the Relationship Between Various Clinical Variables and Surgical Difficulty of Patients Have Impacted Lower Third Molar

Sponsor
University of Baghdad (Other)
Overall Status
Recruiting
CT.gov ID
NCT05320744
Collaborator
(none)
50
1
12.9
3.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: surgical extraction of impacted lower third molar

Detailed Description

  • All patients will provide detailed medical history and will sign a written informed consent. Oral hygiene instruction, scaling, and root planing.

  • Panoramic radiograph will be taken for every patient, It will be used for measuring the angle of impaction along the lamina dura of the lower second and third molar and measuring impaction depth (Winter's Red line) by using software (planmeca romexis). The same software will be used to measure gonial index and antegonial angle as indices of bone density.

  • All patients will have mouth rinsing with 0.2% chlorhexidine digluconate for 1 minute.

Surgical Procedure

  • After administration of local anesthesia, full thickness enveloped or triangular flap incision according to the surgical principles.

  • Flap reflection with periosteal elevator and retraction.

  • Bone removal (if required) by using a slow speed, high torque surgical handpiece with sharp bur with copious normal saline irrigation.

  • Tooth sectioning (if required) by using sharp diamond bur with saline irrigation.

  • Tooth extraction by using appropriate elevator. .The operative difficulty will be determined by the surgical techniques of the extraction and the duration of extraction. With respect to the surgical technique the degree of difficulty is considered low when the extraction is performed by elevator alone, moderate when bone removal (ostectomy) is required, and high when ostectomy and tooth sectioning is required for tooth extraction.

For the duration of surgery, the difficulty is considered low when the duration of surgical extraction is less than 15 minutes, moderate when the duration is 15-30 minutes, and high when the duration is more than 30 minutes.

  • Irrigation and cleaning of surgical site and removing remaining follicle if present.

  • Bone smoothing with bone file and irrigation with saline.

  • Flap Suturing with black silk suture 3/0.

  • Ask the patient to bite on wet gauze.

  • Instruction and medication (analgesic and antibiotic if required).

Study Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Evaluation the Effect of Angle of Impaction, Impaction Depth, and Bone Density on Surgical Difficulty of Impacted Mandibular Third Molar by Using Orthopantomography
Actual Study Start Date :
Jan 3, 2022
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Feb 1, 2023

Outcome Measures

Primary Outcome Measures

  1. Angle of impaction [preoperative]

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

  2. Winter Red line [preoperative]

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

  3. Gonial index [preoperative]

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

  4. Antegonial angle [preoperative]

    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

  5. operative difficulty [intraoperative]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  1. Healthy patients over 18 years old of either gender.

  2. Patients who have mesioangular or horizontal impacted mandibular third molar.

  3. Presence of mandibular second molar.

  4. Ability to tolerate surgical procedure.

Exclusion Criteria:1. Patients with vertically and distoangularlly impacted teeth.

  1. Patients with uncontrolled systemic diseases. 3. Patients with history of chemotherapy or radiotherapy therapy to the head and neck region.

  2. Acute infection at the surgical site at time of operation. 5. The presence of cysts or tumors associated with the impacted teeth.

Contacts and Locations

Locations

Site City State Country Postal Code
1 university of Baghdad/ Baghdad college of dentistry Baghdad Iraq

Sponsors and Collaborators

  • University of Baghdad

Investigators

  • Study Chair: Salwan Y. Bede, F.I.B.M.S, Baghdad college of dentistry/ Department of oral and maxillofacial surgery

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mohammed Ahmed, Principal Investigator, University of Baghdad
ClinicalTrials.gov Identifier:
NCT05320744
Other Study ID Numbers:
  • impacted lower third molar
First Posted:
Apr 11, 2022
Last Update Posted:
Apr 11, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 11, 2022