Clinical trial NCT05743452: Clinical Trial on the Safety and Efficacy of Magnesium Doped Calcium Silicate 3d Alveolar Bone Repair Unit for Periodontal Bone Defects
Official title: Clinical Trial on the Safety and Efficacy of Magnesium Doped Calcium Silicate 3d Alveolar Bone Repair Unit for Periodontal Bone Defects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Alveolar Bone Loss
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2023-02-24
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Device: GBR with CS@Mg The patient was treated by GBR with magnesium calcium silicate scaffold for alveolar bone defect.
Primary purpose: TREATMENT

Brief 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 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

Primary outcomes:
measure: Horizontal bone width
timeFrame: 24 weeks after operation
measure: Evaluation of wound healing
timeFrame: 2 weeks after operation
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Department of Oral Medicine, the Second Affiliated Hospital School of Medicine of Zhejiang University
Study officials:
References: