Alveolar Ridge Preservation With Polycaprolactone Scaffold for Implant Site Development

March 26, 2020 updated by: National University Hospital, Singapore

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.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Singapore, Singapore
        • National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To test the effectiveness of the PCL scaffold in maintaining the physical dimensions of the alveolar ridge after extraction.

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ang Chee Wan, BDS, National University of Singapore
  • Principal Investigator: Lim Thiam Chye, FRCS, National University Hospital, Singapore
  • Principal Investigator: Lim Lum Peng, MSc, National University of Singapore
  • Principal Investigator: Chung Kong Mun, MS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 12, 2007

Primary Completion (Actual)

June 30, 2010

Study Completion (Actual)

June 30, 2010

Study Registration Dates

First Submitted

April 25, 2007

First Submitted That Met QC Criteria

April 25, 2007

First Posted (Estimate)

April 27, 2007

Study Record Updates

Last Update Posted (Actual)

March 30, 2020

Last Update Submitted That Met QC Criteria

March 26, 2020

Last Verified

May 1, 2008

More Information

Terms related to this study

Other Study ID Numbers

  • R-222-000-024-112

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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