Assessment of Ridge Preservation Using Moldable Beta-tricalcium Phosphate Bone Grafting System



Status:Active, not recruiting
Conditions:Dental
Therapuetic Areas:Dental / Maxillofacial Surgery
Healthy:No
Age Range:18 - Any
Updated:9/7/2018
Start Date:August 2, 2016
End Date:September 2019

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Prospective, Comparative Assessment of Alveolar Ridge Preservation Using GUIDOR® Easy-graft® Classic in Atraumatic Extraction Socket

Randomized Controlled study to compare the effectiveness of two different treatment
approaches using a new moldable beta-tricalcium phosphate(TCP) bone graft material in ridge
preservation of an atraumatic extraction socket site compared to allograft with collagen
plug.


Inclusion Criteria:

- Provision of informed consent

- At least 18 years old

- In need of one posterior tooth, excluding third molar molars, planned for extraction
and replacement with a dental implant (If the subject requires two adjacent socket
preservation, they can still be enrolled in the study but only one site will be used
for the study)

- Intact ridge as verified with cone-beam CT scan

- At least one natural tooth adjacent to the study site present.

Exclusion Criteria:

- Insufficient interocclusal space to allow for implant supported prosthesis

- Dehiscence or fenestration identified at the time of reviewing CBCT.

- Non-treated caries or uncontrolled periodontal disease present affecting the teeth in
adjacent to study teeth.

- Any of natural teeth adjacent to the study site presents active periapical endodontic
lesion ("active periapical endodontic lesion" will be determined per consultation by
endodontics specialist).

- Adjacent tooth (mesial and distal) to study site was extracted within last 6 months

- Adjacent teeth (or tooth) to study site with significant soft tissue loss

- Smoker using more than 10 cigarettes or equivalent per day

- Smokeless tobacco use or e-cigarette use

- Current alcohol or drug abuser

- Systemic or local disease or condition that would compromise post-operative healing
and/or osseointegration e.g. uncontrolled diabetes

- Need for systemic corticosteroids or any other medication that would influence
post-operative healing and/or osseointegration

- Pregnancy, as indicated by positive serum human chorionic gonadotropin (HCG) test
result.

- Unable or unwilling to return for follow-up visits for a period of 5 months

- Unlikely to be able to comply with study procedures according to Investigators
judgement

- Subject in other clinical trials
We found this trial at
2
sites
Baltimore, Maryland 21201
Phone: 410-706-7152
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Iowa City, Iowa 52242
Phone: 319-335-7239
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Iowa City, IA
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