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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03857035
Other study ID # NEU3
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 4, 2019
Est. completion date May 7, 2019

Study information

Verified date February 2019
Source Konya Necmettin Erbakan Üniversitesi
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date May 7, 2019
Est. primary completion date May 7, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 30 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Piezosurgery group
Piezosurgery technique will be examined about impacted third molar surgery.

Locations

Country Name City State
Turkey Necmettin Erbakan University Konya Karatay
Turkey Necmettin Erbakan University, Faculty of Dentistry Konya Karatay

Sponsors (1)

Lead Sponsor Collaborator
Konya Necmettin Erbakan Üniversitesi

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
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