Postoperative pain Wounds and Injuries
Conditions
Interventions
This is a three-arm, double-blind, randomized controlled clinical trial. A total of 45 healthy individuals will be recruited and allocated into the following groups: Control group (n = 15) – blood clo
Test group 1 (n = 15) – application of green tea gel with hyaluronic acid
Test group 2 (n = 15) – application of a high-concentration oxygen gel. Clinical assessments will be performed to evaluate pain, bleeding, burning sensation, and swallowing difficulty. Analyses of hea
Sponsors
Universidade Federal de Uberlândia
Universidade Federal de Uberlândia
Eligibility
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Systemically healthy individuals between 18 and 60 years of age; Good oral hygiene (plaque index <20%); Need for free gingival graft surgery and de-epithelialized connective tissue graft due to the absence of keratinized mucosa or the presence of gingival recession
Exclusion criteria
Exclusion criteria: Individuals who do not require surgery; History of periodontal disease; Uncontrolled diabetics (HbA1c > 6.5); Smokers; Pregnant women; Breastfeeding women; Patients who have previously undergone this surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The closure of the defect will be considered the primary outcome of this study, and it is expected that the groups using the green tea gel with hyaluronic acid and the gel with high concentrations of oxygen will accelerate the closure of the defect by 30% compared to the control group | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain assessment will be considered a secondary outcome of this study, and it is expected that the groups using the green tea gel with hyaluronic acid and the gel with high concentrations of oxygen will reduce their VAS scale score by up to 2 points by the 14th postoperative day compared to the control group;The assessment of the defect area will be considered a secondary outcome of this study, and it is expected that the groups using the green tea gel with hyaluronic acid and the gel with high concentrations of oxygen will reduce the area by up to 10% by the 14th postoperative day compared to the control group;The analysis of repair and inflammation markers will be considered secondary outcomes of this study. It is expected that the use of green tea gel with hyaluronic acid and gel with high oxygen concentrations will reduce the expression of inflammatory markers by more than 10% and increase the expression of repair markers by more than 10% up to the 7th postoperative day compared to the control group;The evaluation of volatile sulfur compound emissions will be considered a secondary outcome, and it is expected that the use of green tea and hyaluronic acid gel and high-concentration oxygen gel will reduce volatile sulfur compound emissions by more than 10% up to the 14th postoperative day compared to the control group;Patient-centered outcomes (burning sensation, swallowing, analgesic consumption) will be considered secondary outcomes in this study. It is expected that the green tea and hyaluronic acid gel group and the high-concentration oxygen gel group will show a 2-point reduction on the VAS scale for each of these factors, compared to the control group, by the 14th postoperative day;Bleeding analysis will be considered a secondary outcome of this study, and it is expected that the green tea gel with hyaluronic acid group and the high-concentration oxygen gel group will reduce bleeding by more than 10% compared to the control group by the 14th postoperative day | — |
Countries
BR
Contacts
Public ContactGuilherme Oliveira
Universidade Federal de Uberlândia
Outcome results
None listed