Alveolar Bone LossNCT03909568
Bone Height and Extractions Study
A study testing Third molar surgery in people with Alveolar Bone Loss and Periodontal Attachment Loss, run by King's College London.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alveolar Bone Loss, Periodontal Attachment Loss, Periodontal Pocket
- What is being tested?
- Third molar surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Nov 2019to Aug 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this 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
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.
- Being tested
- Third molar surgery
- Medical subject headings
- Alveolar Bone Loss, Periodontal Attachment Loss, Periodontal Pocket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Third molar surgeryProcedure or surgery
Comparing complete removal of third molar with removal of crown only on contralateral side
| Study group | Role | What they receive |
|---|---|---|
| Third molar surgery | Experimental | Split mouth comparison of effect of complete third molar removal vs coronectomy of contralateral third molar Receives: Procedure: Third molar surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Linear bone height distal to lower second molar tooth
Assessed by comparison of periapical radiographs pre- and post-intervention
Measured: Six months surgical intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study startNov 2019 (estimated)
- Primary completionAug 2021 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Bone LossStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Split-mouth
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03909568
- Sponsor's protocol ID
- 249253
- Status last verified
- Apr 2019
- First submitted
- 8 Apr 2019
- Last updated
- 29 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03909568
- Acronym / sponsor ID
- 249253
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- Nov 2019 (estimated)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 10 Apr 2019 (actual)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Split-mouth
| Arm | Type | Receives |
|---|---|---|
| Third molar surgery | Experimental | Procedure: Third molar surgerySplit mouth comparison of effect of complete third molar removal vs coronectomy of contralateral third molar |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Third molar surgeryComparing complete removal of third molar with removal of crown only on contralateral side | Procedure or surgery | Third molar surgery |
Primary outcome
Linear bone height distal to lower second molar tooth
Time frame: Six months surgical intervention
Assessed by comparison of periapical radiographs pre- and post-intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Third molar surgery in people with Alveolar Bone Loss and Periodontal Attachment Loss, run by King's College London.
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 7 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 29 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Linear bone height distal to lower second molar tooth (time frame: Six months surgical intervention). 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 29 Oct 2019.