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Objective: To evaluate postoperative pain and quality of life in relation to oral health after obtaining a palatal de-epithelialized gingival graft and subsequent coverage of the surgical wound with an adhesive film of cellulose and fluid composite versus a palatal plate or covering with cyanoacrylate.
Study design: Randomized controlled study.
Patients: Patients who require a de-epithelialized gingival graft will be selected from two private clinics in the Community of Madrid.
Allocation: Patients will be randomly assigned to the study group (cellulose film and flowable composite), control group 1 (palatal plank) or control group 2 (cyanoacrylate coverage).
Variables: Postoperative pain will be recorded using a 10 cm visual analogue scale (VAS) and analgesic consumption will be noted. Quality of life in relation to oral health will be recorded using the Oral Health Impact Profile-14 (OHIP-14) questionnaire.
Analysis plan: Descriptive statistics will be used to describe patient characteristics. The possible differences between the 3 study groups will be evaluated using parametric or non-parametric tests depending on the distribution of the variables.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cellulose (OraAid) and fluid composite | Experimental | In this case, collagen sponges will be placed in the palatal wound, then the cellulose adhesive film (OraAid) will be placed on top, and this will be covered by fluid composite adhered to the teeth on their palatal wall. Amoxicillin 750mg 1pill each 8hours during 7 days. Ibuprofen 600mg 1pill each 8hours when needed. |
|
| Palate plate | Active Comparator | In this case, collagen sponges will be placed in the palatal wound, held in place by sutures, and the palatal wound will be covered with a custom-made palatal plate made just after surgery. Amoxicillin 750mg 1pill each 8hours during 7 days. Ibuprofen 600mg 1pill each 8hours when needed. |
|
| Cyanocrylate (periacril) | Active Comparator | In this case, collagen sponges will be placed in the palatal wound held by sutures and the palatal wound will be covered with cyanoacrylate tissue adhesive (Periacryl 90). Amoxicillin 750mg 1pill each 8hours during 7 days. Ibuprofen 600mg 1pill each 8hours when needed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deepithelized graft and protection technique | Device | To obtain the graft in all cases, on the day of surgery, 4% articaine with epinephrine 1:100,000 will be administered to block the greater palatine nerve. Gingival grafts from all groups will be deepithelialized intraorally using a sterile 834 turbine diamond bur. This drill will go deeper into the palatal mucosa 0.5mm (half of the outermost active part of the drill). The gingival grafts will be obtained with the surgical technique described by Zucchelli et al. 2010. |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction assessed by the Visual Analog Scale in the palate | Visual analog escale from 0 (the minimun and best score) to 10 (the maximum and worst pain score) | day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 10, day 14 |
| Satisfaction assessed by analgesic pills consumption | Number of Ibuprofens 600mg every 8hours (if needed) taken | day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 10, day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction assessed by Oral Health Impact Profile 14 (OHIP-14) | OHIP-14 questionnaire: 0 means the best score and 56 the maximum and worst score | day 0, day 3, day 7, day 14 |
| Hematoma assessed by the patient |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| José González Serrano, PhD | Contact | +34662293482 | josego09@ucm.es |
| Name | Affiliation | Role |
|---|---|---|
| Rosa López-Pintor, Professor | Universidad Complutense de Madrid | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica Dental Doctores Garcia Ruiz e Iglesias Esquiroz | Recruiting | Alcorcón | Madrid | 28921 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41212657 | Derived | Garcia-Moreno S, Lopez-Pintor RM, Leco-Berrocal I, Torres J, Gonzalez-Serrano J. Impact of a Bioadhesive Oral Wound Dressing Combined With Flowable Resin on Patient-Reported Outcomes After Palatal Graft Harvesting: A Randomized Clinical Trial. Clin Oral Implants Res. 2026 Mar;37(3):303-313. doi: 10.1111/clr.70070. Epub 2025 Nov 10. |
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|
yes / no
| Assessed day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10 after the surgery |
| Swelling assessed by the patient | yes / no | Assessed day 1, day 2, day 3,day 4, day 5, day 6, day 7, day 10,day 14 after the surgery |
| Palate bleeding assessed by the patient | yes/no | Assessed before and after 24 hours postoperatively |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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