Alveolar Ridge PreservationNCT06141239
2D/3D Imaging to Analyze the Regeneration Rate of Autologous Bone
A study testing Autologous Tooth Root, Vit.D3 and bone graft in people with Alveolar Ridge Preservation, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Alveolar Ridge Preservation
- What is being tested?
- Autologous Tooth Root, Vit.D3 and bone graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTaiwan
- Study dates
- 6 Jun 2024to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital
Taoyuan
Hsi H Hong, 0975365989, f1214@adm.ocgmh.org.tw
About this study
Official title: Using 2D/3D Imaging to Analyze the Regeneration Rate of Autologous Bone During Alveolar Bone Preservation Surgery Using Periodontal Valves to Completely Cover Autologous Tooth Roots, Bone Substitutes, and Vitamin D3 Treatment
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
Read the detailed description
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
- Alveolar Ridge Preservation
- Being tested
- Autologous Tooth Root, Vit.D3, bone graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Tooth RootProcedure or surgery
An autologous Tooth Root is made from one's own tooth root and covered in an extraction socket where bone graft is placed.
Vit.D3Drug
Also called calcitriol
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 graftOther
Also called BG
Selecting bone materials for alveolar ridge preservation according to treatment needs
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Procedure: Autologous Tooth Root; Drug: Vit.D3; Other: bone graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At the 16th~24th week of the experiment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start6 Jun 2024
- Primary completion31 May 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Ridge PreservationStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hsiang-Hsi Hong, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06141239
- Sponsor's protocol ID
- 202102214A0
- Status last verified
- Nov 2024
- First submitted
- 15 Nov 2023
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using 2D/3D Imaging to Analyze the Regeneration Rate of Autologous Bone During Alveolar Bone Preservation Surgery Using Periodontal Valves to Completely Cover Autologous Tooth Roots, Bone Substitutes, and Vitamin D3 Treatment
- ClinicalTrials.gov ID
- NCT06141239
- Acronym / sponsor ID
- 202102214A0
- Conditions
- Alveolar Ridge Preservation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 6 Jun 2024 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 21 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| primary closure +Collagen plug +Bone graft | No intervention | –Placement of bone graft and collagen plug |
| primary closure + Collagen plug +Bone graft +Vit.D3 | Experimental | Drug: Vit.D3, Other: bone graftPlacement of bone graft, collagen plug and local administration of Vit.D3 |
| primary closure +Collagen plug+Bone graft+Autologous Tooth Root | Experimental | Procedure: Autologous Tooth Root, Other: bone graftPlacement of bone graft, collagen plug and placement of autologous root slices |
| primary closure +Collagen plug+Bone graft+Autologous Tooth Root+Vit.D3 | Experimental | Procedure: Autologous Tooth Root, Drug: Vit.D3, Other: bone graftPlacement of bone graft, collagen plug and local administration of Vit.D3, and placement of autologous root slices |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous Tooth RootAn autologous Tooth Root is made from one's own tooth root and covered in an extraction socket where bone graft is placed. | Procedure or surgery | primary closure +Collagen plug+Bone graft+Autologous Tooth Root, primary closure +Collagen plug+Bone graft+Autologous Tooth Root+Vit.D3 |
| Vit.D3Also: calcitriolLocal 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 | Drug | primary closure + Collagen plug +Bone graft +Vit.D3, primary closure +Collagen plug+Bone graft+Autologous Tooth Root+Vit.D3 |
| bone graftAlso: BGSelecting bone materials for alveolar ridge preservation according to treatment needs | Other | 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 |
Primary outcome
3D computed tomography data
Time frame: At the 0th week and 12th~16th week of the experiment
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
periapical X-ray
Time frame: 16 weeks after tooth extraction (before dental implants or other treatments)
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.
Intraoral scanner measurement data
Time frame: At the 0th week and 12th~16th week of the experiment
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.
RFA measures implant stability (ISQ)
Time frame: At the 16th~24th week of the experiment
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Alveolar Ridge Preservation
Not yet recruiting
Effect of Ascorbic Acid-Loaded I-PRF With Partially Demineralized Dentin Graft on Alveolar Ridge Preservation
Alveolar Ridge Preservation Post-Extraction Bone Healing Dental Implant Site Development Tooth Loss, Alveolar Bone Regeneration Following Odontectomy
Recruiting
Effect of Collagen Membrane on Ridge Preservation
Dehiscence, Tooth Extraction
Not yet recruitingPhase 1/2
Alveolar Ridge Preservation (ARP) Study Using Alloplastic Biomaterial and a Resorbable Synthetic Membrane. A Digital Workflow (CBCT/Scanner) Evaluates Hard and Soft Tissue Volumetric Changes at 4 Months, Validating Support for the Gingival Phenotype and Buccal Bone Plate.
Alveolar Ridge Augmentation, Bone Substitutes
RecruitingPhase 4
Biotivity A-C Membrane Socket Preservation Study
Alveolar Ridge Preservation
Active, not recruiting
Vallomix Socket Preservation Study
Alveolar Ridge Augmentation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous Tooth Root, Vit.D3 and bone graft in people with Alveolar Ridge Preservation, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hsiang Hsi Hong (+886975365989, f1214@adm.cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3D computed tomography data (time frame: At the 0th week and 12th~16th week of the experiment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2024.