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

NCT ID: NCT06141239

Last Updated: 2024-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-06

Study Completion Date

2025-07-31

Brief Summary

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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

Detailed Description

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After tooth extraction, the shape of the alveolar bone will be changed. The ridge preservation method combined with the extraction socket sealing method has a significant clinical effect in preserving the vertical and horizontal directions of the alveolar bone ridge, and improves the predictability of the position of the dental bridge. and beautiful. Since there will be different bone formation rates in different locations of the extraction cavity, the literature shows that the bone formation rate is higher in the apical position of the extraction cavity, while the bone formation rate is lower in the coronal location. Therefore, the bone formation rate is 2/3\~1/ under the extraction cavity. Insert the collagen plug at the 2 position and carry Vit.D3, and place appropriate bone material at the 1/3 position. If there is no bone material support, there will be a 50\~60% chance that the autogenous root cover will fall off, but if all bone materials are placed at Under 3D imaging technology, it is impossible to clearly distinguish whether the image is the bone material itself or the formation of autogenous bone. Collagen plug uses its biocompatibility and absorbability and other biological properties to quickly stop bleeding and stabilize the clot in the wound, and has an impact on fibroblasts. It also has a chemotactic effect, accelerating the healing of extraction sockets, and can also promote the secretion of immature osteoid from the extracellular matrix. Vit.D3 can induce the differentiation of mesenchymal cells into osteoblasts and promote bone formation. Try to use these two Can the combination of biological materials and pharmaceuticals increase the bone formation rate? In addition, a cover made of autologous tooth root slices can be used for tooth extraction cavity sealing to prevent the bone material from being disturbed and damaged by the external environment. However, the autologous tooth root cover has a chance of falling off, so The skin flap opened by flap surgery is used to cover the autogenous tooth root cap, which strengthens the fixation and helps primary wound closure, reduces saliva contamination of bone graft materials, and accelerates wound healing. At the same time, it does not increase material costs or the patient's financial burden. Observe and track the treatment effect, and explore whether the shedding rate of autogenous root caps with and without valve coverage has an impact on alveolar ridge resorption. In addition, medical imaging technology is used to replace expensive and complicated biopsies, reduce the damage caused by biopsy to the structural integrity of the extraction socket, test whether there is new bone formation in the extraction socket, and integrate computer tomography and intraoral scan files, while observing the softness of the extraction socket. Hard tissue healing status.

Conditions

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Alveolar Ridge Preservation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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primary closure +Collagen plug +Bone graft

Placement of bone graft and collagen plug

Group Type NO_INTERVENTION

No interventions assigned to this group

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

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

Group Type EXPERIMENTAL

Vit.D3

Intervention Type 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

bone graft

Intervention Type OTHER

Selecting bone materials for alveolar ridge preservation according to treatment needs

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

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

Group Type EXPERIMENTAL

Autologous Tooth Root

Intervention Type PROCEDURE

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

bone graft

Intervention Type OTHER

Selecting bone materials for alveolar ridge preservation according to treatment needs

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

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

Group Type EXPERIMENTAL

Autologous Tooth Root

Intervention Type PROCEDURE

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

Vit.D3

Intervention Type 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

bone graft

Intervention Type OTHER

Selecting bone materials for alveolar ridge preservation according to treatment needs

Interventions

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Autologous Tooth Root

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

Intervention Type PROCEDURE

Vit.D3

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

Intervention Type DRUG

bone graft

Selecting bone materials for alveolar ridge preservation according to treatment needs

Intervention Type OTHER

Other Intervention Names

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calcitriol BG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. 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.
2. Women who are pregnant or breastfeeding.
3. Exclude heavy smokers or betel nut chewers who smoke more than one pack of cigarettes per day.
4. 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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hsiang-Hsi Hong

Professor-level attending physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Chang Gung Memorial Hospital

Taoyuan District, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Hsiang Hsi Hong

Role: CONTACT

[email protected]
+886975365989

Wen H Chi

Role: CONTACT

[email protected]
+886983999157

Facility Contacts

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Hsi H Hong

Role: primary

[email protected]
0975365989

Other Identifiers

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202102214A0

Identifier Type: -

Identifier Source: org_study_id