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Piezosurgery and Conventional Rotary Instruments on Third Molar Surgery

Primary Purpose

Impacted Third Molar Tooth

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Piezosurgery

Conventional burs

About this trial

This is an interventional treatment trial for Impacted Third Molar Tooth focused on measuring Impacted Tooth, Piezo-Electric Surgery, Postoperative Complication

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

ASA I-II
Aged 18-35
Symmetrical Class 2 Position B according to Winter and Pell-gregory classification
Asymptomatic lower third molar tooth with the same difficulty according to the Yuasa difficulty index

Exclusion Criteria:

Individuals who had systemic disease affecting bone or soft tissue metabolism
Smokers (more than 10 cigarettes a day
Alcohol dependent
Systemic disease affecting bone or soft tissue metabolism
Acute pericoronitis or acute periodontal disease at the time of operation, and used antibiotics due to acute infection

Sites / Locations

Marmara University School of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Piezosurgery group

Conventional group

Arm Description

In the experimental group, a piezosurgery device was used to remove the bone surrounding the impacted third molar.

In the control group, conventional burs were used to remove the bone surrounding the impacted third molar.

Outcomes

Primary Outcome Measures

Change in Oral Health-related Quality of Life

Evaluated by OHIP-14

Secondary Outcome Measures

Change in pain

Postoperative pain was assessed using a Visual Analogue Scale (VAS) ranging from the absence of pain (score 0) to the most severe pain imaginable

Change in Mouth opening

The distance between the mesio-incisal corners of the upper and lower central incisors was measured with the help of a ruler when the mouth opening was at its maximum.

Operation time

The total time from the first incision of the operation site to the last suture was measured with the help of a digital stopwatch as the operation time.

Change in facial swelling

With the technique described by Neupert ; Angle of mandible-tragus Angle of mandible-lateral canthus of eye Mandible corner-nose wing Angle of mandible oral-commissures Measurements were made with a tape measure from 5 points, with the mandible corner-pogonion.

Full Information

NCT ID

NCT05545553

First Posted

September 9, 2022

Last Updated

December 12, 2022

Sponsor

Marmara University

1. Study Identification

Unique Protocol Identification Number

NCT05545553

Brief Title

Piezosurgery and Conventional Rotary Instruments on Third Molar Surgery

Official Title

A Randomized Split Mouth Clinical Trial Comparing Piezosurgery and Conventional Rotary Instruments on Impacted Third Molar Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Completed

Study Start Date

October 1, 2021 (Actual)

Primary Completion Date

March 1, 2022 (Actual)

Study Completion Date

August 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Marmara University

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 aim of this study is to compare piezosurgery and conventional surgery in impacted third molar surgery and to determine its effect on postoperative outcomes and quality of life.

6. Conditions and Keywords

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

Impacted Third Molar Tooth

Keywords

Impacted Tooth, Piezo-Electric Surgery, Postoperative Complication

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Piezosurgery group

Arm Type

Experimental

Arm Description

In the experimental group, a piezosurgery device was used to remove the bone surrounding the impacted third molar.

Arm Title

Conventional group

Arm Type

Active Comparator

Arm Description

In the control group, conventional burs were used to remove the bone surrounding the impacted third molar.

Intervention Type

Device

Intervention Name(s)

Piezosurgery

Intervention Description

Piezosurgery used as an osteotomy device

Intervention Type

Device

Intervention Name(s)

Conventional burs

Intervention Description

Conventional burs used as an osteotomy device

Primary Outcome Measure Information:

Title

Change in Oral Health-related Quality of Life

Description

Evaluated by OHIP-14

Time Frame

14 days

Secondary Outcome Measure Information:

Title

Change in pain

Description

Postoperative pain was assessed using a Visual Analogue Scale (VAS) ranging from the absence of pain (score 0) to the most severe pain imaginable

Time Frame

7 days

Title

Change in Mouth opening

Description

The distance between the mesio-incisal corners of the upper and lower central incisors was measured with the help of a ruler when the mouth opening was at its maximum.

Time Frame

7 days

Title

Operation time

Description

The total time from the first incision of the operation site to the last suture was measured with the help of a digital stopwatch as the operation time.

Time Frame

Intraoperative

Title

Change in facial swelling

Description

Time Frame

7 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: ASA I-II Aged 18-35 Symmetrical Class 2 Position B according to Winter and Pell-gregory classification Asymptomatic lower third molar tooth with the same difficulty according to the Yuasa difficulty index Exclusion Criteria: Individuals who had systemic disease affecting bone or soft tissue metabolism Smokers (more than 10 cigarettes a day Alcohol dependent Systemic disease affecting bone or soft tissue metabolism Acute pericoronitis or acute periodontal disease at the time of operation, and used antibiotics due to acute infection

Facility Information:

Facility Name

Marmara University School of Dentistry

City

Istanbul

ZIP/Postal Code

34854

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Time Frame

Data will become available in 1 month and will be available for 2 years

Citations:

PubMed Identifier

22890087

Citation

Rullo R, Addabbo F, Papaccio G, D'Aquino R, Festa VM. Piezoelectric device vs. conventional rotative instruments in impacted third molar surgery: relationships between surgical difficulty and postoperative pain with histological evaluations. J Craniomaxillofac Surg. 2013 Mar;41(2):e33-8. doi: 10.1016/j.jcms.2012.07.007. Epub 2012 Aug 11.

Results Reference

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PubMed Identifier

12029279

Citation

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Results Reference

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PubMed Identifier

17884515

Citation

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PubMed Identifier

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Citation

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PubMed Identifier

25109581

Citation

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PubMed Identifier

25201232

Citation

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PubMed Identifier

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Citation

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PubMed Identifier

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Citation

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PubMed Identifier

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Citation

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PubMed Identifier

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Citation

Mantovani E, Arduino PG, Schierano G, Ferrero L, Gallesio G, Mozzati M, Russo A, Scully C, Carossa S. A split-mouth randomized clinical trial to evaluate the performance of piezosurgery compared with traditional technique in lower wisdom tooth removal. J Oral Maxillofac Surg. 2014 Oct;72(10):1890-7. doi: 10.1016/j.joms.2014.05.002. Epub 2014 May 13.

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Citation

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Piezosurgery and Conventional Rotary Instruments on Third Molar Surgery

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