NCT02440048

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 12, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

June 16, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

April 11, 2018

Status Verified

April 1, 2018

Enrollment Period

2.4 years

First QC Date

May 3, 2015

Last Update Submit

April 10, 2018

Conditions

Alveolar Bone Loss

Keywords

extractionBond Apatite

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Complications

    4 month

Study Arms (3)

HA ®Bond-apatite

EXPERIMENTAL

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

Device: Bond Apatite synthetic bone substitute

BioOss bovine bone substitute

ACTIVE COMPARATOR

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

Device: BioOss bovine bone substitute

extraction

NO INTERVENTION

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

Interventions

Bond Apatite synthetic bone substituteDEVICE

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.

HA ®Bond-apatite
BioOss bovine bone substituteDEVICE

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.

BioOss bovine bone substitute

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Health Care Campus, Dept. of Periodontology

Haifa, 31096, Israel

Location

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone ResorptionBone DiseasesMusculoskeletal DiseasesPeriodontal AtrophyPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • prof. Eli Machtei, DMD

    Department of periodontology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head - School of Graduate Dentistry & Chairman,Department of Periodontology

Study Record Dates

First Submitted

May 3, 2015

First Posted

May 12, 2015

Study Start

June 16, 2015

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

April 11, 2018

Record last verified: 2018-04

Locations

IL(1)