Bone Loss Clinical Trial
Official title:
Phase I/II Trial of Alveolar Bone Engineering Using Bioactive Glass (Sol-Gel) Immediately After Premolar Extraction in Patients Requiring Orthodontic Treatment
Verified date | February 2020 |
Source | Alexandria University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 9 |
Est. completion date | January 2018 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 9 Years to 16 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Egypt | Tissue Engineering Laboratories, Faculty of Dentistry, Alexandria University | Alexandria |
Lead Sponsor | Collaborator |
---|---|
Alexandria University | Lehigh University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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) | assessed at baseline, 1,2,4,8,12,24 weeks post-extraction, baseline,4 and 12 weeks reported. | |
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. | assessed at baseline, 1,2,4,8,12,24 weeks post-extraction, baseline,4 and 12 weeks reported. |
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