PeriodontitisPhase 3NCT01503593
Using Combination of Synthetic Bone Substitutes During Extractions
A Phase 3 study testing Calcium Phosphate, Calcium Sulphate in people with Periodontitis and Dental Caries, run by Rambam Health Care Campus.
Trial summary
The study was designed to assess the effectiveness of conservation ridge preservation (horizontal and vertical dimension) after tooth extraction with and without combination of bone substitutes based on synthetic (calcium sulfate mixed with phosphate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontitis, Dental Caries, Alveolar Bone Losses
- What is being tested?
- Calcium Phosphate, Calcium Sulphate
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- May 2012to May 2013
- Phase
- Phase 3
- 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 over age 18.
- Patients who require extraction of teeth for Periodontal or other dental reasons (up one tooth in each quarter when there are existing adjacent teeth).
Who cannot join
- Inability to pass informed consent procedure
- Pregnant women
- Breastfeeding women
- Patient taking medications that affect bone metabolism such as bisphosphonates
- Extractions sites contaminated
- Smoking over 10 cigarettes a day
- Patients with removable prostheses
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Phase 3 Study of Using Combination of Bi Phasic Calcium Phosphate and Bu Phasic Calcium Sulphate During Extractions
The study was designed to assess the effectiveness of conservation ridge preservation (horizontal and vertical dimension) after tooth extraction with and without combination of bone substitutes based on synthetic (calcium sulfate mixed with phosphate.
Read the detailed description
Using the combination of these two bone substitute is taken in order to diminish the alveolar ridge alternations after tooth extraction. the investigator will measure the horizontal and vertical changes (primary outcome) and the adverse effects (secondary outcome)in 4 months period
- Conditions
- Periodontitis, Dental Caries, Alveolar Bone Losses
- Being tested
- Calcium Phosphate, Calcium Sulphate
- Medical subject headings
- Periodontitis, Dental Caries, Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium Phosphate, Calcium SulphateDevice
1cc of Calcium Phosphate and 1cc of Calcium Sulphate
| Study group | Role | What they receive |
|---|---|---|
| Alveolar ridge dimensions | No intervention | Control group - Only extraction teeth |
| Alverolar ridge dimension | Experimental | Extraction of teeth and implant a bone substitute Receives: Device: Calcium Phosphate, Calcium Sulphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of the dimension of the alveolar ridge
Measurement of socket width (aspect B/L) at three points Height:
- Record-high ridge (buccal/lingual-palatal )
- 3 mm apically to the peak ridge (buccal/lingual-palatal )
- 6mm apically to the peak ridge (buccal/lingual-palatal )
Measurement of alveolar ridge height:
Measured distance between the summit crater and the peak of the ridge and the center line connecting the CEJ of adjacent teeth
Measured: Immediatly after tooth extraction (up to 10 minutes after the extraction) and 4 monthes after extraction
Secondary outcomes (1)
Post operative adverse effects
The investigators will record the optionally adverse effect such as edema, infection, pain, exposure of the membrane.
Measured: immediate after the extraction and until 4 monthes after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2012 (estimated)
- Study startMay 2012
- Primary completionMay 2013 (estimated)
- Study completionMay 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yaniv Mayer, D.M.D., Principal investigator, Rambam Health Care Campus, Haifa, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01503593
- Sponsor's protocol ID
- 0326-11-RMB
- Other IDs
- 0362-11-RMB
- Status last verified
- May 2012
- First submitted
- 18 Dec 2011
- Last updated
- 30 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study of Using Combination of Bi Phasic Calcium Phosphate and Bu Phasic Calcium Sulphate During Extractions
- ClinicalTrials.gov ID
- NCT01503593
- Acronym / sponsor ID
- 0326-11-RMB
- Conditions
- Periodontitis, Dental Caries, Alveolar Bone Losses
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- May 2013 (estimated)
- Study completion
- May 2013 (estimated)
- First posted
- 4 Jan 2012 (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.
The study was designed to assess the effectiveness of conservation ridge preservation (horizontal and vertical dimension) after tooth extraction with and without combination of bone substitutes based on synthetic (calcium sulfate mixed with phosphate.
Detailed description
Using the combination of these two bone substitute is taken in order to diminish the alveolar ridge alternations after tooth extraction. the investigator will measure the horizontal and vertical changes (primary outcome) and the adverse effects (secondary outcome)in 4 months period
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alveolar ridge dimensions | No intervention | –Control group - Only extraction teeth |
| Alverolar ridge dimension | Experimental | Device: Calcium Phosphate, Calcium SulphateExtraction of teeth and implant a bone substitute |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients over age 18.
- Patients who require extraction of teeth for Periodontal or other dental reasons (up one tooth in each quarter when there are existing adjacent teeth).
Key exclusion criteria (7 listed)
- Inability to pass informed consent procedure
- Pregnant women
- Breastfeeding women
- Patient taking medications that affect bone metabolism such as bisphosphonates
- Extractions sites contaminated
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 |
|---|---|---|
| Calcium Phosphate, Calcium Sulphate1cc of Calcium Phosphate and 1cc of Calcium Sulphate | Device | Alverolar ridge dimension |
Primary outcome
The change of the dimension of the alveolar ridge
Time frame: Immediatly after tooth extraction (up to 10 minutes after the extraction) and 4 monthes after extraction
Measurement of socket width (aspect B/L) at three points Height: 1. Record-high ridge (buccal/lingual-palatal ) 2. 3 mm apically to the peak ridge (buccal/lingual-palatal ) 3. 6mm apically to the peak ridge (buccal/lingual-palatal ) Measurement of alveolar ridge height: Measured distance between the summit crater and the peak of the ridge and the center line connecting the CEJ of adjacent teeth
1 secondary outcome
Post operative adverse effects
Time frame: immediate after the extraction and until 4 monthes after
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2012.
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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.
Yaniv Mayer, D.M.D. principal investigator
Rambam Health Care Campus, Haifa, Israel
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Calcium Phosphate, Calcium Sulphate in people with Periodontitis and Dental Caries, run by Rambam Health Care Campus.
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 7 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 30 May 2012. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Dr. Yaniv Mayer, DMD (+972546565905, dr.yaniv.mayer@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of the dimension of the alveolar ridge (time frame: Immediatly after tooth extraction (up to 10 minutes after the extraction) and 4 monthes after extraction). 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 30 May 2012.