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

Impacted Third Molar Tooth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02753439
• Other study ID #: Baruchpmc.CTIL
• 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

• Impacted Third Molar Tooth
• Tooth, Impacted

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