COMPARISON OF PIEZOSURGERY AND CONVENTIONAL ROTARY INSTRUMENTS IN IMPACTED THIRD MOLAR SURGERY

A PROSPECTIVE SPLIT MOUTH CLINICAL STUDY: OF PIEZOSURGERY AND CONVENTIONAL ROTARY INSTRUMENTS IN IMPACTED THIRD MOLAR SURGERY

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.

Study Overview

• Status: Completed
• Conditions: Impacted Third Molar Tooth
• Intervention / Treatment: Other: Piezosurgery group

Detailed Description

The investigators plan a prospective and split mouth study. Thirty patients will be randomly selected. Inclusion criteria were being older than 18 of age, having asymptomatic bilateral mesioangular impacted mandibular third molar (Pell and Gregory class II, position B) fully covered with mucosa and bone, and being otherwise medically healthy.

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. The other side will be accepted as "control group". In the control group, impacted third molar will be extracted using conventional rotary instruments.There will at least one month between two surgeries. The investigators will compare postoperative pain, swelling, trismus and patients' comfort.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Karatay
    • Konya, Karatay, Turkey, 42050
      • Necmettin Erbakan University, Faculty of Dentistry
    • Konya, Karatay, Turkey, 42050
      • Necmettin Erbakan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Inclusion criteria were being older than 18 of age, having asymptomatic bilateral mesioangular impacted mandibular third molar (Pell and Gregory class II, position B) fully covered with mucosa and bone, and being otherwise medically healthy.

Exclusion Criteria:

• Exclusion criteria were as follows: Alcohol abuse, smoking, pregnancy, and presence of acute severe periodontitis.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Piezosurgery group; 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; Piezosurgery technique will be examined about impacted third molar surgery.
PLACEBO_COMPARATOR: Rotary Instruments Group; 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; Piezosurgery technique will be examined about impacted third molar surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain will be assessed using a visual analogue scale.	The level of postoperative pain will be evaluated using a 10-cm visual analogue scale , with zero representing no pain and 10 representing excruciating pain. Pain measurement will be done preoperatively, postoperative 2nd day, 7th day after the surgery.	Up to 1 week
Trismus will be evaluated using a caliper at maximum mouth opening.	Trismus will be assessed by measuring the maximum interincisal opening (in millimetres) - the distance between the incisal margin of the upper and lower central incisors. Trismus measurement will be done preoperatively, postoperative 2nd day, 7th day after the surgery.	Up to 1 week

Collaborators and Investigators

• Sponsor: Konya Necmettin Erbakan Üniversitesi

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 4, 2019
• Primary Completion (ACTUAL): May 7, 2019
• Study Completion (ACTUAL): May 7, 2019

Study Registration Dates

• First Submitted: February 22, 2019
• First Submitted That Met QC Criteria: February 26, 2019
• First Posted (ACTUAL): February 27, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 8, 2019
• Last Update Submitted That Met QC Criteria: May 7, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: pain; swelling; Trismus; piezosurgery
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth, Impacted
• Other Study ID Numbers: NEU3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No