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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| guided soft tissue grafting technique | Active Comparator | aguide was fabricated for harvesting the graft and patient and operater centered outcomes is recorded |
|
| non-guided soft tissue grafting technique | Active Comparator | the graft was taken with the scalpel without guide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| guided soft tissue grafting | Procedure | 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| bassem nabil elfahl, assistant professor | faculty of dentistry,tanta university | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry ,Tanta University | Tanta | tanta | 02040 | Egypt |
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| non-guided soft tissue grafting technique | Procedure | the graft was taken with traditional technique without guide |
|
Secondary outcome will be number of appointments needed to complete the procedure
| 6 months |
| ID | Term |
|---|---|
| D005889 | Gingival Recession |
| ID | Term |
|---|---|
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D055093 | Periodontal Atrophy |
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