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

NCT05743452 | Unknown Early Phase 1

• 1 other identifier: 2022-0535
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Alveolar Bone Loss

Outcome Measures

Primary Outcomes (2)

• Horizontal bone width

  The width of buccal lingual alveolar ridge was measured 1 mm below the crest of alveolar ridge.

  24 weeks after operation

• Evaluation of wound healing

  The wound healing evaluation scale was modified according to the indicators described by Lobene et al (1986) and will be used to evaluate the wound healing after surgery. The gingival tissue in the material implantation area was evaluated.

  2 weeks after operation

Study Arms (1)

CS@Mg

EXPERIMENTAL

The patient was treated by GBR with magnesium calcium silicate scaffold for alveolar bone defect.

Device: GBR with CS@Mg

Interventions

GBR with CS@Mg DEVICE

The patient was treated by GBR with magnesium calcium silicate scaffold for alveolar bone defect.

CS@Mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Department of Oral Medicine, the Second Affiliated Hospital School of Medicine of Zhejiang University

Hangzhou, China

RECRUITING

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Lili Chen, Prof.

CONTACT

13606507966; chenlili_1030@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Device: GBR with CS@Mg The patient was treated by GBR with magnesium calcium silicate scaffold for alveolar bone defect.

Study Record Dates

• First Submitted: February 5, 2023
• First Posted: February 24, 2023
• Study Start: August 18, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: February 24, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)