Radiographic Assessment of Bone Regeneration in Alveolar Sockets With PLGA Scaffold

NCT00836797 | Completed

• 2 other identifiers: BSI-001-VFDSRB A/06/404
• Study Type: observational
• Target: 33
• Locations: 2 countries
• Sites: 2

Brief Summary

After extraction of a tooth, the bony socket heals naturally but due to the absent of the tooth and any presence of support in the socket, bone resorption occur both vertically and bucco lingually or bucco palataly. This bony resorption ultimately effects a lot of things like - the support for the adjacent teeth become weak, the shallow ridge makes it difficult for future prosthesis retention, and less bony support for any implant placement in the future which is the most popular and effective way of tooth replacement now a days. So now a days keeping the integrity and contour of the alveolar bony socket is very important for the patients future rehabilitation. The use of scaffold will help to maintain the integrity of the alveolar bony socket thus provides a vital support for the adjacent teeth, preserve the alveolar crest height, maintain the bony contour, helps to prevent bleeding, and most importantly it will help in bone regeneration which is the vital factor for future rehabilitation.

Conditions

Preservation of Alveolar Bone Height With PLGA Bioscaffold

Keywords

Alveolar Bone Loss; Alveolar ridge; Alveolar Process

Outcome Measures

Primary Outcomes (1)

• Preservation of Alveolar height

  3 months

Study Arms (2)

1 Case with scaffold

This group of patients will be having a placement of PLGA bioscaffold in the alveolar socket after teeth extraction

2 Control without scaffold

The Alveolar socket will be left to heal and no treatment/scaffold placement will be done

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Dental clinic patients undergoing teeth extraction

You may qualify if:

• Under going extraction of tooth including the surgical extraction.
• Healthy individual with no known medical problems.
• Not allergic to foreign body.
• Extractions which are not due to periodontal causes.

You may not qualify if:

• Bony disease.
• Bleeding disorder.
• Allergic to foreign body.
• Mentally retarded persons.
• Diabetic patient.
• Drug addict.
• Extraction due to periodontal disease.

Sponsors & Collaborators

• Bio-Scaffold International Pte Ltd: lead
• National University Hospital, Singapore: collaborator
• Saveetha University: collaborator

Study Sites (2)

Saveetha Dental College, Saveetha University

Chennai, Tamil Nadu, 600077, India

Location

Dental Centre, National University Hospital,

Singapore, 119074, Singapore

Location

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Tai Weng Fan Victor, BDS FDSRCS

  National University of Singapore, Faculty of Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 3, 2009
• First Posted: February 4, 2009
• Study Start: May 1, 2007
• Primary Completion: September 1, 2007
• Study Completion: July 1, 2008
• Last Updated: February 4, 2009

Record last verified: 2009-02

Locations

IN (1); SG (1)