Clinical trial NCT06604676: Patient and Operator Centered Outcomes Concerning Connective Tissue Graft Should Be Considered to Choose Adequately Which Protocol to Use
Official title: Patient and Operator Centered Outcomes in Harvesting Technique of Soft Tissue Graft: Guided Versus Non-Guided
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Gingival Recession
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 \&amp; 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.

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

Primary outcomes:
measure: Patient- and operator-centered outcomes will be assessed through visual analogue scale (VAS)
timeFrame: 6 months
measure: The questionnaires containing self-developed questions about each phase of the treatment
timeFrame: 6 months
Secondary outcomes:
measure: The time-efficiency by assessing workflow duration
timeFrame: 6 months
measure: The number of appointments needed to complete the procedure
timeFrame: 6 months
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Faculty of Dentistry ,Tanta University
Study officials:
affiliation: faculty of dentistry,tanta university
name: bassem nabil elfahl, assistant professor
role: PRINCIPAL_INVESTIGATOR
References: