Alveolar Ridge Resorption After Extraction Clinical Trial
Official title:
Alveolar Ridge Preservation With Polycaprolactone Scaffold for Implant Site Development
| Verified date | May 2008 |
| Source | National University Hospital, Singapore |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 20 |
| Est. completion date | June 30, 2010 |
| Est. primary completion date | June 30, 2010 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 21 Years and older |
| Eligibility |
Inclusion Criteria: 1. Having 1 or more unsalvageable non-molar teeth indicated for extraction due to periodontal disease, endodontic failures, crown/root fractures, extensive caries or trauma 2. Have the indications for dental implant placement 3. Given alternative options and chose replacement by endosseous implants following extractions 4. If more than 1 tooth is to be replaced with implants, they should not be adjacent to each other 5. Position of unsalvageable tooth is close to final implant position 6. Good to fair oral hygiene (No probing depths <5mm and Gingivitis score of <20%) Exclusion Criteria: 1. Immunocompromised state 2. Prior radiotherapy to extraction site 3. Chemotherapy in the past 12 months 4. Blood disorders 5. Uncontrolled diabetes 6. Uncontrolled hypertension 7. Long term steroid or anti-inflammatory therapy 8. Require antibiotic prophylaxis before dental treatment 9. Other uncontrolled systemic disease 10. Drug or alcohol abusers 11. Active infection in extraction site 12. Heavy smoker (> 10 sticks a day) 13. Pregnancy/Lactation 14. Known allergies to plastics or other polymer 15. Unwillingness to undergo basic dental treatment like caries-control and periodontal therapy 16. Failure to sign informed consent form |
| Country | Name | City | State |
|---|---|---|---|
| Singapore | National University Hospital | Singapore |
| Lead Sponsor | Collaborator |
|---|---|
| National University Hospital, Singapore |
Singapore,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To test the effectiveness of the PCL scaffold in maintaining the physical dimensions of the alveolar ridge after extraction. | |||
| Secondary | To assess the percentage of living bone that is formed during healing with presence of PCL scaffold. | |||
| Secondary | To assess the possibility of using density of CT scan to determine the percentage of living bone in the site for implant placement. |