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Recruiting NCT05743452

Clinical Trial on the Safety and Efficacy of Magnesium Doped Calcium Silicate 3d Alveolar Bone Repair Unit for Periodontal Bone Defects

Conditions: Alveolar Bone Loss

Sex: All
Ages: 18 Years – 65 Years
Phase: EARLY_PHASE1
Enrollment: 5
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Location: China

Summary

The goal of this clinical trial is to test in height increment of alveolar bone and safety evaluation index.The main question it aims to answer are:• The safety and effectiveness of magnesium calcium silicate three-dimensional alveolar bone repair unit in the repair of periodontal bone defects Participants will be treated through Guided Bone Regeneration operation with calcium magnesium silicate three-dimensional alveolar bone repair unit.

Eligibility Criteria

Inclusion Criteria:Age 18-65 years old, healthy;Good oral hygiene, do not smoke;There is bone defect at the tooth extraction site, and it is planned to carry out implant repair after tooth extraction;There is at least one healthy adjacent tooth in the mesial and distal surface of the tooth extraction site;The residual height from the bottom of the extraction socket to the crest of the alveolar ridge is ≥ 3 mm, with at least one bone wall;Can understand the purpose of the trialBe willing to cooperate with surgical treatment and follow-up, voluntarily participate in the trialSign the informed consent form.Exclusion Criteria:The affected tooth is in the acute inflammatory stage;Those who have bad habits such as smoking and drinking;Subjects who cause artifacts in oral imaging examination, such as the extraction site and its adjacent teeth are metal Dentures, porcelain teeth;Patients are allergic to ceramic implants;Those who have participated in other clinical trials in the past 3 months;The investigator estimated that the compliance was poor, or there were other factors that were not suitable for the test;Patients with a history of diabetes or abnormal blood glucose detection (fasting blood glucose ≥ 7mmol/L);Abnormal liver and kidney function (AST, ALT, creatinine ≥ 1.5 times ULN);Patients with serious endocrine and metabolic diseases;Have a history of tertiary hypertension;Have a history of osteoporosis;Those who are not suitable for surgery due to the history of malignant tumor or other serious diseases;People with a history of autoimmune diseases;Pregnant or lactating women;Mental disorders without autonomous behavior ability;Patients who are using steroids that interfere with calcium metabolism within 3 months before the signing of informed consent

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05743452). StuddyBuddy aggregates publicly available trial information.