Using Combination of Synthetic Bone Substitutes During Extractions

May 28, 2012 updated by: Rambam Health Care Campus

Phase 3 Study of Using Combination of Bi Phasic Calcium Phosphate and Bu Phasic Calcium Sulphate During Extractions

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 3

Contacts and Locations

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

Study Contact

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

No

Genders Eligible for Study

All

Description

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

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Alveolar ridge dimensions
Control group - Only extraction teeth
Experimental: Alverolar ridge dimension
Extraction of teeth and implant a bone substitute
Device: Calcium Phosphate, Calcium Sulphate
1cc of Calcium Phosphate and 1cc of Calcium Sulphate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change of the dimension of the alveolar ridge
Time Frame: Immediatly after tooth extraction (up to 10 minutes after the extraction) and 4 monthes after extraction

Measurement of socket width (aspect B/L) at three points Height:

  1. Record-high ridge (buccal/lingual-palatal )
  2. 3 mm apically to the peak ridge (buccal/lingual-palatal )
  3. 6mm apically to the peak ridge (buccal/lingual-palatal )

Measurement of alveolar ridge height:

Measured distance between the summit crater and the peak of the ridge and the center line connecting the CEJ of adjacent teeth
Immediatly after tooth extraction (up to 10 minutes after the extraction) and 4 monthes after extraction

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post operative adverse effects
Time Frame: immediate after the extraction and until 4 monthes after
The investigators will record the optionally adverse effect such as edema, infection, pain, exposure of the membrane.
immediate after the extraction and until 4 monthes after

Collaborators and Investigators

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

Sponsor

Rambam Health Care Campus

Investigators

  • Principal Investigator: Yaniv Mayer, D.M.D., Rambam Health Care Campus, Haifa, Israel

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

May 1, 2012

Primary Completion (Anticipated)

May 1, 2013

Study Completion (Anticipated)

May 1, 2013

Study Registration Dates

First Submitted

December 18, 2011

First Submitted That Met QC Criteria

January 3, 2012

First Posted (Estimate)

January 4, 2012

Study Record Updates

Last Update Posted (Estimate)

May 30, 2012

Last Update Submitted That Met QC Criteria

May 28, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0326-11-RMB
  • 0362-11-RMB

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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