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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Bone Loss, Vertical Alveolar Bone Loss, Horizontal Alveolar Bone Loss

Intervention / Treatment
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* Other: bioactive glass (sol-gel)
* Other: empty extraction socket


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: all study participants<br>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) | Other: bioactive glass (sol-gel)<br>* Extraction sockets will be augmented using bioactive glass (sol-gel)<br>* Other names: Tailored Amorphous Multiscale Porous (TAMP) scaffold;Other: empty extraction socket<br>* Extraction socket will be left empty<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Alveolar Crestal Bone Height | The primary objective of the study is to determine the effect of using bioactive glass in preservation of alveolar crestal height and width surgical sockets immediately after premolar extraction assessed at baseline, 1,2,4,8,12,24 weeks post-extraction, baseline ,4 and 12 weeks reported. This change was analyzed by subtracting the values of each interval from the baseline values.the positive values indicate that the alveolar crest is coronal to the cemento enaml junction (reference point) , while the negative values indicate that the alveolar crest in apical to the cemento enamel junction (reference point) | assessed at baseline, 1,2,4,8,12,24 weeks post-extraction, baseline,4 and 12 weeks reported. | 
| Bone Mineral Density | The primary objective of the study is to determine the effect of using bioactive glass in inducing alveolar bone regeneration safely and effectively in surgical sockets immediately after premolar extraction assessed at baseline, 1,2,4,8,12,24 weeks post-extraction, baseline,4 and 12 weeks reported. | assessed at baseline, 1,2,4,8,12,24 weeks post-extraction, baseline,4 and 12 weeks reported. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tissue regeneration, sol gel bioglass, alveolar ridge preservation, children, Egyptian, class II orthodontic cases