Using Boned-Apatite Cement at the Time of Extraction for Ridge Preservation at These Sites

Alveolar Bone Loss Clinical Trial

Official title:

Using Boned-Apatite Cement at the Time of Extractions for Ridge Preservation at These Sites

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02440048
• Other study ID #: 0092-15-RMB CTIL
• Secondary ID: prof. Eli machte
• Status: Completed
• Phase: N/A
• First received: May 3, 2015
• Last updated: April 10, 2018
• Start date: June 16, 2015
• Est. completion date: November 2017

Study information

• Verified date: April 2018
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To assess efficiency of ridge preservation (in vertical and horizontal dimensions) after tooth extraction using Calcium Sulfate with hydroxyapatite(®Bond-apatite) compared to the use of bovine bone substitute (BioOss®) and to extration only as negative control.

Description:

Dental implants have become in the past ten years a popular and promising treatment in the rehabilitation of missing teeth. However, using implants depends on adequate alveolar bone volume. Anatomical restrictions are mostly present in posterior mandibular and maxillary regions. Alveolar bone loss usually occurs because of active periodontal disease, trauma or teeth extractions.

Teeth extractions are associated with some loss of alveolar bone in the horizontal and vertical dimensions. This loss is more pronounced when teeth are extracted because of periodontal disease. Bone grafts from different origins (autogenic, allogenic, xenogenic or alloplastic) can partly reduce the alveolar bone loss. Different ridge preservation techniques were succesfully used in clinical trials, using membranes only or as a combination of membranes and bone substitutes.

Synthetic bone grafts have been proven successfully for ridge preservation. Calcium sulfate is the oldest material, being in use in dentistry for more than 30 years , and in orthopedics for more than 100 years . Calcium sulfate is completely absorbed and constitutes a matrix on wich bone is able to grow (osteoconductive). It does not induce inflammation and doesn't alter calcium levels in the blood flow.Previous studies has shown that calcium sulfate is completely replaced by bone. On the other hand, fast absorption of calcium sulfates can alter the dimensional stability of the graft. Adding Hydroxy Appatite may improve stability during bone remodeling.

This study includes patients who need extractions of incisors, canines or premolars. The extraction sockets must be mostly intact with a maximum 4 mm of one wall missing in the vertical dimension.

30 patients who need extractions from region of interest, with no extended bony defects, will be enrolled from the department of Periodontology, school of graduate dentistry, Rambam Health Care Campus

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Informed consent properly described and signed.

• Patients who need extractions of molars for dental or periodontal reasons.

• At least 18 years old.

• Need for future dental implants in the extraction areas.

Exclusion Criteria:

• No informed consent.

• Pregnant women.

• Women who breastfeed.

• Patients treated with drugs influencing metabolism of bone such as bisphosphonates.

• Heavy smokers (more than 20 cigarettes per day).

• Patients with dentures pressing on the area of extractions/bone grafts

Related Conditions & MeSH terms

• Alveolar Bone Loss

Intervention

Device:
• Bond Apatite synthetic bone substitute
Synthetic bone grafts had been successful for ridge preservation. Calcium sulfate is the oldest material, being in use in dentistry for more than 30 years ago, and in orthopedics for more than 100 years ago. Calcium sulfate is completely absorbed and constitutes a matrix on wich bone is able to grow (osteoconductive). It does not induce inflammation and does not alter calcium levels in the blood flow.Previous studies has shown that calcium sulfate is completely replaced by bone. On the other hand, fast absorption of calcium sulfates can alter the dimensional stability of the graft. Adding Hydroxy Apatite may improve stability during bone remodeling.
• BioOss bovine bone substitute
To assess efficiency of ridge preservation (in vertical and horizontal dimensions) after tooth extraction using Calcium Sulfate with HA (®Bond-apatite) compared to the use of bovine bone substitute (BioOss®) and to extraction only as negative control.

Locations

Country	Name	City	State
Israel	Rambam Health Care Campus, Dept. of Periodontology	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	socket dimensions	Measurement of socket width (B-L aspect) in two vertical points and Distance from alveolar crest height in the middle of the socket to the marked point in the bottom of the stent.	4 months
Secondary	Complications	Complications will be documented: Infection, swelling, discomfort, pain, bone substitutes particles moving away from the tissue.	4 month