Clinical trial NCT05601531: Autologous Tooth Root in Ridge Preservation
Official title: Extraction Socket Sealed with Autologous Tooth Root in Ridge Preservation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alveolar Ridge Preservation
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2022-11-01
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: The anatomy of the alveolar bone around the teeth can be altered by tooth extraction. Bone ridge preservation can preserve/improve the quality and quantity of alveolar bone for future implants or dentures to promote predictable function and esthetics; in addition, extraction cavity closure can be used as an aid, in vertical or alveolar ridges. Horizontal preservation had significantly better clinical outcomes. According to the treatment needs, appropriate bone materials were selected for bone ridge preservation and local administration of Vit.D3, and the extraction cavity closure was performed with autologous root slices to observe and track the therapeutic effect. Free gingival grafts or pedicle soft tissue grafts can help bone and spine preservation with good clinical outcomes, but autologous soft tissue grafts can increase wounds at the donor site and increase the patient's postoperative discomfort. Collagen sponges can help bone graft materials. Stay in the extraction cavity, promote the formation and fixation of blood clots, and prevent soft tissue from growing in, but collagen degrades rapidly, and it will decompose faster once the nearby tissue has symptoms of acute inflammation. The advantage of autologous root slices is that it is biocompatible High performance, it can effectively isolate the bone graft material from the contamination of the oral environment, and it will not absorb or be infected due to the acute inflammation of the nearby tissue. Wounds can reduce postoperative discomfort, so the use of autologous tooth root slices without the periodontal ligament exposed to the oral environment is less likely to cause infection or premature absorption, and can effectively protect the stability of blood clots in the extraction cavity. , reduce the saliva contamination of bone graft materials, and at the same time will not increase the cost of materials or the economic burden of the patient, the side with the periodontal ligament can also promote bone formation and help the retention of alveolar bone, which is both novel and good. The method of sealing the extraction socket can improve the predictability and aesthetics of the bone and spine preservation surgery, and help the patient to be replanted in an ideal position in the future. It is also hoped that the effect of Vit.D3 in promoting bone regeneration can accelerate the healing of the extraction socket.

Eligibility criteria: Inclusion Criteria:

1. Willing to sign written subject consent to surgery
2. The extraction socket is located in the anterior and posterior areas of the upper and lower jaws.
3. The intraoral extraction socket (bone defect) area will need to receive artificial dental implant treatment in the future.
4. The patient does not have systemic disease.
5. 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).

Exclusion Criteria:

1. 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.
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 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
5. 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) \[apical lesion\])

Primary outcomes:
measure: Change from baseline 3D computed tomography data at 12th~16th week
timeFrame: At the 12th~16th week of the experiment
measure: Change from baseline X-ray apical film data at 12th~16th week
timeFrame: At the 12th~16th week of the experiment
measure: Tissue Section Analysis
timeFrame: Average 12th~16th week of the experiment, the day of implant surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Hsiang H Hong
role: PRINCIPAL_INVESTIGATOR
References: