures

Name	Time	Method
Patient- and operator-centered outcomes will be assessed through visual analogue scale (VAS)	6 months	Primary outcome will be patient- and operator-centered outcome. Patient- and operator-centered outcome will be assessed through visual analogue scale (VAS).
The questionnaires containing self-developed questions about each phase of the treatment	6 months	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.

Secondary Outcome Measures

Name	Time	Method
The time-efficiency by assessing workflow duration	6 months	Secondary outcome will be time-efficiency by assessing workflow duration
The number of appointments needed to complete the procedure	6 months	Secondary outcome will be number of appointments needed to complete the procedure

Trial Locations

Locations (1)

Faculty of Dentistry ,Tanta University; 🇪🇬 Tanta, Egypt