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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2018-01-31

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.

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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.

Conditions

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Bone Loss Vertical Alveolar Bone Loss Horizontal Alveolar Bone Loss

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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all study participants

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)

Group Type OTHER

bioactive glass (sol-gel)

Intervention Type OTHER

Extraction sockets will be augmented using bioactive glass (sol-gel)

empty extraction socket

Intervention Type OTHER

Extraction socket will be left empty

Interventions

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bioactive glass (sol-gel)

Extraction sockets will be augmented using bioactive glass (sol-gel)

Intervention Type OTHER

empty extraction socket

Extraction socket will be left empty

Intervention Type OTHER

Other Intervention Names

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Tailored Amorphous Multiscale Porous (TAMP) scaffold

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

Minimum Eligible Age

9 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes