Bone Loss, Horizontal Alveolar Bone Loss, Vertical Alveolar Bone Loss
Conditions
Keywords
Tissue regeneration, sol gel bioglass, alveolar ridge preservation, children, Egyptian, class II orthodontic cases
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.
Interventions
OTHERbioactive glass (sol-gel)
Extraction sockets will be augmented using bioactive glass (sol-gel)
OTHERempty extraction socket
Extraction socket will be left empty
Sponsors
Lehigh University
Alexandria University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention 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)
Eligibility
Sex/Gender
ALL
Age
9 Years to 16 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Alveolar Crestal Bone Height | 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 | 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. |
Countries
Egypt
Participant flow
Recruitment details
participants were recruited from the outpatient clinic of the orthodontic department at the Faculty of Dentistry of Alexandria University From October 2013 to October 2014
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants Bone regeneration utilizing tissue engineering principles and approach via using porous bioactive glass prepared by sol gel technique to properly fill the empty socket after tooth extraction. The target is to preserve the buccal and lingual alveolar plates of the socket regarding width and height, to avoid bone resorption and to stimulate bone regeneration. This novel technique will be evaluated via histological (biopsy), radiographic, and bone density measurements in addition to clinical assessment.
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) | 7 |
| Total | 7 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 2 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Continuous | 12 years STANDARD_DEVIATION 1.38 |
| Race/Ethnicity, Customized Egyptians | 7 participants |
| Region of Enrollment Egypt | 7 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
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.
Time frame: assessed at baseline, 1,2,4,8,12,24 weeks post-extraction, baseline,4 and 12 weeks reported.
Population: previously described
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Study Participants | Bone Mineral Density | baseline control apical bone density value | 75.17 percentage of BMD | Standard Deviation 13.12 |
| All Study Participants | Bone Mineral Density | baseline control coronal bone density value | 38.30 percentage of BMD | Standard Deviation 14.94 |
| All Study Participants | Bone Mineral Density | baseline test coronal bone density value | 42.28 percentage of BMD | Standard Deviation 19.5 |
| All Study Participants | Bone Mineral Density | baseline control middle bone density value | 63.32 percentage of BMD | Standard Deviation 16.2 |
| All Study Participants | Bone Mineral Density | baseline test middle bone density value | 55.92 percentage of BMD | Standard Deviation 17.24 |
| All Study Participants | Bone Mineral Density | baseline test apical bone density value | 75.61 percentage of BMD | Standard Deviation 16.72 |
| All Study Participants | Bone Mineral Density | 4 weeks control coronal bone density value | 39.54 percentage of BMD | Standard Deviation 17.14 |
| All Study Participants | Bone Mineral Density | 4 weeks test coronal bone density value | 40.03 percentage of BMD | Standard Deviation 14.83 |
| All Study Participants | Bone Mineral Density | 4 weeks control middle bone density value | 67.29 percentage of BMD | Standard Deviation 18.28 |
| All Study Participants | Bone Mineral Density | 4 weeks test middle bone density value | 68.95 percentage of BMD | Standard Deviation 16.94 |
| All Study Participants | Bone Mineral Density | 4 weeks control apical bone density value | 76.47 percentage of BMD | Standard Deviation 14.42 |
| All Study Participants | Bone Mineral Density | 4 weeks test apical bone density value | 83.98 percentage of BMD | Standard Deviation 13.3 |
| All Study Participants | Bone Mineral Density | 12 weeks control coronal bone density value | 47.71 percentage of BMD | Standard Deviation 14.85 |
| All Study Participants | Bone Mineral Density | 12 weeks test coronal bone density value | 49.44 percentage of BMD | Standard Deviation 13.92 |
| All Study Participants | Bone Mineral Density | 12 weeks control middle bone density value | 66.59 percentage of BMD | Standard Deviation 15.76 |
| All Study Participants | Bone Mineral Density | 12 weeks test middle bone density value | 67.14 percentage of BMD | Standard Deviation 11.05 |
| All Study Participants | Bone Mineral Density | 12 weeks control apical bone density value | 74.10 percentage of BMD | Standard Deviation 12.08 |
| All Study Participants | Bone Mineral Density | 12 weeks test apical bone density value | 76.15 percentage of BMD | Standard Deviation 13.41 |
Primary
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)
Time frame: assessed at baseline, 1,2,4,8,12,24 weeks post-extraction, baseline,4 and 12 weeks reported.
Population: previously described
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Study Participants | Change in Alveolar Crestal Bone Height | baseline control mesial alveolar bone height value | 0.32 mm | Standard Deviation 0.76 |
| All Study Participants | Change in Alveolar Crestal Bone Height | baseline test mesial alveolar bone height value | 0.84 mm | Standard Deviation 1.57 |
| All Study Participants | Change in Alveolar Crestal Bone Height | baseline control distal alveolar bone height value | 1.59 mm | Standard Deviation 1.03 |
| All Study Participants | Change in Alveolar Crestal Bone Height | baseline test distal alveolar bone height value | 0.96 mm | Standard Deviation 1.57 |
| All Study Participants | Change in Alveolar Crestal Bone Height | 4 weeks control mesial alveolar bone height value | -0.11 mm | Standard Deviation 0.95 |
| All Study Participants | Change in Alveolar Crestal Bone Height | 4 weeks test mesial alveolar bone height value | -0.36 mm | Standard Deviation 1.4 |
| All Study Participants | Change in Alveolar Crestal Bone Height | 4 weeks control distal alveolar bone height value | 1 mm | Standard Deviation 1.28 |
| All Study Participants | Change in Alveolar Crestal Bone Height | 4 weeks test distal alveolar bone height value | 0.03 mm | Standard Deviation 1.76 |
| All Study Participants | Change in Alveolar Crestal Bone Height | 12 weeks control mesial alveolar bone height value | -0.13 mm | Standard Deviation 0.25 |
| All Study Participants | Change in Alveolar Crestal Bone Height | 12 weeks test mesial alveolar bone height value | 0.08 mm | Standard Deviation 1.09 |
| All Study Participants | Change in Alveolar Crestal Bone Height | 12 weeks control distal alveolar bone height value | 0.33 mm | Standard Deviation 0.8 |
| All Study Participants | Change in Alveolar Crestal Bone Height | 12 weeks test distal alveolar bone height value | 0.47 mm | Standard Deviation 0.98 |