Single Missing Tooth RehabilitationNCT05526677
Effectiveness Evaluation of the Digital Workflow for Single-implant Immediate Loading
An observational study of Single Missing Tooth Rehabilitation, run by Kaohsiung Medical University Chung-Ho Memorial Hospital.
Trial summary
Immediately implantation and immediate prosthesis could preserve the alveolar contour and gingival shape. The visiting time is quiet long. Pre-made prosthesis is a way to shorten the visiting time. But the implant has to be placed precisely. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Single Missing Tooth Rehabilitation
- What is being tested?
- x-guide dynamic navigation system
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2022to 30 Jun 2025
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any patient older than 18 years old, including both sexes. Every patient has 2 missing teeth in a jaw and one on each side. All the edentulous ridges suit the immediate loading criteria
Who may be able to join
- 20 to 80 years old
- Miss two functional opposing teeth in one quadrant or the same jaw
- The situation of oral tissue satisfies the condition of implant immediate loading.
Who cannot join
- catastrophic illness,
- diabetes,
- cardiovascular diseases,
- osteoporosis,
- head and neck cancer,
- disabled
- pregnant.
Trial locations and contacts
No sites are listed yet.
About this study
Immediately implantation and immediate prosthesis could preserve the alveolar contour and gingival shape. The visiting time is quiet long. Pre-made prosthesis is a way to shorten the visiting time. But the implant has to be placed precisely. Novel digital workflow integrating dynamic navigation or static surgical guide to process one-visit single -implant immediate loading is possible. The study is to compare the x-guide dynamic navigation system or static guide system which one could assist the surgery more accuracy and place the prosthesis more smoothly.
- Conditions
- Single Missing Tooth Rehabilitation
- Being tested
- x-guide dynamic navigation system
- Keywords
- Single missing tooth, one-visit single-implant immediate loading, digital workflow, dynamic navigation, static surgical guide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
x-guide dynamic navigation systemDevice
Also called static surgical guide
One implant placement is assisted with x-guide dynamic navigation system. The other implant placement is assisted with static surgical guide
| Study group | Role | What they receive |
|---|---|---|
| dynamic navigation group or static guide group | Every patient has 2 missing in one jaw The missing tooth will be restored with one-visit single implant immediate loading.
One implant placed is assisted with dynamic navigation system, and the other one is assisted with static surgical guide. Receives: Device: x-guide dynamic navigation system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Record visiting time
Record the time (minutes) in every clinical procedure
Measured: during procedure
Implant success rate
No osteointegration of implant
Measured: Change in periapical film of the implant on post operation immediately, post operation 1 month, 3 months, 6 months, 1 year
Prosthesis success rate
Morphology of the restoration
Measured: Change in photo on post operation immediately, post operation 1 month, 3 months, 6 months, 1 year
surgical complications
pain, swelling, infection after surgery
Measured: Post operation 1 week
prosthetic success rates
final pink aesthetic score
Measured: Change in post operation immediately, post operation 1 month, 3 months, 6 months, 1 year
Implant stability quotient (ISQ)
implant stability
Measured: Change in post operation immediately, post operation 1 month, 3 months, 6 months, 1 year
Secondary outcomes (1)
Type of incision
flap or flapless
Measured: during the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start1 Sep 2022 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Single Missing Tooth RehabilitationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Health Research Institutes, Taiwan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05526677
- Sponsor's protocol ID
- KMUHIRB-F(II)-20220117
- Status last verified
- Aug 2022
- First submitted
- 4 Aug 2022
- Last updated
- 2 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pozzi A, Arcuri L, Carosi P, Nardi A, Kan J. Clinical and radiological outcomes of novel digital workflow and dynamic navigation for single-implant immediate loading in aesthetic zone: 1-year prospective case series. Clin Oral Implants Res. 2021 Dec;32(12):1397-1410. doi: 10.1111/clr.13839. Epub 2021 Sep 8.
PubMed 34467555Lopes A, de Araujo Nobre M, Santos D. The Workflow of a New Dynamic Navigation System for the Insertion of Dental Implants in the Rehabilitation of Edentulous Jaws: Report of Two Cases. J Clin Med. 2020 Feb 4;9(2):421. doi: 10.3390/jcm9020421.
PubMed 32033089Block MS, Emery RW, Lank K, Ryan J. Implant Placement Accuracy Using Dynamic Navigation. Int J Oral Maxillofac Implants. 2017 Jan/Feb;32(1):92-99. doi: 10.11607/jomi.5004. Epub 2016 Sep 19.
PubMed 27643585Emery RW, Merritt SA, Lank K, Gibbs JD. Accuracy of Dynamic Navigation for Dental Implant Placement-Model-Based Evaluation. J Oral Implantol. 2016 Oct;42(5):399-405. doi: 10.1563/aaid-joi-D-16-00025. Epub 2016 Jun 6.
PubMed 27267658Dure M, Berlinghoff F, Kollmuss M, Hickel R, Huth KC. First comparison of a new dynamic navigation system and surgical guides for implantology: an in vitro study. Int J Comput Dent. 2021 Feb 26;24(1):9-17.
PubMed 34006059Block MS, Emery RW. Static or Dynamic Navigation for Implant Placement-Choosing the Method of Guidance. J Oral Maxillofac Surg. 2016 Feb;74(2):269-77. doi: 10.1016/j.joms.2015.09.022. Epub 2015 Sep 30.
PubMed 26452429
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness Evaluation of the Digital Workflow for Single-implant Immediate Loading
- ClinicalTrials.gov ID
- NCT05526677
- Acronym / sponsor ID
- KMUHIRB-F(II)-20220117
- Conditions
- Single Missing Tooth Rehabilitation
- Keywords
- Single missing tooth, one-visit single-implant immediate loading, digital workflow, dynamic navigation, static surgical guide
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Collaborators
- National Health Research Institutes, Taiwan
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 2 Sep 2022 (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.
Immediately implantation and immediate prosthesis could preserve the alveolar contour and gingival shape. The visiting time is quiet long. Pre-made prosthesis is a way to shorten the visiting time. But the implant has to be placed precisely. Novel digital workflow integrating dynamic navigation or static surgical guide to process one-visit single -implant immediate loading is possible. The study is to compare the x-guide dynamic navigation system or static guide system which one could assist the surgery more accuracy and place the prosthesis more smoothly.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dynamic navigation group or static guide group | – | Device: x-guide dynamic navigation systemEvery patient has 2 missing in one jaw The missing tooth will be restored with one-visit single implant immediate loading. One implant placed is assisted with dynamic navigation system, and the other one is assisted with static surgical guide. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any patient older than 18 years old, including both sexes. Every patient has 2 missing teeth in a jaw and one on each side. All the edentulous ridges suit the immediate loading criteria
Key inclusion criteria (3 listed)
- 20 to 80 years old
- Miss two functional opposing teeth in one quadrant or the same jaw
- The situation of oral tissue satisfies the condition of implant immediate loading.
Key exclusion criteria (7 listed)
- catastrophic illness,
- diabetes,
- cardiovascular diseases,
- osteoporosis,
- head and neck cancer,
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 |
|---|---|---|
| x-guide dynamic navigation systemAlso: static surgical guideOne implant placement is assisted with x-guide dynamic navigation system. The other implant placement is assisted with static surgical guide | Device | dynamic navigation group or static guide group |
Primary outcome
Record visiting time
Time frame: during procedure
Record the time (minutes) in every clinical procedure
Implant success rate
Time frame: Change in periapical film of the implant on post operation immediately, post operation 1 month, 3 months, 6 months, 1 year
No osteointegration of implant
Prosthesis success rate
Time frame: Change in photo on post operation immediately, post operation 1 month, 3 months, 6 months, 1 year
Morphology of the restoration
surgical complications
Time frame: Post operation 1 week
pain, swelling, infection after surgery
prosthetic success rates
Time frame: Change in post operation immediately, post operation 1 month, 3 months, 6 months, 1 year
final pink aesthetic score
Implant stability quotient (ISQ)
Time frame: Change in post operation immediately, post operation 1 month, 3 months, 6 months, 1 year
implant stability
1 secondary outcome
Type of incision
Time frame: during the operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2022.
- Background: PubMed 34467555Pozzi A, Arcuri L, Carosi P, Nardi A, Kan J. Clinical and radiological outcomes of novel digital workflow and dynamic navigation for single-implant immediate loading in aesthetic zone: 1-year prospective case series. Clin Oral Implants Res. 2021 Dec;32(12):1397-1410. doi: 10.1111/clr.13839. Epub 2021 Sep 8.
- Background: PubMed 32033089Lopes A, de Araujo Nobre M, Santos D. The Workflow of a New Dynamic Navigation System for the Insertion of Dental Implants in the Rehabilitation of Edentulous Jaws: Report of Two Cases. J Clin Med. 2020 Feb 4;9(2):421. doi: 10.3390/jcm9020421.
- Background: PubMed 27643585Block MS, Emery RW, Lank K, Ryan J. Implant Placement Accuracy Using Dynamic Navigation. Int J Oral Maxillofac Implants. 2017 Jan/Feb;32(1):92-99. doi: 10.11607/jomi.5004. Epub 2016 Sep 19.
- Background: PubMed 27267658Emery RW, Merritt SA, Lank K, Gibbs JD. Accuracy of Dynamic Navigation for Dental Implant Placement-Model-Based Evaluation. J Oral Implantol. 2016 Oct;42(5):399-405. doi: 10.1563/aaid-joi-D-16-00025. Epub 2016 Jun 6.
- Background: PubMed 34006059Dure M, Berlinghoff F, Kollmuss M, Hickel R, Huth KC. First comparison of a new dynamic navigation system and surgical guides for implantology: an in vitro study. Int J Comput Dent. 2021 Feb 26;24(1):9-17.
- Background: PubMed 26452429Block MS, Emery RW. Static or Dynamic Navigation for Implant Placement-Choosing the Method of Guidance. J Oral Maxillofac Surg. 2016 Feb;74(2):269-77. doi: 10.1016/j.joms.2015.09.022. Epub 2015 Sep 30.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Single Missing Tooth Rehabilitation, run by Kaohsiung Medical University Chung-Ho Memorial Hospital.
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 3 inclusion and 7 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 2 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Han-Jen Hsu, PhD (+886 922909330, d80.wu63@msa.hinet.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Record visiting time (time frame: during procedure). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05526677, which also lists 6 linked publications.
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 Sep 2022.