Radiographic Assessment of Bone Regeneration in Alveolar Sockets With PLGA Scaffold
Preservation of Alveolar Bone Height With PLGA Bioscaffold
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Phase I Radiographic Assessment of Bone Regeneration in Alveolar Sockets With PLGA Bioscaffold After Teeth Extraction|
- Preservation of Alveolar height [ Time Frame: 3 months ] [ Designated as safety issue: No ]
|Study Start Date:||May 2007|
|Study Completion Date:||July 2008|
|Primary Completion Date:||September 2007 (Final data collection date for primary outcome measure)|
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
A case controlled study design is adopted. Patients who will be having extraction of any tooth including surgical extraction but not due to any periodontal reasons are selected. Consent of the patient will be taken for the procedure and all the effects and possibilities will be explained to the patients. Extraction will be done and scaffold material will be placed inside the socket. Sockets with the scaffold will be the variable studied and the sockets without scaffold placed inside the sockets will be the control group. An OPG x ray will be taken with the head position standardized by a positioning device. A second x-ray will be taken following the same technique after two months (for assessment of bone healing as is practiced normally) and a final x-ray will be taken after 3 months of the first x-ray (normally done in clinics for assessment of socket prior to implantation.
The OPG x ray is taken with the patient biting on a bite plate device fabricated with an embedded wire inside which is radiopague. If the distance from the wire line (the occlusal plane) to the alveolar bony height is 'a' and if the actual diameter of the metallic ball is 'b' and radiographic ball diameter is 'c' then the equation ( a×b)/c will give us the distance of the alveolar bony crest from the wire line. The measurements taken will determine if the distance of the alveolar crest from the wire line remained the same or has increased. If it remains the same, it will suggest that the scaffold material had maintained the socket and prevented alveolar bone resorption, but if the distance increases that will indicate vertical loss of alveolar bone and the extent measured can be compared with sockets without the support of an immediate post-extraction scaffold. This study will determine firstly whether the scaffold allows for bone regeneration in human alveolar sockets in the normal time and secondly whether it would help to preserve alveolar bone height as compared to cases without scaffold.
Consent of the selected patient will be taken for the procedure. Extraction will be done and scaffold material will be placed inside the socket. Socket with the scaffold will be our cases and the socket without scaffold will be the control group in multiple extraction cases. Radiographic assessment will be done to assess bone regeneration at the prescribed pre-extraction stage, at the 2 months bone healing stage and at the 3 months (from initial extraction) implant planning stage as in usual clinical practice . Assessment of the bony height is made with the prescribed formula from the radiographs taken and comparison will be made with the control cases. The following are the criteria for selecting the patients.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00836797
|Saveetha Dental College, Saveetha University|
|Chennai, Tamil Nadu, India, 600077|
|Dental Centre, National University Hospital,|
|Singapore, Singapore, 119074|
|Principal Investigator:||Tai Weng Fan Victor, BDS FDSRCS||National University of Singapore, Faculty of Dentistry|