Overview

This trial is active, not recruiting.

Conditions bone loss, vertical alveolar bone loss, horizontal alveolar bone loss
Treatments bioactive glass (sol-gel), empty extraction socket
Phase phase 1/phase 2
Sponsor Alexandria University
Collaborator Lehigh University
Start date October 2013
End date May 2017
Trial size 30 participants
Trial identifier NCT01878084, BIOGLASS-STDF#116

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Arm
(Sham Comparator)
Extraction sockets will be left empty
empty extraction socket
Extraction socket will be left empty
(Experimental)
Bone regeneration utilizing tissue engineering principles and approach via using porous bioactive glass prepared by sol gel technique to properly fill the empty socket after tooth extraction. The target is to preserve the buccal and lingual alveolar plates of the socket regarding width and height, to avoid bone resorption and to stimulate bone regeneration. This novel technique will be evaluated via histological (biopsy), radiographic, and bone density measurements in addition to clinical assessment.
bioactive glass (sol-gel) Tailored Amorphous Multiscale Porous (TAMP) scaffold
Extraction sockets will be augmented using bioactive glass (sol-gel)

Primary Outcomes

Measure
change in alveolar crestal bone height/width
time frame: change from baseline at 1,2,4,12,24 weeks
change in bone mineral density
time frame: change from baseline at 1,2,4,12,24 weeks

Secondary Outcomes

Measure
Rate of tooth movement
time frame: 12 months

Eligibility Criteria

Male or female participants from 9 years up to 16 years old.

Inclusion Criteria: - Patients must have good oral hygiene (confirmed by OHI-S) - Patients who had voluntarily agreed on signing an informed consent including the duration and all the steps of the trial - Patients who are indicated for the administration of the type of local anesthesia used in the trial - Patients who need myofunctional therapy including premolar extraction as part of two stage treatment (class II division I) - Patients indicated for premolar extraction as a normal step in the treatment plan not intentionally for the experiment. - Patients who had undergone x- rays on the premolar teeth showing root form and the shape of the socket prior to extraction Exclusion Criteria: - Patients with history of bleeding disorders which will hinder the normal healing process of the needed sockets for the trial - Patients with history of allergy to foreign bodies , i.e. susceptible to reactions from Bioglass - Patients with history of hypertension and diabetes , rendering them not indicated for administration of the recommended type of local anesthesia nor even for extraction - Patients having HCV , HBV , HIV or other infectious diseases to make sure of the safety of the research team and the participants from probable infection . - Mentally retarded patients who are not able to understand the steps of the trial Patients with systemic diseases or febrile illness making them unable to follow the appointments arranged - Patients who simultaneously participate in other research studies - Patients with traumatic surgical extraction

Additional Information

Official title Phase I/II Trial of Alveolar Bone Engineering Using Bioactive Glass (Sol-Gel) Immediately After Premolar Extraction in Patients Requiring Orthodontic Treatment
Principal investigator Mona Marei, prof
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Alexandria University.