Dental ImplantNCT04986761
PROMs 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 25 years and olderHealthy 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 31 Mar 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 25 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -The participants are in the age of more than 20 years old and not more than 80 years old.
- The participants who have a transmucosal implant system (Straumann TL RN/WN, Institut Straumann, AG, Basel, Switzerland) placed in single-tooth gap in the area of premolar or molar regions in the maxilla and mandible with existing interproximal and antagonist contacts.
- The participants' general medical health is healthy or has a well-controlled systemic disease.
- The participants' general oral health has shown no sign of infection or unsuccessfully treated diseases such as chronic periodontitis.
Who cannot join
- The participants who are smoking more than 10 cigarettes per day.
- The participants with pregnancy.
- The participants with a psychiatric disorder
- The participants with a history of radiation therapy at the head and neck area.
- The participants with a history of chemotherapy.
- The participants with 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: Patient-reported Outcome Measures (PROMs) Comparing Digital and Conventional Workflows for Treatment With Single-unit Implant Restorations: A Randomized Controlled Trial
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 subjective patient perception in terms of PROMs comparing digital and conventional impression techniques as well as patients' satisfaction related to the final implant restoration among difference workflows and materials. The secondary outcome was to investigate the objective evaluation by a dental professional applying the functional implant prosthodontic score (FIPS). The null-hypothesis of this RCT was that both workflows and the two materials for the monolithic implant restorations 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, Patient-Reported Outcome Measures (PROMs), Crowns, Functional Implant Prosthodontic Score (FIPS)
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.
Patient reported outcome measure (PROM): satisfaction with impression technique via VAS questionnaire
After impression-taking, questionnaires were handed out to the participants to evaluate PROMs via visual analog scales (VAS). Six categories were assessed: (1) overall treatment time of impression-taking procedure (0=unsatisfactory to 10=excellent); (2) convenience level of the impression technique (0=unsatisfactory to 10=excellent); (3) anxiety level of impression technique (0=low to 10=high); (4) bad taste and (5) nausea caused by the impression (each 0=no sensation to 10=a lot of sensation); and (6) pain during impression-taking procedure (0=no pain to 10=a lot of pain).
Measured: After impression, At first visit within 30 minutes
Patient reported outcome measure (PROM): satisfaction with final implant restoration via VAS questionnaire
Patients were requested to score their feeling on screw-retained monolithic implant crowns in a 10cm VAS one week after delivery of the final implant crowns. The level of patients' satisfaction was measured in four categories: (1) perception of the overall treatment outcome (0=unsatisfactory to 10=excellent); (2) opinion on the function of the restoration (0=unsatisfactory to 10=excellent); (3) esthetic perspective (0=unsatisfactory to 10=excellent), and (4) ease of oral hygiene care (0=unsatisfactory to 10=excellent).
Measured: 1 week after prosthesis delivery
Secondary outcomes (1)
Functional implant prosthodontic score (FIPS)
objective evaluation by a dental professional applying the functional implant prosthodontic score (FIPS).
Measured: Prosthesis delivery visit, an average of 2 weeks after first visit for impression procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start1 Jul 2020
- Primary completion31 Mar 2021
- Study completion31 Mar 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
- ITI International Team for Implantology, Switzerland
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04986761
- Sponsor's protocol ID
- MU-DT/PY-IRB 2019/DT146
- Status last verified
- Aug 2021
- First submitted
- 1 Jul 2021
- Last updated
- 4 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Joda T, Bragger U. Patient-centered outcomes comparing digital and conventional implant impression procedures: a randomized crossover trial. Clin Oral Implants Res. 2016 Dec;27(12):e185-e189. doi: 10.1111/clr.12600. Epub 2015 Apr 12.
PubMed 25864771
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-reported Outcome Measures (PROMs) Comparing Digital and Conventional Workflows for Treatment With Single-unit Implant Restorations: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04986761
- Acronym / sponsor ID
- MU-DT/PY-IRB 2019/DT146
- Conditions
- Dental Implant
- Keywords
- Clinical Research, Dental Implant, Digital Workflow, Patient-Reported Outcome Measures (PROMs), Crowns, Functional Implant Prosthodontic Score (FIPS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Collaborators
- ITI International Team for Implantology, Switzerland
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 3 Aug 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 subjective patient perception in terms of PROMs comparing digital and conventional impression techniques as well as patients' satisfaction related to the final implant restoration among difference workflows and materials. The secondary outcome was to investigate the objective evaluation by a dental professional applying the functional implant prosthodontic score (FIPS). The null-hypothesis of this RCT was that both workflows and the two materials for the monolithic implant restorations 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
- 25 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- -The participants are in the age of more than 20 years old and not more than 80 years old.
- The participants who have a transmucosal implant system (Straumann TL RN/WN, Institut Straumann, AG, Basel, Switzerland) placed in single-tooth gap in the area of premolar or molar regions in the maxilla and mandible with existing interproximal and antagonist contacts.
- The participants' general medical health is healthy or has a well-controlled systemic disease.
- The participants' general oral health has shown no sign of infection or unsuccessfully treated diseases such as chronic periodontitis.
Key exclusion criteria (6 listed)
- The participants who are smoking more than 10 cigarettes per day.
- The participants with pregnancy.
- The participants with a psychiatric disorder
- The participants with a history of radiation therapy at the head and neck area.
- The participants with a 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
Patient reported outcome measure (PROM): satisfaction with impression technique via VAS questionnaire
Time frame: After impression, At first visit within 30 minutes
After impression-taking, questionnaires were handed out to the participants to evaluate PROMs via visual analog scales (VAS). Six categories were assessed: (1) overall treatment time of impression-taking procedure (0=unsatisfactory to 10=excellent); (2) convenience level of the impression technique (0=unsatisfactory to 10=excellent); (3) anxiety level of impression technique (0=low to 10=high); (4) bad taste and (5) nausea caused by the impression (each 0=no sensation to 10=a lot of sensation); and (6) pain during impression-taking procedure (0=no pain to 10=a lot of pain).
Patient reported outcome measure (PROM): satisfaction with final implant restoration via VAS questionnaire
Time frame: 1 week after prosthesis delivery
Patients were requested to score their feeling on screw-retained monolithic implant crowns in a 10cm VAS one week after delivery of the final implant crowns. The level of patients' satisfaction was measured in four categories: (1) perception of the overall treatment outcome (0=unsatisfactory to 10=excellent); (2) opinion on the function of the restoration (0=unsatisfactory to 10=excellent); (3) esthetic perspective (0=unsatisfactory to 10=excellent), and (4) ease of oral hygiene care (0=unsatisfactory to 10=excellent).
1 secondary outcome
Functional implant prosthodontic score (FIPS)
Time frame: Prosthesis delivery visit, an average of 2 weeks after first visit for impression procedure
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 4 Aug 2021.
- Results publication: PubMed 25864771Joda T, Bragger U. Patient-centered outcomes comparing digital and conventional implant impression procedures: a randomized crossover trial. Clin Oral Implants Res. 2016 Dec;27(12):e185-e189. doi: 10.1111/clr.12600. Epub 2015 Apr 12.
- 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 4 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 4 Aug 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?
Patient reported outcome measure (PROM): satisfaction with impression technique via VAS questionnaire (time frame: After impression, At first visit within 30 minutes). The study lists 2 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 NCT04986761, 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 4 Aug 2021; AzTrials last refreshed its copy on 27 Oct 2026.