Propolis Extract, Nanovitamin C and Nanovitamin E on Desquamative Gingivitis

November 8, 2021 updated by: Rosa María López-Pintor Muñoz, Universidad Complutense de Madrid

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28005
        • Recruiting
        • Universidad Complutense de Madrid
        • Contact:
          • Rosa María López-Pintor, PhD
          • Phone Number: 0034913942013
          • Email: rmlopezp@ucm.es

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients over 18 years of age.
  2. Patients with a clinical and histological diagnosis of some mucocutaneous disease. Patients diagnosed with oral lichen planus will be selected according to the American Academy of Oral and Maxillofacial Pathology, pemphigus vulgaris and / or scarring pemphigoid according to the 2015 World Workshop on Oral Medicine.
  3. Patients who present GD, that is, erythema, epithelial desquamation, atrophy, painful erosions or ulceration of the free and / or attached gingiva, which is not related to the local accumulation of plaque.

Exclusion Criteria:

  1. Being in cancer treatment with head and neck radiotherapy, chemotherapy or immunotherapy.
  2. Being diabetic.
  3. Being on topical corticosteroid treatment in the previous 4 weeks or systemic treatment in the previous 8 weeks.
  4. Those patients who do not present the anterosuperior sector (from canine to upper canine) or the anteroinferior sector (from canine to lower canine) will also be excluded.
  5. Pregnant or breastfeeding.
  6. Being a smoker.
  7. Use of rinses for plaque control.
  8. Being medicated with drugs associated with gingival enlargement such as cyclosporine, calcium channel blockers and phenytoin.
  9. To have taken antibiotics and / or anti-inflammatories 3 months before the study.
  10. Taking medications capable of producing lichenoid reactions.
  11. Patients who do not want to sign the informed consent.
  12. Patients with periodontitis according to the consensus criteria of Papapanou et al. 2018 or patients treated for unstable periodontal disease according to the classification of Chapple et al. 2017.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study group
Nanovitamin E, nanovitamin C and propolis extract gel
Procedure: dental prophylaxis + oral hygiene instructions
Follow up: 2 weeks and 4 weeks
Placebo Comparator: Placebo
Gel without nanovitamin E, nanovitamin C and propolis extract
Procedure: dental prophylaxis + oral hygiene instructions
Follow up: 2 weeks and 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The severity of the GD will be collected according to the scale of Arduino et al. 2017
Time Frame: Baseline
The Scale collects a value for each sextant in vestibular and another value in lingual / palatal (12 in total, six times vestibular and six times lingual / palatal). The criteria for scoring are as follows: (0) no detectable gingival lesions present, (1) only white lesions, (2) mild erythema (<3mm from the gingival margins), (3) one or more blisters or erythema clinically obvious (> 3mm from the gingival margins), (4) erosion or ulcer. When there are different characteristics, the clinician should choose the highest index, so the total score can vary from 0 to 48. Higher results indicate a more serious clinical disease.
Baseline
The severity of the GD will be collected according to the scale of Arduino et al. 2017
Time Frame: 2 weeks
The Scale collects a value for each sextant in vestibular and another value in lingual / palatal (12 in total, six times vestibular and six times lingual / palatal). The criteria for scoring are as follows: (0) no detectable gingival lesions present, (1) only white lesions, (2) mild erythema (<3mm from the gingival margins), (3) one or more blisters or erythema clinically obvious (> 3mm from the gingival margins), (4) erosion or ulcer. When there are different characteristics, the clinician should choose the highest index, so the total score can vary from 0 to 48. Higher results indicate a more serious clinical disease.
2 weeks
The severity of the GD will be collected according to the scale of Arduino et al. 2017
Time Frame: 4 weeks
The Scale collects a value for each sextant in vestibular and another value in lingual / palatal (12 in total, six times vestibular and six times lingual / palatal). The criteria for scoring are as follows: (0) no detectable gingival lesions present, (1) only white lesions, (2) mild erythema (<3mm from the gingival margins), (3) one or more blisters or erythema clinically obvious (> 3mm from the gingival margins), (4) erosion or ulcer. When there are different characteristics, the clinician should choose the highest index, so the total score can vary from 0 to 48. Higher results indicate a more serious clinical disease.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Complutense de Madrid

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2019

Primary Completion (Actual)

October 16, 2021

Study Completion (Anticipated)

June 30, 2022

Study Registration Dates

First Submitted

October 16, 2021

First Submitted That Met QC Criteria

November 8, 2021

First Posted (Actual)

November 18, 2021

Study Record Updates

Last Update Posted (Actual)

November 18, 2021

Last Update Submitted That Met QC Criteria

November 8, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0005 (VACHS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

We will try to publish it as a scientific article

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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