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Using Combination of Synthetic Bone Substitutes During Extractions

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2012 by Rambam Health Care Campus.
Recruitment status was:  Not yet recruiting
Information provided by (Responsible Party):
Rambam Health Care Campus Identifier:
First received: December 18, 2011
Last updated: May 28, 2012
Last verified: May 2012
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.

Condition Intervention Phase
Dental Caries
Alveolar Bone Losses
Device: Calcium Phosphate, Calcium Sulphate
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Phase 3 Study of Using Combination of Bi Phasic Calcium Phosphate and Bu Phasic Calcium Sulphate During Extractions

Resource links provided by NLM:

Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • Post operative adverse effects [ Time Frame: immediate after the extraction and until 4 monthes after ]
    The investigators will record the optionally adverse effect such as edema, infection, pain, exposure of the membrane.

Estimated Enrollment: 40
Study Start Date: May 2012
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Alveolar ridge dimensions
Control group - Only extraction teeth
Experimental: Alverolar ridge dimension
Extraction of teeth and implant a bone substitute
Device: Calcium Phosphate, Calcium Sulphate
1cc of Calcium Phosphate and 1cc of Calcium Sulphate

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients over age 18.
  2. Patients who require extraction of teeth for Periodontal or other dental reasons (up one tooth in each quarter when there are existing adjacent teeth).

Exclusion Criteria:

  1. Inability to pass informed consent procedure
  2. Pregnant women
  3. Breastfeeding women
  4. Patient taking medications that affect bone metabolism such as bisphosphonates
  5. Extractions sites contaminated
  6. Smoking over 10 cigarettes a day
  7. Patients with removable prostheses
  Contacts and Locations
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Please refer to this study by its identifier: NCT01503593

Contact: Dr. Yaniv Mayer, DMD +972546565905

Sponsors and Collaborators
Rambam Health Care Campus
Principal Investigator: Yaniv Mayer, D.M.D. Rambam Health Care Campus, Haifa, Israel
  More Information

Responsible Party: Rambam Health Care Campus Identifier: NCT01503593     History of Changes
Other Study ID Numbers: 0326-11-RMB
Study First Received: December 18, 2011
Last Updated: May 28, 2012

Additional relevant MeSH terms:
Dental Caries
Alveolar Bone Loss
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Tooth Demineralization
Tooth Diseases
Bone Resorption
Bone Diseases
Musculoskeletal Diseases
Periodontal Atrophy
Calcium, Dietary
Bone Density Conservation Agents
Physiological Effects of Drugs processed this record on April 28, 2017