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Using Combination of Synthetic Bone Substitutes During Extractions

This study is not yet open for participant recruitment.
Verified May 2012 by Rambam Health Care Campus
Sponsor:
Information provided by (Responsible Party):
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01503593
First received: December 18, 2011
Last updated: May 28, 2012
Last verified: May 2012
History of Changes
  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
Endpoint Classification: Efficacy Study
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:

MedlinePlus related topics: Calcium Tooth Decay
U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01503593     History of Changes
Other Study ID Numbers: 0326-11-RMB, 0362-11-RMB
Study First Received: December 18, 2011
Last Updated: May 28, 2012
Health Authority: Israel: Ethics Commission

Additional relevant MeSH terms:
Calcium, Dietary
Alveolar Bone Loss
Dental Caries
Periodontitis
Bone Resorption
Bone Diseases
Musculoskeletal Diseases
Periodontal Atrophy
 Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Tooth Demineralization
Tooth Diseases
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013