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Impacted Third Molar ToothPhase 4NCT03179813

Topical Hydrocortisone for Pain and Edema Control After Third Molar Surgery

A Phase 4 study testing Hydrocortisone in people with Impacted Third Molar Tooth, run by University of Sao Paulo 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

The investigators set out to develop a clinical trial in order to test the topical use of hydrocortisone as a intraoperative irrigant solution. As this route of administration as well as being low cost and not add new steps to the surgical procedure, can contribute to an improved quality of life in the postoperative… Read more about this study

Who is it for?
Ages 14 years and olderHealthy volunteers can take part
Conditions the study is for
Impacted Third Molar Tooth
What is being tested?
Hydrocortisone
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteBrazil
Study dates
1 May 2017to 1 Mar 2018
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 14 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Health patients of any sex, with symmetric bilateral bone-impacted mandibular third molars requiring surgical removal, and with no history of allergy to the drugs used in this study.

Who cannot join

  • Use of analgesic or anti-inflammatory drugs 24 hours before the surgery.
  • Pregnant or breastfeeding patients,
  • Use of other drugs beyond of that one's prescribed by the researchers;

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Vitor Pereira Rodrigues

    São Paulo, São Paulo, 04105000

Other trials in Brazil

About this study

Official title: Topical Hydrocortisone for Pain and Edema Control After Third Molar Surgery: a Clinical, Crossover, Randomized, Double-blind, Controlled Study

The investigators set out to develop a clinical trial in order to test the topical use of hydrocortisone as a intraoperative irrigant solution. As this route of administration as well as being low cost and not add new steps to the surgical procedure, can contribute to an improved quality of life in the postoperative period of patients undergoing extraction of third molars.

Read the detailed description

Third molars are the teeth with a higher prevalence of failure in eruption and surgery for extraction of these impacted teeth is one of the most commonly procedures performed by the oral and maxillofacial surgeon. In most cases these are not traumatic procedures, however factors such as patient age, habits, degree of tooth impaction and surgeon experience can influence the surgical trauma and therefore the postoperative period could include swelling and pain of varying magnitudes which can significantly affect the patient's quality of life.

The study is designed as a prospective, randomized, placebo-controlled, split-mouth crossover trial. All the patients will be informed of the experimental methodology and signed a institutionally approved consent form. The study is been conducted in compliance with Declaration of Helsinki (1989), and was revised by the Institutional Ethical Committee (protocol 1.167.908).

Being tested
Hydrocortisone, Control
Keywords
hydrocortisone, third molar, oral surgery, postoperative pain, edema
Medical subject headings
Pain, Postoperative, Edema

What participants receive

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

  • HydrocortisoneProcedure or surgery

    During the third molar extraction the hydrocortisone solution will be used in the test group

  • ControlProcedure or surgery

    During the third molar extraction the saline solution will be used in the control group

Study groups in NCT03179813
Study groupRoleWhat they receive
Hydrocortisone groupExperimentalIntraoperative topical use of hydrocortisone as a irrigation solution in third molar surgery.
Receives: Procedure: Hydrocortisone
Control GroupPlacebo comparatorIntraoperative irrigation with saline solution.
Receives: Procedure: Control

What is being measured

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

  1. Edema

    Change in edema measures

    Measured: From the preoperative moment to the second postoperative day

Secondary outcomes (2)

  1. Pain

    Quantitative evaluation (amount of analgesic medication intake)

    Measured: Up to 2 days (amount of analgesic medication intake form the immediate postoperative moment to the second postoperative day)

  2. Pain

    Subjective evaluation - Visual Analog Scale

    Measured: Up to 2 days (from the immediate postoperative moment to the second postoperative day)

Timeline

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

  1. First posted7 Jun 2017
  2. Study start1 May 2017
  3. Primary completion3 Jan 2018
  4. Study completion1 Mar 2018

Resources

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
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03179813
Sponsor's protocol ID
44657315.4.0000.0075
Status last verified
Nov 2017
First submitted
29 May 2017
Last updated
7 Mar 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ngeow WC, Lim D. Do Corticosteroids Still Have a Role in the Management of Third Molar Surgery? Adv Ther. 2016 Jul;33(7):1105-39. doi: 10.1007/s12325-016-0357-y. Epub 2016 Jun 10.

    PubMed 27287853

  • Herrera-Briones FJ, Prados Sanchez E, Reyes Botella C, Vallecillo Capilla M. Update on the use of corticosteroids in third molar surgery: systematic review of the literature. Oral Surg Oral Med Oral Pathol Oral Radiol. 2013 Nov;116(5):e342-51. doi: 10.1016/j.oooo.2012.02.027. Epub 2012 Aug 17.

    PubMed 22902498

  • Grossi GB, Maiorana C, Garramone RA, Borgonovo A, Beretta M, Farronato D, Santoro F. Effect of submucosal injection of dexamethasone on postoperative discomfort after third molar surgery: a prospective study. J Oral Maxillofac Surg. 2007 Nov;65(11):2218-26. doi: 10.1016/j.joms.2006.11.036.

    PubMed 17954317

  • Ceccheti MM, Negrato GV, Peres MP, Deboni MC, Naclerio-Homem Mda G. Analgesic and adjuvant anesthetic effect of submucosal tramadol after mandibular third molar surgery. Oral Surg Oral Med Oral Pathol Oral Radiol. 2014 Mar;117(3):e249-54. doi: 10.1016/j.oooo.2012.05.015. Epub 2012 Sep 12.

    PubMed 22981094

  • Pourdanesh F, Khayampour A, Jamilian A. Therapeutic effects of local application of dexamethasone during bilateral sagittal split ramus osteotomy surgery. J Oral Maxillofac Surg. 2014 Jul;72(7):1391-4. doi: 10.1016/j.joms.2013.12.025. Epub 2014 Jan 15.

    PubMed 24576440

  • Mahmoud Hashemi H, Mohammadi F, Hasheminasab M, Mahmoud Hashemi A, Zahraei S, Mahmoud Hashemi T. Effect of low-concentration povidone iodine on postoperative complications after third molar surgery: a pilot split-mouth study. J Oral Maxillofac Surg. 2015 Jan;73(1):18-21. doi: 10.1016/j.joms.2014.06.454. Epub 2014 Jul 5.

    PubMed 25249172

  • UStun Y, Erdogan O, Esen E, Karsli ED. Comparison of the effects of 2 doses of methylprednisolone on pain, swelling, and trismus after third molar surgery. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2003 Nov;96(5):535-9. doi: 10.1016/S1079210403004645.

    PubMed 14600686

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Hydrocortisone in people with Impacted Third Molar Tooth, 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 1 inclusion and 3 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 7 Mar 2018. 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?

Edema (time frame: From the preoperative moment to the second postoperative day). 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 NCT03179813, which also lists 7 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 7 Mar 2018.

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