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

April 10, 2018 updated by: machtei, Rambam Health Care Campus

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel, 31096
        • Rambam Health Care Campus, Dept. of Periodontology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: HA ®Bond-apatite
10 extraction sockets will be preserved with Bond Apatite synthetic bone substitutes as test group
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.
ACTIVE_COMPARATOR: BioOss bovine bone substitute
10 extraction sockets will be preserved with BioOss particles bovine bone substitute as a positive control
Device: 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.
NO_INTERVENTION: extraction
10 extraction sockets with no use of bone substitute as negative control.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
socket dimensions
Time Frame: 4 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: 4 month
Complications will be documented: Infection, swelling, discomfort, pain, bone substitutes particles moving away from the tissue.
4 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rambam Health Care Campus

Investigators

  • Principal Investigator: prof. Eli Machtei, DMD, Department of Periodontology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 16, 2015

Primary Completion (ACTUAL)

November 1, 2017

Study Completion (ACTUAL)

November 1, 2017

Study Registration Dates

First Submitted

May 3, 2015

First Submitted That Met QC Criteria

May 8, 2015

First Posted (ESTIMATE)

May 12, 2015

Study Record Updates

Last Update Posted (ACTUAL)

April 11, 2018

Last Update Submitted That Met QC Criteria

April 10, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0092-15-RMB CTIL
  • prof. Eli machtei (OTHER: Rambam Health Care Campus)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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