Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06408792
Status:
RECRUITING
Last Update Posted:
2024-05-10
First Post:
2024-03-13
Brief Title:
To Evaluate Postoperative Pain and Quality of Life After Taking a Deephethelized Gingival Graft and Covering it With Different Treatments
Sponsor:
Universidad Complutense de Madrid
Organization:
Universidad Complutense de Madrid
Study Overview
Official Title:
Randomized Controlled Tiral to Evaluate Postoperative Pain and Quality of Life in Relation to Oral Health After Taking a Deephethelized Gingival Graft and Covering it With an Adhesive Film of Cellulose and Fluid Composite in Comparison With a Palate Plate or Cyanocrylate
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None