An interventional study of guided soft tissue grafting and non-guided soft tissue grafting technique in Gingival Recession, sponsored by Tanta University. Active, not recruiting at 1 site in Egypt. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Tanta University · Not applicable, Interventional, and Treatment
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:
Participants will:
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.
402 studies on the registry are indexed under Gingival Recession; 98 are open to participants now.
This study's enrollment of 50 is above the median of 30 across 368 interventional studies indexed under Gingival Recession.
Browse Gingival Recession studies →Tanta University is the lead sponsor of 963 studies on the registry; 304 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
aguide was fabricated for harvesting the graft and patient and operater centered outcomes is recorded
Procedure: guided soft tissue grafting
the graft was taken with the scalpel without guide
Procedure: non-guided soft tissue grafting technique
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
the graft was taken with traditional technique without guide
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).
Time frame: 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.
Time frame: 6 months
The time-efficiency by assessing workflow duration
Secondary outcome will be time-efficiency by assessing workflow duration
Time frame: 6 months
The number of appointments needed to complete the procedure
Secondary outcome will be number of appointments needed to complete the procedure
Time frame: 6 months
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Tanta University