NCT03857035

Brief Summary

The purpose is to compare the effects of piezosurgery and conventional rotary instruments on postoperative pain, swelling, trismus and patients' comfort after mandibular third molar surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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 4, 2019

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

February 22, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 27, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 7, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 7, 2019

Completed
Last Updated

May 8, 2019

Status Verified

February 1, 2019

Enrollment Period

3 months

First QC Date

February 22, 2019

Last Update Submit

May 7, 2019

Conditions

Impacted Third Molar Tooth

Keywords

Trismuspiezosurgerypainswelling

Outcome Measures

Primary Outcomes (1)

  • All the patients will be given a form containing verbal rating scale ranging from 0 to 5, showing the degree of swelling.

    The edema measurement will be done during the one week after surgery.

    Up to 1 week

Secondary Outcomes (2)

  • Pain will be assessed using a visual analogue scale.

    Up to 1 week

  • Trismus will be evaluated using a caliper at maximum mouth opening.

    Up to 1 week

Study Arms (2)

Piezosurgery group

EXPERIMENTAL

One side of the patients will be randomly selected and labeled as "experimental group". In experimental group, impacted third molar will be extracted using piezosurgery.

Other: Piezosurgery group

Rotary Instruments Group

PLACEBO COMPARATOR

The other side will be accepted as "control group". In the control group, impacted third molar will be extracted using conventional rotary instruments.

Other: Piezosurgery group

Interventions

Piezosurgery groupOTHER

Piezosurgery technique will be examined about impacted third molar surgery.

Piezosurgery groupRotary Instruments Group

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Necmettin Erbakan University, Faculty of Dentistry

Konya, Karatay, 42050, Turkey (Türkiye)

Location

Necmettin Erbakan University

Konya, Karatay, 42050, Turkey (Türkiye)

Location

MeSH Terms

Conditions

TrismusPain

Condition Hierarchy (Ancestors)

SpasmNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Dilek Menziletoglu, Dr

    Necmettin Erbakan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

February 22, 2019

First Posted

February 27, 2019

Study Start

February 4, 2019

Primary Completion

May 7, 2019

Study Completion

May 7, 2019

Last Updated

May 8, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(2)