Clinical trial NCT01878084: Bioactive Glass (Sol-gel) for Alveolar Bone Regeneration After Surgical Extraction
Official title: Phase I/II Trial of Alveolar Bone Engineering Using Bioactive Glass (Sol-Gel) Immediately After Premolar Extraction in Patients Requiring Orthodontic Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bone Loss
Vertical Alveolar Bone Loss
Horizontal Alveolar Bone Loss
Keywords: Tissue regeneration
sol gel bioglass
alveolar ridge preservation
children
Egyptian
class II orthodontic cases
Lead sponsor: Alexandria University
Sponsor class: OTHER
Collaborators: name: Lehigh University
First posted: 2013-06-14
Enrollment: 9
Sex: ALL
Minimum age (years): 9
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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)
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Alveolar Crestal Bone Height
timeFrame: assessed at baseline, 1,2,4,8,12,24 weeks post-extraction, baseline,4 and 12 weeks reported.
measure: Bone Mineral Density
timeFrame: assessed at baseline, 1,2,4,8,12,24 weeks post-extraction, baseline,4 and 12 weeks reported.
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Tissue Engineering Laboratories, Faculty of Dentistry, Alexandria University
Study officials:
affiliation: Alexandria University
name: Mona Marei, prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: El Shazley N, Hamdy A, El-Eneen HA, El Backly RM, Saad MM, Essam W, Moussa H, El Tantawi M, Jain H, Marei MK. Bioglass in Alveolar Bone Regeneration in Orthodontic Patients: Randomized Controlled Clinical Trial. JDR Clin Trans Res. 2016 Oct;1(3):244-255. doi: 10.1177/2380084416660672. Epub 2016 Aug 6.