Dentin SensitivityPhase 4NCT02461030

Efficacy of Two Oral Hygiene Regimens in the Reduction of Dentin Hypersensitivity After Periodontal Treatment

A Phase 4 study testing In-office and at home Colgate sensitive pro-relief - CSPR, In-office Villevie® prophy paste + Colgate Toothpaste and Non-surgical periodontal treatment in people with Dentin Sensitivity and Periodontal Diseases, run by University of Campinas, Brazil at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study aim is to determine the efficacy of two Oral Hygiene Regimens in the reduction of dentin hypersensitivity on subjects undergoing non-surgical periodontal treatment, over a period of 8 weeks. Read more about this study

Who is it for?: Ages 30 to 75 years
Conditions the study is for: Dentin Sensitivity, Periodontal Diseases
What is being tested?: In-office and at home Colgate sensitive pro-relief - CSPR, In-office Villevie® prophy paste + Colgate Toothpaste and Non-surgical periodontal treatment
Type of treatment: Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: 1 siteBrazil
Study dates: Aug 2014to Dec 2014
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 30 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Males and females, between 30-75 years of age;
Availability for the duration of the study;
Individuals diagnosed with moderate chronic periodontal disease (4-5 mm loss of clinical attachment, according to AAP), and indication for non-surgical periodontal therapy;
Diagnosis, by air blast, of at least two (2) hypersensitive teeth with a score of 2 or 3 on the Schiff Cold Air Sensitivity Scale;
Subjects in good general health and no allergies to products that are being tested.

Who cannot join

Oral pathology, chronic disease, or a history of allergy to testing products;
Qualifying sensitive teeth with extensive/defective restorations, pulpitis, caries, cracked enamel, or these teeth used as abutments for removable partial dentures;
Subject using anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, anti-inflammatory medication or daily analgesics within one month prior to the start of the study or scheduled to start such intake during the course of the study;
Subject regularly using desensitizing toothpaste;
Current smokers;
Subject pregnant or breast feeding;
Allergies to oral care products, personal care consumer products, or their ingredients.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Piracicaba Dental School, State University of Campinas
Piracicaba, São Paulo, 13414-903

Other trials in Brazil

About this study

Official title: An 8-Week Clinical Study to Evaluate the Efficacy of Two Oral Hygiene Regimens in the Reduction of Dentin Hypersensitivity After Non-surgical Periodontal Treatment: Randomized Clinical Trial

Read the detailed description

This study aim was to determine the efficacy of two Oral Hygiene Regimens in the reduction of dentin hypersensitivity on subjects undergoing non-surgical periodontal treatment, over a period of 8 weeks. The study was conducted in Piracicaba Dental School, Piracicaba, São Paulo, Brazil, using a double-blind/two treatment design. Sixty subjects (30 per group) that meet the inclusion and exclusion criteria were assigned to the groups: Test group (Non-surgical periodontal treatment + In-office application of Colgate Sensitive Pro-Relief - CSPR + tooth brushing with at home CSPR toothpaste) and Control group (Non-surgical periodontal treatment + In-office application of a fluoride-free prophy paste + tooth brushing with a Colgate Cavity Protection Toothpaste). Air blast sensitivity assessments were used to compare the efficacy of the two approaches using both the Schiff scale. The sensitivity parameters were measured at baseline, 1, 4 and 8 weeks.

Conditions: Dentin Sensitivity, Periodontal Diseases
Being tested: In-office and at home Colgate sensitive pro-relief - CSPR, In-office Villevie® prophy paste + Colgate Toothpaste, Non-surgical periodontal treatment
Keywords: Dentin hypersensitivity, Periodontal disease, Arginine
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.

In-office and at home Colgate sensitive pro-relief - CSPRDrug
Also called CSPR
Prophylaxis with rubber cup using In-office Colgate sensitive pro-relief (CSPR), after non-surgical periodontal therapy, and tooth brushing with at home CSPR toothpaste.
In-office Villevie® prophy paste + Colgate ToothpasteDrug
Also called Colgate Cavity Protection Toohtpaste
Prophylaxis with rubber cup using In-office Villevie® (fluoride-free) prophy paste + Colgate Toothpaste, after non-surgical periodontal therapy.
Non-surgical periodontal treatmentProcedure or surgery
Full-mouth debridment, scaling and root planing with ultrasonic/hand instruments

Study groups in NCT02461030
Study group	Role	What they receive
CSPR + NS treatment	Experimental	In-office and at home Colgate sensitive pro-relief - CSPR Intervention: Non-surgical periodontal treatment (full-mouth debridement, scaling and root planing with ultrasonic/hand instruments) associated with In-office application of Colgate Sensitive Pro-Relief (CSPR) + tooth brushing with at home CSPR toothpaste during 8 weeks. Receives: Drug: In-office and at home Colgate sensitive pro-relief - CSPR; Procedure: Non-surgical periodontal treatment
Villevie® + NS treatment	Placebo comparator	In-office Villevie® prophy paste + Colgate Toothpaste Treatment: In-office application of a Villevie® (fluoride-free) prophy paste + tooth brushing with a Colgate Cavity Protection Toothpaste during 8 weeks, after non-surgical periodontal treatment. (Full-mouth debridment/ Scaling and root planing with ultrasonic/hand instruments) Receives: Drug: In-office Villevie® prophy paste + Colgate Toothpaste; Procedure: Non-surgical periodontal treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

Dentin hypersensitivity reduction
Air blast sensitivity assessments using Schiff scale at baseline and up to 8 weeks after non-surgical periodontal treatment.
Measured: Baseline, 8 weeks

Secondary outcomes (1)

Probing depth reduction
Full-mouth probing, at baseline and up to 8 weeks after non-surgical periodontal treatment.
Measured: Baseline, 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2014Dec 2014

First posted3 Jun 2015 (estimated)
Study startAug 2014
Primary completionNov 2014
Study completionDec 2014

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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02461030
Sponsor's protocol ID: 058/2013
Status last verified: May 2015
First submitted: 28 May 2015
Last updated: 3 Jun 2015
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A Study to Assess the Efficacy of a Calcium Sodium Phosphosilicate Toothpaste for the Relief of Dentine Hypersensitivity
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Active, not recruiting
Clinical Evaluation of Short Dentin Etching
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Recruiting
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All Dentin Sensitivity trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An 8-Week Clinical Study to Evaluate the Efficacy of Two Oral Hygiene Regimens in the Reduction of Dentin Hypersensitivity After Non-surgical Periodontal Treatment: Randomized Clinical Trial
ClinicalTrials.gov ID: NCT02461030
Acronym / sponsor ID: 058/2013
Conditions: Dentin Sensitivity, Periodontal Diseases
Keywords: Dentin hypersensitivity, Periodontal disease, Arginine
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: University of Campinas, BrazilUniversity, hospital or other
Collaborators: Colgate Palmolive
Study start: Aug 2014
Primary completion: Nov 2014 (actual)
Study completion: Dec 2014 (actual)
First posted: 3 Jun 2015 (estimated)
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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
CSPR + NS treatment	Experimental	Drug: In-office and at home Colgate sensitive pro-relief - CSPR, Procedure: Non-surgical periodontal treatmentIn-office and at home Colgate sensitive pro-relief - CSPR Intervention: Non-surgical periodontal treatment (full-mouth debridement, scaling and root planing with ultrasonic/hand instruments) associated with In-office application of Colgate Sensitive Pro-Relief (CSPR) + tooth brushing with at home CSPR toothpaste during 8 weeks.
Villevie® + NS treatment	Placebo comparator	Drug: In-office Villevie® prophy paste + Colgate Toothpaste, Procedure: Non-surgical periodontal treatmentIn-office Villevie® prophy paste + Colgate Toothpaste Treatment: In-office application of a Villevie® (fluoride-free) prophy paste + tooth brushing with a Colgate Cavity Protection Toothpaste during 8 weeks, after non-surgical periodontal treatment. (Full-mouth debridment/ Scaling and root planing with ultrasonic/hand instruments)

Who may qualify

Ages: 30 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Males and females, between 30-75 years of age;
Availability for the duration of the study;
Individuals diagnosed with moderate chronic periodontal disease (4-5 mm loss of clinical attachment, according to AAP), and indication for non-surgical periodontal therapy;
Diagnosis, by air blast, of at least two (2) hypersensitive teeth with a score of 2 or 3 on the Schiff Cold Air Sensitivity Scale;
Subjects in good general health and no allergies to products that are being tested.

Key exclusion criteria (7 listed)

Oral pathology, chronic disease, or a history of allergy to testing products;
Qualifying sensitive teeth with extensive/defective restorations, pulpitis, caries, cracked enamel, or these teeth used as abutments for removable partial dentures;
Subject using anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, anti-inflammatory medication or daily analgesics within one month prior to the start of the study or scheduled to start such intake during the course of the study;
Subject regularly using desensitizing toothpaste;
Current smokers;

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
In-office and at home Colgate sensitive pro-relief - CSPRAlso: CSPRProphylaxis with rubber cup using In-office Colgate sensitive pro-relief (CSPR), after non-surgical periodontal therapy, and tooth brushing with at home CSPR toothpaste.	Drug	CSPR + NS treatment
In-office Villevie® prophy paste + Colgate ToothpasteAlso: Colgate Cavity Protection ToohtpasteProphylaxis with rubber cup using In-office Villevie® (fluoride-free) prophy paste + Colgate Toothpaste, after non-surgical periodontal therapy.	Drug	Villevie® + NS treatment
Non-surgical periodontal treatmentFull-mouth debridment, scaling and root planing with ultrasonic/hand instruments	Procedure or surgery	CSPR + NS treatment, Villevie® + NS treatment

Primary outcome

Dentin hypersensitivity reduction
Time frame: Baseline, 8 weeks
Air blast sensitivity assessments using Schiff scale at baseline and up to 8 weeks after non-surgical periodontal treatment.

1 secondary outcome

Probing depth reduction
Time frame: Baseline, 8 weeks

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 3 Jun 2015.

Related trials for Dentin Sensitivity

Not yet recruiting
The Effect of Decoupling With Time Technique on the Clinical Performance of Proximal Posterior Composite Restorations
Dental Restoration Failure, Postoperative Hypersensitivity
Recruiting
A Study to Assess the Efficacy of a Calcium Sodium Phosphosilicate Toothpaste for the Relief of Dentine Hypersensitivity
Dentin Sensitivity
Active, not recruiting
Clinical Evaluation of Short Dentin Etching
Hypersensitivity Dentin, Dental Restoration Failure of Marginal Integrity
Recruiting
Peroxide Versus Non-Peroxide In-Office Tooth Bleaching
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Recruiting
Dentine Hypersensitivity Using Dentine Adhesive With Strontium-doped Bioactive Glass-Ceramic
Dentine Hypersensitivity

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.

Enilson A Sallum, PhD principal investigator

University of Campinas, Brazil

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 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 3 Jun 2015. 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 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?

Dentin hypersensitivity reduction (time frame: Baseline, 8 weeks). 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 NCT02461030.

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 3 Jun 2015.