Bone Height and Extractions Study

Sponsor

King's College London (Other)

Overall Status

Unknown status

CT.gov ID

NCT03909568

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

A coronectomy is often chosen over complete extraction of a lower third molar when the tooth appears to be in close proximity to the inferior dental (ID) canal, as assessed on a plain radiograph or a cone beam computer tomograph (CBCT). Following a coronectomy, the roots of the third molar may migrate in a coronal direction. This effect, along with the bone-preserving technique of a coronectomy over extraction, may provide increased bone height distal to the lower second molars, when compared to extraction. Partially erupted lower third molars, specifically those with mesio-angular impactions, are commonly associated with reduced bone height distal to lower second molars, and cause damage to the periodontal support of these neighboring teeth. It is assumed that maintenance of the impacted third molars or extraction of these teeth may compromise the periodontal status of the lower second molars. This study will investigate if coronectomy improves the bone levels, and therefore the periodontal status, of lower second molars, and may propose an indication for a coronectomy regardless of the proximity of the tooth to the ID canal.

Coronectomies were first proposed as a treatment option just over thirty years ago, but there are very few long-term studies on the procedure reported in the literature. To the best of the investigator's knowledge, this will be the first randomised controlled trial comparing the bone height distal to the lower second molar following a coronectomy or extraction of the lower third molar.

Condition or Disease	Intervention/Treatment	Phase
Alveolar Bone Loss Periodontal Attachment Loss Periodontal Pocket	Procedure: Third molar surgery	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Split-mouthSplit-mouth

Masking:

None (Open Label)

Masking Description:

Patients will be initially masked to which treatment is performed on each side, but will be notified at the follow-up appointment. In addition, the outcomes assessor carrying out the periodontal measurements (clinical attachment level and probing depths), will be unaware which treatment will be performed. The same surgical flap designs will be used for the treatment of both the right and left third molars, regardless of whether a coronectomy or extraction is carried out, and therefore the patient and clinician should be unable to differentiate between the procedures performed. Intervention will only be revealed to care provider once surgical flaps have been raised.

Primary Purpose:

Treatment

Official Title:

A Randomised Controlled Trial to Assess the Alveolar Bone Height Distal to Lower Second Molar Following Either Coronectomy or Extraction of the Adjacent Impacted Lower Third Molar

Anticipated Study Start Date :

Nov 1, 2019

Anticipated Primary Completion Date :

Aug 1, 2021

Anticipated Study Completion Date :

Aug 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Third molar surgery Split mouth comparison of effect of complete third molar removal vs coronectomy of contralateral third molar	Procedure: Third molar surgery Comparing complete removal of third molar with removal of crown only on contralateral side

Arm

Intervention/Treatment

Experimental: Third molar surgery

Split mouth comparison of effect of complete third molar removal vs coronectomy of contralateral third molar

Procedure: Third molar surgery

Comparing complete removal of third molar with removal of crown only on contralateral side

Outcome Measures

Primary Outcome Measures

Linear bone height distal to lower second molar tooth [Six months surgical intervention]
Assessed by comparison of periapical radiographs pre- and post-intervention

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients requiring extraction of both lower third molars
Both lower third molars to have mesio-angular impa
ctions, as assessed by location of the contact point between the crown of the third molar and the cemento-enamel junction (CEJ) of the second molar and the angulation of the third molar
Both lower third molars must lie above or clear of the ID canal as assessed on a plain radiograph or CBCT
Presence of lower second molars
Patients must be ≥18yrs old
Patients willing to attend follow up appointments

Exclusion Criteria:

Lower third molars with caries, periapical pathology or associated lesions such as cysts
Patients who are immunocompromised, have a history of or due to have head and neck radiotherapy, chemotherapy, have previously been given or due to start intravenous bisphosphonates
Smokers (>5 cigarettes/day)
Patients involved in current research or have recently been involved with research prior to recruitment

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

King's College London

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

King's College London

ClinicalTrials.gov Identifier:

NCT03909568

Other Study ID Numbers:

249253

First Posted:

Apr 10, 2019

Last Update Posted:

Oct 29, 2019

Last Verified:

Apr 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Alveolar Bone Loss

Periodontal Pocket

Periodontal Attachment Loss

Study Results

No Results Posted as of Oct 29, 2019