Gingival Recession
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREPinhole surgical technique and tunnel technique in a split mouth design
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).
Sponsors
Mohanad Al-Sabbagh
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
PI and statistician will be blinded to the type of investigation for
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* between 18-75 years old * have at least one non-mobile tooth with Cairo class I gingival recession of 2 to 6 mm. * American Society of Anesthesiology class I and II * full mouth plaque score (FMPS) and full mouth bleeding score (FMBS) below 20%
Exclusion criteria
* sites of gingival recession around teeth that are non-salvageable * presence of any exudate, infection or local inflammation around the area to be grafted * pregnant or breastfeeding females
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in gingival thickness | 6 months (pre operative and at the 6-month follow-up visit) | Two digital scans (pre- and 6-month post-operative) will be overlapped to measure the change in gingival thickness. |
| Change in gingival recession | 6 months (pre operative and at the 6-month follow-up visit) | Two digital scans (pre- and 6-month post-operative) will be overlapped to measure the change in gingival recession. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in papillary recession | 6 months (pre operative and at the 6-month follow-up visit) | Two digital scans (pre- and 6-month post-operative) will be overlapped to measure papillary gingival recession. |
| Change in root coverage | 6 months (pre operative and at the 6-month follow-up visit) | Two digital scans (pre- and 6-month post-operative) will be overlapped to measure the complete elimination of gingival recession. |
| Change in sulcus probing depth | 6 months (pre operative and at the 6-month follow-up visit) | 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. |
| Change in clinical attachment. | 6 months (pre operative and at the 6-month follow-up visit) | Clinical attachment will be calculated during the pre- and post-operative clinical exam. |
| Change in zone of keratinized tissue | 6 months (pre operative and at the 6-month follow-up visit) | During a clinical exam, the zone of keratinized tissue will be measured during the pre- and post-operative clinical exam. |
| Change in bleeding on probing. | 6 months (pre operative and at the 6-month follow-up visit) | The presence or absense of bleeding during probing during will be noted during the pre- and post-operative clinical exam. |
| Post-operative pain | 1 week | 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. |
| Aesthetic satisfaction | 1 day | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMohanad Al-Sabbagh
University of Kentucky
Outcome results
None listed