Alveolar Ridge Preservation With Polycaprolactone Scaffold for Implant Site Development

NCT ID: NCT00466414

Last Updated: 2020-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-12
• Study Completion Date: 2010-06-30

Brief Summary

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.

Conditions

Alveolar Ridge Resorption After Extraction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Interventions

Polycaprolactone Scaffold

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National University Hospital, Singapore

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ang Chee Wan, BDS

Role: PRINCIPAL_INVESTIGATOR

National University of Singapore

Lim Thiam Chye, FRCS

Role: PRINCIPAL_INVESTIGATOR

National University Hospital, Singapore

Lim Lum Peng, MSc

Role: PRINCIPAL_INVESTIGATOR

National University of Singapore

Chung Kong Mun, MS

Role: PRINCIPAL_INVESTIGATOR

Locations

National University Hospital

Singapore, , Singapore

Countries

Singapore

Other Identifiers

R-222-000-024-112

Identifier Type: -

Identifier Source: org_study_id