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

Primary Purpose

Alveolar Bone Loss

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Bond Apatite synthetic bone substitute
BioOss bovine bone substitute
Sponsored by
Rambam Health Care Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alveolar Bone Loss focused on measuring extraction, Bond Apatite

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Rambam Health Care Campus, Dept. of Periodontology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

HA ®Bond-apatite

BioOss bovine bone substitute

extraction

Arm Description

10 extraction sockets will be preserved with Bond Apatite synthetic bone substitutes as test group

10 extraction sockets will be preserved with BioOss particles bovine bone substitute as a positive control

10 extraction sockets with no use of bone substitute as negative control.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Complications
Complications will be documented: Infection, swelling, discomfort, pain, bone substitutes particles moving away from the tissue.

Full Information

First Posted
May 3, 2015
Last Updated
April 10, 2018
Sponsor
Rambam Health Care Campus
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1. Study Identification

Unique Protocol Identification Number
NCT02440048
Brief Title
Using Boned-Apatite Cement at the Time of Extraction for Ridge Preservation at These Sites
Official Title
Using Boned-Apatite Cement at the Time of Extractions for Ridge Preservation at These Sites
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
June 16, 2015 (Actual)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rambam Health Care Campus

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alveolar Bone Loss
Keywords
extraction, Bond Apatite

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HA ®Bond-apatite
Arm Type
Experimental
Arm Description
10 extraction sockets will be preserved with Bond Apatite synthetic bone substitutes as test group
Arm Title
BioOss bovine bone substitute
Arm Type
Active Comparator
Arm Description
10 extraction sockets will be preserved with BioOss particles bovine bone substitute as a positive control
Arm Title
extraction
Arm Type
No Intervention
Arm Description
10 extraction sockets with no use of bone substitute as negative control.
Intervention Type
Device
Intervention Name(s)
Bond Apatite synthetic bone substitute
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
BioOss bovine bone substitute
Intervention Description
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.
Primary Outcome Measure Information:
Title
socket dimensions
Description
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.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Complications
Description
Complications will be documented: Infection, swelling, discomfort, pain, bone substitutes particles moving away from the tissue.
Time Frame
4 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
prof. Eli Machtei, DMD
Organizational Affiliation
Department of periodontology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rambam Health Care Campus, Dept. of Periodontology
City
Haifa
ZIP/Postal Code
31096
Country
Israel

12. IPD Sharing Statement

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

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