ToothacheNCT02463552

Naproxen on Tooth Sensitivity Caused by In-office Bleaching

A study testing Naproxen in people with Toothache and Tooth Bleaching, run by Universidade Federal de Sergipe 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

Search all trials

Trial summary

This study aims to evaluate the effects of prior use of non-steroidal anti-inflammatory Naproxen on risk and level of tooth sensitivity caused by in-office bleaching procedures. Read more about this study

Who is it for?: Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for: Toothache, Tooth Bleaching
What is being tested?: Naproxen
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 50 participants
Where: 1 siteBrazil
Study dates: May 2015to Oct 2016
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 35 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

At least 18 years old patients of both genders presenting good general/oral health;
All maxillary anterior teeth presenting shade equal or darker than 2M2 at Vita bleachguide guide (Vita-Zahnfabrik, Germany);
Signed the form accepting to participate of this study.

Who cannot join

Presence of caries lesions, restorations and/or endodontic treatment at any maxillary anterior teeth.
Undergone tooth-whitening procedures;
Pregnant/lactating;
Presence of periodontal diseases;
Presence of severe tooth discoloration by tetracycline stains or fluorosis;
Any kind of medicine, bruxism habits or any other pathology that can cause sensitivity (such as recession, dentin exposure);

Show all 10Show fewer

Continuous use of drugs with anti-inflammatory actions;
Presence of tooth hypersensitivity at baseline measurement;
Any known adverse effects caused by Naproxen;
Non-attendance to any session of evaluation or bleaching.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Universidade Federal de Sergipe
Aracaju, Sergipe, 49060100

Other trials in Brazil

About this study

Official title: Rior Use of Naproxen on Tooth Sensitivity Reduction After In-office Bleaching: Randomized Clinical Trial

This study aims to evaluate the effects of prior use of non-steroidal anti-inflammatory Naproxen on risk and level of tooth sensitivity caused by in-office bleaching procedures.

Conditions: Toothache, Tooth Bleaching
Being tested: Naproxen
Medical subject headings: Toothache

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NaproxenDrug
The patient will receive a single-dose of Naproxen (500 mg) one hour before the bleaching procedure.

Study groups in NCT02463552
Study group	Role	What they receive
Placebo	Placebo comparator	Not described Receives: Drug: Naproxen
Naproxen	Experimental	Not described Receives: Drug: Naproxen

What is being measured

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

Risk to Tooth sensitivity - during procedure
The tooth sensitivity will be evaluated using a 5-point Verbal rating scale (VRS), where 0 = none, 1 = mild, 2 = moderate, 3 = considerable and 4 = severe. Score different from 0 will determine presence of sensitivity. The risk of tooth sensitivity will be determined by relative risk assessed by ratio between absolute risk of experimental condition by those observed in control. The 95% confidence interval will be calculated.
Measured: During the bleaching procedure

Secondary outcomes (3)

Level of tooth sensitivity - during procedure
The tooth sensitivity will be evaluated using a 5-point Verbal rating scale (VRS), where 0 = none, 1 = mild, 2 = moderate, 3 = considerable and 4 = severe.
Measured: During the bleaching procedure
Risk of tooth sensitivity - after procedure
The tooth sensitivity will be evaluated using a 5-point Verbal rating scale (VRS), where 0 = none, 1 = mild, 2 = moderate, 3 = considerable and 4 = severe. Score different from 0 will determine presence of sensitivity. The risk of tooth sensitivity will be determined by relative risk assessed by ratio between absolute risk of experimental condition by those observed in control. The 95% confidence interval will be calculated.
Measured: 24 hours after bleaching prcedure
Level of tooth sensitivity - after procedure
The tooth sensitivity will be evaluated using a 5-point Verbal rating scale (VRS), where 0 = none, 1 = mild, 2 = moderate, 3 = considerable and 4 = severe.
Measured: 24 hours after bleaching prcedure

Timeline

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

May 2015Oct 2016

First posted4 Jun 2015 (estimated)
Study startMay 2015
Primary completionJun 2016
Study completionOct 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for ToothacheStudies 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: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02463552
Sponsor's protocol ID: UFSergipe
Status last verified: Oct 2016
First submitted: 29 May 2015
Last updated: 26 Oct 2016
Results posted: No
Data monitoring committee: No

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

RecruitingPhase 1/2
A Study of CYT-1010 in Healthy Volunteers and Participants With Acute Pain After Third Molar Extraction
Acute Postoperative Pain, Dental Pain
RecruitingObservational study
Compare the Intensity of Pain Felt by Children During the Local Anesthesia Procedure to That Perceived by the Accompanying Parent.
Dental Pain, Dental Anxiety
Active, not recruiting
Laser Assisted Pulpotomy Versus MTA Pulpotomy in Permanent Teeth With Irreversible Pulpitis
Irreversible Pulpitis (Toothache)
Recruiting
Photobiomodulation and Tooth Analgesia
Dental Anaesthesia, Dental Pain
Active, not recruiting
Er:YAG Laser Versus Conventional Cavity Preparation in Children With Molar-Incisor Hypomineralization
Molar-Incisor Hypomineralization (MIH)

All Toothache trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Rior Use of Naproxen on Tooth Sensitivity Reduction After In-office Bleaching: Randomized Clinical Trial
ClinicalTrials.gov ID: NCT02463552
Acronym / sponsor ID: UFSergipe
Conditions: Toothache, Tooth Bleaching
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Universidade Federal de SergipeUniversity, hospital or other
Study start: May 2015
Primary completion: Jun 2016 (actual)
Study completion: Oct 2016 (actual)
First posted: 4 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.

This study aims to evaluate the effects of prior use of non-steroidal anti-inflammatory Naproxen on risk and level of tooth sensitivity caused by in-office bleaching procedures.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Drug: Naproxen
Naproxen	Experimental	Drug: Naproxen

Who may qualify

Ages: 18 to 35 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

At least 18 years old patients of both genders presenting good general/oral health;
All maxillary anterior teeth presenting shade equal or darker than 2M2 at Vita bleachguide guide (Vita-Zahnfabrik, Germany);
Signed the form accepting to participate of this study.

Key exclusion criteria (10 listed)

Presence of caries lesions, restorations and/or endodontic treatment at any maxillary anterior teeth.
Undergone tooth-whitening procedures;
Pregnant/lactating;
Presence of periodontal diseases;
Presence of severe tooth discoloration by tetracycline stains or fluorosis;

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
NaproxenThe patient will receive a single-dose of Naproxen (500 mg) one hour before the bleaching procedure.	Drug	Naproxen, Placebo

Primary outcome

Risk to Tooth sensitivity - during procedure
Time frame: During the bleaching procedure
The tooth sensitivity will be evaluated using a 5-point Verbal rating scale (VRS), where 0 = none, 1 = mild, 2 = moderate, 3 = considerable and 4 = severe. Score different from 0 will determine presence of sensitivity. The risk of tooth sensitivity will be determined by relative risk assessed by ratio between absolute risk of experimental condition by those observed in control. The 95% confidence interval will be calculated.

3 secondary outcomes

Level of tooth sensitivity - during procedure
Time frame: During the bleaching procedure
Risk of tooth sensitivity - after procedure
Time frame: 24 hours after bleaching prcedure
Level of tooth sensitivity - after procedure
Time frame: 24 hours after bleaching prcedure

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 26 Oct 2016.

Related trials for Toothache

RecruitingPhase 1/2
A Study of CYT-1010 in Healthy Volunteers and Participants With Acute Pain After Third Molar Extraction
Acute Postoperative Pain, Dental Pain
RecruitingObservational study
Compare the Intensity of Pain Felt by Children During the Local Anesthesia Procedure to That Perceived by the Accompanying Parent.
Dental Pain, Dental Anxiety
Active, not recruiting
Laser Assisted Pulpotomy Versus MTA Pulpotomy in Permanent Teeth With Irreversible Pulpitis
Irreversible Pulpitis (Toothache)
Recruiting
Photobiomodulation and Tooth Analgesia
Dental Anaesthesia, Dental Pain
Active, not recruiting
Er:YAG Laser Versus Conventional Cavity Preparation in Children With Molar-Incisor Hypomineralization
Molar-Incisor Hypomineralization (MIH)

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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

A study testing Naproxen in people with Toothache and Tooth Bleaching, run by Universidade Federal de Sergipe 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 3 inclusion and 10 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 26 Oct 2016. 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?

Risk to Tooth sensitivity - during procedure (time frame: During the bleaching procedure). 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 NCT02463552.

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 26 Oct 2016; AzTrials last refreshed its copy on 30 Oct 2026.