Impacted Third Molar ToothNCT02753439
Extraction of Impacted 3rd Molars, Can Bone Support of the Second Molar be Promoted by a Bio-Oss Graft?
A study testing Geistlich Bio Oss in people with Impacted Third Molar Tooth, run by The Baruch Padeh Medical Center, Poriya.
Trial summary
A prospective study examining bilateral 3rd molar extraction, by a split mouth protocol the investigators augment unilaterally and compare periodontal parameters in between. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Impacted Third Molar Tooth
- What is being tested?
- Geistlich Bio Oss
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Feb 2017to Feb 2019
- 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
- Bilateral impacted 3rd molars.
- Healthy individuals
Who cannot join
- Smokers
- Alcohol abusers
- Pregnancy
About this study
A prospective study examining bilateral 3rd molar extraction, by a split mouth protocol the investigators augment unilaterally and compare periodontal parameters in between.
Read the detailed description
40 patients will undergo bilateral 3rd molar extractions, in each patient one side would be augmented by a "Bio-Oss" xenograft.
Post operative, periodontal parameters such as pocket depth and mobility will be evaluated and compared.
- Conditions
- Impacted Third Molar Tooth
- Being tested
- Geistlich Bio Oss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Geistlich Bio OssDrug
Also called Bone Support
Extraction of Impacted 3rd Molars,
| Study group | Role | What they receive |
|---|---|---|
| 3rd molar | Experimental | Drug: Geistlich Bio Oss Receives: Drug: Geistlich Bio Oss |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mobility (Scale 0,1,2,3), change is being assessed.
Mobility will be assessed in the intervals mentioned above, and compared over time.
Measured: Pre opp (base line), 1 month post opp, 3 months post opp, 6 months post opp
Pocket Depth (mm), change is being assessed.
Pocket depth will be assessed in the intervals mentioned above, and compared over time.
Measured: Pre opp (base line), 1 month post opp, 3 months post opp, 6 months post opp
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2016 (estimated)
- Study startFeb 2017
- Primary completionFeb 2018 (estimated)
- Study completionFeb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impacted Third Molar ToothStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Baruch Padeh Medical Center, Poriya
- Sponsor type
- Other government
- Collaborators
- Geistlich Pharma AG
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02753439
- Sponsor's protocol ID
- Baruchpmc.CTIL
- Status last verified
- Mar 2016
- First submitted
- 20 Mar 2016
- Last updated
- 27 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extraction of Impacted 3rd Molars, Can Bone Support of the Second Molar be Promoted by a Bio-Oss Graft?
- ClinicalTrials.gov ID
- NCT02753439
- Acronym / sponsor ID
- Baruchpmc.CTIL
- Conditions
- Impacted Third Molar Tooth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The Baruch Padeh Medical Center, PoriyaOther government
- Collaborators
- Geistlich Pharma AG
- Study start
- Feb 2017
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 27 Apr 2016 (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.
A prospective study examining bilateral 3rd molar extraction, by a split mouth protocol the investigators augment unilaterally and compare periodontal parameters in between.
Detailed description
40 patients will undergo bilateral 3rd molar extractions, in each patient one side would be augmented by a "Bio-Oss" xenograft.
Post operative, periodontal parameters such as pocket depth and mobility will be evaluated and compared.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3rd molar | Experimental | Drug: Geistlich Bio OssDrug: Geistlich Bio Oss |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Bilateral impacted 3rd molars.
- Healthy individuals
Key exclusion criteria (3 listed)
- Smokers
- Alcohol abusers
- Pregnancy
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 |
|---|---|---|
| Geistlich Bio OssAlso: Bone SupportExtraction of Impacted 3rd Molars, | Drug | 3rd molar |
Primary outcome
Mobility (Scale 0,1,2,3), change is being assessed.
Time frame: Pre opp (base line), 1 month post opp, 3 months post opp, 6 months post opp
Mobility will be assessed in the intervals mentioned above, and compared over time.
Pocket Depth (mm), change is being assessed.
Time frame: Pre opp (base line), 1 month post opp, 3 months post opp, 6 months post opp
Pocket depth will be assessed in the intervals mentioned above, and compared over time.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2016.
- 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 Geistlich Bio Oss in people with Impacted Third Molar Tooth, run by The Baruch Padeh Medical Center, Poriya.
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 2 inclusion and 3 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 27 Apr 2016. 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?
Mobility (Scale 0,1,2,3), change is being assessed. (time frame: Pre opp (base line), 1 month post opp, 3 months post opp, 6 months post opp). The study lists 2 primary outcomes in all. 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 27 Apr 2016.