InflammationNCT02956070

Anti-inflammatory Steroids in the Prevention of Tooth Sensitivity

A study testing Dexamethasone acetate and Potassium Nitrate in people with Inflammation, run by Universidade Federal Fluminense.

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

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Inflammation
What is being tested?: Dexamethasone acetate and Potassium Nitrate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 70 participants
Where: No sites listed yet
Study dates: Oct 2015to May 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

The selected volunteers should present a good general state of health, be at least 18 years of age, regardless of gender, color / race and ethnicity, sexual orientation, and gender identity.
Volunteers must have an acceptable oral hygiene, present the upper and lower arches without absence of teeth of first premolar right to the left first premolar.
These elements have to be healthy, that is, not having any kind of restoration.
Volunteers must sign the consent form and clarification, have committed to return for periodic examinations and belong to the group of nonsmokers.

Who cannot join

Do not have medical history of diseases that can affect the results of the study;
subjects could not have made use of cigarettes in the last 30 days; have some important pathology in the oral cavity;
not being pregnant and also are not breastfeeding;
having any history of sensitivity or adverse reactions to anti-inflammatory used in the study;
not having calculations or advanced periodontal disease;
have not consumed drugs, alcohol or any medication that can cover the results, as other types of anti-inflammatories or painkillers;
The volunteers should not have used products indicated for dental sensitivity, as desensitizing toothpaste or similar product and not present recession or exacerbated hypersensitivity history.

About this study

Official title: Evaluation of Anti-inflammatory Steroids of Use in the Prevention of Tooth Sensitivity in Teeth Whitening Technique Office

Clinical randomized, triple-blind, used to measure the level of tooth sensitivity on volunteers using a modified virtual analog scale (VAS). Sixty-six volunteers will be selected and recruited, following inclusion criteria and pre-established exclusion. All volunteers will be guided and sign a term of clarification and consent. Volunteers will be randomly divided into two groups: the control group to receive placebo capsules and application of desensitizing gel containing 6% potassium nitrate and 0.10% fluoro- (conventional treatment) and the experimental group will receive the anti-inflammatory corticosteroids (dexamethasone, capsule - 8mg) and application of a placebo gel. Patients will be treated in two clinical sessions with an interval of 7 days (one week) between them. The protocol for use of the product is as follows: The volunteers in the experimental group will receive six capsules of dexamethasone 8 mg each to be administered orally, initially two days before the first bleaching query as follows: 8 mg (1 capsule) 9 am in the morning two days before the first clinical session whitening; 8 mg (1 capsule) the 9 am to 1 day before the first practice session whitening, 8 mg (1 capsule) to 9 am on the day of the first practice session of whitening. After 7 days (one week), the same protocol will be held for the second and final practice session office bleaching.

Read the detailed description

The experimental design will follow the consolidated standards for test reports (CONSORT). After approval by the Ethics Committee for Research duly registered, the trial will be conducted in the clinic of dental school at the Federal Fluminense University located in Nova Friburgo.Every Health Institute participants will be informed about the nature and objectives of the study.It will be one test study Clinical randomized, parallel, triple-blind, used to measure the level of tooth sensitivity volunteers using a modified virtual analog scale (VAS). Sixty-six volunteers will be selected and recruited, following inclusion criteria and pre-established exclusion. All volunteers will be guided and sign a term of clarification and consent. Volunteers will be randomly divided into two groups: the control group to receive placebo capsules and application of desensitizing gel containing 6% potassium nitrate and 0.10% fluoro- (conventional treatment) and the experimental group will receive the anti-inflammatory corticosteroids (dexamethasone, capsule - 8mg) and application of a placebo gel. Patients will be treated in two clinical sessions with an interval of 7 days (one week) between them. The protocol for use of the product is as follows: The volunteers in the experimental group will receive six capsules of dexamethasone 8 mg each to be administered orally, initially two days before the first bleaching query as follows: 8 mg (1 capsule) 9 am in the morning two days before the first clinical session whitening; 8 mg (1 capsule) the 9 am to 1 day before the first practice session whitening, 8 mg (1 capsule) to 9 am on the day of the first practice session of whitening. After 7 days (one week), the same protocol will be held for the second and final practice session office bleaching.

Conditions: Inflammation
Being tested: Dexamethasone acetate, Potassium Nitrate
Keywords: dental bleaching, antiinflammatory, tooth sensitivity
Medical subject headings: Inflammation, Dentin Sensitivity

What participants receive

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

Dexamethasone acetateDrug
Also called Dexamethasone
The volunteers in the Dexamethasone acetate group (experimental group) will receive six capsules of dexamethasone 8 mg each to be administered orally, initially two days before the first bleaching query as follows: 8 mg (1 capsule) 9 am two days before the first clinical session whitening; 8 mg (1 capsule) the 9 am to 1 day before session whitening, 8 mg (1 capsule) to 9 am on the day of the first session of whitening.Clinical intervention: 1- Dry teeth and apply Gingival Barrier to both arches. 2- Light cure. 3- Firmly attach a mixing nozzle to the Pola Office+. 4- Apply a thin layer of gel to all teeth undergoing treatment. 5- Leave gel on for 8 minutes. 6- Suction it off. 7- Repeat steps 5-6 twice times. 8- After the last application, suction all the gel off, then wash and apply suction. 9- Remove Gingival Barrier. 10- A placebo gel will be applied with a brush on the labial surface of the teeth whitened for 2 to 3 minutes .
Potassium NitrateDrug
Also called Smoothe SDI
The volunteers in the Potassium Nitrate Group (Placebo group) will receive 6 placebo capsules, who contained the same components of de dexamethasone drug except the active ingredient (starch [50%], lactose monohydrate [35%], dibasic calcium phosphate [14%], and magnesium stearate [1%]).Clinical session:1- Dry teeth and apply Gingival Barrier to both arches. 2- Light cure. 3- Firmly attach a mixing nozzle to the Pola Office+. 4- Apply a thin layer of gel to all teeth undergoing treatment. 5- Leave gel on for 8 minutes. 6- Suction it off. 7- Repeat steps 5-6 twice times. 8- After the last application, suction all the gel off, then wash and apply suction. 9- Remove Gingival Barrier. 10- A desensitizing gel containing 6% potassium nitrate will be applied with a brush on the labial surface of the teeth whitened for 2 to 3 minutes .

Study groups in NCT02956070
Study group	Role	What they receive
Experimental	Experimental	35 patients in this group will undergo the whitening procedure using the Dexamethasone acetate intervention. Receives: Drug: Dexamethasone acetate
Placebo	Placebo comparator	35 patients in this group will undergo the whitening procedure using the Potassium Nitrate intervention Receives: Drug: Potassium Nitrate

What is being measured

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

Visual Analogic Scale (0-100) for Tooth Sensibility.
The investigators evaluated the tooth sensibility 1 hour post-bleaching. Scale from 0-100 0 means no sensibility 100 means maximum sensibility
Measured: One hour
Visual Analogic Scale(0-100) for Tooth Sensibility.
The investigators evaluated the tooth sensibility 24 hours post-bleaching. Scale from 0-100 0 means no sensibility 100 means maximum sensibility
Measured: Twenty four hours
Visual Analogic Scale(0-100) for Tooth Sensibility.
The investigators evaluated the tooth sensibility 48 hours post-bleaching. Scale from 0-100 0 means no sensibility 100 means maximum sensibility
Measured: Forty eight hours

Timeline

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

Oct 2015May 2016

First posted4 Nov 2016 (estimated)
Study startOct 2015
Primary completionMay 2016
Study completionMay 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (19)Papers the sponsor has linked to this study.
Other trials for InflammationStudies 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: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02956070
Sponsor's protocol ID: bleaching
Status last verified: Nov 2020
First submitted: 25 Oct 2016
Last updated: 25 Nov 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Carey CM. Tooth whitening: what we now know. J Evid Based Dent Pract. 2014 Jun;14 Suppl:70-6. doi: 10.1016/j.jebdp.2014.02.006. Epub 2014 Feb 13.
PubMed 24929591
de Paula EA, Loguercio AD, Fernandes D, Kossatz S, Reis A. Perioperative use of an anti-inflammatory drug on tooth sensitivity caused by in-office bleaching: a randomized, triple-blind clinical trial. Clin Oral Investig. 2013 Dec;17(9):2091-7. doi: 10.1007/s00784-013-0918-2. Epub 2013 Jan 31.
PubMed 23371755
de Paula EA, Kossatz S, Fernandes D, Loguercio AD, Reis A. Administration of ascorbic acid to prevent bleaching-induced tooth sensitivity: a randomized triple-blind clinical trial. Oper Dent. 2014 Mar-Apr;39(2):128-35. doi: 10.2341/12-483-C. Epub 2013 Jun 26.
PubMed 23802640
de Paula EA, Nava JA, Rosso C, Benazzi CM, Fernandes KT, Kossatz S, Loguercio AD, Reis A. In-office bleaching with a two- and seven-day intervals between clinical sessions: A randomized clinical trial on tooth sensitivity. J Dent. 2015 Apr;43(4):424-9. doi: 10.1016/j.jdent.2014.09.009. Epub 2014 Sep 23.
PubMed 25257824
Bonafe E, Loguercio AD, Reis A, Kossatz S. Effectiveness of a desensitizing agent before in-office tooth bleaching in restored teeth. Clin Oral Investig. 2014 Apr;18(3):839-45. doi: 10.1007/s00784-013-1055-7.
PubMed 23959376
Bonafe E, Bacovis CL, Iensen S, Loguercio AD, Reis A, Kossatz S. Tooth sensitivity and efficacy of in-office bleaching in restored teeth. J Dent. 2013 Apr;41(4):363-9. doi: 10.1016/j.jdent.2013.01.007. Epub 2013 Jan 26.
PubMed 23357647
Faria-E-Silva AL, Nahsan FP, Fernandes MT, Martins-Filho PR. Effect of preventive use of nonsteroidal anti-inflammatory drugs on sensitivity after dental bleaching: a systematic review and meta-analysis. J Am Dent Assoc. 2015 Feb;146(2):87-93.e1. doi: 10.1016/j.adaj.2014.10.007.
PubMed 25637206
He LB, Shao MY, Tan K, Xu X, Li JY. The effects of light on bleaching and tooth sensitivity during in-office vital bleaching: a systematic review and meta-analysis. J Dent. 2012 Aug;40(8):644-53. doi: 10.1016/j.jdent.2012.04.010. Epub 2012 Apr 21.
PubMed 22525016
Vadivelu N, Mitra S, Schermer E, Kodumudi V, Kaye AD, Urman RD. Preventive analgesia for postoperative pain control: a broader concept. Local Reg Anesth. 2014 May 29;7:17-22. doi: 10.2147/LRA.S62160. eCollection 2014.
PubMed 24872720
Li Y, Greenwall L. Safety issues of tooth whitening using peroxide-based materials. Br Dent J. 2013 Jul;215(1):29-34. doi: 10.1038/sj.bdj.2013.629.
PubMed 23846062
Markowitz K. Pretty painful: why does tooth bleaching hurt? Med Hypotheses. 2010 May;74(5):835-40. doi: 10.1016/j.mehy.2009.11.044. Epub 2009 Dec 31.
PubMed 20045265
Costa CA, Riehl H, Kina JF, Sacono NT, Hebling J. Human pulp responses to in-office tooth bleaching. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2010 Apr;109(4):e59-64. doi: 10.1016/j.tripleo.2009.12.002.
PubMed 20303048
Rhen T, Cidlowski JA. Antiinflammatory action of glucocorticoids--new mechanisms for old drugs. N Engl J Med. 2005 Oct 20;353(16):1711-23. doi: 10.1056/NEJMra050541. No abstract available.
PubMed 16236742
Bamgbose BO, Akinwande JA, Adeyemo WL, Ladeinde AL, Arotiba GT, Ogunlewe MO. Effects of co-administered dexamethasone and diclofenac potassium on pain, swelling and trismus following third molar surgery. Head Face Med. 2005 Nov 7;1:11. doi: 10.1186/1746-160X-1-11.
PubMed 16274480
Paula E, Kossatz S, Fernandes D, Loguercio A, Reis A. The effect of perioperative ibuprofen use on tooth sensitivity caused by in-office bleaching. Oper Dent. 2013 Nov-Dec;38(6):601-8. doi: 10.2341/12-107-C. Epub 2013 Apr 15.
PubMed 23586657

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?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 25 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Anti-inflammatory Steroids of Use in the Prevention of Tooth Sensitivity in Teeth Whitening Technique Office
ClinicalTrials.gov ID: NCT02956070
Acronym / sponsor ID: bleaching
Conditions: Inflammation
Keywords: dental bleaching, antiinflammatory, tooth sensitivity
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: Universidade Federal FluminenseUniversity, hospital or other
Study start: Oct 2015
Primary completion: May 2016 (actual)
Study completion: May 2016 (actual)
First posted: 4 Nov 2016 (estimated)
Results: Posted 25 Nov 2020

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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Experimental	Experimental	Drug: Dexamethasone acetate35 patients in this group will undergo the whitening procedure using the Dexamethasone acetate intervention.
Placebo	Placebo comparator	Drug: Potassium Nitrate35 patients in this group will undergo the whitening procedure using the Potassium Nitrate intervention

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

The selected volunteers should present a good general state of health, be at least 18 years of age, regardless of gender, color / race and ethnicity, sexual orientation, and gender identity.
Volunteers must have an acceptable oral hygiene, present the upper and lower arches without absence of teeth of first premolar right to the left first premolar.
These elements have to be healthy, that is, not having any kind of restoration.
Volunteers must sign the consent form and clarification, have committed to return for periodic examinations and belong to the group of nonsmokers.

Key exclusion criteria (7 listed)

Do not have medical history of diseases that can affect the results of the study;
subjects could not have made use of cigarettes in the last 30 days; have some important pathology in the oral cavity;
not being pregnant and also are not breastfeeding;
having any history of sensitivity or adverse reactions to anti-inflammatory used in the study;
not having calculations or advanced periodontal disease;

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
Dexamethasone acetateAlso: DexamethasoneThe volunteers in the Dexamethasone acetate group (experimental group) will receive six capsules of dexamethasone 8 mg each to be administered orally, initially two days before the first bleaching query as follows: 8 mg (1 capsule) 9 am two days before the first clinical session whitening; 8 mg (1 capsule) the 9 am to 1 day before session whitening, 8 mg (1 capsule) to 9 am on the day of the first session of whitening.Clinical intervention: 1- Dry teeth and apply Gingival Barrier to both arches. 2- Light cure. 3- Firmly attach a mixing nozzle to the Pola Office+. 4- Apply a thin layer of gel to all teeth undergoing treatment. 5- Leave gel on for 8 minutes. 6- Suction it off. 7- Repeat steps 5-6 twice times. 8- After the last application, suction all the gel off, then wash and apply suction. 9- Remove Gingival Barrier. 10- A placebo gel will be applied with a brush on the labial surface of the teeth whitened for 2 to 3 minutes .	Drug	Experimental
Potassium NitrateAlso: Smoothe SDIThe volunteers in the Potassium Nitrate Group (Placebo group) will receive 6 placebo capsules, who contained the same components of de dexamethasone drug except the active ingredient (starch [50%], lactose monohydrate [35%], dibasic calcium phosphate [14%], and magnesium stearate [1%]).Clinical session:1- Dry teeth and apply Gingival Barrier to both arches. 2- Light cure. 3- Firmly attach a mixing nozzle to the Pola Office+. 4- Apply a thin layer of gel to all teeth undergoing treatment. 5- Leave gel on for 8 minutes. 6- Suction it off. 7- Repeat steps 5-6 twice times. 8- After the last application, suction all the gel off, then wash and apply suction. 9- Remove Gingival Barrier. 10- A desensitizing gel containing 6% potassium nitrate will be applied with a brush on the labial surface of the teeth whitened for 2 to 3 minutes .	Drug	Placebo

Primary outcome

Visual Analogic Scale (0-100) for Tooth Sensibility.
Time frame: One hour
The investigators evaluated the tooth sensibility 1 hour post-bleaching. Scale from 0-100 0 means no sensibility 100 means maximum sensibility
Visual Analogic Scale(0-100) for Tooth Sensibility.
Time frame: Twenty four hours
The investigators evaluated the tooth sensibility 24 hours post-bleaching. Scale from 0-100 0 means no sensibility 100 means maximum sensibility
Visual Analogic Scale(0-100) for Tooth Sensibility.
Time frame: Forty eight hours
The investigators evaluated the tooth sensibility 48 hours post-bleaching. Scale from 0-100 0 means no sensibility 100 means maximum sensibility

Results and safety

Results posted to the registry on 25 Nov 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Experimental	35	35
Placebo	35	35

Primary outcome: Visual Analogic Scale (0-100) for Tooth Sensibility.

Time frame: One hour. Mean (Standard Deviation). Unit: units on a scale

Measure	Experimental n = 35	Placebo n = 35
Value	6.31 (12.78)	11.14 (20.08)

Primary outcome: Visual Analogic Scale(0-100) for Tooth Sensibility.

Time frame: Twenty four hours. Mean (Standard Deviation). Unit: units on a scale

Measure	Experimental n = 35	Placebo n = 35
Value	5.06 (9.86)	8.26 (13.48)

Primary outcome: Visual Analogic Scale(0-100) for Tooth Sensibility.

Time frame: Forty eight hours. Mean (Standard Deviation). Unit: units on a scale

Measure	Experimental n = 35	Placebo n = 35
Value	0.37 (1.54)	2.91 (9.14)

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Experimental	0 of 35 (0%)	0 of 35 (0%)	0 of 35
Placebo	0 of 35 (0%)	0 of 35 (0%)	0 of 35

Limitations and caveats (from the sponsor): No discontinuity in both treatment groups was found in the clinical investigation. All volunteers attended the recall visit 1 week postbleaching.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 24929591Carey CM. Tooth whitening: what we now know. J Evid Based Dent Pract. 2014 Jun;14 Suppl:70-6. doi: 10.1016/j.jebdp.2014.02.006. Epub 2014 Feb 13.
Background: PubMed 23371755de Paula EA, Loguercio AD, Fernandes D, Kossatz S, Reis A. Perioperative use of an anti-inflammatory drug on tooth sensitivity caused by in-office bleaching: a randomized, triple-blind clinical trial. Clin Oral Investig. 2013 Dec;17(9):2091-7. doi: 10.1007/s00784-013-0918-2. Epub 2013 Jan 31.
Background: PubMed 23802640de Paula EA, Kossatz S, Fernandes D, Loguercio AD, Reis A. Administration of ascorbic acid to prevent bleaching-induced tooth sensitivity: a randomized triple-blind clinical trial. Oper Dent. 2014 Mar-Apr;39(2):128-35. doi: 10.2341/12-483-C. Epub 2013 Jun 26.
Background: PubMed 25257824de Paula EA, Nava JA, Rosso C, Benazzi CM, Fernandes KT, Kossatz S, Loguercio AD, Reis A. In-office bleaching with a two- and seven-day intervals between clinical sessions: A randomized clinical trial on tooth sensitivity. J Dent. 2015 Apr;43(4):424-9. doi: 10.1016/j.jdent.2014.09.009. Epub 2014 Sep 23.
Background: PubMed 23959376Bonafe E, Loguercio AD, Reis A, Kossatz S. Effectiveness of a desensitizing agent before in-office tooth bleaching in restored teeth. Clin Oral Investig. 2014 Apr;18(3):839-45. doi: 10.1007/s00784-013-1055-7.
Background: PubMed 23357647Bonafe E, Bacovis CL, Iensen S, Loguercio AD, Reis A, Kossatz S. Tooth sensitivity and efficacy of in-office bleaching in restored teeth. J Dent. 2013 Apr;41(4):363-9. doi: 10.1016/j.jdent.2013.01.007. Epub 2013 Jan 26.
Background: PubMed 25637206Faria-E-Silva AL, Nahsan FP, Fernandes MT, Martins-Filho PR. Effect of preventive use of nonsteroidal anti-inflammatory drugs on sensitivity after dental bleaching: a systematic review and meta-analysis. J Am Dent Assoc. 2015 Feb;146(2):87-93.e1. doi: 10.1016/j.adaj.2014.10.007.
Background: PubMed 22525016He LB, Shao MY, Tan K, Xu X, Li JY. The effects of light on bleaching and tooth sensitivity during in-office vital bleaching: a systematic review and meta-analysis. J Dent. 2012 Aug;40(8):644-53. doi: 10.1016/j.jdent.2012.04.010. Epub 2012 Apr 21.
Background: PubMed 24872720Vadivelu N, Mitra S, Schermer E, Kodumudi V, Kaye AD, Urman RD. Preventive analgesia for postoperative pain control: a broader concept. Local Reg Anesth. 2014 May 29;7:17-22. doi: 10.2147/LRA.S62160. eCollection 2014.
Background: PubMed 23846062Li Y, Greenwall L. Safety issues of tooth whitening using peroxide-based materials. Br Dent J. 2013 Jul;215(1):29-34. doi: 10.1038/sj.bdj.2013.629.
Background: PubMed 20045265Markowitz K. Pretty painful: why does tooth bleaching hurt? Med Hypotheses. 2010 May;74(5):835-40. doi: 10.1016/j.mehy.2009.11.044. Epub 2009 Dec 31.
Background: PubMed 20303048Costa CA, Riehl H, Kina JF, Sacono NT, Hebling J. Human pulp responses to in-office tooth bleaching. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2010 Apr;109(4):e59-64. doi: 10.1016/j.tripleo.2009.12.002.
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.

Marcos O Barceleiro, MSD, PhD principal investigator

Fluminense Federal University

Questions about this trial

What is this clinical trial studying?

A study testing Dexamethasone acetate and Potassium Nitrate in people with Inflammation, run by Universidade Federal Fluminense.

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 4 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 25 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

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?

Yes. Results are posted in the registry (first posted 25 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Visual Analogic Scale (0-100) for Tooth Sensibility. (time frame: One hour). The study lists 3 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 NCT02956070, which also lists 19 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 25 Nov 2020.