NCT06604676

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

Patient and Operator Centered Outcomes in Harvesting Technique of Soft Tissue Graft: Guided Versus Non-Guided

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Tanta University · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	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
PROCEDURE	non-guided soft tissue grafting technique	the graft was taken with traditional technique without guide

Timeline

• Start date: 2024-04-15
• Primary completion: 2024-09-15
• Completion: 2024-10-15
• First posted: 2024-09-19
• Last updated: 2024-09-19

Locations

1 site across 1 country: Egypt