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

Primary Purpose

Alveolar Bone Loss

Status
Recruiting
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
GBR with CS@Mg
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alveolar Bone Loss

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Oral Medicine, the Second Affiliated Hospital School of Medicine of Zhejiang UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CS@Mg

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 5, 2023
Last Updated
February 15, 2023
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT05743452
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 18, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alveolar Bone Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Device: GBR with CS@Mg The patient was treated by GBR with magnesium calcium silicate scaffold for alveolar bone defect.
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CS@Mg
Arm Type
Experimental
Arm Description
The patient was treated by GBR with magnesium calcium silicate scaffold for alveolar bone defect.
Intervention Type
Device
Intervention Name(s)
GBR with CS@Mg
Intervention Description
The patient was treated by GBR with magnesium calcium silicate scaffold for alveolar bone defect.
Primary Outcome Measure Information:
Title
Horizontal bone width
Description
The width of buccal lingual alveolar ridge was measured 1 mm below the crest of alveolar ridge.
Time Frame
24 weeks after operation
Title
Evaluation of wound healing
Description
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.
Time Frame
2 weeks after operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lili Chen, Prof.
Phone
13606507966
Email
chenlili_1030@163.com
Facility Information:
Facility Name
Department of Oral Medicine, the Second Affiliated Hospital School of Medicine of Zhejiang University
City
Hangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lili Chen, Prof.
Phone
13606507966
Email
chenlili_1030@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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