Bone Height and Extractions Study
Primary Purpose
Alveolar Bone Loss, Periodontal Attachment Loss, Periodontal Pocket
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Third molar surgery
Sponsored by
About this trial
This is an interventional treatment trial for Alveolar Bone Loss
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Third molar surgery
Arm Description
Split mouth comparison of effect of complete third molar removal vs coronectomy of contralateral third molar
Outcomes
Primary Outcome Measures
Linear bone height distal to lower second molar tooth
Assessed by comparison of periapical radiographs pre- and post-intervention
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03909568
Brief Title
Bone Height and Extractions Study
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 2019 (Anticipated)
Primary Completion Date
August 2021 (Anticipated)
Study Completion Date
August 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King's College London
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alveolar Bone Loss, Periodontal Attachment Loss, Periodontal Pocket
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Split-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.
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Third molar surgery
Arm Type
Experimental
Arm Description
Split mouth comparison of effect of complete third molar removal vs coronectomy of contralateral third molar
Intervention Type
Procedure
Intervention Name(s)
Third molar surgery
Intervention Description
Comparing complete removal of third molar with removal of crown only on contralateral side
Primary Outcome Measure Information:
Title
Linear bone height distal to lower second molar tooth
Description
Assessed by comparison of periapical radiographs pre- and post-intervention
Time Frame
Six months surgical intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
No
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Bone Height and Extractions Study
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