NCT01878084

Bioactive Glass (Sol-gel) for Alveolar Bone Regeneration After Surgical Extraction

Phase I/II Trial of Alveolar Bone Engineering Using Bioactive Glass (Sol-Gel) Immediately After Premolar Extraction in Patients Requiring Orthodontic Treatment

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Alexandria University · Academic / Other
• Sex: All
• Age: 9 Years – 16 Years
• Healthy volunteers: Accepted

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.

Conditions

• Bone Loss
• Vertical Alveolar Bone Loss
• Horizontal Alveolar Bone Loss

Interventions

Type	Name	Description
OTHER	bioactive glass (sol-gel)	Extraction sockets will be augmented using bioactive glass (sol-gel)
OTHER	empty extraction socket	Extraction socket will be left empty

Timeline

• Start date: 2013-10-01
• Primary completion: 2016-12-01
• Completion: 2018-01-01
• First posted: 2013-06-14
• Last updated: 2020-02-18
• Results posted: 2020-02-18

Locations

1 site across 1 country: Egypt