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

Zhejiang University

Status and phase

Enrolling

Early Phase 1

Conditions

Alveolar Bone Loss

Treatments

Device: GBR with CS@Mg

Study type

Interventional

Funder types

Other

Identifiers

NCT05743452

2022-0535

Details and patient eligibility

About

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.

Enrollment

5 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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 trial
Be willing to cooperate with surgical treatment and follow-up, voluntarily participate in the trial
Sign 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