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

February 10, 2020 updated by: Prof. Mona K. Marei, Alexandria University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt
        • Tissue Engineering Laboratories, Faculty of Dentistry, Alexandria University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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)
Other: bioactive glass (sol-gel)
Extraction sockets will be augmented using bioactive glass (sol-gel)
Other Names:
  • Tailored Amorphous Multiscale Porous (TAMP) scaffold
Other: empty extraction socket
Extraction socket will be left empty

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Alveolar Crestal Bone Height
Time Frame: assessed at baseline, 1,2,4,8,12,24 weeks post-extraction, baseline,4 and 12 weeks reported.
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
Time Frame: assessed at baseline, 1,2,4,8,12,24 weeks post-extraction, baseline,4 and 12 weeks reported.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Collaborators

Lehigh University

Investigators

  • Principal Investigator: Mona Marei, prof, Alexandria University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2013

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

June 10, 2013

First Submitted That Met QC Criteria

June 12, 2013

First Posted (Estimate)

June 14, 2013

Study Record Updates

Last Update Posted (Actual)

February 18, 2020

Last Update Submitted That Met QC Criteria

February 10, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIOGLASS-STDF#116

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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