Bone LossNCT01878084
Bioactive Glass (Sol-gel) for Alveolar Bone Regeneration After Surgical Extraction
A study testing bioactive glass (sol-gel) and empty extraction socket in people with Bone Loss and Vertical Alveolar Bone Loss, run by Alexandria University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 9 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Loss, Vertical Alveolar Bone Loss, Horizontal Alveolar Bone Loss
- What is being tested?
- bioactive glass (sol-gel) and empty extraction socket
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2013to Jan 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Tissue Engineering Laboratories, Faculty of Dentistry, Alexandria University
Alexandria
About this study
Official title: 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.
Read the 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.
- Being tested
- bioactive glass (sol-gel), empty extraction socket
- Keywords
- Tissue regeneration, sol gel bioglass, alveolar ridge preservation, children, Egyptian, class II orthodontic cases
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bioactive glass (sol-gel)Other
Also called Tailored Amorphous Multiscale Porous (TAMP) scaffold
Extraction sockets will be augmented using bioactive glass (sol-gel)
empty extraction socketOther
Extraction socket will be left empty
| Study group | Role | What they receive |
|---|---|---|
| all study participants | Other | 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) Receives: Other: bioactive glass (sol-gel); Other: empty extraction socket |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: assessed at baseline, 1,2,4,8,12,24 weeks post-extraction, baseline,4 and 12 weeks reported.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2016
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bone LossStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Collaborators
- Lehigh University
- Responsible party
- Principal investigator, Prof. Mona K. Marei, Alexandria University
- Investigators
- Mona Marei, prof, Principal investigator, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01878084
- Sponsor's protocol ID
- BIOGLASS-STDF#116
- Status last verified
- Feb 2020
- First submitted
- 10 Jun 2013
- Last updated
- 18 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 30931746
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Trial of Alveolar Bone Engineering Using Bioactive Glass (Sol-Gel) Immediately After Premolar Extraction in Patients Requiring Orthodontic Treatment
- ClinicalTrials.gov ID
- NCT01878084
- Acronym / sponsor ID
- BIOGLASS-STDF#116
- Keywords
- Tissue regeneration, sol gel bioglass, alveolar ridge preservation, children, Egyptian, class II orthodontic cases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Collaborators
- Lehigh University
- Study start
- Oct 2013 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 14 Jun 2013 (estimated)
- Results
- Posted 18 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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)
| Arm | Type | Receives |
|---|---|---|
| all study participants | Other | Other: bioactive glass (sol-gel), Other: empty extraction socketThis 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) |
Who may qualify
- Ages
- 9 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bioactive glass (sol-gel)Also: Tailored Amorphous Multiscale Porous (TAMP) scaffoldExtraction sockets will be augmented using bioactive glass (sol-gel) | Other | all study participants |
| empty extraction socketExtraction socket will be left empty | Other | all study participants |
Primary outcome
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)
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30931746El 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mona Marei, prof principal investigator
Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bioactive glass (sol-gel) and empty extraction socket in people with Bone Loss and Vertical Alveolar Bone Loss, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01878084, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2020.