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Facial SwellingPhase 4NCT05830747

Effect of Pre-emptive Dose of Prednisone Versus Placebo in Impacted Third Molar Surgery

A Phase 4 study testing Prednisone in people with Facial Swelling and Tooth Position Anomalies, run by University Magna Graecia at 1 site in Italy.

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 present study proposes to compare the effect of a single preoperative dose of prednisone versus placebo in terms of facial swelling, trismus and pain after surgical removal of the mandibular third molar (M3M) in a split-mouth randomized controlled clinical trial. Read more about this study

Who is it for?
Ages 18 to 32 yearsHealthy volunteers can take part
What is being tested?
Prednisone
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
34 participants
Where
1 siteItaly
Study dates
1 Feb 2022to 10 Dec 2022
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 32 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Patients aged 18 to 32 years who required both M3M extractions were recruited
  • Good health status
  • Indication to surgical extraction of both M3M
  • Complete root formation
  • Surgical risk level classified as "Conventional" or "Moderate" according to Daugela et al. classification

Who cannot join

  • Person under the age of 18 or over 32
  • Allergy or contraindications to administration of corticosteroids
  • Acute infection in any of the teeth to be extracted
  • Patients with chronic liver disease, diabetes, immune system dysfunction, or haematological disease
  • Pregnancy or breastfeeding
  • History of treatment with antiresorptive drugs
  • Chronic kidney disease
  • History of systemic corticosteroid therapy in the past 4 weeks

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Magna Graecia University of Catanzaro

    Catanzaro, CZ, 88100

Other trials in Italy

About this study

Official title: Three-dimensional Facial Swelling Evaluation of Pre-operative Single-dose of Prednisone in Third Molar Surgery: a Split-mouth Randomized Controlled Trial

The present study proposes to compare the effect of a single preoperative dose of prednisone versus placebo in terms of facial swelling, trismus and pain after surgical removal of the mandibular third molar (M3M) in a split-mouth randomized controlled clinical trial.

Read the detailed description

This study aims to compare the effect of a single preoperative dose of prednisone versus placebo in terms of facial swelling, trismus, and pain after surgical removal of M3M in a split-mouth randomized controlled clinical trial. Facial swelling will be evaluated using an innovative three-dimensional digital technique.

Being tested
Prednisone, Placebo
Keywords
third molar surgery, facial swelling, 3D facial swelling evaluation, tooth impacted, prednisone drug administration, corticosteroids administration
Medical subject headings
Tooth, Impacted, Tooth Avulsion

What participants receive

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

  • PrednisoneDrug

    Pre-operative drug administration before third molar surgery

  • PlaceboDrug

    Pre-operative Placebo administration before third molar surgery

Study groups in NCT05830747
Study groupRoleWhat they receive
Prednisone group (PG)ExperimentalPatients receiving a preoperative administration of prednisone 25 mg/os.
Receives: Drug: Prednisone
Control group (CG)Placebo comparatorPatients receiving a preoperative administration of Placebo.
Receives: Drug: Placebo

What is being measured

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

  1. Change in facial swelling

    To compare the effectiveness of prednisone/os versus placebo in reducing facial swelling using qualitative three-dimensional analysis (measured by colorimetric variation given by the overlapping volumes) .

    Measured: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery

  2. Change in facial swelling

    To compare the effectiveness of prednisone/os versus placebo in reducing facial swelling using quantitative three-dimensional analysis (differences are measured in cm3).

    Measured: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery

Secondary outcomes (2)

  1. Change in trismus

    To assess the effects of prednisone/os administration on trismus (measured in cm)

    Measured: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery

  2. Change in pain with Visual analogue scale (VAS)

    To assess the effects of prednisone/os administration on pain (measured by VAS-score from 0 to 10 point, with 10 as the worst outcome)

    Measured: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery

Timeline

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

  1. First posted26 Apr 2023
  2. Study start1 Feb 2022
  3. Primary completion25 Oct 2022
  4. Study completion10 Dec 2022

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
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05830747
Sponsor's protocol ID
465/2020
Status last verified
Apr 2023
First submitted
27 Mar 2023
Last updated
26 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cankaya AB, Akcay C, Kahraman N, Koseoglu BG. Oral surgical procedures under local anaesthesia in day surgery. BMC Oral Health. 2018 Oct 30;18(1):179. doi: 10.1186/s12903-018-0648-6.

    PubMed 30376855

  • Sifuentes-Cervantes JS, Carrillo-Morales F, Castro-Nunez J, Cunningham LL, Van Sickels JE. Third molar surgery: Past, present, and the future. Oral Surg Oral Med Oral Pathol Oral Radiol. 2021 Nov;132(5):523-531. doi: 10.1016/j.oooo.2021.03.004. Epub 2021 Mar 14.

    PubMed 34030996

  • Sainz de Baranda B, Silvestre FJ, Silvestre-Rangil J. Relationship Between Surgical Difficulty of Third Molar Extraction Under Local Anesthesia and the Postoperative Evolution of Clinical and Blood Parameters. J Oral Maxillofac Surg. 2019 Jul;77(7):1337-1345. doi: 10.1016/j.joms.2019.02.020. Epub 2019 Feb 20.

    PubMed 30878593

  • Yamalik K, Bozkaya S. The predictivity of mandibular third molar position as a risk indicator for pericoronitis. Clin Oral Investig. 2008 Mar;12(1):9-14. doi: 10.1007/s00784-007-0131-2. Epub 2007 Jul 10.

    PubMed 17619915

  • Yoo JH, Yeom HG, Shin W, Yun JP, Lee JH, Jeong SH, Lim HJ, Lee J, Kim BC. Deep learning based prediction of extraction difficulty for mandibular third molars. Sci Rep. 2021 Jan 21;11(1):1954. doi: 10.1038/s41598-021-81449-4.

    PubMed 33479379

  • Acham S, Klampfl A, Truschnegg A, Kirmeier R, Sandner-Kiesling A, Jakse N. Beneficial effect of methylprednisolone after mandibular third molar surgery: a randomized, double-blind, placebo-controlled split-mouth trial. Clin Oral Investig. 2013 Sep;17(7):1693-700. doi: 10.1007/s00784-012-0867-1. Epub 2012 Oct 30.

    PubMed 23108628

  • 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

  • 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

  • Tiigimae-Saar J, Leibur E, Tamme T. The effect of prednisolone on reduction of complaints after impacted third molar removal. Stomatologija. 2010;12(1):17-22.

    PubMed 20440092

  • Kaewkumnert S, Phithaksinsuk K, Changpoo C, Nochit N, Muensaiyat Y, Wilaipornsawai S, Piriyaphokai U, Powcharoen W. Comparison of intraosseous and submucosal dexamethasone injection in mandibular third molar surgery: a split-mouth randomized clinical trial. Int J Oral Maxillofac Surg. 2020 Apr;49(4):529-535. doi: 10.1016/j.ijom.2019.10.006. Epub 2019 Oct 25.

    PubMed 31668666

  • Juodzbalys G, Daugela P. Mandibular third molar impaction: review of literature and a proposal of a classification. J Oral Maxillofac Res. 2013 Jul 1;4(2):e1. doi: 10.5037/jomr.2013.4201.

    PubMed 24422029

  • Lau AAL, De Silva RK, Thomson M, De Silva H, Tong D. Third Molar Surgery Outcomes: A Randomized Clinical Trial Comparing Submucosal and Intravenous Dexamethasone. J Oral Maxillofac Surg. 2021 Feb;79(2):295-304. doi: 10.1016/j.joms.2020.09.020. Epub 2020 Sep 17.

    PubMed 33058774

  • Antonelli A, Barone S, Bennardo F, Giudice A. Three-dimensional facial swelling evaluation of pre-operative single-dose of prednisone in third molar surgery: a split-mouth randomized controlled trial. BMC Oral Health. 2023 Aug 31;23(1):614. doi: 10.1186/s12903-023-03334-y.

    PubMed 37653378

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Prednisone in people with Facial Swelling and Tooth Position Anomalies, run by University Magna Graecia at 1 site in Italy.

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 8 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 Apr 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 Italy. 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?

Change in facial swelling (time frame: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery). The study lists 2 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 NCT05830747, which also lists 13 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 26 Apr 2023.

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