Bioactive Glass (Sol-gel) for Alveolar Bone Regeneration After Surgical Extraction
Condition: Bone Loss; Vertical Alveolar Bone Loss; Horizontal Alveolar Bone Loss
MeSH terms: Alveolar Bone Loss
Study type: Interventional

Summary: 
      The purpose of the present research is to evaluate the effect of bioactive glass in bone
      regeneration immediately following extraction of mandibular and maxillary premolars.The
      hypothesis of the study assumes that this treatment would promote the healing of the
      extraction socket while preserving both the height and width of the bone. Furthermore, it
      would allow more effective tooth movement during orthodontic treatment.
    

Detailed description: 
      Bioactive glass has long been known as a bone graft substitute capable of bone augmentation.
      The current proposal introduces a newly tailored bioactive glass scaffold with multi-scale
      porosity prepared using the sol-gel technique to regenerate bone in extraction sockets with
      the aim of preserving the alveolar ridge. This novel material has the potential to enhance
      angiogenesis and osteogenesis thereby preserving the overall height and width of the alveolar
      bone by regenerating new bone that closely mimics the adjacent healthy one. Thirty patients
      requiring myofunctional therapy including premolar extraction as part of a two stage
      orthodontic treatment (class II division I) will be enrolled in this phase I/II clinical
      study. Patients will undergo extraction of their maxillary and mandibular premolar teeth.
      This will serve as a split-mouth study where on one side the extraction sockets will be left
      empty while on the other side they will receive the bioactive glass as a bone graft
      substitute. Clinical and radiographic assessment of healing will be performed at the
      following time intervals; 1,2,4,12,24 weeks. Clinical criteria will include scoring for pain,
      inflammation, and occurrence of any post-operative complications using a well-defined scoring
      system. Radiographic assessment will monitor the changes in crestal bone height and bone
      mineral density. Computed tomographic scans will also be taken preoperatively and at 6 months
      for each patient for 3D assessment of bone changes. A core biopsy will also be taken after
      informed consent at the 6 months time-point to evaluate the quality and quantity of new bone
      formed.
    

Intervention name(s): bioactive glass (sol-gel); empty extraction socket
Intervention type(s): Other; Other
Intervention description(s): Extraction sockets will be augmented using bioactive glass (sol-gel); Extraction socket will be left empty
Other intervention name(s): Tailored Amorphous Multiscale Porous (TAMP) scaffold
Intervention model: Single Group Assignment
Intervention model description: This study represents a split-mouth study where the right or left/ upper or lower premolar could be assigned to either the control group (socket left empty) or test group (socket filled with bioactive glass (sol-gel)
The extraction sockets will be allocated either to the control : Extraction socket will be left empty
or
Test: Extraction socket will be augmented using bioactive glass (sol-gel)
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tissue regeneration; sol gel bioglass; alveolar ridge preservation; children; Egyptian; class II orthodontic cases