NCT00752284

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
349

participants targeted

Target at P75+ for not_applicable pain

Timeline
Completed

Started Jun 2006

Typical duration for not_applicable pain

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 1, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 15, 2008

Completed
Last Updated

December 8, 2008

Status Verified

September 1, 2008

Enrollment Period

2.2 years

First QC Date

September 1, 2008

Last Update Submit

December 5, 2008

Conditions

Keywords

coronectomyneurosensory deficitthird molar surgery

Outcome Measures

Primary Outcomes (1)

  • The incidence of neurosensory disturbance, infection or dry socket of control group and coronectomy group

    1 week-2 years

Secondary Outcomes (1)

  • Migration rate of root in coronectomy group

    1 week - 2 years

Study Arms (2)

A

EXPERIMENTAL

Coronectomy Group. Removal of crown of lower wisdom tooth, trim down root below crestal bone and primary closure

Procedure: Coronectomy

B

ACTIVE COMPARATOR

Control Group: total excision of lower wisdom tooth

Procedure: Total Excision

Interventions

CoronectomyPROCEDURE

Coronectomy Group. Removal of crown of lower wisdom tooth, trim down root below crestal bone and primary closure

Also known as: Coronectomy Group
A

Total excision of lower third molar

B

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince Philip Dental Hospital

Hong Kong, China

Location

MeSH Terms

Conditions

PainInfections

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Yiu Yan Leung, BDS

    U Hong Kong

    PRINCIPAL INVESTIGATOR
  • Lim Kwong Cheung, BDS, PhD

    U Hong Kong

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 1, 2008

First Posted

September 15, 2008

Study Start

June 1, 2006

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

December 8, 2008

Record last verified: 2008-09

Locations