PainNCT06872749
Effect of an Experimental Gel Containing Copaiba Oil-resin in the Control of Dentin Hypersensitivity
A study testing KF2 (Potassium nitrate gel) and experimental Copaiba gel in people with Pain and Dentin Sensitivity, run by Universidade Federal do Para at 1 site in Brazil.
Trial summary
This randomized, single-blind, placebo-controlled clinical trial aims to clinically evaluate the effect of an experimental gel containing copaiba oleo-resin in the control of dentin hypersensitivity (DH) in non-carious cervical lesions (NCCL). Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Dentin Sensitivity, Dentin Desensitizing Agents
- What is being tested?
- KF2 (Potassium nitrate gel) and experimental Copaiba gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Sep 2024to 10 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- hypersensitive areas on the vestibular surface of the teeth with exposed cervical dentin up to 1 mm deep and/or class I gingival recession according to the Miller classification;
- individuals who have at least two hypersensitive teeth
- periodontal health,
- good general physical health;
- willingness to participate in the research by providing written informed consent;
- no eating disorders or very acidic diets
Who cannot join
- presence of restorations;
- presence of dental caries and periodontal pockets;
- ongoing treatment with antibiotics and/or anti-inflammatory and/or analgesic drugs;
- professional desensitizing treatment received three months prior to the study;
- pregnancy or lactation; systemic diseases;
- pulpitis;
- use of orthodontic appliances or 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 on an Experimental Gel Containing Copaiba Oil-resin in the Control of Dentin Hypersensitivity: a Randomized Clinical Study
This randomized, single-blind, placebo-controlled clinical trial aims to clinically evaluate the effect of an experimental gel containing copaiba oleo-resin in the control of dentin hypersensitivity (DH) in non-carious cervical lesions (NCCL). Seventy-five hypersensitive teeth will be selected into three groups (N=25) and approved in three treatment sessions. The groups will be: GROUP P= water-soluble placebo gel without active ingredient; GROUP KF2: Potassium nitrate 5% + Sodium fluoride 2%; GROUP GC: Gel containing copaiba oleo-resin. A visual analogue scale (VAS) will be used to compare the DH after tactile stimulation with an exploratory probe and evaporative stimulation with air jets. The DH assessments will be performed at four times: baseline, after 1 week, 15 days and 30 days after the beginning of treatment.
Read the detailed description
The sequence of application of the gels, whether active or placebo, will be as follows:
A professional prophylaxis will be performed using a rubber cup on the dental elements. The corresponding gel for each group will be applied with the aid of a micro-applicator and will remain undisturbed on the surface for 10 minutes. After the gel application time has elapsed, and while it is still on the teeth, the product will be rubbed with a micro-applicator using circular and intermittent movements. Subsequently, the gel will be removed with cotton and abundant water.
- Conditions
- Pain, Dentin Sensitivity, Dentin Desensitizing Agents
- Being tested
- Placebo gel, KF2 (Potassium nitrate gel), experimental Copaiba gel
- Medical subject headings
- Pain, Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo gelOther
will receive the application of a placebo gel (without active ingredient), under the same conditions described for the experimental gel.
KF2 (Potassium nitrate gel)Other
will receive application of potassium nitrate gel on hypersensitive dental surfaces, in an active way, for 10 minutes.
experimental Copaiba gelOther
will receive the application of the experimental desensitizing gel on the vestibular surfaces of the hypersensitive teeth in an active manner, for 10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Placebo gel | Placebo comparator | the group will receive the application of gel without active ingredient Receives: Other: Placebo gel |
| KF2 (Potassium nitrate gel) | Active comparator | the group will receive the application of gel containing potassium nitrate Receives: Other: KF2 (Potassium nitrate gel) |
| Copaiba gel | Experimental | the group will receive the application of gel containing copaiba Receives: Other: experimental Copaiba gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitivity assessment
Evaluation of hypersensitivity in teeth with non-carious cervical lesions. Patients will be instructed to complete a form to record tooth sensitivity before the application of the gels. An evaluation will be performed at baseline, 7 days, 15 days and 30 days, based on their individual perception of pain. The evaluation form will consist of a visual analogue scale (VAS). This scale consists of a 10 cm horizontal line with points of 0 and 10 at its ends, where 0 means no sensitivity and 10 means severe tooth sensitivity. The patient will be instructed to draw a vertical line along the horizontal line of the scale, recording the intensity of tooth sensitivity. So that the distance in millimeters from the zero end can later be measured with the aid of a millimeter ruler, thus obtaining the intensity level of the patient's back.
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 posted12 Mar 2025
- Study start20 Sep 2024
- Primary completion10 Mar 2025
- Study completion10 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 75 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, Doctor, Principal investigator, universidade federal do pará
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06872749
- Sponsor's protocol ID
- 6.787.218
- Status last verified
- Mar 2025
- First submitted
- 16 Jan 2025
- Last updated
- 20 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect on an Experimental Gel Containing Copaiba Oil-resin in the Control of Dentin Hypersensitivity: a Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT06872749
- Acronym / sponsor ID
- 6.787.218
- Conditions
- Pain, Dentin Sensitivity, Dentin Desensitizing Agents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Universidade Federal do ParaUniversity, hospital or other
- Study start
- 20 Sep 2024 (actual)
- Primary completion
- 10 Mar 2025 (actual)
- Study completion
- 10 Mar 2025 (actual)
- First posted
- 12 Mar 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 clinically evaluate the effect of an experimental gel containing copaiba oleo-resin in the control of dentin hypersensitivity (DH) in non-carious cervical lesions (NCCL). Seventy-five hypersensitive teeth will be selected into three groups (N=25) and approved in three treatment sessions. The groups will be: GROUP P= water-soluble placebo gel without active ingredient; GROUP KF2: Potassium nitrate 5% + Sodium fluoride 2%; GROUP GC: Gel containing copaiba oleo-resin. A visual analogue scale (VAS) will be used to compare the DH after tactile stimulation with an exploratory probe and evaporative stimulation with air jets. The DH assessments will be performed at four times: baseline, after 1 week, 15 days and 30 days after the beginning of treatment.
Detailed description
The sequence of application of the gels, whether active or placebo, will be as follows:
A professional prophylaxis will be performed using a rubber cup on the dental elements. The corresponding gel for each group will be applied with the aid of a micro-applicator and will remain undisturbed on the surface for 10 minutes. After the gel application time has elapsed, and while it is still on the teeth, the product will be rubbed with a micro-applicator using circular and intermittent movements. Subsequently, the gel will be removed with cotton and abundant water.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo gel | Placebo comparator | Other: Placebo gelthe group will receive the application of gel without active ingredient |
| KF2 (Potassium nitrate gel) | Active comparator | Other: KF2 (Potassium nitrate gel)the group will receive the application of gel containing potassium nitrate |
| Copaiba gel | Experimental | Other: experimental Copaiba gelthe group will receive the application of gel containing copaiba |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- hypersensitive areas on the vestibular surface of the teeth with exposed cervical dentin up to 1 mm deep and/or class I gingival recession according to the Miller classification;
- individuals who have at least two hypersensitive teeth
- periodontal health,
- good general physical health;
- willingness to participate in the research by providing written informed consent;
Key exclusion criteria (7 listed)
- presence of restorations;
- presence of dental caries and periodontal pockets;
- ongoing treatment with antibiotics and/or anti-inflammatory and/or analgesic drugs;
- professional desensitizing treatment received three months prior to the study;
- pregnancy or lactation; systemic diseases;
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 |
|---|---|---|
| Placebo gelwill receive the application of a placebo gel (without active ingredient), under the same conditions described for the experimental gel. | Other | Placebo gel |
| KF2 (Potassium nitrate gel)will receive application of potassium nitrate gel on hypersensitive dental surfaces, in an active way, for 10 minutes. | Other | KF2 (Potassium nitrate gel) |
| experimental Copaiba gelwill receive the application of the experimental desensitizing gel on the vestibular surfaces of the hypersensitive teeth in an active manner, for 10 minutes. | Other | Copaiba gel |
Primary outcome
sensitivity assessment
Time frame: 30 days
Evaluation of hypersensitivity in teeth with non-carious cervical lesions. Patients will be instructed to complete a form to record tooth sensitivity before the application of the gels. An evaluation will be performed at baseline, 7 days, 15 days and 30 days, based on their individual perception of pain. The evaluation form will consist of a visual analogue scale (VAS). This scale consists of a 10 cm horizontal line with points of 0 and 10 at its ends, where 0 means no sensitivity and 10 means severe tooth sensitivity. The patient will be instructed to draw a vertical line along the horizontal line of the scale, recording the intensity of tooth sensitivity. So that the distance in millimeters from the zero end can later be measured with the aid of a millimeter ruler, thus obtaining the intensity level of the patient's back.
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 20 May 2025.
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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, Doctor 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 KF2 (Potassium nitrate gel) and experimental Copaiba gel in people with Pain and 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 6 inclusion and 7 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 20 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 20 May 2025.