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Inferior Alveolar Nerve InjuriesNCT05744882

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

A study testing coronectony and root canal treatment in people with Inferior Alveolar Nerve Injuries and Root Canal Treatment, run by Altamash Institute of Dental Medicine at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 30 yearsHealthy volunteers can take part
What is being tested?
coronectony and root canal treatment
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
1 sitePakistan
Study dates
1 Jan 2021to 1 Jan 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 30 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • cooperative,
  • no known uncontrolled medical conditions
  • no history of radiotherapy in the head and neck region

Who cannot join

  • not willing to participate
  • history of uncontrolled medical condition
  • sign of any local pathology
  • history of radiotherapy in head and neck region

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Altamash Institute of Dental Medicine

    Karachi, Sindh

Other trials in Pakistan

About this study

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

Read the 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.

Being tested
coronectony, root canal treatment
Medical subject headings
Mandibular Nerve Injuries, Paresthesia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • coronectonyProcedure or surgery

    Also called procedure

    root canal treatment

  • root canal treatmentProcedure or surgery

    Also called rct

    root canal treatment

Study groups in NCT05744882
Study groupRoleWhat they receive
Control GroupPlacebo comparatorno further treatment provided after coronectomy
Receives: Procedure: coronectony
Experimental GroupActive comparatorroot canal treatment provided after the coronectomy procedure
Receives: Procedure: coronectony; Procedure: root canal treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Infection

    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.

    Measured: 3 months

Secondary outcomes (2)
  1. Paresthesia

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

    Measured: 3 months

  2. Movement of remnant root fragment

    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.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2023
  2. Study start1 Jan 2021
  3. Primary completion1 Jan 2021
  4. Study completion1 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05744882
Sponsor's protocol ID
AIDM/ERC/12/2022/04
Status last verified
Feb 2023
First submitted
25 Jan 2023
Last updated
27 Feb 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • O'Riordan BC. Coronectomy (intentional partial odontectomy of lower third molars). Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2004 Sep;98(3):274-80. doi: 10.1016/S1079210404000496.

    PubMed 15356463
  • Renton T, Hankins M, Sproate C, McGurk M. A randomised controlled clinical trial to compare the incidence of injury to the inferior alveolar nerve as a result of coronectomy and removal of mandibular third molars. Br J Oral Maxillofac Surg. 2005 Feb;43(1):7-12. doi: 10.1016/j.bjoms.2004.09.002.

    PubMed 15620767
  • Howe, G.L. and Poyton, H.G. (1960) Prevention of Damage to the Inferior Dental Nerve during the Extraction of Mandibular Third Molars. British Dental Journal, 109, 355-363.

  • MERRILL RG. DECOMPRESSION FOR INFERIOR ALVEOLAR NERVE INJURY. J Oral Surg Anesth Hosp Dent Serv. 1964 Jul;22:291-300. No abstract available.

    PubMed 14155469
  • Kubota S, Imai T, Nakazawa M, Uzawa N. Risk stratification against inferior alveolar nerve injury after lower third molar extraction by scoring on cone-beam computed tomography image. Odontology. 2020 Jan;108(1):124-132. doi: 10.1007/s10266-019-00438-2. Epub 2019 Jun 17.

    PubMed 31209581
  • Cilasun U, Yildirim T, Guzeldemir E, Pektas ZO. Coronectomy in patients with high risk of inferior alveolar nerve injury diagnosed by computed tomography. J Oral Maxillofac Surg. 2011 Jun;69(6):1557-61. doi: 10.1016/j.joms.2010.10.026. Epub 2011 Feb 1.

    PubMed 21288616
  • Monaco G, D'Ambrosio M, De Santis G, Vignudelli E, Gatto MRA, Corinaldesi G. Coronectomy: A Surgical Option for Impacted Third Molars in Close Proximity to the Inferior Alveolar Nerve-A 5-Year Follow-Up Study. J Oral Maxillofac Surg. 2019 Jun;77(6):1116-1124. doi: 10.1016/j.joms.2018.12.017. Epub 2018 Dec 31.

    PubMed 30689961
  • Leung YY, Cheung LK. Long-term morbidities of coronectomy on lower third molar. Oral Surg Oral Med Oral Pathol Oral Radiol. 2016 Jan;121(1):5-11. doi: 10.1016/j.oooo.2015.07.012. Epub 2015 Jul 22.

    PubMed 26337212
  • Pedersen MH, Bak J, Matzen LH, Hartlev J, Bindslev J, Schou S, Norholt SE. Coronectomy of mandibular third molars: a clinical and radiological study of 231 cases with a mean follow-up period of 5.7years. Int J Oral Maxillofac Surg. 2018 Dec;47(12):1596-1603. doi: 10.1016/j.ijom.2018.06.006. Epub 2018 Jul 14.

    PubMed 30017572
  • Dalle Carbonare M, Zavattini A, Duncan M, Williams M, Moody A. Injury to the inferior alveolar and lingual nerves in successful and failed coronectomies: systematic review. Br J Oral Maxillofac Surg. 2017 Nov;55(9):892-898. doi: 10.1016/j.bjoms.2017.09.006. Epub 2017 Oct 20.

    PubMed 29061470
  • Nishimoto RN, Moshman AT, Dodson TB, Beirne OR. Why Is Mandibular Third Molar Coronectomy Successful Without Concurrent Root Canal Treatment? J Oral Maxillofac Surg. 2020 Nov;78(11):1886-1891. doi: 10.1016/j.joms.2020.05.046. Epub 2020 Jun 11.

    PubMed 32640205
  • Valmaseda-Castellon E, Berini-Aytes L, Gay-Escoda C. Inferior alveolar nerve damage after lower third molar surgical extraction: a prospective study of 1117 surgical extractions. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2001 Oct;92(4):377-83. doi: 10.1067/moe.2001.118284.

    PubMed 11598570
  • Pitros P, Jackson I, O'Connor N. Coronectomy: a retrospective outcome study. Oral Maxillofac Surg. 2019 Dec;23(4):453-458. doi: 10.1007/s10006-019-00794-x. Epub 2019 Aug 27.

    PubMed 31456131
  • Frenkel B, Givol N, Shoshani Y. Coronectomy of the mandibular third molar: a retrospective study of 185 procedures and the decision to repeat the coronectomy in cases of failure. J Oral Maxillofac Surg. 2015 Apr;73(4):587-94. doi: 10.1016/j.joms.2014.10.011. Epub 2014 Oct 22.

    PubMed 25544301
  • Kohara K, Kurita K, Kuroiwa Y, Goto S, Umemura E. Usefulness of mandibular third molar coronectomy assessed through clinical evaluation over three years of follow-up. Int J Oral Maxillofac Surg. 2015 Feb;44(2):259-66. doi: 10.1016/j.ijom.2014.10.003. Epub 2014 Nov 8.

    PubMed 25457826

Questions about this trial

What is this clinical trial studying?

A study testing coronectony and root canal treatment in people with Inferior Alveolar Nerve Injuries and Root Canal Treatment, run by Altamash Institute of Dental Medicine at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Infection (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05744882, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2023.

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