Autologous Tooth Root in Ridge Preservation

NCT05601531 | Completed

• 1 other identifier: 202002350A0
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Use your extracted teeth for routine dental care to make an autologous root slice, cover it in your extraction cavity, and give you Vit.D3 locally with the bone material you use. The difference from traditional therapy is autologous Local use of tooth root slices and Vit.D3, bone materials and Vit.D3 are already qualified drugs on the market, but there is no precedent for making slices from autologous tooth roots, which will be a new medical technology that has not been used before test.

Conditions

Alveolar Ridge Preservation

Outcome Measures

Primary Outcomes (3)

• Change from baseline 3D computed tomography data at 12th~16th week

  This experiment mainly used the relative position of the extraction socket and the adjacent tooth CEJ in CT images for height positioning and correction, and measured and compared the changes of the width and height of the bone ridge and the shape and volume during the treatment. The Hu value of the adjacent dentin of the secondary CT was used as the standard and correction to measure and compare the change of the Hu value of the extraction socket during the treatment

  At the 12th~16th week of the experiment

• Change from baseline X-ray apical film data at 12th~16th week

  Irradiate X-rays before implantation or other treatment operations, record the width and height of the alveolar bone and the relative position to the CEJ of the adjacent teeth, and compare the pixel values between the extraction socket and the adjacent non-extraction area. By calculating the number of images The difference of pixel values before and after tooth extraction healing can be inferred by judging the gray-scale depth (ie density) of the image.

  At the 12th~16th week of the experiment

• Tissue Section Analysis

  During artificial dental implant surgery, 3mm diameter x 6mm depth alveolar bone was taken out for section observation. Hematoxylin and eosin staining (H\&E) was used to observe the morphology of bone tissue. At the same time, the sections were subjected to immunohistochemical staining (IHC) to observe bone-related biomarkers, and optical microscopy was used to perform morphological analysis and to analyze the difference in the rate of new bone formation.

  Average 12th~16th week of the experiment, the day of implant surgery

Study Arms (4)

Autologous Tooth Root+Vit.D3+Bone graft

EXPERIMENTAL

Placement of bone graft and local administration of Vit.D3, and placement of autologous root slices

Procedure: Autologous Tooth Root; Drug: Vit.D3; Other: bone graft

Autologous Tooth Root+ Bone graft

EXPERIMENTAL

Placement of bone graft without local administration of Vit.D3 and placement of autogenous root slices

Procedure: Autologous Tooth Root; Other: bone graft

Bone graft

EXPERIMENTAL

Only bone graft materials were placed, no local administration of Vit.D3, and no autologous root slices were placed

Other: bone graft

Natural healing

NO INTERVENTION

After the wound healed naturally, no bone graft material was filled, and Vit.D3 was not administered locally, and autologous tooth root slices were not placed.

Interventions

Autologous Tooth Root PROCEDURE

An autologous Tooth Root is made from one's own tooth root and covered in an extraction socket where bone graft is placed.

Autologous Tooth Root+ Bone graft; Autologous Tooth Root+Vit.D3+Bone graft

Vit.D3 DRUG

Local administration of Vit.D3, through the effect of Vit.D3 to explore whether it can help to accelerate the healing of tooth extraction cavity and the clinical effectiveness of bone regeneration.

Also known as: calcitriol

Autologous Tooth Root+Vit.D3+Bone graft

bone graft OTHER

Selecting bone materials for alveolar ridge preservation according to treatment needs

Also known as: BG

Autologous Tooth Root+ Bone graft; Autologous Tooth Root+Vit.D3+Bone graft; Bone graft

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing to sign written subject consent to surgery
• The extraction socket is located in the anterior and posterior areas of the upper and lower jaws.
• The intraoral extraction socket (bone defect) area will need to receive artificial dental implant treatment in the future.
• The patient does not have systemic disease.
• Patients who do not have systemic diseases (such as hypertension, diabetes, heart disease, osteoporosis, bone-related diseases, kidney diseases, thyroid and parathyroid diseases, etc.), and those who need to take preventive antibiotics before tooth extraction/surgery (artificial valve/stent, artificial joint).

You may not qualify if:

• Patients with potentially impaired healing capacity such as cancer, diabetes, bone infection, tuberculosis, hemoglobin abnormal anemia or congenital immunodeficiency conditions, cellulitis, acute periodontal cysts, severe cusp lesions (cyst size) \>2mm2) or subjects with dental and jaw lesions.
• Women who are pregnant or breastfeeding.
• Exclude heavy smokers or betel nut chewers who smoke more than one pack of cigarettes per day.
• The bone defect of the extraction socket is severe (especially if the vertical height of the buccal bone defect \[corono-apical\] exceeds 1/2), other bone regeneration surgery (GBR) is required, otherwise it is impossible to have sufficient alveolar bone height in the future and widths to provide artificial dental implants
• The root of the tooth has been severely damaged, the root of the active periodontal ligament is lacking, and it is not suitable for autologous root sectioning, and the alveolar bone and apical defect after tooth extraction are severe (the apical lesion with a defect diameter of \>3mm in root apex X-ray examination) \[apical lesion\])

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, Taiwan

Location

MeSH Terms

Interventions

Calcitriol; Bone Transplantation

Intervention Hierarchy (Ancestors)

Dihydroxycholecalciferols; Hydroxycholecalciferols; Cholecalciferol; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Orthopedic Procedures; Surgical Procedures, Operative; Transplantation

Study Officials

• Hsiang H Hong

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor-level attending physician

Study Record Dates

• First Submitted: October 21, 2022
• First Posted: November 1, 2022
• Study Start: January 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: July 31, 2024
• Last Updated: February 13, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)