Using Combination of Synthetic Bone Substitutes During Extractions

NCT ID: NCT01503593

Last Updated: 2012-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2013-05-31

Brief Summary

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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.

Detailed Description

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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

Conditions

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Periodontitis Dental Caries Alveolar Bone Losses

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Alveolar ridge dimensions

Control group - Only extraction teeth

Group Type NO_INTERVENTION

No interventions assigned to this group

Alverolar ridge dimension

Extraction of teeth and implant a bone substitute

Group Type EXPERIMENTAL

Calcium Phosphate, Calcium Sulphate

Intervention Type DEVICE

1cc of Calcium Phosphate and 1cc of Calcium Sulphate

Interventions

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Calcium Phosphate, Calcium Sulphate

1cc of Calcium Phosphate and 1cc of Calcium Sulphate

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rambam Health Care Campus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yaniv Mayer, D.M.D.

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus, Haifa, Israel

Central Contacts

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Dr. Yaniv Mayer, DMD

Role: CONTACT

+972546565905

Other Identifiers

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0362-11-RMB

Identifier Type: -

Identifier Source: secondary_id

0326-11-RMB

Identifier Type: -

Identifier Source: org_study_id

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