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

Tanta University

Status: Active, not recruiting

Conditions: Gingival Recession

Treatments: Procedure: guided soft tissue grafting; Procedure: non-guided soft tissue grafting technique

Study type: Interventional

Funder types: Other

Identifiers

NCT06604676

#R-OMPDR-2-24-3096

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

guided soft tissue grafting technique

Active Comparator group

Description:

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

Treatment:

Procedure: guided soft tissue grafting

non-guided soft tissue grafting technique

Active Comparator group

Description:

the graft was taken with the scalpel without guide

Treatment:

Procedure: non-guided soft tissue grafting technique