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Propolis Extract, Nanovitamin C and Nanovitamin E on Desquamative Gingivitis

Primary Purpose

Desquamative Gingivitis

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
dental prophylaxis + oral hygiene instructions
Sponsored by
Universidad Complutense de Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Desquamative Gingivitis focused on measuring desquamative gingivitis, lichen planus, propolis

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Universidad Complutense de MadridRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Study group

Placebo

Arm Description

Nanovitamin E, nanovitamin C and propolis extract gel

Gel without nanovitamin E, nanovitamin C and propolis extract

Outcomes

Primary Outcome Measures

The severity of the GD will be collected according to the scale of Arduino et al. 2017
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.
The severity of the GD will be collected according to the scale of Arduino et al. 2017
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.
The severity of the GD will be collected according to the scale of Arduino et al. 2017
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.

Secondary Outcome Measures

Full Information

First Posted
October 16, 2021
Last Updated
November 8, 2021
Sponsor
Universidad Complutense de Madrid
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1. Study Identification

Unique Protocol Identification Number
NCT05124366
Brief Title
Propolis Extract, Nanovitamin C and Nanovitamin E on Desquamative Gingivitis
Official Title
Propolis Extract, Nanovitamin C and Nanovitamin E on Desquamative Gingivitis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
October 16, 2021 (Actual)
Study Completion Date
June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Complutense de Madrid

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Desquamative Gingivitis
Keywords
desquamative gingivitis, lichen planus, propolis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
21 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Experimental
Arm Description
Nanovitamin E, nanovitamin C and propolis extract gel
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Gel without nanovitamin E, nanovitamin C and propolis extract
Intervention Type
Procedure
Intervention Name(s)
dental prophylaxis + oral hygiene instructions
Intervention Description
Follow up: 2 weeks and 4 weeks
Primary Outcome Measure Information:
Title
The severity of the GD will be collected according to the scale of Arduino et al. 2017
Description
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.
Time Frame
Baseline
Title
The severity of the GD will be collected according to the scale of Arduino et al. 2017
Description
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.
Time Frame
2 weeks
Title
The severity of the GD will be collected according to the scale of Arduino et al. 2017
Description
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.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients over 18 years of age. 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. 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: Being in cancer treatment with head and neck radiotherapy, chemotherapy or immunotherapy. Being diabetic. Being on topical corticosteroid treatment in the previous 4 weeks or systemic treatment in the previous 8 weeks. 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. Pregnant or breastfeeding. Being a smoker. Use of rinses for plaque control. Being medicated with drugs associated with gingival enlargement such as cyclosporine, calcium channel blockers and phenytoin. To have taken antibiotics and / or anti-inflammatories 3 months before the study. Taking medications capable of producing lichenoid reactions. Patients who do not want to sign the informed consent. 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.
Facility Information:
Facility Name
Universidad Complutense de Madrid
City
Madrid
ZIP/Postal Code
28005
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosa María López-Pintor, PhD
Phone
0034913942013
Email
rmlopezp@ucm.es

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
We will try to publish it as a scientific article
Citations:
PubMed Identifier
35900605
Citation
Gonzalez-Serrano J, Serrano J, Sanz M, Torres J, Hernandez G, Lopez-Pintor RM. Efficacy and safety of a bioadhesive gel containing propolis extract, nanovitamin C and nanovitamin E on desquamative gingivitis: a double-blind, randomized, clinical trial. Clin Oral Investig. 2023 Feb;27(2):879-888. doi: 10.1007/s00784-022-04653-0. Epub 2022 Jul 28.
Results Reference
derived

Learn more about this trial

Propolis Extract, Nanovitamin C and Nanovitamin E on Desquamative Gingivitis

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