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

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
bioactive glass (sol-gel)
empty extraction socket
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bone Loss focused on measuring Tissue regeneration, sol gel bioglass, alveolar ridge preservation, children, Egyptian, class II orthodontic cases

Eligibility Criteria

9 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Tissue Engineering Laboratories, Faculty of Dentistry, Alexandria University

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

all study participants

Arm 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)

Outcomes

Primary Outcome Measures

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)
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.

Secondary Outcome Measures

Full Information

First Posted
June 10, 2013
Last Updated
February 10, 2020
Sponsor
Alexandria University
Collaborators
Lehigh University
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1. Study Identification

Unique Protocol Identification Number
NCT01878084
Brief Title
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

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
October 2013 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria University
Collaborators
Lehigh University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
all study participants
Arm Type
Other
Arm 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)
Intervention Type
Other
Intervention Name(s)
bioactive glass (sol-gel)
Other Intervention Name(s)
Tailored Amorphous Multiscale Porous (TAMP) scaffold
Intervention Description
Extraction sockets will be augmented using bioactive glass (sol-gel)
Intervention Type
Other
Intervention Name(s)
empty extraction socket
Intervention Description
Extraction socket will be left empty
Primary Outcome Measure Information:
Title
Change in Alveolar Crestal Bone Height
Description
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)
Time Frame
assessed at baseline, 1,2,4,8,12,24 weeks post-extraction, baseline,4 and 12 weeks reported.
Title
Bone Mineral Density
Description
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.
Time Frame
assessed at baseline, 1,2,4,8,12,24 weeks post-extraction, baseline,4 and 12 weeks reported.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mona Marei, prof
Organizational Affiliation
Alexandria University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tissue Engineering Laboratories, Faculty of Dentistry, Alexandria University
City
Alexandria
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30931746
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.
Results Reference
derived

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

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