PaincoronrctNCT00752284
Safety of Coronectomy vs Excision of Wisdom Teeth
A study testing Coronectomy and Total Excision in people with Pain and Infection, run by The University of Hong Kong at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pain, Infection, Alveolar Nerve Injury
- What is being tested?
- Coronectomy and Total Excision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 349 participants
- Where
- 1 siteChina
- Study dates
- Jun 2006to Aug 2008
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pain, Infection, Alveolar Nerve Injury
- Being tested
- Coronectomy, Total Excision
- Keywords
- coronectomy, neurosensory deficit, third molar surgery
- Medical subject headings
- Pain, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoronectomyProcedure or surgery
Also called Coronectomy Group
Coronectomy Group. Removal of crown of lower wisdom tooth, trim down root below crestal bone and primary closure
Total ExcisionProcedure or surgery
Total excision of lower third molar
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Coronectomy Group. Removal of crown of lower wisdom tooth, trim down root below crestal bone and primary closure Receives: Procedure: Coronectomy |
| B | Active comparator | Control Group:
total excision of lower wisdom tooth Receives: Procedure: Total Excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of neurosensory disturbance, infection or dry socket of control group and coronectomy group
Measured: 1 week-2 years
Secondary outcomes (1)
Migration rate of root in coronectomy group
Measured: 1 week - 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2008 (estimated)
- Study startJun 2006
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 349 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Investigators
- Yiu Yan Leung, BDS, Principal investigator, U Hong KongLim Kwong Cheung, BDS, PhD, Study director, U Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00752284
- Sponsor's protocol ID
- UW 06-218 T/1243
- Acronym
- coronrct
- Status last verified
- Sep 2008
- First submitted
- 1 Sep 2008
- Last updated
- 8 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Safety of Coronectomy Versus Excision of Wisdom Teeth
- ClinicalTrials.gov ID
- NCT00752284
- Acronym / sponsor ID
- coronrct / UW 06-218 T/1243
- Conditions
- Pain, Infection, Alveolar Nerve Injury
- Keywords
- coronectomy, neurosensory deficit, third molar surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 349 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 15 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Procedure: CoronectomyCoronectomy Group. Removal of crown of lower wisdom tooth, trim down root below crestal bone and primary closure |
| B | Active comparator | Procedure: Total ExcisionControl Group: total excision of lower wisdom tooth |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CoronectomyAlso: Coronectomy GroupCoronectomy Group. Removal of crown of lower wisdom tooth, trim down root below crestal bone and primary closure | Procedure or surgery | A |
| Total ExcisionTotal excision of lower third molar | Procedure or surgery | B |
Primary outcome
The incidence of neurosensory disturbance, infection or dry socket of control group and coronectomy group
Time frame: 1 week-2 years
1 secondary outcome
Migration rate of root in coronectomy group
Time frame: 1 week - 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yiu Yan Leung, BDS principal investigator
U Hong Kong
Lim Kwong Cheung, BDS, PhD study director
U Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coronectomy and Total Excision in people with Pain and Infection, run by The University of Hong Kong at 1 site in China.
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 6 inclusion and 5 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 8 Dec 2008. 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 China. 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. 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?
The incidence of neurosensory disturbance, infection or dry socket of control group and coronectomy group (time frame: 1 week-2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Dec 2008.