NCT04889781

Brief Summary

The purpose of my study is to test the effect of using piezosurgery and dexamethasone injection in the surgical extraction of impacted mandibular third molars, on Postoperative Pain.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2019

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 17, 2021

Completed
Last Updated

May 17, 2021

Status Verified

May 1, 2021

Enrollment Period

4 months

First QC Date

May 9, 2021

Last Update Submit

May 14, 2021

Conditions

Impacted Mandibular Third Molar Extraction

Keywords

Impacted Mandibular Third molar surgery.PainDexamethasonePiezosurgery

Outcome Measures

Primary Outcomes (2)

  • Change of Postoperative Pain level From Baseline

    Postoperative Pain level using Visual Analogue Scale (VAS): 100 mm in length ranging from 0 for " no pain" to 100 for "the worse imaginable pain

    Days 1, 3, and 7 Post-op

  • Working time

    Surgery time from the start of the incision until the end of the suturing (min).

    Per-op

Secondary Outcomes (1)

  • Change oh The maximal mouth opening From Baseline

    At Day 0 and Day 3

Study Arms (4)

Rotatory Instruments without Dexamethasone injection

EXPERIMENTAL

Surgical extraction of Impacted Mandibular Third Molar using conventional rotatory instruments to perform osteotomy without Intramuscular Dexamethasone injection

Procedure: Conventional Rotatory instruments

Rotatory Instruments with Dexamethasone injection

EXPERIMENTAL

Surgical extraction of Impacted Mandibular Third Molar using conventional rotatory instruments to perform osteotomy with 8 mg Intramuscular Dexamethasone injection 30 min before surgery

Drug: Dexamethasone injection

Piezosurgery technique without Dexamethasone injection

EXPERIMENTAL

Surgical extraction of Impacted Mandibular Third Molar using the piezosurgery technique without Intramuscular Dexamethasone injection

Procedure: PiezosurgeryProcedure: Conventional Rotatory instruments

Piezosurgery technique with Dexamethasone injection

EXPERIMENTAL

Surgical extraction of Impacted Mandibular Third Molar using the piezosurgery technique with 8 mg Intramuscular Dexamethasone injection 30 min before surgery

Drug: Dexamethasone injectionProcedure: Piezosurgery

Interventions

Dexamethasone injectionDRUG

Compare the effect of dexamethasone injection on reducing post-op pain after impacted third molar Surgery

Piezosurgery technique with Dexamethasone injectionRotatory Instruments with Dexamethasone injection
PiezosurgeryPROCEDURE

Compare the effect of Piezosurgery device use on reducing post-op pain after impacted third molar Surgery

Piezosurgery technique with Dexamethasone injectionPiezosurgery technique without Dexamethasone injection
Conventional Rotatory instrumentsPROCEDURE

Surgical extraction using conventional rotatory instruments to perform osteotomy

Piezosurgery technique without Dexamethasone injectionRotatory Instruments without Dexamethasone injection

Eligibility Criteria

Age15 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age from 15 to 30 years,
  • Having mandibular impacted third molars,

You may not qualify if:

  • Heavy smokers (≥20 cigarettes),
  • Uncontrolled systemic conditions,
  • Infection of the surgery site,
  • Psychological problems,
  • History of allergy to dexamethasone, amoxicillin, or acetaminophen.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Central Military Hospital

Beirut, 1100, Lebanon

Location

Related Publications (1)

  • Nehme W, Fares Y, Abou-Abbas L. Piezo-surgery technique and intramuscular dexamethasone injection to reduce postoperative pain after impacted mandibular third molar surgery: a randomized clinical trial. BMC Oral Health. 2021 Aug 11;21(1):393. doi: 10.1186/s12903-021-01759-x.

    PMID: 34380473DERIVED

MeSH Terms

Conditions

Pain

Interventions

Calcium DobesilatePiezosurgery

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzenesulfonatesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsArylsulfonatesArylsulfonic AcidsSulfonic AcidsSulfur AcidsSulfur CompoundsUltrasonic Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Oral and Maxillofacial Surgery Department

Study Record Dates

First Submitted

May 9, 2021

First Posted

May 17, 2021

Study Start

February 1, 2019

Primary Completion

June 1, 2019

Study Completion

July 1, 2019

Last Updated

May 17, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

LE(1)