Using Combination of Synthetic Bone Substitutes During Extractions

Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01503593
• Other study ID #: 0326-11-RMB
• Secondary ID: 0362-11-RMB
• Status: Unknown status
• Phase: Phase 3
• First received: December 18, 2011
• Last updated: May 28, 2012
• Start date: May 2012
• Est. completion date: May 2013

Study information

• Verified date: May 2012
• Source: Rambam Health Care Campus
• Contact: Dr. Yaniv Mayer, DMD
• Phone: +972546565905
• Email: dr.yaniv.mayer[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 40
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alveolar Bone Loss
• Alveolar Bone Losses
• Dental Caries
• Periodontitis

Intervention

Device:
• Calcium Phosphate, Calcium Sulphate
1cc of Calcium Phosphate and 1cc of Calcium Sulphate

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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