NCT05170516

Brief Summary

Third molar surgery is one of the most common procedures in oral surgery and the most common postoperative complications are swelling, pain, and trismus. This study aims to evaluate the postoperative morbidity (pain, swelling, and trismus) in third molar surgery performed using different degrees of cooled and room temperature irrigation solutions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2018

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2018

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2020

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

December 21, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 28, 2021

Completed
Last Updated

February 10, 2022

Status Verified

January 1, 2022

Enrollment Period

2.3 years

First QC Date

December 21, 2021

Last Update Submit

January 26, 2022

Conditions

Impacted Third Molar Tooth

Keywords

Cooled irrigationImpacted third molarPostoperative morbidityCooled saline

Outcome Measures

Primary Outcomes (3)

  • Change in trismus

    Trismus was assessed by measuring the distance between the mesial incisal corners of the right upper and lower central teeth when the patient had maximum mouth opening. The difference between each postoperative measurement and the preoperative measurement indicated the trismus for that day.

    7 days

  • Change in Facial Swelling

    three measurements between 5 reference points were performed with a flexible ruler: tragus to soft tissue pogonion, lateral corner of the eye to the angle of the mandible, and tragus to the outer corner of the mouth. The sum of the 3 measurements was calculated preoperatively and repeated.The difference between each postoperative measurement and the preoperative measurement was determined as the value for facial swelling.

    7 days

  • Change in pain

    Postoperative pain was evaluated by the Visual Analogue Scale (VAS) from "0" (as no pain) to "10" (as the most severe pain experienced).

    7 days

Secondary Outcomes (1)

  • Change in the number of analgesic

    7 days

Study Arms (4)

Experimental Group A

EXPERIMENTAL

In experimental group A, 4°C saline irrigation was used for removal of the bone surrounding the right or left third molars.

Procedure: 4 °C colled saline irrigation

Experimental Group B

EXPERIMENTAL

In experimental group B, 10°C saline irrigation was used for removal of the bone surrounding the right or left third molars.

Procedure: 10 °C cooled saline irrigation

Control Group A

ACTIVE COMPARATOR

In control group A, room temperature saline was used for the other side extractions of patients whose impacted tooth was extracted under 4 °C saline irrigation on one side.

Procedure: Room temperature saline irrigation

Control Group B

ACTIVE COMPARATOR

In control group B, room temperature saline was used for the other side extractions of patients whose impacted tooth was extracted under 10 °C saline irrigation on one side.

Procedure: Room temperature saline irrigation

Interventions

4 °C colled saline irrigationPROCEDURE

In Experimental Group A , 4 °C colled saline irrigation was used during impacted third molar surgery

Experimental Group A
10 °C cooled saline irrigationPROCEDURE

Experimental Group B, 10°C colled saline irrigation was used during impacted third molar surgery.

Experimental Group B
Room temperature saline irrigationPROCEDURE

In Control Group A and B, salin irrigation at room temperature was used during impacted third molar surgery.

Control Group AControl Group B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Volunteers over the age of 18
  • Patients who had no significant medical diseases or use of drugs, were not pregnant, had no allergy, and did not smoke.
  • Patients who had bilateral asymptomatic vertical third molar teeth with impaction of class I, level C according to Pell and Gregory Classification, and no history of recent antibiotic or anti-inflammatory treatment.

You may not qualify if:

  • Patients who had symptomatic impacted third molars.
  • Patients who had a medical history described above.
  • Patients under the age of 18.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Trakya University

Edirne, Merkez, 22030, Turkey (Türkiye)

Location

Study Officials

  • F. Gülfeşan Çanakçi

    Trakya University, Faculty of Dentistry

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 21, 2021

First Posted

December 28, 2021

Study Start

September 15, 2018

Primary Completion

December 15, 2020

Study Completion

December 15, 2020

Last Updated

February 10, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)