The Need Of Root Canal Treatment After Coronectomy In Mandibular Third Molars

Sponsor
Altamash Institute of Dental Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT05744882
Collaborator
(none)
24
1
2
12
2

Study Details

Study Description

Brief Summary

The study included 24 patients with written and verbal consent Results with close proximity to IAN diagnosed based on radiographs and evaluation on the criteria of Howe, and Poyton were selected and divided into two groups by lottery method into coronectomy and coronectomy with root canal treatment following coronectomy groups. Patients were re-evaluated on three weeks for complications and three months follow-ups for radiographic evaluations of root-fragment migration

Condition or Disease Intervention/Treatment Phase
  • Procedure: coronectony
  • Procedure: root canal treatment
N/A

Detailed Description

The study enrolled 24 patients with written and verbal consent, out of which 15 were females and 9 were males aged between 18-30 years, with a mean age of males 24 ± 2.6 years and females 23.5 ± 2.8 years. Ethical approval was taken from the ethical review board of Altamash Institute of Dental Medicine with IRB No: AIDM/ERC/12/2022/04.

A total of 24 impacted mandibular teeth from 24 Patients with close proximity to IAN diagnosed based on radiographs and evaluation on the criteria of Howe and Poyton4 were selected for the purpose of this study. The timeline of the study was between January 2021 till January 2022.

The estimated sample size calculated for the study was 12 (6 participants in each group) which was raised to minimum of 24 (12 participants in each group). The calculations were performed using 12.5% as a proportion of infection in the control group and 87.5% as the proportion of infection in experimentation group from the study published by Sencimen et al.1 The software used for the sample size estimation was STATA 13.0 using "pearson's chi-squared test for two-samples proportions test". The following parameters were considered:

Alpha = 0.05 Power = 0.8 Delta = 0.75 Proportions of control group = 0.125 (12.5%) Proportions of Experimental group = 0.875 (87.5%) Considering the high lost to followup cases into account the sample size was raised to 24 participants with one tooth per individual. (ANNEXURE-I)

Patients were diagnosed and then referred to the Oral Maxillofacial department of Altamash Institute of Dental Medicine. Twenty-four patients with 24 impacted mandibular third molars were equally divided into a control group and a study group. Twelve patients in the study group had their root canal treatment after coronectomies while the other half, the control group only had their coronectomies done without any further procedure performed.

All the participants were equally divided into a control group and a study group by making them pick concealed envelopes containing a participant code for the participant allocation into groups. The experimental group contained twelve participants who had root canal treatment following coronectomies, while on the other hand, only coronectomies were performed in the rest of the participants without root canal treatment.

Patients who were willing and cooperative, along with no known uncontrolled medical conditions and no history of radiotherapy in the head and neck region, were included as a part of this research, while patients who showed resistance or were uncooperative, gave a history of uncontrolled medical condition, showed signs of local pathology or infection, history of radiotherapy in head and neck area were excluded from being included in the study.

All surgical procedures were performed under local anesthesia by the same surgeon. None of the patients were prescribed prophylactic antibiotics but were give a chlorhexidine mouth was a given before the procedure. Patients were prescribed post operative antibiotics with analgesics and thorough written instructions for proper wound care. A buccal approach for coronectomy was performed for all of them by the surgeon. Furthermore, all the endodontic treatment was performed by the same endodontist.

In the study group, the endodontist performed a pulpectomy and used a hypochlorite solution for irrigation of the canals. Finally, gutta-percha (GP) was used as a canal-filling material. All procedures performed by the endodontic followed the aseptic conditions and protocol.

The surgeon decided on a buccal approach with a three-cornered envelope incision resulting in a full thickness mucoperiosteal flap. The incision and eventually the flap was raised following the principles of incision and flap in order to promote a clean surgery leading to an uneventful and complication-free healing. The crown along the dental follicle was eliminated in addition to removing one-third of the root coronally.

The clinician decided on establishing a tilted or angled slope, the level of the slope descending lingually via buccal surface. This inclination resulted in a discrepancy of about 3-4mm in the levels of the corresponding root surfaces, consequence of which was a formation of a sharp edge on the buccal root surface. While the lingual root was 3-4mm below the lingual alveolar crest level. To compensate for the height, difference the buccal and lingual root surfaces, a reduction in the height of the buccal surface was performed in order to match with the lowered lingual root portion. Winding up the surgery with copious irrigation with saline followed by primary wound closure The mentioned step was carried out for both the study and the control group but in the in the study group, after removal of the pulp and biomechanical preparation, the canals were filled with GP. Multiple periapical radiographs were taken during endodontic procedure to ensure the correct filling of the canals and optimum filling till the apices.

More over the surgeon made a point to use a sharp bur for every operation in order to excise the crown without mobilizing the roots. In the control group the pulp was left in place. Follows up initially third week followed by sixth month were done with the help of panoramic radiograph.

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Other
Official Title:
The Need Of Root Canal Treatment After Coronectomy In Mandibular Third Molars
Actual Study Start Date :
Jan 1, 2021
Actual Primary Completion Date :
Jan 1, 2021
Actual Study Completion Date :
Jan 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Control Group

no further treatment provided after coronectomy

Procedure: coronectony
root canal treatment
Other Names:
  • procedure
  • Active Comparator: Experimental Group

    root canal treatment provided after the coronectomy procedure

    Procedure: coronectony
    root canal treatment
    Other Names:
  • procedure
  • Procedure: root canal treatment
    root canal treatment
    Other Names:
  • rct
  • Outcome Measures

    Primary Outcome Measures

    1. Infection [3 months]

      Patients presenting with pain or swelling or both postoperatively within 3rd week to 3rd month of procedure. The the clinical presentation was confirmed by a clinician on clinical examination.

    Secondary Outcome Measures

    1. Paresthesia [3 months]

      Patient presenting with history of numbness on any follow-up visit.

    2. Movement of remnant root fragment [3 months]

      Apical movement remenant root fragment measured perpendicularly from occlusal plane by conparing pre-operative OPG-radiograph and another one taken at 3 month follow-up.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 30 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • cooperative,

    • no known uncontrolled medical conditions

    • no history of radiotherapy in the head and neck region

    Exclusion Criteria:
    • not willing to participate

    • history of uncontrolled medical condition

    • sign of any local pathology

    • history of radiotherapy in head and neck region

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Altamash Institute of Dental Medicine Karachi Sindh Pakistan

    Sponsors and Collaborators

    • Altamash Institute of Dental Medicine

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Rehan Ahmad, Rehan Ahmad, Altamash Institute of Dental Medicine
    ClinicalTrials.gov Identifier:
    NCT05744882
    Other Study ID Numbers:
    • AIDM/ERC/12/2022/04
    First Posted:
    Feb 27, 2023
    Last Update Posted:
    Feb 27, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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 Feb 27, 2023