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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06408792
Other study ID # 24/175-EC_X
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 2, 2024
Est. completion date October 1, 2024

Study information

Verified date March 2024
Source Universidad Complutense de Madrid
Contact José González Serrano, PhD
Phone +34662293482
Email josego09@ucm.es
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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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Study Design


Related Conditions & MeSH terms


Intervention

Device:
Deepithelized graft and protection technique
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.

Locations

Country Name City State
Spain Clinica Dental Doctores Garcia Ruiz e Iglesias Esquiroz Alcorcón Madrid

Sponsors (1)

Lead Sponsor Collaborator
Universidad Complutense de Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Secondary 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
Secondary Hematoma assessed by the patient 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
Secondary 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
Secondary Palate bleeding assessed by the patient yes/no Assessed before and after 24 hours postoperatively
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