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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Gingival Recession
• Intervention / Treatment: Procedure: guided soft tissue grafting; Procedure: non-guided soft tissue grafting technique

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Tanta, Egypt, 02040
    • Faculty of Dentistry ,Tanta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: guided soft tissue grafting technique; aguide was fabricated for harvesting the graft and patient and operater centered outcomes is recorded	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
Active Comparator: non-guided soft tissue grafting technique; the graft was taken with the scalpel without guide	Procedure: non-guided soft tissue grafting technique; the graft was taken with traditional technique without guide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The time-efficiency by assessing workflow duration	Secondary outcome will be time-efficiency by assessing workflow duration	6 months
The number of appointments needed to complete the procedure	Secondary outcome will be number of appointments needed to complete the procedure	6 months

Collaborators and Investigators

• Sponsor: Tanta University
• Investigators: Principal Investigator: bassem nabil elfahl, assistant professor, Faculty of Dentistry,Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2024
• Primary Completion (Estimated): September 15, 2024
• Study Completion (Estimated): October 15, 2024

Study Registration Dates

• First Submitted: September 13, 2024
• First Submitted That Met QC Criteria: September 18, 2024
• First Posted (Estimated): September 19, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 18, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontal Atrophy; Gingival Recession
• Other Study ID Numbers: #R-OMPDR-2-24-3096

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No