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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
King's College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alveolar Bone Loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

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

    First Posted
    April 8, 2019
    Last Updated
    October 28, 2019
    Sponsor
    King's College London
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    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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