Dentin HypersensitivityPhase 4NCT04422184
Comparative Clinical Evaluation of Three Different Agents in Reducing Dental Hypersensitivity in Periodontal Patients
A Phase 4 study testing Sensodyne Repair and Protect, Dentalclean Daily Regenerator and Dentalclean Daily Regenerator with potassium citrate in people with Dentin Hypersensitivity and Periodontal Diseases, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The present project will compare the effect of DH reduction using three different dentifrices (Sensodyne Repair and Protect - NOVAMIN technology; Dentalclean Daily Regenerator - REFIX technology; Dentalclean Daily Regenerator - REFIX technology + potassium citrate) in periodontal patients. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Dentin Hypersensitivity, Periodontal Diseases
- What is being tested?
- Sensodyne Repair and Protect, Dentalclean Daily Regenerator and Dentalclean Daily Regenerator with potassium citrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteBrazil
- Study dates
- 29 Jul 2019to 3 May 2023
- Phase
- Phase 4
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients diagnosed with periodontitis
- 18 to 70 years old
- systemically healthy
- without any allergy to the dentifrices components
- patients who needed scaling and root planing procedures
- patients who had at least 2 teeth with DH (incisors, canines or premolars).
Who cannot join
- pregnancy
- patients in orthodontic treatment
- patients with oral tumors, caries, fractured teeth, suspected endodontic involvement or excessive mobility;
- patients who used medication that could mask the painful sensation or who had used desensitizing agents in the last 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Clinical Evaluation of Three Different Technologies (Novamin, Refix and Refix-k) in Reducing Dental Hypersensitivity in Periodontal Patients
The present project will compare the effect of DH reduction using three different dentifrices (Sensodyne Repair and Protect - NOVAMIN technology; Dentalclean Daily Regenerator - REFIX technology; Dentalclean Daily Regenerator - REFIX technology + potassium citrate) in periodontal patients. The evaluation will be in 6 moments: T1 and T2- immediately before and after scaling and root planing (SRP) procedures; T3-after polishing sensitive areas with rubbers cups and the dentifrice determined for each group of patients and T4, 5, 6- After 2, 4 and 8 weeks of SRP. Profissional assessments and patient perception data will be performed.
Read the detailed description
Periodontal patients may report dentinal hypersensitivity (DH) caused by root surface exposure as part of disease process or as a result of periodontal treatment. Although some studies evaluated DH reduction using desensitizing toothpastes, no specific chemical/physical agent is reported for periodontal patients. Thus, the present project will compare the effect of DH reduction using three different dentifrices (Sensodyne Repair and Protect - NOVAMIN technology; Dentalclean Daily Regenerator - REFIX technology; Dentalclean Daily Regenerator - REFIX technology + potassium citrate) in periodontal patients. This randomized, parallel and blinded clinical trial will be divided into 3 groups (SEN GROUP: Sensodyne; REG GROUP: Regenerator; REGK GROUP: Regenerator + Potassium Citrate) and evaluated at 6 moments: T1 and T2- immediately before and after scaling and root planing (SRP) procedures; T3-after polishing sensitive areas with rubbers cups and the dentifrice determined for each group of patients and T4, 5, 6- After 2, 4 and 8 weeks of SRP. Air blast sensitivity assessments (Schiff scale) and patient perception data on DH will be performed using visual analog scales (VAS). The comparison between treatment groups will be done by paired T-test if normal distribution is observed or Wilcoxon if non-normal distribution. The significance level adopted will be 5% (p <0.05).
- Conditions
- Dentin Hypersensitivity, Periodontal Diseases
- Being tested
- Sensodyne Repair and Protect, Dentalclean Daily Regenerator, Dentalclean Daily Regenerator with potassium citrate
- Keywords
- root exposure, periodontal treatment, desensitizing agents.
- Medical subject headings
- Dentin Sensitivity, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensodyne Repair and ProtectDrug
Also called Dentifrice with desensitizing agents
Dentifricie with NOVAMIN technology
Dentalclean Daily RegeneratorDrug
Also called Dentifrice with desensitizing agents
Dentifricie with Refix technology
Dentalclean Daily Regenerator with potassium citrateDrug
Also called Dentifrice with desensitizing agents
Dentifricie with Refix technology+ potassium citrate
| Study group | Role | What they receive |
|---|---|---|
| SEN GROUP | Experimental | Sensodyne Repair and Protect - NOVAMIN technology Receives: Drug: Sensodyne Repair and Protect |
| REG GROUP | Experimental | Dentalclean Daily Regenerator - REFIX technology Receives: Drug: Dentalclean Daily Regenerator |
| REGK GROUP | Experimental | Dentalclean Daily Regenerator - REFIX technology + potassium citrate Receives: Drug: Dentalclean Daily Regenerator with potassium citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Professional evaluation of Dentin Hypersensitivity
Air blast sensitivity evaluated by an experienced dentist (Schiff scale) Score 0 = Tooth/Subject does not show sensitivity in response to air stimulation; 1 = Tooth/Subject responds to air stimulus, but does not request discontinuation of stimulus; 2 = Tooth/Subject responds to air stimulus, and requests discontinuation or moves from stimulus; 3 = Tooth/Subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.
Measured: T1- immediately before scaling and root planing procedures (SRP)
Professional evaluation of Dentin Hypersensitivity
Air blast sensitivity evaluated by an experienced dentist (Schiff scale) Score 0 = Tooth/Subject does not show sensitivity in response to air stimulation; 1 = Tooth/Subject responds to air stimulus, but does not request discontinuation of stimulus; 2 = Tooth/Subject responds to air stimulus, and requests discontinuation or moves from stimulus; 3 = Tooth/Subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.
Measured: T2 - immediately after scaling and root planing procedures (SRP)
Professional evaluation of Dentin Hypersensitivity
Air blast sensitivity evaluated by an experienced dentist (Schiff scale) Score 0 = Tooth/Subject does not show sensitivity in response to air stimulation; 1 = Tooth/Subject responds to air stimulus, but does not request discontinuation of stimulus; 2 = Tooth/Subject responds to air stimulus, and requests discontinuation or moves from stimulus; 3 = Tooth/Subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.
Measured: T3 - immediately after polishing sensitive areas with rubber cups and the dentifrice determined for each group of patients.
Professional evaluation of Dentin Hypersensitivity
Air blast sensitivity evaluated by an experienced dentist (Schiff scale) Score 0 = Tooth/Subject does not show sensitivity in response to air stimulation; 1 = Tooth/Subject responds to air stimulus, but does not request discontinuation of stimulus; 2 = Tooth/Subject responds to air stimulus, and requests discontinuation or moves from stimulus; 3 = Tooth/Subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.
Measured: T4 - 2 weeks after SRP.
Professional evaluation of Dentin Hypersensitivity
Air blast sensitivity evaluated by an experienced dentist (Schiff scale) Score 0 = Tooth/Subject does not show sensitivity in response to air stimulation; 1 = Tooth/Subject responds to air stimulus, but does not request discontinuation of stimulus; 2 = Tooth/Subject responds to air stimulus, and requests discontinuation or moves from stimulus; 3 = Tooth/Subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.
Measured: T5 - 4 weeks after SRP.
Professional evaluation of Dentin Hypersensitivity
Air blast sensitivity evaluated by an experienced dentist (Schiff scale) Score 0 = Tooth/Subject does not show sensitivity in response to air stimulation; 1 = Tooth/Subject responds to air stimulus, but does not request discontinuation of stimulus; 2 = Tooth/Subject responds to air stimulus, and requests discontinuation or moves from stimulus; 3 = Tooth/Subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.
Measured: T6 - 8 weeks after SRP.
Secondary outcomes (6)
Patient's perception of DH
Patient's perception of DH was also evaluated with visual analogue scale (VAS), being 0 without any painful sensation and 100 the most painful scenario.
Measured: T1- immediately before scaling and root planing procedures (SRP)
Patient's perception of DH
Patient's perception of DH was also evaluated with visual analogue scale (VAS), being 0 without any painful sensation and 100 the most painful scenario.
Measured: T2 - immediately after scaling and root planing procedures (SRP)
Patient's perception of DH
Patient's perception of DH was also evaluated with visual analogue scale (VAS), being 0 without any painful sensation and 100 the most painful scenario.
Measured: T3 - immediately after polishing sensitive areas with rubber cups and the dentifrice determined for each group of patients.
Patient's perception of DH
Patient's perception of DH was also evaluated with visual analogue scale (VAS), being 0 without any painful sensation and 100 the most painful scenario.
Measured: T4 - 2 weeks after SRP.
Patient's perception of DH
Patient's perception of DH was also evaluated with visual analogue scale (VAS), being 0 without any painful sensation and 100 the most painful scenario.
Measured: T5 - 4 weeks after SRP.
Patient's perception of DH
Patient's perception of DH was also evaluated with visual analogue scale (VAS), being 0 without any painful sensation and 100 the most painful scenario.
Measured: T6 - 8 weeks after SRP.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start29 Jul 2019
- Primary completion3 May 2023
- Study completion3 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dentin HypersensitivityStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariana Ragghianti Zangrando, University of Sao Paulo
- Investigators
- Mariana S Ragghianti Zangrando, Prof, Principal investigator, USP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04422184
- Sponsor's protocol ID
- DHPP60
- Status last verified
- May 2023
- First submitted
- 29 May 2020
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
West NX, Seong J, Davies M. Management of dentine hypersensitivity: efficacy of professionally and self-administered agents. J Clin Periodontol. 2015 Apr;42 Suppl 16:S256-302. doi: 10.1111/jcpe.12336.
PubMed 25495777Patil SA, Naik BD, Suma R. Evaluation of three different agents for in-office treatment of dentinal hypersensitivity: a controlled clinical study. Indian J Dent Res. 2015 Jan-Feb;26(1):38-42. doi: 10.4103/0970-9290.156796.
PubMed 25961613
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Clinical Evaluation of Three Different Technologies (Novamin, Refix and Refix-k) in Reducing Dental Hypersensitivity in Periodontal Patients
- ClinicalTrials.gov ID
- NCT04422184
- Acronym / sponsor ID
- DHPP60
- Conditions
- Dentin Hypersensitivity, Periodontal Diseases
- Keywords
- root exposure, periodontal treatment, desensitizing agents.
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 29 Jul 2019 (actual)
- Primary completion
- 3 May 2023 (actual)
- Study completion
- 3 May 2023 (actual)
- First posted
- 9 Jun 2020 (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.
The present project will compare the effect of DH reduction using three different dentifrices (Sensodyne Repair and Protect - NOVAMIN technology; Dentalclean Daily Regenerator - REFIX technology; Dentalclean Daily Regenerator - REFIX technology + potassium citrate) in periodontal patients. The evaluation will be in 6 moments: T1 and T2- immediately before and after scaling and root planing (SRP) procedures; T3-after polishing sensitive areas with rubbers cups and the dentifrice determined for each group of patients and T4, 5, 6- After 2, 4 and 8 weeks of SRP. Profissional assessments and patient perception data will be performed.
Detailed description
Periodontal patients may report dentinal hypersensitivity (DH) caused by root surface exposure as part of disease process or as a result of periodontal treatment. Although some studies evaluated DH reduction using desensitizing toothpastes, no specific chemical/physical agent is reported for periodontal patients. Thus, the present project will compare the effect of DH reduction using three different dentifrices (Sensodyne Repair and Protect - NOVAMIN technology; Dentalclean Daily Regenerator - REFIX technology; Dentalclean Daily Regenerator - REFIX technology + potassium citrate) in periodontal patients. This randomized, parallel and blinded clinical trial will be divided into 3 groups (SEN GROUP: Sensodyne; REG GROUP: Regenerator; REGK GROUP: Regenerator + Potassium Citrate) and evaluated at 6 moments: T1 and T2- immediately before and after scaling and root planing (SRP) procedures; T3-after polishing sensitive areas with rubbers cups and the dentifrice determined for each group of patients and T4, 5, 6- After 2, 4 and 8 weeks of SRP. Air blast sensitivity assessments (Schiff scale) and patient perception data on DH will be performed using visual analog scales (VAS). The comparison between treatment groups will be done by paired T-test if normal distribution is observed or Wilcoxon if non-normal distribution. The significance level adopted will be 5% (p <0.05).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SEN GROUP | Experimental | Drug: Sensodyne Repair and ProtectSensodyne Repair and Protect - NOVAMIN technology |
| REG GROUP | Experimental | Drug: Dentalclean Daily RegeneratorDentalclean Daily Regenerator - REFIX technology |
| REGK GROUP | Experimental | Drug: Dentalclean Daily Regenerator with potassium citrateDentalclean Daily Regenerator - REFIX technology + potassium citrate |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- patients diagnosed with periodontitis
- 18 to 70 years old
- systemically healthy
- without any allergy to the dentifrices components
- patients who needed scaling and root planing procedures
Key exclusion criteria (4 listed)
- pregnancy
- patients in orthodontic treatment
- patients with oral tumors, caries, fractured teeth, suspected endodontic involvement or excessive mobility;
- patients who used medication that could mask the painful sensation or who had used desensitizing agents in the last 3 months.
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 |
|---|---|---|
| Sensodyne Repair and ProtectAlso: Dentifrice with desensitizing agentsDentifricie with NOVAMIN technology | Drug | SEN GROUP |
| Dentalclean Daily RegeneratorAlso: Dentifrice with desensitizing agentsDentifricie with Refix technology | Drug | REG GROUP |
| Dentalclean Daily Regenerator with potassium citrateAlso: Dentifrice with desensitizing agentsDentifricie with Refix technology+ potassium citrate | Drug | REGK GROUP |
Primary outcome
Professional evaluation of Dentin Hypersensitivity
Time frame: T1- immediately before scaling and root planing procedures (SRP)
Air blast sensitivity evaluated by an experienced dentist (Schiff scale) Score 0 = Tooth/Subject does not show sensitivity in response to air stimulation; 1 = Tooth/Subject responds to air stimulus, but does not request discontinuation of stimulus; 2 = Tooth/Subject responds to air stimulus, and requests discontinuation or moves from stimulus; 3 = Tooth/Subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.
Professional evaluation of Dentin Hypersensitivity
Time frame: T2 - immediately after scaling and root planing procedures (SRP)
Air blast sensitivity evaluated by an experienced dentist (Schiff scale) Score 0 = Tooth/Subject does not show sensitivity in response to air stimulation; 1 = Tooth/Subject responds to air stimulus, but does not request discontinuation of stimulus; 2 = Tooth/Subject responds to air stimulus, and requests discontinuation or moves from stimulus; 3 = Tooth/Subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.
Professional evaluation of Dentin Hypersensitivity
Time frame: T3 - immediately after polishing sensitive areas with rubber cups and the dentifrice determined for each group of patients.
Air blast sensitivity evaluated by an experienced dentist (Schiff scale) Score 0 = Tooth/Subject does not show sensitivity in response to air stimulation; 1 = Tooth/Subject responds to air stimulus, but does not request discontinuation of stimulus; 2 = Tooth/Subject responds to air stimulus, and requests discontinuation or moves from stimulus; 3 = Tooth/Subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.
Professional evaluation of Dentin Hypersensitivity
Time frame: T4 - 2 weeks after SRP.
Air blast sensitivity evaluated by an experienced dentist (Schiff scale) Score 0 = Tooth/Subject does not show sensitivity in response to air stimulation; 1 = Tooth/Subject responds to air stimulus, but does not request discontinuation of stimulus; 2 = Tooth/Subject responds to air stimulus, and requests discontinuation or moves from stimulus; 3 = Tooth/Subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.
Professional evaluation of Dentin Hypersensitivity
Time frame: T5 - 4 weeks after SRP.
Air blast sensitivity evaluated by an experienced dentist (Schiff scale) Score 0 = Tooth/Subject does not show sensitivity in response to air stimulation; 1 = Tooth/Subject responds to air stimulus, but does not request discontinuation of stimulus; 2 = Tooth/Subject responds to air stimulus, and requests discontinuation or moves from stimulus; 3 = Tooth/Subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.
Professional evaluation of Dentin Hypersensitivity
Time frame: T6 - 8 weeks after SRP.
Air blast sensitivity evaluated by an experienced dentist (Schiff scale) Score 0 = Tooth/Subject does not show sensitivity in response to air stimulation; 1 = Tooth/Subject responds to air stimulus, but does not request discontinuation of stimulus; 2 = Tooth/Subject responds to air stimulus, and requests discontinuation or moves from stimulus; 3 = Tooth/Subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.
6 secondary outcomes
Patient's perception of DH
Time frame: T1- immediately before scaling and root planing procedures (SRP)
Patient's perception of DH
Time frame: T2 - immediately after scaling and root planing procedures (SRP)
Patient's perception of DH
Time frame: T3 - immediately after polishing sensitive areas with rubber cups and the dentifrice determined for each group of patients.
Patient's perception of DH
Time frame: T4 - 2 weeks after SRP.
Patient's perception of DH
Time frame: T5 - 4 weeks after SRP.
Patient's perception of DH
Time frame: T6 - 8 weeks after SRP.
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 28 Nov 2023.
- Background: PubMed 25495777West NX, Seong J, Davies M. Management of dentine hypersensitivity: efficacy of professionally and self-administered agents. J Clin Periodontol. 2015 Apr;42 Suppl 16:S256-302. doi: 10.1111/jcpe.12336.
- Background: PubMed 25961613Patil SA, Naik BD, Suma R. Evaluation of three different agents for in-office treatment of dentinal hypersensitivity: a controlled clinical study. Indian J Dent Res. 2015 Jan-Feb;26(1):38-42. doi: 10.4103/0970-9290.156796.
- 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.
Mariana S Ragghianti Zangrando, Prof principal investigator
USP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sensodyne Repair and Protect, Dentalclean Daily Regenerator and Dentalclean Daily Regenerator with potassium citrate in people with Dentin Hypersensitivity and Periodontal Diseases, run by University of Sao Paulo 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 4 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 28 Nov 2023. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Professional evaluation of Dentin Hypersensitivity (time frame: T1- immediately before scaling and root planing procedures (SRP)). The study lists 6 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 NCT04422184, which also lists 2 linked publications.
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 28 Nov 2023; AzTrials last refreshed its copy on 3 Nov 2026.