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

Primary Purpose

Facial Swelling, Tooth Position Anomalies, Tooth, Impacted

Status

Completed

Phase

Phase 4

Locations

Italy

Study Type

Interventional

Intervention

Prednisone

Placebo

About this trial

This is an interventional treatment trial for Facial Swelling focused on measuring third molar surgery, facial swelling, 3D facial swelling evaluation, tooth impacted, prednisone drug administration, corticosteroids administration

Eligibility Criteria

18 Years - 32 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

Magna Graecia University of Catanzaro

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Prednisone group (PG)

Control group (CG)

Arm Description

Patients receiving a preoperative administration of prednisone 25 mg/os.

Patients receiving a preoperative administration of Placebo.

Outcomes

Primary Outcome Measures

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) .

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).

Secondary Outcome Measures

Change in trismus

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

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)

Full Information

NCT ID

NCT05830747

First Posted

March 27, 2023

Last Updated

April 23, 2023

Sponsor

University Magna Graecia

1. Study Identification

Unique Protocol Identification Number

NCT05830747

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

February 1, 2022 (Actual)

Primary Completion Date

October 25, 2022 (Actual)

Study Completion Date

December 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Magna Graecia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Facial Swelling, Tooth Position Anomalies, Tooth, Impacted, Tooth Extraction Status Nos, Tooth Avulsion

Keywords

third molar surgery, facial swelling, 3D facial swelling evaluation, tooth impacted, prednisone drug administration, corticosteroids administration

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

34 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Prednisone group (PG)

Arm Type

Experimental

Arm Description

Patients receiving a preoperative administration of prednisone 25 mg/os.

Arm Title

Control group (CG)

Arm Type

Placebo Comparator

Arm Description

Patients receiving a preoperative administration of Placebo.

Intervention Type

Drug

Intervention Name(s)

Prednisone

Intervention Description

Pre-operative drug administration before third molar surgery

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Pre-operative Placebo administration before third molar surgery

Primary Outcome Measure Information:

Title

Change in facial swelling

Description

Time Frame

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

Title

Change in facial swelling

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

Change in trismus

Description

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

Time Frame

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

Title

Change in pain with Visual analogue scale (VAS)

Description

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)

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

32 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alessandro Antonelli, PhDs, DDS

Organizational Affiliation

Magna Graecia University of Catanzaro

Official's Role

Principal Investigator

Facility Information:

Facility Name

Magna Graecia University of Catanzaro

City

Catanzaro

State/Province

ZIP/Postal Code

88100

Country

Italy

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

30376855

Citation

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Results Reference

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PubMed Identifier

34030996

Citation

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Results Reference

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PubMed Identifier

30878593

Citation

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Results Reference

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PubMed Identifier

17619915

Citation

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Citation

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Citation

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Results Reference

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PubMed Identifier

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Citation

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Results Reference

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Citation

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Citation

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Citation

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PubMed Identifier

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Citation

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Citation

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Results Reference

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

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