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This is an assessor-blinded split-mouth randomized clinical study to compare root coverage and gingival tissue thickness following two different surgical procedures for non-autologous grafting: the pinhole surgical technique (PST) and tunnel technique.
Each patient will undergo both surgeries on either quadrant; the PST and tunnel technique. The site will be randomized to receive either type of surgeries. Both types of surgeries are considered minimally invasive procedures to obtain root coverage for gingival recession. Both surgeries are clinically utilized in clinical practice and yield comparable results according to the literature, however, No prospective studies are published to compare between the outcomes of both techniques. patients will receive intra oral scan before the surgery and 6 months after the surgery to compare change in root coverage and gingival thickness outcomes between the two techniques. Post operative pain as well as patient satisfaction will be measured by visual analog scale and compared between the two techniques. Patients will be monitored at different time points to asses healing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pinhole/Tunnel | Experimental | Participants will receive Pinhole surgical technique for treatment of soft tissue recession at one side of the mouth and Tunnel technique for treatment of soft tissue recession at the other side of the mouth |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pinhole surgical technique and tunnel technique in a split mouth design | Procedure | Each subject will have the each surgical procedure which are both considered routine minimally invasive clinical care for gingival recession. Gum recession on one side will receive Pinhole surgical technique (test procedure). The other side will receive Tunnel technique (control procedure), Research component involved is the capture of digital impression using intra-oral scanner in the baseline (preoperative) and the final visit (6 months postoperative). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in gingival thickness | Two digital scans (pre- and 6-month post-operative) will be overlapped to measure the change in gingival thickness. | 6 months (pre operative and at the 6-month follow-up visit) |
| Change in gingival recession | Two digital scans (pre- and 6-month post-operative) will be overlapped to measure the change in gingival recession. | 6 months (pre operative and at the 6-month follow-up visit) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in papillary recession | Two digital scans (pre- and 6-month post-operative) will be overlapped to measure papillary gingival recession. | 6 months (pre operative and at the 6-month follow-up visit) |
| Change in root coverage |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohanad Al-Sabbagh | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Lexington | Kentucky | 40536 | United States |
Individual participants data will not be shared, rather the accumulated data for all participants could be shared to eliminate identification of participants.
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| ID | Term |
|---|---|
| D005889 | Gingival Recession |
| ID | Term |
|---|---|
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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Right and left sides of the mouth will be randomly assigned to test and control group by computer generated randomization table in a split mouth design
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PI and statistician will be blinded to the type of investigation for
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Two digital scans (pre- and 6-month post-operative) will be overlapped to measure the complete elimination of gingival recession.
| 6 months (pre operative and at the 6-month follow-up visit) |
| Change in sulcus probing depth | During a clinical exam, a sulcus will be used to measure the depth from the free gingival margin to the base of the sulcus pre- and 6-months post-operative. | 6 months (pre operative and at the 6-month follow-up visit) |
| Change in clinical attachment. | Clinical attachment will be calculated during the pre- and post-operative clinical exam. | 6 months (pre operative and at the 6-month follow-up visit) |
| Change in zone of keratinized tissue | During a clinical exam, the zone of keratinized tissue will be measured during the pre- and post-operative clinical exam. | 6 months (pre operative and at the 6-month follow-up visit) |
| Change in bleeding on probing. | The presence or absense of bleeding during probing during will be noted during the pre- and post-operative clinical exam. | 6 months (pre operative and at the 6-month follow-up visit) |
| Post-operative pain | A Visual Analog Score for pain will be used to assess post-operative pain one week after surgery. Scores range from 0-10; higher scores indicate greater pain. | 1 week |
| Aesthetic satisfaction | A Visual Analog Score for aesthetic satisfaction will be used to assess patient satisfaction 6 months after surgery. Scores range from 0-10; higher scores indicate greater satisfaction. | 1 day |
| D055093 |
| Periodontal Atrophy |