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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
Sponsor:
ClinicalTrials.gov Identifier:
NCT01503593
First Posted: January 4, 2012
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Rambam Health Care Campus
  Purpose
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
Periodontitis 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 (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
  Eligibility

Information from the National Library of Medicine

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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01503593


Contacts
Contact: Dr. Yaniv Mayer, DMD +972546565905 dr.yaniv.mayer@gmail.com

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

Responsible Party: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01503593     History of Changes
Other Study ID Numbers: 0326-11-RMB
0362-11-RMB
First Submitted: December 18, 2011
First Posted: January 4, 2012
Last Update Posted: October 12, 2017
Last Verified: May 2012

Additional relevant MeSH terms:
Periodontitis
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