Dentin DesensitizersNCT06971783
Effect of an Experimental Gel Based on Acmella Oleracea Extract Associated or Not With Fluoride on Dentin Hypersensitivity
A study testing NP- Potassium nitrate gel, AO - Acmella Oleracea Extract Gel and AF - Gel of Acmella Oleracea extract associated with Fluoride. in people with Dentin Desensitizers and Non-carious Cervical Lesions, run by Universidade Federal do Para at 1 site in Brazil.
Trial summary
This randomized, single-blind, placebo-controlled clinical trial aims to evaluate the effect of an experimental gel based on Acmella oleracea (jambú) extract, associated or not with fluoride, in reducing dentin hypersensitivity (DH) in non-carious cervical lesions. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Dentin Desensitizers, Non-carious Cervical Lesions, Dentin Hypersensitivity
- What is being tested?
- NP- Potassium nitrate gel, AO - Acmella Oleracea Extract Gel and AF - Gel of Acmella Oleracea extract associated with Fluoride.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Aug 2024to 20 Mar 2025
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Presence of non-carious cervical lesions with sensitivity and up to 2 mm in depth
- Miller Class I gingival recession
- Lesions located on the buccal surface of the teeth
- Score ≥ 4 on the Visual Analog Scale (VAS) after tactile and evaporative stimuli
- Healthy periodontal condition
- No other conditions that could explain dentin hypersensitivity
Show all 9Show fewer
- Good general physical health
- No eating disorders or high-acid diets
- Occlusal stability
Who cannot join
- Presence of restorations in the hypersensitive areas
- Presence of dental caries, pulpitis, or periodontal pockets
- Enamel cracks
- Systemic diseases
- Continuous use of antibiotics, anti-inflammatory drugs, analgesics, or corticosteroids
- Professional desensitizing treatment received within the three months prior to study recruitment
- Pregnancy or breastfeeding Ongoing orthodontic treatment
- Dental prostheses that may interfere with the assessment of hypersensitivity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of an Experimental Gel Based on Acmella Oleracea Extract Associated or Not With Fluoride on Dentin Hypersensitivity: a Randomized Clinical Study
This randomized, single-blind, placebo-controlled clinical trial aims to evaluate the effect of an experimental gel based on Acmella oleracea (jambú) extract, associated or not with fluoride, in reducing dentin hypersensitivity (DH) in non-carious cervical lesions. The volunteers were randomized into 4 groups according to the treatments applied: CT (control), NP (potassium nitrate), AO (Acmella oleracea) and AF (Acmella oleracea associated with fluoride). Prophylaxis with pumice stone and water was performed on the previously selected teeth and, subsequently, the gels were applied to the cervical region with a microbrush, rubbed for 10 seconds, and remained on the tooth surface for 10 minutes. Three gel application sessions were performed, with 1-week interval between them. The DH evaluation was performed at four time points: baseline (before the first session), T1 (before the second session), T2 (before the third session) and T3, one week after the final application of the products.
Read the detailed description
Initially, all volunteers will undergo prophylaxis with pumice and water and will receive an oral hygiene kit containing a soft-bristled toothbrush, dental floss, and their assigned toothpaste, along with oral hygiene instructions. Relative isolation with cotton rolls will be performed in the region of the sensitive lesions, followed by the application of the gel corresponding to the participant's group (CT, NP, AO, AF). All gels will be applied in the same manner, using a microbrush applicator. After being rubbed for 20 seconds on each tooth, the gel will remain on the tooth surface for 10 minutes. At the end of this period, the gel will be removed using gauze and thoroughly rinsed. Three clinical sessions will be conducted, with one-week intervals between them.
- Being tested
- CT- control group, NP- Potassium nitrate gel, AO - Acmella Oleracea Extract Gel, AF - Gel of Acmella Oleracea extract associated with Fluoride.
- Keywords
- Acmella oleracea, Spilanthol, Dentin hypersensitivity
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT- control groupOther
will receive the application of a placebo gel (without active ingredient), under the same conditions described for the experimental gel.
NP- Potassium nitrate gelOther
The gels will be applied to the sensitive lesions according to the experimental group and will be rubbed for 20 seconds using a microbrush, remaining on the lesions for 10 minutes.
AO - Acmella Oleracea Extract GelOther
The Acmella oleracea gel will be applied to sensitive lesions and rubbed for 20 seconds with the aid of a microbrush, remaining on the lesions for 10 minutes.
AF - Gel of Acmella Oleracea extract associated with Fluoride.Other
The Acmella oleracea gel associated with fluoride will be applied to sensitive lesions and rubbed for 20 seconds with the aid of a microbrush, remaining on the lesions for 10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| CT group: negative control group | Placebo comparator | the group will receive the application of gel without active ingredient Receives: Other: CT- control group |
| NP Group - Potassium nitrate associated with 2% Fluoride | Active comparator | the group will receive the application of gel containing potassium nitrate Receives: Other: NP- Potassium nitrate gel |
| Group AO - Acmella Oleracea extract gel | Experimental | the group will receive the application of gel containing Acmella Oleracea Extract Gel Receives: Other: AO - Acmella Oleracea Extract Gel |
| AF Group - Acmella Oleracea extract gel associated with Fluoride. | Experimental | the group will receive the application of gel containing Acmella Oleracea Extract Gel associated with fluoride Receives: Other: AF - Gel of Acmella Oleracea extract associated with Fluoride. |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitivity assessment
Dentin hypersensitivity (DH) will be assessed at four time points: baseline (immediately before the first session), T1 (immediately before the second session), T2 (immediately before the third session), and T3 (one week after the final application of the products). DH will be evaluated using the Visual Analog Scale (VAS). This scale consists of a 10 cm horizontal line with scores of 0 and 10 at each end, where 0 indicates no sensitivity and 10 indicates severe dental sensitivity. Patients will be instructed to draw a vertical line along the horizontal scale to indicate the intensity of their dental sensitivity on the day of assessment.The distance from the zero end to the patient's mark will be measured using a millimeter ruler. These data will be recorded and tabulated for subsequent analysis.
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 posted14 May 2025
- Study start20 Aug 2024
- Primary completion20 Mar 2025
- Study completion20 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dentin DesensitizersStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 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, Principal investigator, universidade federal do pará
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06971783
- Sponsor's protocol ID
- 7.513.177
- Status last verified
- May 2025
- First submitted
- 6 May 2025
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Experimental Gel Based on Acmella Oleracea Extract Associated or Not With Fluoride on Dentin Hypersensitivity: a Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT06971783
- Acronym / sponsor ID
- 7.513.177
- Keywords
- Acmella oleracea, Spilanthol, Dentin hypersensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Universidade Federal do ParaUniversity, hospital or other
- Study start
- 20 Aug 2024 (actual)
- Primary completion
- 20 Mar 2025 (actual)
- Study completion
- 20 Mar 2025 (actual)
- First posted
- 14 May 2025 (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.
This randomized, single-blind, placebo-controlled clinical trial aims to evaluate the effect of an experimental gel based on Acmella oleracea (jambú) extract, associated or not with fluoride, in reducing dentin hypersensitivity (DH) in non-carious cervical lesions. The volunteers were randomized into 4 groups according to the treatments applied: CT (control), NP (potassium nitrate), AO (Acmella oleracea) and AF (Acmella oleracea associated with fluoride). Prophylaxis with pumice stone and water was performed on the previously selected teeth and, subsequently, the gels were applied to the cervical region with a microbrush, rubbed for 10 seconds, and remained on the tooth surface for 10 minutes. Three gel application sessions were performed, with 1-week interval between them. The DH evaluation was performed at four time points: baseline (before the first session), T1 (before the second session), T2 (before the third session) and T3, one week after the final application of the products.
Detailed description
Initially, all volunteers will undergo prophylaxis with pumice and water and will receive an oral hygiene kit containing a soft-bristled toothbrush, dental floss, and their assigned toothpaste, along with oral hygiene instructions. Relative isolation with cotton rolls will be performed in the region of the sensitive lesions, followed by the application of the gel corresponding to the participant's group (CT, NP, AO, AF). All gels will be applied in the same manner, using a microbrush applicator. After being rubbed for 20 seconds on each tooth, the gel will remain on the tooth surface for 10 minutes. At the end of this period, the gel will be removed using gauze and thoroughly rinsed. Three clinical sessions will be conducted, with one-week intervals between them.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CT group: negative control group | Placebo comparator | Other: CT- control groupthe group will receive the application of gel without active ingredient |
| NP Group - Potassium nitrate associated with 2% Fluoride | Active comparator | Other: NP- Potassium nitrate gelthe group will receive the application of gel containing potassium nitrate |
| Group AO - Acmella Oleracea extract gel | Experimental | Other: AO - Acmella Oleracea Extract Gelthe group will receive the application of gel containing Acmella Oleracea Extract Gel |
| AF Group - Acmella Oleracea extract gel associated with Fluoride. | Experimental | Other: AF - Gel of Acmella Oleracea extract associated with Fluoride.the group will receive the application of gel containing Acmella Oleracea Extract Gel associated with fluoride |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Presence of non-carious cervical lesions with sensitivity and up to 2 mm in depth
- Miller Class I gingival recession
- Lesions located on the buccal surface of the teeth
- Score ≥ 4 on the Visual Analog Scale (VAS) after tactile and evaporative stimuli
- Healthy periodontal condition
Key exclusion criteria (8 listed)
- Presence of restorations in the hypersensitive areas
- Presence of dental caries, pulpitis, or periodontal pockets
- Enamel cracks
- Systemic diseases
- Continuous use of antibiotics, anti-inflammatory drugs, analgesics, or corticosteroids
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 |
|---|---|---|
| CT- control groupwill receive the application of a placebo gel (without active ingredient), under the same conditions described for the experimental gel. | Other | CT group: negative control group |
| NP- Potassium nitrate gelThe gels will be applied to the sensitive lesions according to the experimental group and will be rubbed for 20 seconds using a microbrush, remaining on the lesions for 10 minutes. | Other | NP Group - Potassium nitrate associated with 2% Fluoride |
| AO - Acmella Oleracea Extract GelThe Acmella oleracea gel will be applied to sensitive lesions and rubbed for 20 seconds with the aid of a microbrush, remaining on the lesions for 10 minutes. | Other | Group AO - Acmella Oleracea extract gel |
| AF - Gel of Acmella Oleracea extract associated with Fluoride.The Acmella oleracea gel associated with fluoride will be applied to sensitive lesions and rubbed for 20 seconds with the aid of a microbrush, remaining on the lesions for 10 minutes. | Other | AF Group - Acmella Oleracea extract gel associated with Fluoride. |
Primary outcome
sensitivity assessment
Time frame: 30 days
Dentin hypersensitivity (DH) will be assessed at four time points: baseline (immediately before the first session), T1 (immediately before the second session), T2 (immediately before the third session), and T3 (one week after the final application of the products). DH will be evaluated using the Visual Analog Scale (VAS). This scale consists of a 10 cm horizontal line with scores of 0 and 10 at each end, where 0 indicates no sensitivity and 10 indicates severe dental sensitivity. Patients will be instructed to draw a vertical line along the horizontal scale to indicate the intensity of their dental sensitivity on the day of assessment.The distance from the zero end to the patient's mark will be measured using a millimeter ruler. These data will be recorded and tabulated for subsequent analysis.
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 21 May 2025.
- Individual participant dataSharing planned: No
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 principal investigator
universidade federal do 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 NP- Potassium nitrate gel, AO - Acmella Oleracea Extract Gel and AF - Gel of Acmella Oleracea extract associated with Fluoride. in people with Dentin Desensitizers and Non-carious Cervical Lesions, 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 9 inclusion and 8 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 21 May 2025. 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?
sensitivity assessment (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 21 May 2025; AzTrials last refreshed its copy on 6 Nov 2026.