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Clinical Trials/NCT06620718
NCT06620718CompletedNot Applicable

Evaluation of Pain and Root Migration Distance After Coronectomy Procedure of Impacted Third Molars Based on Age

Mustafa Kemal University1 site in 1 country73 target enrollmentStarted: January 1, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
73
Locations
1
Primary Endpoint
the mesaurement of root migration distance

Study Overview

Brief Summary

The aims of this study were to investigate postoperative pain, edema, and trismus after coronectomy procedure, to assess the risk of endodontic lesion formation at sixth month, and to determine relationship of the root migration distance with age.

Detailed Description

The roots of impacted lower third molars may be associated with the inferior alveolar nerve (IAN). To mitigate this risk and reduce trauma to the patient, a conservative approach involving the removal of the problematic crown portion and leaving the root may be adopted.

This clinical study was conducted between 2021-2022 years and was accordance with the Helsinki Declaration of 1975, as revised 2013. All subjects were informed about the study and clinical procedures and provided written consent The study included 73 patients aged between 18-55 years. These patients were divided into two age groups: The first group, consisting of patients aged 18-30. The second group, consisting of patients aged 31-55.

The coronectomy was surgically performed. Postoperative pain, swelling, and interincisal distance were evaluated based on age. Pain was assessed using a 10 cm Visual Analog Scale (VAS) with patients providing ratings before the operation and on the 3rd and 7th postoperative days. The progresion of endodontic lesion was evaluated in 6 months after coronectomy.

The distance of root migration achieved at 6 months after coronectomy was measured by independent examiner. Calibrated panoramic radiographs were used to determine the level of migration.

The statistical analysis of the data obtained in our study was performed using SPSS software The needed statistical analyses were used for comparison of the data. The Levene test was used for comparison of the root migration distances in the age groups. The significance level was set at 0.05.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Masking Description

measurement the distance of root migration at sixth month

Eligibility Criteria

Ages
18 Years to 55 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • The study focused on applying coronectomy, a more conservative approach, instead of extraction for mandibular third molars associated with the inferior alveolar nerve that were indicated for prosthetic, orthodontic, prophylactic purposes, or those causing pericoronitis
  • Systemically health,
  • To maintain ideal oral hygiene,
  • Absence of caries, pulpal and endodontic lesions in the impacted third molar indicated for extraction
  • No known allergies to any antibiotics, or no use or history of bisphosphonate medication
  • No use of tobacco or any illicit drugs by the patient.
  • Not being pregnant

Exclusion Criteria

  • Other conditions unlike abovementioned items.

Outcomes

Primary Outcomes

the mesaurement of root migration distance

Time Frame: six months after coronectomy procedure

the distance from the enamel-cement line of the adjacent tooth to the remaining root or roots after coronectomy.

Secondary Outcomes

  • the percentage of edema(postoperatively 3rd and 7th day after coronectomy)
  • the measurement of the distance of interincisal opening(postoperatively 3rd and 7th day after coronectomy)
  • the pain assessment(postoperatively 3rd and 7th day after coronectomy)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Osman Fatih Arpag

Associate professor, PhD

Mustafa Kemal University

Study Sites (1)

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