Desquamative GingivitisNCT05124366
Propolis Extract, Nanovitamin C and Nanovitamin E on Desquamative Gingivitis
A study testing dental prophylaxis + oral hygiene instructions in people with Desquamative Gingivitis, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Desquamative Gingivitis
- What is being tested?
- dental prophylaxis + oral hygiene instructions
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2019to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Universidad Complutense de Madrid
Madrid, 28005
Rosa María López-Pintor, PhD, 0034913942013, rmlopezp@ucm.es
About this study
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.
Read more
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
- Desquamative Gingivitis
- Being tested
- dental prophylaxis + oral hygiene instructions
- Keywords
- desquamative gingivitis, lichen planus, propolis
- Medical subject headings
- Gingival Diseases, Lichen Planus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dental prophylaxis + oral hygiene instructionsProcedure or surgery
Follow up: 2 weeks and 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Nanovitamin E, nanovitamin C and propolis extract gel Receives: Procedure: dental prophylaxis + oral hygiene instructions |
| Placebo | Placebo comparator | Gel without nanovitamin E, nanovitamin C and propolis extract Receives: Procedure: dental prophylaxis + oral hygiene instructions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
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.
Measured: 2 weeks
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2021
- Study start1 Sep 2019
- Primary completion16 Oct 2021
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Desquamative GingivitisStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rosa María López-Pintor Muñoz, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05124366
- Sponsor's protocol ID
- 0005
- Status last verified
- Nov 2021
- First submitted
- 16 Oct 2021
- Last updated
- 18 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We will try to publish it as a scientific article
Publications
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.
PubMed 35900605
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Propolis Extract, Nanovitamin C and Nanovitamin E on Desquamative Gingivitis
- ClinicalTrials.gov ID
- NCT05124366
- Acronym / sponsor ID
- 0005
- Conditions
- Desquamative Gingivitis
- Keywords
- desquamative gingivitis, lichen planus, propolis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 16 Oct 2021 (actual)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 18 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Procedure: dental prophylaxis + oral hygiene instructionsNanovitamin E, nanovitamin C and propolis extract gel |
| Placebo | Placebo comparator | Procedure: dental prophylaxis + oral hygiene instructionsGel without nanovitamin E, nanovitamin C and propolis extract |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dental prophylaxis + oral hygiene instructionsFollow up: 2 weeks and 4 weeks | Procedure or surgery | Placebo, Study group |
Primary outcome
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2021.
- Derived from this study: PubMed 35900605Gonzalez-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.
- Individual participant dataSharing planned: Undecided. We will try to publish it as a scientific article
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dental prophylaxis + oral hygiene instructions in people with Desquamative Gingivitis, run by Universidad Complutense de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The severity of the GD will be collected according to the scale of Arduino et al. 2017 (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05124366, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2021.