Dental ImplantNCT05165563
Treatment Time Comparing Digital & Conventional Workflows
A study testing Treatment of implant single crown in people with Dental Implant, run by Mahidol University at 1 site in Thailand.
Trial summary
This randomized controlled trial (RCT) analyzed monolithic single-unit implant restorations out of lithium disilicate (LS2) or polymer-infiltrated ceramic networks (PICN) in a chairside digital workflow (Test) and a conventional protocol (Control). Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implant
- What is being tested?
- Treatment of implant single crown
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jul 2020to 26 Oct 2021
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The participants having a transmucosal implant system (Straumann TL RN/WN, Institut Straumann, AG, Basel, Switzerland) were placed in a single-tooth gap in the area of premolar or molar regions in the maxilla and mandible with existing interproximal and antagonist contacts.
- general medical health is healthy or has a well-controlled systemic disease.
- general oral health has shown no sign of infection or unsuccessfully treated diseases such as chronic periodontitis.
Who cannot join
- smoking more than 10 cigarettes per day.
- pregnancy.
- psychiatric disorder
- history of radiation therapy at the head and neck area.
- history of chemotherapy.
- history of bony pathologies such as osseous dysplasia, odontogenic cyst or tumor, etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Treatment Time Between Digital and Conventional Workflows for Treatment With Posterior Implant Restorations
This randomized controlled trial (RCT) analyzed monolithic single-unit implant restorations out of lithium disilicate (LS2) or polymer-infiltrated ceramic networks (PICN) in a chairside digital workflow (Test) and a conventional protocol (Control). The primary outcome was to investigate the treatment time of the overall operation. The null hypothesis of this RCT was that both workflows had comparable results with respect to the defined outcomes.
- Conditions
- Dental Implant
- Being tested
- Treatment of implant single crown
- Keywords
- Clinical Research, Dental Implant, Digital Workflow, Crowns, Treatment time
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment of implant single crownProcedure or surgery
Digital or Conventional Workflows for treatment of implant single crown and materials used.
| Study group | Role | What they receive |
|---|---|---|
| Workflows | Experimental | Digital and conventional workflows for treatment of implant single crowns Receives: Procedure: Treatment of implant single crown |
| Materials | Experimental | Materials for treatment of implant single crowns (polymer-infiltrated ceramic networks, PICNs and lithium disilicate, LS2). Receives: Procedure: Treatment of implant single crown |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment time
Treatment time in every steps were recorded.
Measured: First visit to prosthesis delivery visit, through study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2021
- Study start1 Jul 2020
- Primary completion26 Oct 2021
- Study completion26 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental ImplantStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Digital and conventional workflows for treatment of implant single crowns, and also the material used.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Collaborators
- Align Technology, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05165563
- Sponsor's protocol ID
- MU-DT/PY-IRB 2020/DT010
- Status last verified
- Dec 2021
- First submitted
- 22 Nov 2021
- Last updated
- 21 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Joda T, Bragger U. Time-Efficiency Analysis Comparing Digital and Conventional Workflows for Implant Crowns: A Prospective Clinical Crossover Trial. Int J Oral Maxillofac Implants. 2015 Sep-Oct;30(5):1047-53. doi: 10.11607/jomi.3963.
PubMed 26394340
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Treatment Time Between Digital and Conventional Workflows for Treatment With Posterior Implant Restorations
- ClinicalTrials.gov ID
- NCT05165563
- Acronym / sponsor ID
- MU-DT/PY-IRB 2020/DT010
- Conditions
- Dental Implant
- Keywords
- Clinical Research, Dental Implant, Digital Workflow, Crowns, Treatment time
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Collaborators
- Align Technology, Inc.
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 26 Oct 2021 (actual)
- Study completion
- 26 Oct 2021 (actual)
- First posted
- 21 Dec 2021 (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.
This randomized controlled trial (RCT) analyzed monolithic single-unit implant restorations out of lithium disilicate (LS2) or polymer-infiltrated ceramic networks (PICN) in a chairside digital workflow (Test) and a conventional protocol (Control). The primary outcome was to investigate the treatment time of the overall operation. The null hypothesis of this RCT was that both workflows had comparable results with respect to the defined outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Digital and conventional workflows for treatment of implant single crowns, and also the material used.
| Arm | Type | Receives |
|---|---|---|
| Workflows | Experimental | Procedure: Treatment of implant single crownDigital and conventional workflows for treatment of implant single crowns |
| Materials | Experimental | Procedure: Treatment of implant single crownMaterials for treatment of implant single crowns (polymer-infiltrated ceramic networks, PICNs and lithium disilicate, LS2). |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The participants having a transmucosal implant system (Straumann TL RN/WN, Institut Straumann, AG, Basel, Switzerland) were placed in a single-tooth gap in the area of premolar or molar regions in the maxilla and mandible with existing interproximal and antagonist contacts.
- general medical health is healthy or has a well-controlled systemic disease.
- general oral health has shown no sign of infection or unsuccessfully treated diseases such as chronic periodontitis.
Key exclusion criteria (6 listed)
- smoking more than 10 cigarettes per day.
- pregnancy.
- psychiatric disorder
- history of radiation therapy at the head and neck area.
- history of chemotherapy.
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 |
|---|---|---|
| Treatment of implant single crownDigital or Conventional Workflows for treatment of implant single crown and materials used. | Procedure or surgery | Materials, Workflows |
Primary outcome
Treatment time
Time frame: First visit to prosthesis delivery visit, through study completion, an average of 1 month
Treatment time in every steps were recorded.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2021.
- Background: PubMed 26394340Joda T, Bragger U. Time-Efficiency Analysis Comparing Digital and Conventional Workflows for Implant Crowns: A Prospective Clinical Crossover Trial. Int J Oral Maxillofac Implants. 2015 Sep-Oct;30(5):1047-53. doi: 10.11607/jomi.3963.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment of implant single crown in people with Dental Implant, run by Mahidol University at 1 site in Thailand.
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 6 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: finished, as of the sponsor's last update on 21 Dec 2021. 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 Thailand. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment time (time frame: First visit to prosthesis delivery visit, through study completion, an average of 1 month). 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 NCT05165563, which also lists 1 linked publication.
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 21 Dec 2021.