Safety of Coronectomy vs Excision of Wisdom Teeth (coronrct)

December 5, 2008 updated by: The University of Hong Kong

Randomized Controlled Trial of Safety of Coronectomy Versus Excision of Wisdom Teeth

The purpose of this study is to compare the surgical complications and neurosensory disturbance of coronectomy and conventional excision of wisdom teeth with roots in close proximity to inferior alveolar nerve. Hypothesis: Coronectomy of wisdom tooth can reduce the chance of injury to the inferior alveolar nerve in cases of radiographic proximity to the roots when compared with conventional method of surgical removal of wisdom teeth, and there is no difference in other surgical morbidities.

Study Overview

Detailed Description

Complications of impacted wisdom teeth, such as pericoronitis, caries and periodontal disease are common, and these contribute to the indications that third molar surgery is still the most common oral surgical procedure performed. Damages to the inferior alveolar nerve (IAN) during surgical removal of deeply impacted wisdom teeth is a well-known complication. Over the years, reports of IAN deficit after wisdom teeth surgery were recorded from 0.4% to 8.4%. Injury to IAN can be due to compression of the nerve, either by indirect force transmitted by the root during elevation or directly by elevators. It is also possible for the nerve to be transected causing neurotmesis by rotary instruments or when the tooth is grooved or perforated by IAN. Several studies have tried to correlate radiographic markers and relationship of IAN and the root of wisdom teeth. Howe and Poyton identified 3 radiographical signs that the roots of wisdom teeth maybe grooved, notched, or perforated by the IAN 2. Rood and Shehab in 1990 suggested diversion of the canal, darkening of the root and interruption of the white line of IAN to be significantly related to IAN injury. Sedaghatfar et al. in 2005 performed a retrospective cohort study and confirmed that, and adding to it narrowing of the root to be an additional significant sign to predict the proximity of nerve and root. These radiographic signs only indicate to surgeons and patients that there is an increased risk of nerve damage associated with the removal of the corresponding wisdom tooth, but not a prevention to it if the tooth is being removed.

Coronectomy is a procedure intentionally aiming to remove only the crown of an impacted mandibular third molar, leaving the root undisturbed, and thus avoiding possible direct or indirect damage to the IAN. This technique was first described by Knutsson et al. in 1989 in a retrospective study of 33 patients. 6 more papers about coronectomy were published to date, with 3 case reports and 2 retrospective studies, and one randomized controlled trial by Renton et al. in 2005.In this last study, 128 patients were randomized to undergo either extraction or coronectomy of wisdom teeth. The group undergoing extraction was found to be significantly more common in experiencing IAN deficit after surgery than the coronectomy group, while no significant differences could be concluded in terms of other surgical morbidities. The other studies also drew similar conclusions. One common finding, however, was the slow superficial migration of the wisdom tooth root after coronectomy. It had been suggested the root is only indicated to be removed only if it is exposed intraorally, but the risk of IAN damage of the second surgery is reduced as the root has migrated away from the nerve.

Study Type

Interventional

Enrollment (Actual)

349

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Hong Kong, China
        • Prince Philip Dental Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Radiographically the wisdom tooth root is touching or overlapping with the superior cortical line of inferior alveolar nerve or showing one or more of the following signs:

    • darkening of root
    • abrupt narrowing of root
    • interruption and loss of the white line of IAN canal
    • displacement of the IAN canal by the roots
    • Abrupt narrowing of one or both of the canal white lin

Exclusion Criteria:

  • Wisdom tooth roots not touching the IAN cortical lines
  • Wisdom tooth presented with apical pathology
  • Pre-existing neurosensory deficit of IAN
  • Systemic condition predisposing local infection: diabetes, AIDS, concurrent chemotherapy.
  • Local factors predisposing infection: metabolic bone diseases e.g. fibrous dysplasia, history of radiotherapy on mandible

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Coronectomy Group. Removal of crown of lower wisdom tooth, trim down root below crestal bone and primary closure
Coronectomy Group. Removal of crown of lower wisdom tooth, trim down root below crestal bone and primary closure
Other Names:
  • Coronectomy Group
Active Comparator: B

Control Group:

total excision of lower wisdom tooth

Total excision of lower third molar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The incidence of neurosensory disturbance, infection or dry socket of control group and coronectomy group
Time Frame: 1 week-2 years
1 week-2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Migration rate of root in coronectomy group
Time Frame: 1 week - 2 years
1 week - 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Yiu Yan Leung, BDS, U Hong Kong
  • Study Director: Lim Kwong Cheung, BDS, PhD, U Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

September 1, 2008

First Submitted That Met QC Criteria

September 12, 2008

First Posted (Estimate)

September 15, 2008

Study Record Updates

Last Update Posted (Estimate)

December 8, 2008

Last Update Submitted That Met QC Criteria

December 5, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Other Study ID Numbers

  • UW 06-218 T/1243

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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