Tooth SensitivityPhase 3NCT07478640
Bioadhesive Film of Acmella Oleracea (Jambu) in the Reduction of Post-bleaching Dental Sensitivity Caused by Bleaching With 35% Hydrogen Peroxide.
A Phase 3 study testing Bioadhesive film of Acmella Oleracea (jambu), Gel containing 5% potassium nitrate and 2% sodium fluoride. and Spilanthol-free bioadhesive bioplastic film in people with Tooth Sensitivity and Teeth Whitening, run by Universidade Federal do Para at 1 site in Brazil.
Trial summary
Despite the wide range of desensitizing agents available on the market, there is still no gold standard treatment that is fully effective in managing sensitivity by dental bleaching. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Sensitivity, Teeth Whitening
- What is being tested?
- Bioadhesive film of Acmella Oleracea (jambu), Gel containing 5% potassium nitrate and 2% sodium fluoride. and Spilanthol-free bioadhesive bioplastic film
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Apr 2024to 2 Mar 2026
- Phase
- Phase 3
- 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
- Participants must have at least 28 teeth in the cavity
- good oral and general health
Who cannot join
- active caries or periodontal disease
- visible cracks in front teeth upper or lower
- with evident malocclusion
- restorations and prosthetics in teeth anterior teeth
- gastroesophageal disorders
- severe internal tooth discoloration (tetracycline , fluorosis or pulped teeth)
Show all 11Show fewer
- dentin exposure in anterior teeth and /or later
- parafunctional habits
- tooth sensitivity
- whitening treatment prior to or undergoing orthodontic treatment
- Furthermore, smokers, pregnant or breastfeeding women do not will be included.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Faculdade de Odontologia da Universidade Federal do Pará
Belém, Pará, 66075-110
About this study
Official title: Application of Acmella Oleracea (Jambu) Bioadhesive Film in Reducing Tooth Sensitivity Induced by Dental Bleaching: a Randomized Clinical Trial.
Despite the wide range of desensitizing agents available on the market, there is still no gold standard treatment that is fully effective in managing sensitivity by dental bleaching. In this context, a bioadhesive film containing Acmella oleracea (jambu)-a natural product with anti-inflammatory and, most notably, analgesic properties-may represent an effective alternative for controlling this discomfort. Therefore, this project aims to clinically evaluate the efficacy of an Acmella oleracea extract bioadhesive film on tooth sensitivity induced by 35% hydrogen peroxide bleaching.
Read the detailed description
Dental bleaching with hydrogen peroxide (HP) is a frequent treatment in dentistry, but it can present some adverse effects such as alterations in the surface structure of the teeth and tooth sensitivity. This study aimed to evaluate an experimental bioadhesive film of Acmella oleracea (jambu) extract on tooth sensitivity caused by bleaching with 35% hydrogen peroxide and its impact on the participants' oral health-related quality of life (OHRQoL). Seventy-two volunteers were divided into three different groups: GCP - Control group with bioadhesive bioplastic film without spilanthol, GKF - Desensitizing treatment group with 5% potassium nitrate and 2% sodium fluoride (Desensitize KF 2%), and GAO - Group with the experimental bioadhesive film of Acmella oleracea extract. In each group, the corresponding product was applied to the vestibular surfaces of the visible teeth for 10 minutes. Subsequently, all groups underwent an in-office dental bleaching protocol with 35% hydrogen peroxide. Tooth sensitivity was measured using the visual analog scale (VAS), the impact on oral health-related quality of life (OHRQoL) was assessed using the QEDH-15 questionnaire at baseline and at the last sensitivity record, and color measurement was performed at two time points: at baseline and one week after the 3rd bleaching session. Data were subjected to the Shapiro-Wilk normality test. For normally distributed variables, we used repeated measures ANOVA for intragroup analysis and one-way ANOVA for intergroup comparisons, with post-hoc tests when applicable. For non-parametric data, Friedman (intragroup) and Kruskal-Wallis (intergroup) tests were used. Color analysis (ΔE), considering the difference between initial and final times, and the impact on oral health-related quality of life followed the same statistical criteria, according to the data distribution. The significance level adopted was 5% for all analyses. The bioadhesive film is expected to have an effect on nociception and reduce sensitivity caused by bleaching.
- Conditions
- Tooth Sensitivity, Teeth Whitening
- Being tested
- Bioadhesive film of Acmella Oleracea (jambu), Gel containing 5% potassium nitrate and 2% sodium fluoride., Spilanthol-free bioadhesive bioplastic film
- Keywords
- Acmella oleracea, tooth sensitivity, teeth whitening, dentin desensitizers
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioadhesive film of Acmella Oleracea (jambu)Drug
Bioadhesive film of Acmella Oleracea (jambu) for topical application as a tape on teeth prior to teeth whitening with hydrogen peroxide.
Gel containing 5% potassium nitrate and 2% sodium fluoride.Drug
Gel containing 5% potassium nitrate and 2% sodium fluoride for topical application to teeth prior to bleaching with hydrogen peroxide.
Spilanthol-free bioadhesive bioplastic filmOther
Spilanthol-free bioadhesive bioplastic film for topical application as a tape on teeth prior to bleaching with hydrogen peroxide.
| Study group | Role | What they receive |
|---|---|---|
| Bioadhesive film of Acmella Oleracea (jambu) | Experimental | The bioadhesive film of Acmella Oleracea (jambu) will be applied to the vestibular surfaces of the upper and lower central and lateral incisors, canines, and premolars, like a tape, for 10 minutes. Subsequently, all groups will undergo in-office dental whitening treatment with 35% hydrogen peroxide (Whiteness HP, FGM). Sensitivity assessment will be performed using a form composed of a visual analog scale (VAS). Patients will be instructed to record tooth sensitivity daily during the 21-day follow-up period. For color measurement, the VITA Easyshade spectrophotometer (VITA, Germany) will be used at two time points: at baseline (Ti) and one week after the 3rd whitening session (Tf). Receives: Drug: Bioadhesive film of Acmella Oleracea (jambu) |
| Gel containing 5% potassium nitrate and 2% sodium fluoride | Active comparator | A gel containing 5% potassium nitrate and 2% sodium fluoride (NKFG) will be applied to the buccal surfaces of the upper and lower central and lateral incisors, canines, and premolars using an active microbrush for 10 minutes. Subsequently, all groups will undergo in-office dental whitening treatment with 35% hydrogen peroxide (Whiteness HP, FGM). Sensitivity will be assessed using a visual analog scale (VAS) form. Patients will be instructed to record tooth sensitivity daily during the 21-day follow-up period. For color measurement, the VITA Easyshade spectrophotometer (VITA, Germany) will be used at two time points: at baseline (Ti) and one week after the 3rd whitening session (Tf). Receives: Drug: Gel containing 5% potassium nitrate and 2% sodium fluoride. |
| Spilanthol-free bioadhesive bioplastic film | Placebo comparator | A spilanthol-free bioadhesive film made of bioplastic will be applied to the buccal surfaces of the upper and lower central and lateral incisors, canines, and premolars, as a tape, actively for 10 minutes. Subsequently, all groups will undergo in-office dental whitening treatment with 35% hydrogen peroxide (Whiteness HP, FGM). Sensitivity will be assessed using a form consisting of a visual analog scale (VAS). Patients will be instructed to record tooth sensitivity daily during the 21-day follow-up period. To measure color, the VITA Easyshade spectrophotometer (VITA, Germany) will be used at two time points: at baseline (Ti) and one week after the 3rd whitening session (Tf). Receives: Other: Spilanthol-free bioadhesive bioplastic film |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of tooth sensitivity after teeth whitening with hydrogen peroxide.
The bioadhesive film of Acemella Oleracea (jambu) reduces sensitivity related to teeth whitening with 35% hydrogen peroxide.
Measured: immediately after the procedure and during a 21-day treatment period.
Secondary outcomes (1)
Changes in the color of teeth bleached with hydrogen peroxide.
Changes in the color of teeth bleached with hydrogen peroxide, even with the application of Acmella Oleracea (jambu) bioadhesive film.
Measured: one week after the last whitening session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start1 Apr 2024
- Primary completion22 Jun 2025
- Study completion2 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Para
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jesuína Lamartine Nogueira Araújo, Universidade Federal do Para
- Investigators
- Jesuina L Nogueira Araujo, doutoura, Principal investigator, Universidade Federal do Pará
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07478640
- Sponsor's protocol ID
- 7.589.000
- Status last verified
- Mar 2026
- First submitted
- 28 Feb 2026
- Last updated
- 17 Mar 2026
- 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 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Acmella Oleracea (Jambu) Bioadhesive Film in Reducing Tooth Sensitivity Induced by Dental Bleaching: a Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT07478640
- Acronym / sponsor ID
- 7.589.000
- Conditions
- Tooth Sensitivity, Teeth Whitening
- Keywords
- Acmella oleracea, tooth sensitivity, teeth whitening, dentin desensitizers
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Universidade Federal do ParaUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 22 Jun 2025 (actual)
- Study completion
- 2 Mar 2026 (actual)
- First posted
- 17 Mar 2026 (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.
Despite the wide range of desensitizing agents available on the market, there is still no gold standard treatment that is fully effective in managing sensitivity by dental bleaching. In this context, a bioadhesive film containing Acmella oleracea (jambu)-a natural product with anti-inflammatory and, most notably, analgesic properties-may represent an effective alternative for controlling this discomfort. Therefore, this project aims to clinically evaluate the efficacy of an Acmella oleracea extract bioadhesive film on tooth sensitivity induced by 35% hydrogen peroxide bleaching.
Detailed description
Dental bleaching with hydrogen peroxide (HP) is a frequent treatment in dentistry, but it can present some adverse effects such as alterations in the surface structure of the teeth and tooth sensitivity. This study aimed to evaluate an experimental bioadhesive film of Acmella oleracea (jambu) extract on tooth sensitivity caused by bleaching with 35% hydrogen peroxide and its impact on the participants' oral health-related quality of life (OHRQoL). Seventy-two volunteers were divided into three different groups: GCP - Control group with bioadhesive bioplastic film without spilanthol, GKF - Desensitizing treatment group with 5% potassium nitrate and 2% sodium fluoride (Desensitize KF 2%), and GAO - Group with the experimental bioadhesive film of Acmella oleracea extract. In each group, the corresponding product was applied to the vestibular surfaces of the visible teeth for 10 minutes. Subsequently, all groups underwent an in-office dental bleaching protocol with 35% hydrogen peroxide. Tooth sensitivity was measured using the visual analog scale (VAS), the impact on oral health-related quality of life (OHRQoL) was assessed using the QEDH-15 questionnaire at baseline and at the last sensitivity record, and color measurement was performed at two time points: at baseline and one week after the 3rd bleaching session. Data were subjected to the Shapiro-Wilk normality test. For normally distributed variables, we used repeated measures ANOVA for intragroup analysis and one-way ANOVA for intergroup comparisons, with post-hoc tests when applicable. For non-parametric data, Friedman (intragroup) and Kruskal-Wallis (intergroup) tests were used. Color analysis (ΔE), considering the difference between initial and final times, and the impact on oral health-related quality of life followed the same statistical criteria, according to the data distribution. The significance level adopted was 5% for all analyses. The bioadhesive film is expected to have an effect on nociception and reduce sensitivity caused by bleaching.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bioadhesive film of Acmella Oleracea (jambu) | Experimental | Drug: Bioadhesive film of Acmella Oleracea (jambu)The bioadhesive film of Acmella Oleracea (jambu) will be applied to the vestibular surfaces of the upper and lower central and lateral incisors, canines, and premolars, like a tape, for 10 minutes. Subsequently, all groups will undergo in-office dental whitening treatment with 35% hydrogen peroxide (Whiteness HP, FGM). Sensitivity assessment will be performed using a form composed of a visual analog scale (VAS). Patients will be instructed to record tooth sensitivity daily during the 21-day follow-up period. For color measurement, the VITA Easyshade spectrophotometer (VITA, Germany) will be used at two time points: at baseline (Ti) and one week after the 3rd whitening session (Tf). |
| Gel containing 5% potassium nitrate and 2% sodium fluoride | Active comparator | Drug: Gel containing 5% potassium nitrate and 2% sodium fluoride.A gel containing 5% potassium nitrate and 2% sodium fluoride (NKFG) will be applied to the buccal surfaces of the upper and lower central and lateral incisors, canines, and premolars using an active microbrush for 10 minutes. Subsequently, all groups will undergo in-office dental whitening treatment with 35% hydrogen peroxide (Whiteness HP, FGM). Sensitivity will be assessed using a visual analog scale (VAS) form. Patients will be instructed to record tooth sensitivity daily during the 21-day follow-up period. For color measurement, the VITA Easyshade spectrophotometer (VITA, Germany) will be used at two time points: at baseline (Ti) and one week after the 3rd whitening session (Tf). |
| Spilanthol-free bioadhesive bioplastic film | Placebo comparator | Other: Spilanthol-free bioadhesive bioplastic filmA spilanthol-free bioadhesive film made of bioplastic will be applied to the buccal surfaces of the upper and lower central and lateral incisors, canines, and premolars, as a tape, actively for 10 minutes. Subsequently, all groups will undergo in-office dental whitening treatment with 35% hydrogen peroxide (Whiteness HP, FGM). Sensitivity will be assessed using a form consisting of a visual analog scale (VAS). Patients will be instructed to record tooth sensitivity daily during the 21-day follow-up period. To measure color, the VITA Easyshade spectrophotometer (VITA, Germany) will be used at two time points: at baseline (Ti) and one week after the 3rd whitening session (Tf). |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Participants must have at least 28 teeth in the cavity
- good oral and general health
Key exclusion criteria (11 listed)
- active caries or periodontal disease
- visible cracks in front teeth upper or lower
- with evident malocclusion
- restorations and prosthetics in teeth anterior teeth
- gastroesophageal disorders
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 |
|---|---|---|
| Bioadhesive film of Acmella Oleracea (jambu)Bioadhesive film of Acmella Oleracea (jambu) for topical application as a tape on teeth prior to teeth whitening with hydrogen peroxide. | Drug | Bioadhesive film of Acmella Oleracea (jambu) |
| Gel containing 5% potassium nitrate and 2% sodium fluoride.Gel containing 5% potassium nitrate and 2% sodium fluoride for topical application to teeth prior to bleaching with hydrogen peroxide. | Drug | Gel containing 5% potassium nitrate and 2% sodium fluoride |
| Spilanthol-free bioadhesive bioplastic filmSpilanthol-free bioadhesive bioplastic film for topical application as a tape on teeth prior to bleaching with hydrogen peroxide. | Other | Spilanthol-free bioadhesive bioplastic film |
Primary outcome
Degree of tooth sensitivity after teeth whitening with hydrogen peroxide.
Time frame: immediately after the procedure and during a 21-day treatment period.
The bioadhesive film of Acemella Oleracea (jambu) reduces sensitivity related to teeth whitening with 35% hydrogen peroxide.
1 secondary outcome
Changes in the color of teeth bleached with hydrogen peroxide.
Time frame: one week after the last whitening session.
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 17 Mar 2026.
- 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.
Jesuina L Nogueira Araujo, doutoura 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 Phase 3 study testing Bioadhesive film of Acmella Oleracea (jambu), Gel containing 5% potassium nitrate and 2% sodium fluoride. and Spilanthol-free bioadhesive bioplastic film in people with Tooth Sensitivity and Teeth Whitening, 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 11 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 17 Mar 2026. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Degree of tooth sensitivity after teeth whitening with hydrogen peroxide. (time frame: immediately after the procedure and during a 21-day treatment period.). 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 17 Mar 2026.