NCT05320744

Brief Summary

This study is to evaluate the effect of angle of impaction, impaction depth, and bone density on surgical difficulty of impacted lower third molar, by measuring the angle of impaction, the depth of impaction (Winter's Red line), and bone density (gonial, and antegonial indices) preoperatively by using panoramic radiograph and to correlate the angle, the depth of impaction, and bone density with the surgical difficulty by operation time and surgical technique.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 11, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

April 11, 2022

Status Verified

April 1, 2022

Enrollment Period

9 months

First QC Date

March 23, 2022

Last Update Submit

April 2, 2022

Conditions

Outcome Measures

Primary Outcomes (5)

  • Angle of impaction

    is measured along the lamina dura of lower second and third molar by using Planmeca Romexis Software.

    preoperative

  • Winter Red line

    is measured by drawing perpendicular line from amber line to the point of application of dental elevator by using Planmeca Romexis Software

    preoperative

  • Gonial index

    is measurement of mandibular cortical thickness by using bisectrix the gonial angle by using Planmeca Romexis Software

    preoperative

  • Antegonial angle

    is the measurement of the mandibular cortical thickness measured on the line perpendicular to the mandibular cortex at the intersection with the tangent line to the anterior border of the ramus by using Planmeca Romexis Software

    preoperative

  • operative difficulty

    determined by the surgical techniques of the extraction and the duration of extraction according to Pernambuco difficulty scale

    intraoperative

Interventions

surgical removal of impacted third molar under local anesthesia.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study will include a minimum of 50 patients indicated for surgical removal of impacted mandibular third molars at Baghdad college of dentistry.

You may qualify if:

  • Healthy patients over 18 years old of either gender.
  • Patients who have mesioangular or horizontal impacted mandibular third molar.
  • Presence of mandibular second molar.
  • Ability to tolerate surgical procedure.

You may not qualify if:

  • \. Patients with uncontrolled systemic diseases. 3. Patients with history of chemotherapy or radiotherapy therapy to the head and neck region.
  • \. Acute infection at the surgical site at time of operation. 5. The presence of cysts or tumors associated with the impacted teeth.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

university of Baghdad/ Baghdad college of dentistry

Baghdad, Iraq

RECRUITING

Related Publications (2)

  • de Carvalho RWF, Vasconcelos BC. Pernambuco index: predictability of the complexity of surgery for impacted lower third molars. Int J Oral Maxillofac Surg. 2018 Feb;47(2):234-240. doi: 10.1016/j.ijom.2017.07.013. Epub 2017 Aug 14.

  • Zhang X, Wang L, Gao Z, Li J, Shan Z. Development of a New Index to Assess the Difficulty Level of Surgical Removal of Impacted Mandibular Third Molars in an Asian Population. J Oral Maxillofac Surg. 2019 Jul;77(7):1358.e1-1358.e8. doi: 10.1016/j.joms.2019.03.005. Epub 2019 Mar 14.

Study Officials

  • Salwan Y. Bede, F.I.B.M.S

    Baghdad college of dentistry/ Department of oral and maxillofacial surgery

    STUDY CHAIR

Central Study Contacts

Mohammed A. Muter, B.D.S.

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 23, 2022

First Posted

April 11, 2022

Study Start

January 3, 2022

Primary Completion

October 1, 2022

Study Completion

February 1, 2023

Last Updated

April 11, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will share

all the results

Shared Documents
STUDY PROTOCOL, SAP, CSR

Locations