2D/3D Imaging to Analyze the Regeneration Rate of Autologous Bone

NCT06141239 | Recruiting

• 1 other identifier: 202102214A0
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Place a collagen plug (collagen plug) in the lower 2/3 to 1/2 of your tooth extraction site while giving you Vit. The extracted teeth are made into autogenous tooth root thin slices and covered in your tooth extraction cavity, and the skin flap raised by your flap surgery is used to cover the autologous tooth root cover to help the autologous tooth roots stabilize and heal the wound, which is different from traditional surgery. The difference in treatment lies in the local use of autogenous tooth root thin slices and Vit.D3. Collagen plug and Vit.D3 are already qualified medical materials and drugs on the market. However, there is no precedent for making thin autologous tooth root slices. will be a trial of a new medical technology that has not yet been used

Conditions

Alveolar Ridge Preservation

Outcome Measures

Primary Outcomes (4)

• 3D computed tomography data

  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 \- Page 3 of 5 - 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 0th week and 12th~16th week of the experiment

• periapical X-ray

  Take X-rays 16 weeks after tooth extraction (before dental implants or other treatments), record the width and height of the alveolar bone, and compare whether there is any difference in pixel values between the extraction socket and the adjacent non-extraction area, by calculating the number of pixels The difference in gray scale depth (i.e. density) of the image is determined by size to infer the formation of autogenous bone.

  16 weeks after tooth extraction (before dental implants or other treatments)

• Intraoral scanner measurement data

  Follow-up observation and measurement: Intraoral photography scans were performed 0 weeks after tooth extraction/alveolar ridge preservation to record the appearance of soft tissues, including soft tissue thickness, buccal keratinized gingival width and thickness, and 16 weeks after surgery before dental implant surgery or other treatments. A second intraoral photography scan was performed to record the soft tissue condition again and compare the soft tissue wound healing evolution of the two tooth extraction cavities.

  At the 0th week and 12th~16th week of the experiment

• RFA measures implant stability (ISQ)

  The implant stability was measured twice during the dental implant surgery at 16 to 24 weeks. The ISQ value of the 3.3mm diameter implant measured by Osstell Mentor was used as the standard ISQ value for correction. After the 3.3mm implant was removed, the matching funds would not be Then use a 3.3mm implant, and then measure the ISQ value of the implant (diameter 4.1 or 4.8mm) as the actual ISQ value of the initial stability of the implant. The implant repair will be made 3-4 months after the operation. Before implantation), measure the ISQ value of the second-stage stability of the implant to compare and analyze the changes in ISQ value of different implant groups and/or time points. Each subject followed this procedure.

  At the 16th~24th week of the experiment

Study Arms (4)

primary closure +Collagen plug +Bone graft

NO INTERVENTION

Placement of bone graft and collagen plug

primary closure + Collagen plug +Bone graft +Vit.D3

EXPERIMENTAL

Placement of bone graft, collagen plug and local administration of Vit.D3

Drug: Vit.D3; Other: bone graft

primary closure +Collagen plug+Bone graft+Autologous Tooth Root

EXPERIMENTAL

Placement of bone graft, collagen plug and placement of autologous root slices

Procedure: Autologous Tooth Root; Other: bone graft

primary closure +Collagen plug+Bone graft+Autologous Tooth Root+Vit.D3

EXPERIMENTAL

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

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

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.

primary closure +Collagen plug+Bone graft+Autologous Tooth Root; primary closure +Collagen plug+Bone graft+Autologous Tooth Root+Vit.D3

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

primary closure + Collagen plug +Bone graft +Vit.D3; primary closure +Collagen plug+Bone graft+Autologous Tooth Root+Vit.D3

bone graft OTHER

Selecting bone materials for alveolar ridge preservation according to treatment needs

Also known as: BG

primary closure + Collagen plug +Bone graft +Vit.D3; primary closure +Collagen plug+Bone graft+Autologous Tooth Root; primary closure +Collagen plug+Bone graft+Autologous Tooth Root+Vit.D3

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing to sign written subject consent
• The tooth extraction socket is located in the anterior and posterior areas of the upper and lower jaws.
• The area of the extraction socket (bone defect) in the mouth will need to be treated with artificial dental implants in the future.
• The patient does not have systemic diseases (such as patients with hypertension, osteoporosis, bone-related diseases, kidney disease, thyroid and parathyroid diseases, etc.).

You may not qualify if:

• Patients with potentially weakened healing abilities such as cancer, diabetes, bone infection, tuberculosis, anemia due to heme abnormalities or congenital immune deficiency, cellulitis, acute periodontal cyst, severe cusp disease (cyst size) \>2mm2) or patients 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 in the extraction socket is severe and requires other bone regeneration surgeries (GBR), otherwise it will not be possible to have enough volume to provide artificial dental implants in the future.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, Taiwan

RECRUITING

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

Central Study Contacts

Hsiang Hsi Hong

CONTACT

+886975365989; f1214@adm.cgmh.org.tw

Wen H Chi

CONTACT

+886983999157; news760730@gmail.com

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: November 15, 2023
• First Posted: November 21, 2023
• Study Start: June 6, 2024
• Primary Completion: May 31, 2025
• Study Completion: July 31, 2025
• Last Updated: December 2, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)