RecruitingACTRN12608000092392

chronOS Implant Evaluation Study. The Canberra Surgicentre and Synthes Australia are conducting a clinical study to evaluate the performance of chronOS granules (bone substitute) following the extraction of wisdom tooth/teeth to prevent the risk of periodontal defects.

To measure the efficacy of beta-TriCalcium Phosphate (TCP) bone graft filler in preventing periodontal defect on the distal aspect of the M2 following M3 extraction.


Sponsor

Canberra Surgicentre

Enrollment

100 participants

Start Date

Jul 1, 2007

Study Type

Interventional

Conditions

Summary

The primary purpose of this study is to confirm that chronOS (bone substitute) can decrease the risk of peridodontal defects following extraction of their wisdom tooth/teeth (M3) extraction. It has been reported that by extracting the mandibular M3 bony peridontal defects can occur on the distal surface of the adjacent second molar. These bony defects are particularly present in patients who had their wisdom teeth extracted when over 26 years of age.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether filling the socket left after a wisdom tooth (mandibular third molar) is removed with a synthetic bone substitute called chronOS can prevent a specific type of gum and bone problem that sometimes develops on the adjacent second molar. When wisdom teeth are removed — particularly in adults over 26 — a bony defect can form nearby, leading to a gum problem called a periodontal defect. This study will follow patients for at least 12 months after the procedure to see if chronOS reduces this risk. You may be eligible if: - You are 18 years of age or older - You are having both lower wisdom teeth removed - Your wisdom teeth are in a mesioangular or horizontal position (leaning forward) - You are willing to attend follow-up appointments for at least 12 months You may NOT be eligible if: - You are under 18 years of age - The tooth next to your wisdom tooth (second molar) is missing - You have diabetes - You are taking long-term steroid medications - You have had radiation therapy to the jaw - You have or have had a malignant condition Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

beta-TriCalcium Phosphate granules will be placed in the socket of one of the bilaterally extracted M3. After six months a first set of x-rays will be done to observe bone level at the cemento-enamel

beta-TriCalcium Phosphate granules will be placed in the socket of one of the bilaterally extracted M3. After six months a first set of x-rays will be done to observe bone level at the cemento-enamel junction of the chronOS filled socket versus the non-filled socket. A second set of x-rays will be done at 12 months.


Locations(1)

Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12608000092392