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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02753439
Other study ID # Baruchpmc.CTIL
Secondary ID
Status Not yet recruiting
Phase N/A
First received March 20, 2016
Last updated April 25, 2016
Start date February 2017
Est. completion date February 2019

Study information

Verified date March 2016
Source The Baruch Padeh Medical Center, Poriya
Contact n/a
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Interventional

Clinical Trial Summary

A prospective study examining bilateral 3rd molar extraction, by a split mouth protocol the investigators augment unilaterally and compare periodontal parameters in between.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date February 2019
Est. primary completion date February 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Bilateral impacted 3rd molars.

- Healthy individuals

Exclusion Criteria:

- Smokers

- Alcohol abusers

- Pregnancy

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Drug:
Geistlich Bio Oss
Extraction of Impacted 3rd Molars,

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
The Baruch Padeh Medical Center, Poriya Geistlich Pharma AG

Outcome

Type Measure Description Time frame Safety issue
Primary Mobility (Scale 0,1,2,3), change is being assessed. 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 No
Primary Pocket Depth (mm), change is being assessed. 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 No
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