Using Combination of Synthetic Bone Substitutes During Extractions

Phase 3

• Conditions: Dental Caries; Alveolar Bone Losses; Periodontitis
• Interventions: Device: Calcium Phosphate, Calcium Sulphate

• Registration Number: NCT01503593
• Lead Sponsor: Rambam Health Care Campus

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

Study Timeline

• Study First Submitted: 2011-12-18
• Study First Submitted QC: 2012-01-03
• Study First Posted: 2012-01-04
• Status Verified: 2012-05
• Study Start: 2012-05
• Last Update Submitted: 2012-05-28
• Last Update Posted: 2012-05-30
• Primary Completion: 2013-05
• Study Completion: 2013-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Alverolar ridge dimension	Calcium Phosphate, Calcium Sulphate	Extraction of teeth and implant a bone substitute

Primary Outcome Measures

Name	Time	Method
The change of the dimension of the alveolar ridge	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

Name	Time	Method
Post operative adverse effects	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.