Dental ImplantationRAINCT06449391
The Application of Root Analogy Implant in Immediate Implantation
A study testing RAI in people with Dental Implantation and Dental Implants, run by The Dental Hospital of Zhejiang University School of Medicine at 1 site in China.
Trial summary
The current clinical implant techniques used include immediate implantation, early implantation, and delayed implantation. With the acceleration of the current pace of life, immediate implantation is increasingly favored by patients due to its advantages such as fewer surgeries, shorter waiting times, and less impact… Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implantation, Dental Implants, Osseointegration
- What is being tested?
- RAI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2024to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age:20-60 years old, gender unlimited
- Good oral hygiene
- No systemic diseases
- There are irreparable residual roots, no obvious apical periodontitis, no looseness greater than degree II, and the tooth position includes four quadrant anterior teeth and premolars
- Root length greater than 10 mm, and no significant bone resorption at the alveolar crest
- There is no significant displacement of adjacent teeth and no significant elongation of opposing teeth
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- The bone density of the target implant area is Class II and Class III
- The lateral bone wall of the lips (cheeks), palate (tongue) is intact and larger than 1mm
- The subjects are able to understand the purpose of the experiment, willing to -cooperate with surgical treatment and follow-up, voluntarily participate in the experiment, and sign an informed consent form.
Who cannot join
- Patients with moderate to severe periodontitis
- Missing proximal and distal adjacent teeth in the target residual root
- Residual roots with root adhesion
- The target implant area has a bone density of Class I or IV
- Acute infectious disease or metabolic bone disease activity period
- Patients with diabetes history and poor blood glucose control (fasting blood glucose ≥ 8.8 mmol/L L)
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- Patients with liver and kidney dysfunction (AST, ALT ≥ 1.5 times ULNULN, creatinine ≥ 1.5 times ULNULN)
- Individuals with a history of osteoporosis
- Individuals with a history of malignant tumors or other serious illnesses who are not suitable for surgery
- Individuals with mental disorders and lack of autonomous behavior ability Pregnant women, lactating or menstruating women, and women with pregnancy plans within six months
- Various possible causes of imaging artifacts in the surgical area
- Receiving medication that may affect bone metabolism (such as bisphosphonates) within the past 3 months
- The researchers estimate poor compliance or other factors that are not suitable for conducting this experiment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Affiliated Stomatology Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310006
Xiaowen Yu, Doctor, +8615068107876, yuxiaowen@zju.edu.cn
About this study
Official title: A Clinical Exploratory Study of Root Analogy Implant
The current clinical implant techniques used include immediate implantation, early implantation, and delayed implantation. With the acceleration of the current pace of life, immediate implantation is increasingly favored by patients due to its advantages such as fewer surgeries, shorter waiting times, and less impact on aesthetics. The research group has shown that the mismatch between traditional implants and extraction sockets in immediate implantation surgery has caused some complications. Therefore, it is believed that 3D printed personalized root shaped implants with certain roughness are more suitable for use in immediate implantation surgery.
Read the detailed description
The current clinical implant techniques used include immediate implantation, early implantation, and delayed implantation. With the acceleration of the current pace of life, immediate implantation is increasingly favored by patients due to its advantages such as fewer surgeries, shorter waiting times, and less impact on aesthetics. The research group has shown that the mismatch between traditional implants and extraction sockets in immediate implantation surgery has caused some complications. Therefore, it is believed that 3D printed personalized root shaped implants with certain roughness are more suitable for use in immediate implantation surgery. A 3D printed personalized root implant system jointly developed by Zhejiang University School of Medicine Affiliated Stomatology Hospital, Zhejiang University School of Mechanical Engineering, and Hangzhou Ya Natural Technology Co., Ltd. The implant part of this implant system is implanted into the bone using laser melting printing technology in additive manufacturing methods. The raw material is pure titanium powder, and research results in New Zealand white rabbits and beagles have confirmed that the implant has good bone bonding ability, which can shorten surgical time, reduce surgical frequency, compress implant cycle, restore chewing function, and other advantages. The relevant research results have been published in the top oral journal Journal of Dental Research, and the chemical composition and biological safety of the material have been tested by the Zhejiang Medical Device Inspection and Research Institute (test report number: Z20221903), Z20222527，G20233158）。 The base and other accessories are cut from titanium rods using conventional reduction manufacturing techniques.
- Conditions
- Dental Implantation, Dental Implants, Osseointegration
- Being tested
- RAI
- Keywords
- root analogy implant, Immediate implantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RAIDevice
Immediate implantation
| Study group | Role | What they receive |
|---|---|---|
| implanted group | Experimental | This study is a single arm study, with only immediate implantation of root analogy implants Receives: Device: RAI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alveolar ridge height
The distance from the top of the alveolar ridge to the tip of the implant
Measured: day 0,12 weeks,24weeks,48weeks
Secondary outcomes (7)
Width of alveolar ridge, buccal and lingual directions
The width of the implant platform from the buccal and lingual to the alveolar bone
Measured: day 0，12 weeks, 24 weeks, 48 weeks
Implant mobility
Measure the movement of the implant using an implant mobility meter and record the ISQ value
Measured: day 0，12 weeks
Gingival condition
Two independent clinical doctors conducted gingival examination in the oral implant area of the patient, and gave a comprehensive score for gingival condition based on changes in gingival color, shape, and texture. A 3-point scoring method was used, with good, average, and poor results.
Measured: day 0, 12 weeks, 24 weeks, 48weeks
Exploration depth and Exploring bleeding
Same periodontal probing. Use blunt head periodontal probing to measure the depth of probing at six points around the implant, including the buccal mesial, buccal central, buccal distal, lingual palatal mesial, lingual palatal central, and lingual palatal distal. Record the depth of probing and calculate the average value, 2-4mm if normal, if depth >5mm, consider the occurrence of periimplantitis. The improved gingival sulcus bleeding index (mSBI) can be used to detect bleeding: 0=Along the periphery of the implant, no bleeding after soft tissue edge exploration; 1=scattered points after exploration, hemorrhage in shape; 2=After diagnosis, the bleeding appears linear in the groove; 3=severe or Spontaneous bleeding.
Measured: 12 weeks, 24 weeks, 48 weeks
Clinical looseness of implants
Evaluation of tooth looseness. Use tweezers to clamp and shake the cutting edge during the examination of anterior dental implants; When checking the posterior dental implant, fold the forceps together and place them in the center of the occlusal fissure, shaking them towards the buccal, lingual (palatal), and mesial and distal directions (clamping the anterior tooth ridge, and pressing the posterior tooth forceps against the posterior occlusal fissure). The commonly used method for recording tooth looseness in clinical practice is to calculate the degree of looseness in millimeters: degree I looseness: the looseness amplitude is within 1mm; Second degree loosening: the loosening amplitude is within 1-2mm; Third degree loosening: the loosening amplitude is above 2mm.
Measured: 12 weeks, 24 weeks, 48 weeks
Recovery of chewing function
The basic method is to use a vernier ruler about 10 cm long, where "0" represents complete dissatisfaction and "10" represents complete satisfaction. The patient marks the line segment based on their own satisfaction, and the physician scores them based on the position marked by the patient.
Measured: 24 weeks, 48 weeks
Aesthetic satisfaction
Use a survey questionnaire to evaluate patient satisfaction, including aesthetics and other suggestions and opinions on treatment. The evaluation adopts a 3-point scoring method, which is satisfied, average, and dissatisfied.
Measured: 24 weeks，48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start1 Apr 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantationStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Dental Hospital of Zhejiang University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06449391
- Sponsor's protocol ID
- 2024035
- Acronym
- RAI
- Status last verified
- Jun 2024
- First submitted
- 27 May 2024
- Last updated
- 10 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Exploratory Study of Root Analogy Implant
- ClinicalTrials.gov ID
- NCT06449391
- Acronym / sponsor ID
- RAI / 2024035
- Conditions
- Dental Implantation, Dental Implants, Osseointegration
- Keywords
- root analogy implant, Immediate implantation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- The Dental Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 10 Jun 2024 (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.
The current clinical implant techniques used include immediate implantation, early implantation, and delayed implantation. With the acceleration of the current pace of life, immediate implantation is increasingly favored by patients due to its advantages such as fewer surgeries, shorter waiting times, and less impact on aesthetics. The research group has shown that the mismatch between traditional implants and extraction sockets in immediate implantation surgery has caused some complications. Therefore, it is believed that 3D printed personalized root shaped implants with certain roughness are more suitable for use in immediate implantation surgery.
Detailed description
The current clinical implant techniques used include immediate implantation, early implantation, and delayed implantation. With the acceleration of the current pace of life, immediate implantation is increasingly favored by patients due to its advantages such as fewer surgeries, shorter waiting times, and less impact on aesthetics. The research group has shown that the mismatch between traditional implants and extraction sockets in immediate implantation surgery has caused some complications. Therefore, it is believed that 3D printed personalized root shaped implants with certain roughness are more suitable for use in immediate implantation surgery. A 3D printed personalized root implant system jointly developed by Zhejiang University School of Medicine Affiliated Stomatology Hospital, Zhejiang University School of Mechanical Engineering, and Hangzhou Ya Natural Technology Co., Ltd. The implant part of this implant system is implanted into the bone using laser melting printing technology in additive manufacturing methods. The raw material is pure titanium powder, and research results in New Zealand white rabbits and beagles have confirmed that the implant has good bone bonding ability, which can shorten surgical time, reduce surgical frequency, compress implant cycle, restore chewing function, and other advantages. The relevant research results have been published in the top oral journal Journal of Dental Research, and the chemical composition and biological safety of the material have been tested by the Zhejiang Medical Device Inspection and Research Institute (test report number: Z20221903), Z20222527，G20233158）。 The base and other accessories are cut from titanium rods using conventional reduction manufacturing techniques.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| implanted group | Experimental | Device: RAIThis study is a single arm study, with only immediate implantation of root analogy implants |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Age:20-60 years old, gender unlimited
- Good oral hygiene
- No systemic diseases
- There are irreparable residual roots, no obvious apical periodontitis, no looseness greater than degree II, and the tooth position includes four quadrant anterior teeth and premolars
- Root length greater than 10 mm, and no significant bone resorption at the alveolar crest
Key exclusion criteria (13 listed)
- Patients with moderate to severe periodontitis
- Missing proximal and distal adjacent teeth in the target residual root
- Residual roots with root adhesion
- The target implant area has a bone density of Class I or IV
- Acute infectious disease or metabolic bone disease activity period
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 |
|---|---|---|
| RAIImmediate implantation | Device | implanted group |
Primary outcome
Alveolar ridge height
Time frame: day 0,12 weeks,24weeks,48weeks
The distance from the top of the alveolar ridge to the tip of the implant
7 secondary outcomes
Width of alveolar ridge, buccal and lingual directions
Time frame: day 0，12 weeks, 24 weeks, 48 weeks
Implant mobility
Time frame: day 0，12 weeks
Gingival condition
Time frame: day 0, 12 weeks, 24 weeks, 48weeks
Exploration depth and Exploring bleeding
Time frame: 12 weeks, 24 weeks, 48 weeks
Clinical looseness of implants
Time frame: 12 weeks, 24 weeks, 48 weeks
Recovery of chewing function
Time frame: 24 weeks, 48 weeks
Aesthetic satisfaction
Time frame: 24 weeks，48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2024.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RAI in people with Dental Implantation and Dental Implants, run by The Dental Hospital of Zhejiang University School of Medicine at 1 site in China.
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 9 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 10 Jun 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yixu Chen (+86 571 8721 9287, 11818293@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alveolar ridge height (time frame: day 0,12 weeks,24weeks,48weeks). 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 10 Jun 2024.