Extraction of Impacted 3rd Molars, Can Bone Support of the Second Molar be Promoted by a Bio-Oss Graft?

April 25, 2016 updated by: The Baruch Padeh Medical Center, Poriya
A prospective study examining bilateral 3rd molar extraction, by a split mouth protocol the investigators augment unilaterally and compare periodontal parameters in between.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

40 patients will undergo bilateral 3rd molar extractions, in each patient one side would be augmented by a "Bio-Oss" xenograft.

Post operative, periodontal parameters such as pocket depth and mobility will be evaluated and compared.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Bilateral impacted 3rd molars.
  • Healthy individuals

Exclusion Criteria:

  • Smokers
  • Alcohol abusers
  • Pregnancy

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: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 3rd molar
Drug: Geistlich Bio Oss
Drug: Geistlich Bio Oss
Extraction of Impacted 3rd Molars,
Other Names:
  • Bone Support

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mobility (Scale 0,1,2,3), change is being assessed.
Time Frame: Pre opp (base line), 1 month post opp, 3 months post opp, 6 months post opp
Mobility will be assessed in the intervals mentioned above, and compared over time.
Pre opp (base line), 1 month post opp, 3 months post opp, 6 months post opp
Pocket Depth (mm), change is being assessed.
Time Frame: Pre opp (base line), 1 month post opp, 3 months post opp, 6 months post opp
Pocket depth will be assessed in the intervals mentioned above, and compared over time.
Pre opp (base line), 1 month post opp, 3 months post opp, 6 months post opp

Collaborators and Investigators

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

Sponsor

The Baruch Padeh Medical Center, Poriya

Collaborators

Geistlich Pharma AG

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

February 1, 2017

Primary Completion (Anticipated)

February 1, 2018

Study Completion (Anticipated)

February 1, 2019

Study Registration Dates

First Submitted

March 20, 2016

First Submitted That Met QC Criteria

April 25, 2016

First Posted (Estimate)

April 27, 2016

Study Record Updates

Last Update Posted (Estimate)

April 27, 2016

Last Update Submitted That Met QC Criteria

April 25, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Baruchpmc.CTIL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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