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Alveolar Ridge Preservation With Polycaprolactone Scaffold for Implant Site Development

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by National University Hospital, Singapore.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National University Hospital, Singapore
ClinicalTrials.gov Identifier:
NCT00466414
First received: April 25, 2007
Last updated: May 14, 2008
Last verified: May 2008
  Purpose

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.


Condition Intervention Phase
Alveolar Ridge Resorption After Extraction
Device: Polycaprolactone Scaffold
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Alveolar Ridge Preservation With Polycaprolactone Scaffold for Implant Site Development

Further study details as provided by National University Hospital, Singapore:

Primary Outcome Measures:
  • To test the effectiveness of the PCL scaffold in maintaining the physical dimensions of the alveolar ridge after extraction.

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 20
Study Start Date: March 2007
Estimated Study Completion Date: April 2007
  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00466414

Contacts
Contact: Ang Chee Wan, BDS +65 9843 9578 angcheewan@yahoo.com.sg
Contact: Lim Thiam Chye, FRCS +65 6772 4226 surlimtc@nus.edu.sg

Locations
Singapore
National University Hospital Recruiting
Singapore, Singapore
Contact: Ang Chee Wan, BDS    +65 9843 9578    angcheewan@yahoo.com.sg   
Contact: Lim Thiam Chye, FRCS    +65 772 4226    surlimtc@nus.edu.sg   
Principal Investigator: Ang Chee Wan, BDS         
Sub-Investigator: Lim Thiam Chye, FRCS         
Principal Investigator: Lim Lum Peng, MSc         
Sponsors and Collaborators
National University Hospital, Singapore
Investigators
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
  More Information

No publications provided

Responsible Party: Ang Chee Wan, BDS
ClinicalTrials.gov Identifier: NCT00466414     History of Changes
Other Study ID Numbers: R-222-000-024-112
Study First Received: April 25, 2007
Last Updated: May 14, 2008
Health Authority: Singapore: Domain Specific Review Boards

ClinicalTrials.gov processed this record on November 23, 2014