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.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12608000092392

Enrollment

100

Registered

2008-02-15

Start date

2007-07-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 junction of the chronOS filled socket versus the non-filled socket. A second set of x-rays will be done at 12 months.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

Age >= 18 years Removal of two mandibular M3 Mesioangular or horizontal M3 position Agreement for return follow-up for at least 12 months.

Exclusion criteria

Age < 18 years No adjacent M2 Diabetic Chronic steroid use. Malignant condition Previous radiotherapy to the maxilla or mandible. Significant difference between the cementoenamel junction (CEJ) bilaterally, defined as attachment level variance of 1mm or more.

Outcome results