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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
33
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.
Clinica Dental Doctores Garcia Ruiz e Iglesias Esquiroz
Alcorcón, Madrid, Spain
RECRUITINGSatisfaction 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)
Time frame: 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
Time frame: day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 10, day 14
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
Time frame: day 0, day 3, day 7, day 14
Hematoma assessed by the patient
yes / no
Time frame: 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
Time frame: 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
Time frame: Assessed before and after 24 hours postoperatively
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