NCT05744882

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

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 1, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 25, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 27, 2023

Completed
Last Updated

February 27, 2023

Status Verified

February 1, 2023

Enrollment Period

Same day

First QC Date

January 25, 2023

Last Update Submit

February 15, 2023

Conditions

Inferior Alveolar Nerve InjuriesRoot Canal TreatmentParesthesiaThird MolarImpacted Third Molar ToothCoronectomy

Outcome Measures

Primary Outcomes (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.

    3 months

Secondary Outcomes (2)

  • Paresthesia

    3 months

  • Movement of remnant root fragment

    3 months

Study Arms (2)

Control Group

PLACEBO COMPARATOR

no further treatment provided after coronectomy

Procedure: coronectony

Experimental Group

ACTIVE COMPARATOR

root canal treatment provided after the coronectomy procedure

Procedure: coronectonyProcedure: root canal treatment

Interventions

coronectonyPROCEDURE

root canal treatment

Also known as: procedure
Control GroupExperimental Group
root canal treatmentPROCEDURE

root canal treatment

Also known as: rct
Experimental Group

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Altamash Institute of Dental Medicine

Karachi, Sindh, Pakistan

Location

Related Publications (17)

  • 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.

    PMID: 15356463BACKGROUND

  • 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.

    PMID: 15620767BACKGROUND

  • 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.

    BACKGROUND

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

    PMID: 14155469BACKGROUND

  • 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.

    PMID: 31209581BACKGROUND

  • 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.

    PMID: 21288616BACKGROUND

  • 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.

    PMID: 30689961BACKGROUND

  • 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.

    PMID: 26337212BACKGROUND

  • 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.

    PMID: 30017572BACKGROUND

  • 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.

    PMID: 29061470BACKGROUND

  • 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.

    PMID: 32640205BACKGROUND

  • 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.

    PMID: 11598570BACKGROUND

  • 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.

    PMID: 31456131BACKGROUND

  • 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.

    PMID: 25544301BACKGROUND

  • 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.

    PMID: 25457826BACKGROUND

  • Patel V, Sproat C, Kwok J, Beneng K, Thavaraj S, McGurk M. Histological evaluation of mandibular third molar roots retrieved after coronectomy. Br J Oral Maxillofac Surg. 2014 May;52(5):415-9. doi: 10.1016/j.bjoms.2014.02.016. Epub 2014 Mar 29.

    PMID: 24684971BACKGROUND

  • Sencimen M, Ortakoglu K, Aydin C, Aydintug YS, Ozyigit A, Ozen T, Gunaydin Y. Is endodontic treatment necessary during coronectomy procedure? J Oral Maxillofac Surg. 2010 Oct;68(10):2385-90. doi: 10.1016/j.joms.2010.02.024. Epub 2010 Jul 21.

    PMID: 20663600RESULT

MeSH Terms

Conditions

Mandibular Nerve InjuriesParesthesia

Interventions

Methods

Condition Hierarchy (Ancestors)

Trigeminal Nerve InjuriesTrigeminal Nerve DiseasesFacial NeuralgiaFacial Nerve DiseasesMouth DiseasesStomatognathic DiseasesCranial Nerve InjuriesCranial Nerve DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesSomatosensory DisordersSensation DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Rehan Ahmad

Study Record Dates

First Submitted

January 25, 2023

First Posted

February 27, 2023

Study Start

January 1, 2021

Primary Completion

January 1, 2021

Study Completion

January 1, 2022

Last Updated

February 27, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)