Dentin SensitivityNCT05083052
Propolis in Reducing Dentin Hypersensitivity
A study testing Propolis 15% and Propolis 10% in people with Dentin Sensitivity, run by Universidade Federal do Para at 1 site in Brazil.
Trial summary
Objective: This randomized, double-blind, parallel, placebo-controlled clinical trial aims to evaluate the effect of propolis with two distinct concentrations (10% and 15%), and the impact on volunteers' quality of life. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Dentin Sensitivity
- What is being tested?
- Propolis 15% and Propolis 10%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteBrazil
- Study dates
- 5 Nov 2020to 20 Dec 2021
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Two to four hypersensitive teeth with a response ≥ 04 on the visual analogue scale (VAS) from 0 to 10, where 0 represents no pain and 10 extreme pain, during the application of tactile (explorer probe) and evaporative (jet air);
- Dentinal exposure on the posterior teeth, due to the presence of a shallow non-carious lesion up to 02 mm in depth, according to the Smith \& Knight index (measured with a millimeter probe), and / or class I gingival recession according to Miller classification.
Who cannot join
- Restorations; tooth decay and/or periodontal pockets; dental pulpitis; enamel cracks or fractures on sensitive teeth;
- Continuous treatment with anti-inflammatory drugs and/or analgesics or desensitizing treatment induced three months prior to research recruitment data;
- Pregnancy or lactation;
- Systemic diseases;
- Fixed orthodontic appliances;
- Occlusal instability.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Propolis in Reducing Dentin Hypersensitivity: a Randomized Clinical Trial
Objective: This randomized, double-blind, parallel, placebo-controlled clinical trial aims to evaluate the effect of propolis with two distinct concentrations (10% and 15%), and the impact on volunteers' quality of life.
Materials and methods: Volunteers meeting the inclusion and exclusion criteria will be randomized and allocated into three groups: Group 1- placebo - toothpaste without active ingredient, Group 2- toothpaste with 10% propolis and Group 3. - toothpaste with 15% propolis. Number of teeth will be used as sample unit, totaling 22 teeth per group. Volunteers will receive oral hygiene instruction with guidance to brush their teeth three times a day with toothpaste corresponding to the groups in which they will be allocated for 30 days. The evaluation of dentin hypersensitivity will be performed with three (3) evaluation times: baseline (immediately before the beginning of treatment), 15 and 30 days, through tactile and evaporative stimuli, using the visual analog scale (VAS). The self-reported evaluation of the volunteers will be done through a questionnaire before the beginning and after one month with the completion of the research to determine the impact of treatment on their quality of life. The data regarding HD in VAS, if present normal distribution, will be used Two-way analysis of variance (ANOVA) with Tukey's post hoc for comparison between treatments. However, if the data show anormal distribution, Friedman to compare the different times in the same group (intra group), and Kruskal Wallis to make the comparison between groups (inter group). To evaluate the QEHD ordinal data, Wilcoxon and Mann-Whitney tests will be used. Bioestat 5.3 (Belém, Pará, Brazil) will be used, considering an alpha level of 5%.
- Conditions
- Dentin Sensitivity
- Being tested
- Propolis 15%, Propolis 10%, Placebo
- Keywords
- Dentin Desensitizing Agents; Propolis.
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propolis 15%Other
oothpaste formulation with 15% propolis.
Propolis 10%Other
Toothpaste formulation with 10% propolis.
PlaceboOther
Formulation of toothpaste without active ingredient.
| Study group | Role | What they receive |
|---|---|---|
| PLACEBO | Placebo comparator | Carbonato de cálcio: 40,0%, Glicerina: 20,0%, Lauril Sulfato de sódio: 1,2%, Carboximetilcelulose: 2,0%, Goma xantana: 1,0%, Metilparabeno (nipagim): 0,15%, EDTA: 0,5%, Sacarina: 0,1%, Flavorizante: 0,75%, Água deionizada q.s.p - 100mL. Receives: Other: Placebo |
| PROPOLIS 10% | Experimental | Carbonato de cálcio: 40,0%, Glicerina: 20,0%, Lauril Sulfato de sódio: 1,2%, Carboximetilcelulose: 2,0%, Goma xantana: 1,0%, Metilparabeno (nipagim): 0,15%, EDTA: 0,5%, Sacarina: 0,1%, Flavorizante: 0,75%, Própolis a 10%, Água deionizada q.s.p - 100mL. Receives: Other: Propolis 10% |
| PROPOLIS 15% | Experimental | Carbonato de cálcio: 40,0%, Glicerina: 20,0%, Lauril Sulfato de sódio: 1,2%, Carboximetilcelulose: 2,0%, Goma xantana: 1,0%, Metilparabeno (nipagim): 0,15%, EDTA: 0,5%, Sacarina: 0,1%, Flavorizante: 0,75%, Própolis a 15%, Água deionizada q.s.p - 100mL. Receives: Other: Propolis 15% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dentin hypersensitivity
The evaluation of dentin hypersensitivity will be performed with three (3) evaluation times: baseline (immediately before the beginning of treatment), 15 and 30 days, through tactile and evaporative stimuli, using the visual analog scale (VAS) from 0 to 10, where 0 represents no pain and 10 extreme pain.
Measured: 30 days
Secondary outcomes (1)
Quality of life
The self-reported evaluation of the volunteers will be completed through a questionnaire before the beginning and after one month with the completion of the research to determine the impact of treatment on their quality of life.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start5 Nov 2020
- Primary completion5 Nov 2021
- Study completion20 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dentin SensitivityStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Para
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cecy Martins Silva, Universidade Federal do Para
- Investigators
- Cecy M Silva, PhD, Study chair, Federal University of Pará
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05083052
- Sponsor's protocol ID
- UFPa - 0011
- Status last verified
- May 2024
- First submitted
- 6 Oct 2021
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Propolis in Reducing Dentin Hypersensitivity: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05083052
- Acronym / sponsor ID
- UFPa - 0011
- Conditions
- Dentin Sensitivity
- Keywords
- Dentin Desensitizing Agents; Propolis.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Universidade Federal do ParaUniversity, hospital or other
- Study start
- 5 Nov 2020 (actual)
- Primary completion
- 5 Nov 2021 (actual)
- Study completion
- 20 Dec 2021 (actual)
- First posted
- 19 Oct 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: This randomized, double-blind, parallel, placebo-controlled clinical trial aims to evaluate the effect of propolis with two distinct concentrations (10% and 15%), and the impact on volunteers' quality of life.
Materials and methods: Volunteers meeting the inclusion and exclusion criteria will be randomized and allocated into three groups: Group 1- placebo - toothpaste without active ingredient, Group 2- toothpaste with 10% propolis and Group 3. - toothpaste with 15% propolis. Number of teeth will be used as sample unit, totaling 22 teeth per group. Volunteers will receive oral hygiene instruction with guidance to brush their teeth three times a day with toothpaste corresponding to the groups in which they will be allocated for 30 days. The evaluation of dentin hypersensitivity will be performed with three (3) evaluation times: baseline (immediately before the beginning of treatment), 15 and 30 days, through tactile and evaporative stimuli, using the visual analog scale (VAS). The self-reported evaluation of the volunteers will be done through a questionnaire before the beginning and after one month with the completion of the research to determine the impact of treatment on their quality of life. The data regarding HD in VAS, if present normal distribution, will be used Two-way analysis of variance (ANOVA) with Tukey's post hoc for comparison between treatments. However, if the data show anormal distribution, Friedman to compare the different times in the same group (intra group), and Kruskal Wallis to make the comparison between groups (inter group). To evaluate the QEHD ordinal data, Wilcoxon and Mann-Whitney tests will be used. Bioestat 5.3 (Belém, Pará, Brazil) will be used, considering an alpha level of 5%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PLACEBO | Placebo comparator | Other: PlaceboCarbonato de cálcio: 40,0%, Glicerina: 20,0%, Lauril Sulfato de sódio: 1,2%, Carboximetilcelulose: 2,0%, Goma xantana: 1,0%, Metilparabeno (nipagim): 0,15%, EDTA: 0,5%, Sacarina: 0,1%, Flavorizante: 0,75%, Água deionizada q.s.p - 100mL. |
| PROPOLIS 10% | Experimental | Other: Propolis 10%Carbonato de cálcio: 40,0%, Glicerina: 20,0%, Lauril Sulfato de sódio: 1,2%, Carboximetilcelulose: 2,0%, Goma xantana: 1,0%, Metilparabeno (nipagim): 0,15%, EDTA: 0,5%, Sacarina: 0,1%, Flavorizante: 0,75%, Própolis a 10%, Água deionizada q.s.p - 100mL. |
| PROPOLIS 15% | Experimental | Other: Propolis 15%Carbonato de cálcio: 40,0%, Glicerina: 20,0%, Lauril Sulfato de sódio: 1,2%, Carboximetilcelulose: 2,0%, Goma xantana: 1,0%, Metilparabeno (nipagim): 0,15%, EDTA: 0,5%, Sacarina: 0,1%, Flavorizante: 0,75%, Própolis a 15%, Água deionizada q.s.p - 100mL. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Two to four hypersensitive teeth with a response ≥ 04 on the visual analogue scale (VAS) from 0 to 10, where 0 represents no pain and 10 extreme pain, during the application of tactile (explorer probe) and evaporative (jet air);
- Dentinal exposure on the posterior teeth, due to the presence of a shallow non-carious lesion up to 02 mm in depth, according to the Smith \& Knight index (measured with a millimeter probe), and / or class I gingival recession according to Miller classification.
Key exclusion criteria (6 listed)
- Restorations; tooth decay and/or periodontal pockets; dental pulpitis; enamel cracks or fractures on sensitive teeth;
- Continuous treatment with anti-inflammatory drugs and/or analgesics or desensitizing treatment induced three months prior to research recruitment data;
- Pregnancy or lactation;
- Systemic diseases;
- Fixed orthodontic appliances;
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 |
|---|---|---|
| Propolis 15%oothpaste formulation with 15% propolis. | Other | PROPOLIS 15% |
| Propolis 10%Toothpaste formulation with 10% propolis. | Other | PROPOLIS 10% |
| PlaceboFormulation of toothpaste without active ingredient. | Other | PLACEBO |
Primary outcome
Dentin hypersensitivity
Time frame: 30 days
The evaluation of dentin hypersensitivity will be performed with three (3) evaluation times: baseline (immediately before the beginning of treatment), 15 and 30 days, through tactile and evaporative stimuli, using the visual analog scale (VAS) from 0 to 10, where 0 represents no pain and 10 extreme pain.
1 secondary outcome
Quality of life
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- Individual participant dataSharing planned: No
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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.
Cecy M Silva, PhD study chair
Federal University of Pará
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propolis 15% and Propolis 10% in people with Dentin Sensitivity, run by Universidade Federal do Para at 1 site in Brazil.
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 2 inclusion and 6 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: finished, as of the sponsor's last update on 7 May 2024. 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 Brazil. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dentin hypersensitivity (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 May 2024.