N/A
N=9
Bioactive Glass (Sol-gel) for Alveolar Bone Regeneration After Surgical Extraction
Bone Loss · Vertical Alveolar Bone Loss · Horizontal Alveolar Bone Loss
Bottom Line
View on ClinicalTrials.gov: NCT01878084 ↗Enrolled (actual)
9
Serious AEs
—
Results posted
Feb 2020
Primary outcome: Primary: Change in Alveolar Crestal Bone Height — 0.32; 0.84; 1.59; 0.96 mm
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- bioactive glass (sol-gel) (Other); empty extraction socket (Other)
- Age
- Pediatric · 9+ yrs
- Sex
- All
- Sponsor
- Alexandria University
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Alveolar Crestal Bone Height |
0.32; 0.84; 1.59; 0.96; -0.11; -0.36 | — |
| PRIMARY Bone Mineral Density |
38.30; 42.28; 63.32; 55.92; 75.17; 75.61 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01878084). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.