Alveolar Ridge Preservation With Polycaprolactone Scaffold for Implant Site Development
Recruitment status was: Recruiting
It has been shown through research that alveolar ridges (Part of jaw bone holding teeth) tend to lose width and height after extraction of teeth. Lost in height and width of the ridge can cause problems in the restoration of missing teeth with bridges and implants. Hence, this study is proposed to assess the use of polycaprolactone (PCL) scaffolds for alveolar ridge preservation following extraction of teeth in humans.
20 patients will be divided into 2 groups. In one group, patients will have a PCL scaffold placed into the socket after extraction. In other group, no scaffold will be placed. After a healing period of 6 months, changes in width and height from baseline is measured for both groups. A bone biopsy is also taken at this time from both groups. Hardness of bone, histologic (microscopic) features of cells, percentage of living bone, radiographic density of alveolar ridge and mechanical properties of the bone biopsy are then assessed.
This study will attempt to show that a resorbable (can be removed by body) material like a PCL scaffold can be used to maintain physical dimensions of the alveolar ridge after extraction and will not interfere with osseointegration (fusion with bone). It will avoid the necessity for additional corrective surgeries for patients when alveolar ridges presented with inadequate width and height for placement of aesthetically pleasing and functionally sound restorations. This would improve chances of success for the patient.
If the study successfully shows that the PCL scaffold can be accepted by the body with good bone growth, uses for the PCL scaffold can be extended to other areas of clinical medicine and dentistry.
The PCL scaffold to be used in this study is designed and developed by a local company (Osteopore International Pte Ltd). With the success of this product, Singapore's standing as a biomedical hub will be further enhanced.
|Alveolar Ridge Resorption After Extraction||Device: Polycaprolactone Scaffold||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
|Official Title:||Alveolar Ridge Preservation With Polycaprolactone Scaffold for Implant Site Development|
- To test the effectiveness of the PCL scaffold in maintaining the physical dimensions of the alveolar ridge after extraction.
- To assess the percentage of living bone that is formed during healing with presence of PCL scaffold.
- To assess the possibility of using density of CT scan to determine the percentage of living bone in the site for implant placement.
|Study Start Date:||March 2007|
|Estimated Study Completion Date:||April 2007|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00466414
|Contact: Ang Chee Wan, BDS||+65 9843 firstname.lastname@example.org|
|Contact: Lim Thiam Chye, FRCS||+65 6772 email@example.com|
|National University Hospital||Recruiting|
|Contact: Ang Chee Wan, BDS +65 9843 9578 firstname.lastname@example.org|
|Contact: Lim Thiam Chye, FRCS +65 772 4226 email@example.com|
|Principal Investigator: Ang Chee Wan, BDS|
|Sub-Investigator: Lim Thiam Chye, FRCS|
|Principal Investigator: Lim Lum Peng, MSc|
|Principal Investigator:||Ang Chee Wan, BDS||National University, Singapore|
|Principal Investigator:||Lim Thiam Chye, FRCS||National University Hospital, Singapore|
|Principal Investigator:||Lim Lum Peng, MSc||National University, Singapore|
|Principal Investigator:||Chung Kong Mun, MS|