Ignite Creation Date:
2025-12-24 @ 4:41 PM
Ignite Modification Date:
2025-12-27 @ 4:12 AM
Study NCT ID:
NCT05124366
Status:
UNKNOWN
Last Update Posted:
2021-11-18
First Post:
2021-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Propolis Extract, Nanovitamin C and Nanovitamin E on Desquamative Gingivitis
Sponsor:
Universidad Complutense de Madrid
Organization:
Study Overview
Official Title:
Propolis Extract, Nanovitamin C and Nanovitamin E on Desquamative Gingivitis
Status:
UNKNOWN
Status Verified Date:
2021-11
Last Known Status:
RECRUITING
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 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.
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.
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?:
None
Is an FDA AA801 Violation?: