Using Combination of Synthetic Bone Substitutes During Extractions

Study Overview
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Brief Summary
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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
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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

Official Title
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Phase 3 Study of Using Combination of Bi Phasic Calcium Phosphate and Bu Phasic Calcium Sulphate During Extractions

Conditions
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Periodontitis, Dental Caries, Alveolar Bone Losses

Intervention / Treatment
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* Device: Calcium Phosphate, Calcium Sulphate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Alveolar ridge dimensions<br>Control group - Only extraction teeth | |
| Experimental: Alverolar ridge dimension<br>Extraction of teeth and implant a bone substitute | Device: Calcium Phosphate, Calcium Sulphate<br>* 1cc of Calcium Phosphate and 1cc of Calcium Sulphate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Immediatly after tooth extraction (up to 10 minutes after the extraction) and 4 monthes after extraction | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post operative adverse effects | The investigators will record the optionally adverse effect such as edema, infection, pain, exposure of the membrane. | immediate after the extraction and until 4 monthes after |