Trials / Unknown
UnknownNCT05124366
Propolis Extract, Nanovitamin C and Nanovitamin E on Desquamative Gingivitis
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 21 (estimated)
- Sponsor
- Universidad Complutense de Madrid · Academic / Other
- Sex
- All
- Age
- 18 Years – 100 Years
- Healthy volunteers
- Not accepted
Summary
Objective: To evaluate the effectiveness of a gel containing nanovitamin C, nanovitamin E and propolis extract compared to a placebo in the treatment of desquamative gingivitis (GD) in patients with mucocutaneous diseases with gingival involvement. The possible improvement in the quality of life of these patients after treatment will also be evaluated. Study design: Double-blind, randomized controlled study. Patients: GD patients are being selected from the Postgraduate 'Specialist in Oral Medicine' of the Faculty of Dentistry, Complutense University of Madrid. Allocation: Patients are being randomly assigned to the study group (dental prophylaxis + oral hygiene instructions + use of propolis gel for 4 weeks) or to the placebo group (dental prophylaxis + oral hygiene instructions + use of placebo gel for 4 weeks ). Both the study gel and the placebo are being used for brushing their teeth and for application in areas with GD. Variables: The severity of the GD will be collected according to the scale of Arduino et al. 2017 and the periodontal variables (plaque index, probing bleeding index and probing depth). Pain during treatment will be recorded using a 10 cm visual analog scale (VAS). The quality of life in relation to oral health will be recorded using the Oral Health Impact Profile-14 (OHIP-14) questionnaire. These variables will be collected on day 0, 2 and 4 weeks after using the study gel or placebo.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | dental prophylaxis + oral hygiene instructions | Follow up: 2 weeks and 4 weeks |
Timeline
- Start date
- 2019-09-01
- Primary completion
- 2021-10-16
- Completion
- 2022-06-30
- First posted
- 2021-11-18
- Last updated
- 2021-11-18
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT05124366. Inclusion in this directory is not an endorsement.