Back to resultsUsing Combination of Synthetic Bone Substitutes During Extractions
Primary Purpose
Periodontitis, Dental Caries, Alveolar Bone Losses
Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Calcium Phosphate, Calcium Sulphate
Sponsored by
About this trial
This is an interventional treatment trial for Periodontitis
Eligibility Criteria
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Alveolar ridge dimensions
Alverolar ridge dimension
Arm Description
Control group - Only extraction teeth
Extraction of teeth and implant a bone substitute
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Post operative adverse effects
The investigators will record the optionally adverse effect such as edema, infection, pain, exposure of the membrane.
Full Information
NCT ID
NCT01503593
First Posted
December 18, 2011
Last Updated
May 28, 2012
Sponsor
Rambam Health Care Campus
1. Study Identification
Unique Protocol Identification Number
NCT01503593
Brief Title
Using Combination of Synthetic Bone Substitutes During Extractions
Official Title
Phase 3 Study of Using Combination of Bi Phasic Calcium Phosphate and Bu Phasic Calcium Sulphate During Extractions
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Unknown status
Study Start Date
May 2012 (undefined)
Primary Completion Date
May 2013 (Anticipated)
Study Completion Date
May 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rambam Health Care Campus
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis, Dental Caries, Alveolar Bone Losses
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Alveolar ridge dimensions
Arm Type
No Intervention
Arm Description
Control group - Only extraction teeth
Arm Title
Alverolar ridge dimension
Arm Type
Experimental
Arm Description
Extraction of teeth and implant a bone substitute
Intervention Type
Device
Intervention Name(s)
Calcium Phosphate, Calcium Sulphate
Intervention Description
1cc of Calcium Phosphate and 1cc of Calcium Sulphate
Primary Outcome Measure Information:
Title
The change of the dimension of the alveolar ridge
Description
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
Time Frame
Immediatly after tooth extraction (up to 10 minutes after the extraction) and 4 monthes after extraction
Secondary Outcome Measure Information:
Title
Post operative adverse effects
Description
The investigators will record the optionally adverse effect such as edema, infection, pain, exposure of the membrane.
Time Frame
immediate after the extraction and until 4 monthes after
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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).
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr. Yaniv Mayer, DMD
Phone
+972546565905
Email
dr.yaniv.mayer@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yaniv Mayer, D.M.D.
Organizational Affiliation
Rambam Health Care Campus, Haifa, Israel
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Using Combination of Synthetic Bone Substitutes During Extractions
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