Tooth-lossNCT04855084
Occlusal Relationship Assesment of Monolithic Zirconia FDPs
A study testing Monolithic FDPs: before adjustment, Monolithic FDPs: after adjustment and Metal fused porcelain FDPs: before adjustment in people with Tooth-loss, run by Duygu Karasan at 1 site in Turkey (Türkiye).
Trial summary
To analyze in vivo occlusal accuracy and occlusal adjustment requirement, a cross-over clinical trial was designed. Two 3-unit tooth-supported posterior FDPs were planned to be made for each patient's single missing tooth gap, one with complete analog workflow (control group) and the other complete digital workflow… Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth-loss
- What is being tested?
- Monolithic FDPs: before adjustment, Monolithic FDPs: after adjustment and Metal fused porcelain FDPs: before adjustment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 May 2018to 27 Aug 2018
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The individuals with the mandibular or maxillary single missing occlusal unit (2nd premolar, 1st molar) adjacent to a premolar and/or molar tooth
- Participants over 20 years old with no contradiction of dental treatment.
- Good oral hygiene habits, healthy periodontal status, no sign of bruxism (e.g. attrition score >2 according to Wigdorowicz-Makowerowa, and/or muscle pain), and no self-reported grinding and/or clenching.
- No visible periapical lesion
- Presence of minimum 1:1 crown/root ratio
- Class I mobility (Nyman \& Lindhe 2003)
Show all 9Show fewer
- No probing depth more than 4mm
- Presence of natural opposing teeth with no restorative treatment.
- Presence of a stable maximum intercuspation (MI) relationship
Who cannot join
- Patients and teeth that are not fulfilling the inclusion criteria
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University Faculty of Dentistry
Ankara, 06230
About this study
Official title: Occlusal Relationship Assesment of Monolithic Zirconia Fixed Dental Prosthesis
To analyze in vivo occlusal accuracy and occlusal adjustment requirement, a cross-over clinical trial was designed. Two 3-unit tooth-supported posterior FDPs were planned to be made for each patient's single missing tooth gap, one with complete analog workflow (control group) and the other complete digital workflow (test group). The analog workflow aims for a porcelain fused to metal (PFM) FDP whereas the digital workflow aims for 3-unit monolithic Zr FDP. PFor half of the restorations, digital impression was planned to be taken first and to be followed by analog impression. As for the occlusal adjustment, in half of the study sites monolithic Zr FDPs were planned to be tried-in first, followed by metal-ceramic FDP and vice versa.
One investigator (DK) was assigned to prepare the restoration sites and deliver the FDPs. All monolithic Zr and all metal-ceramic FDPs were designed and fabricated by the same experienced dental technician. One investigator (HL), that was not involved in the treatment intervention was assigned to make the 3D analysis of the volumetric occlusal adjustment amount.
Read the detailed description
All teeth preparations will be carried out ensuring the minimum material thickness for monolithic FDPs (0.8-1 mm margin thickness, 1 mm occlusal thickness) by one experienced investigator (DK). To prevent any possible carry-over effect, the impression acquisition order will be randomized.
The control group FDPs (metal-ceramic) will be fabricated with a complete analog workflow. Accordingly, a polyether dual-phase impression (Impregum Penta Soft Quick and Soft Quick, 3M) will be taken from the restoration arch and a Polyvinylsiloxane (PVS) impression material will be used for the impression of the antagonist arch. Face bow transfer (Whip Mix Face bow0 will be done. Following the stone master model (Type IV dental rock, Fuji) obtention, the maxillary models will be mounted to a semi-adjustable articulator based on the face bow record and mandibular models will be then mounted with the aid of laterotrusive and MI records. The MI and laterotrusive records will be taken with a PVS bite registration material. The Cr-Ni frameworks will be fabricated with lost-wax technique (Brand?), manually layered with feldspathic veneering porcelain (Vita), and glazed by one experienced dental technician.
The test group FDPs (high translucent monolithic Zr) (Aidite Multilayer 3D) will be fabricated by a complete/model-free digital workflow. The digital quadrant impressions of the preparation, antagonist as well as bite registration will be obtained by the use of an IOS (Trios 3, 3Shape). The files will be sent to a CAD software (Dental System, 3Shape) directly via the communication tool (3 Shape Communicate, 3Shape). Following CAD, the high translucent monolithic Zr 3-unit FDPs will be computer-aided manufactured (CORITEC 350i Loader, imes-icore GmbH). FDPs will be high-gloss polished, glazed, and sent to the dental clinic for the try-in session. Monolithic Zr design and manufacturing process will be completed by one dental technician that is highly experienced in CAD/CAM.
Clinical occlusal adjustment:
A standardized occlusal adjustment strategy will be adopted and executed by one investigator for both control and test group FDPs. In half of the restoration sites, monolithic Zr restorations will be the ones to have been tried first whereas in the other half metal-ceramic FDPs were the first. Initially, distal and mesial approximal contact areas, then the internal fit will be checked and adjusted to eliminate any interferences in order to ensure the optimal fitting of the restorations. For the occlusal adjustment amount calculation, the FDPs will be fixed on the prepared teeth provisionally and scanned by an IOS (Trios 3, 3Shape) to record the pre-adjustment FDP volume. The occlusal contacts and adjustment needs were assessed while still the restorations are fixed. The occlusal adjustment strategy will be as follows: Under normal occlusal forces, 40-micron articulation paper (Arti-Check micro-thin, Bausch, Cologne, Germany) will be used and followed by 12-micron articulation foil (Shimstock-foil, Bausch, Cologne, Germany) under strong occlusal force. The FDPs' occlusal contact design will be ensured to hold the articulation foil under strong occlusal force. Thereafter, once ensuring the FDPs to remain fixed, intraoral digital quadrant impressions (Trios 3, 3 Shape) will be taken by the same investigator in order to record the post-adjustment volume of the FDPs. After chairside finishing and polishing of the adjustment areas, Monolithiz Zr FDPs will be adhesively luted by a composite cement as the definitive restoration.
2.4. Quantitative analysis Both .stl files (pre-and-post adjustment) will be exported in order to process in an inspection software (Gom Inspect 2019, GOM GmbH, Braunschweig, Germany). The pre-and post-adjustment .stl files will be superimposed with the surface of restorations excluding occlusal adjusted area. After that, they will be sectioned from the same planes, mesial, distal, and 3mm apical to occlusal plane. The total volume of the sections that will be analyzed will be measured and the quantitative volume difference of the sectioned parts then was Calculated three-dimensionally (3Matic, Materialise NV, Leuven, Belgium). The total volumetric difference in mm3 between pre-and post-adjustment .stl files will be calculated for each 3-unit FDP
- Conditions
- Tooth-loss
- Being tested
- Monolithic FDPs: before adjustment, Monolithic FDPs: after adjustment, Metal fused porcelain FDPs: before adjustment, Metal fused porcelain FDPs: after adjustment
- Keywords
- Occlusal Relationship, Complete Digital Work-flow, Fixed Partial Denture, Fixed Dental Prosthesis
- Medical subject headings
- Anodontia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monolithic FDPs: before adjustmentOther
Before the occlusal adjustment, Occlusal relationship recording of the 3-unit monolithic FDPs which was fabricated following the complete digital work-flow.
Monolithic FDPs: after adjustmentOther
After the occlusal adjustment, Occlusal relationship recording of the 3-unit monolithic FDPs which was fabricated following the complete digital work-flow.
Metal fused porcelain FDPs: before adjustmentOther
Before the occlusal adjustment, Occlusal relationship recording of the 3-unit metal fused porcelain FDPs which was fabricated following the complete conventional manufacturing procedure.
Metal fused porcelain FDPs: after adjustmentOther
After the occlusal adjustment, digital occlusal relationship recording was done of the 3-unit metal fused porcelain FDPs which was fabricated following the complete conventional manufacturing procedure.
| Study group | Role | What they receive |
|---|---|---|
| Complete Digital Fixed Dental Prosthesis | Experimental | Following the Digital Impression using 3 Shape Trios Intraoral scanner, digital design, and manufacturing of the Monolithic Zirconia FDPs.
Monolithic FDPs: before adjustment
Using Intraoral Scanner, occlusal relationship assessment of the Monolithic FDPs before the occlusal adjustment.
Monolithic FDPs: after adjustment
Using Intraoral Scanner, occlusal relationship assessment of the Monolithic FDPs after the occlusal adjustment. Receives: Other: Monolithic FDPs: before adjustment; Other: Monolithic FDPs: after adjustment; Other: Metal fused porcelain FDPs: before adjustment; Other: Metal fused porcelain FDPs: after adjustment |
| Analog Fixed Dental Prosthesis | Active comparator | Following the Conventional Impression, transfer to the articulator with Face bow. Manufacturing of the FDPs with lost wax technique and veneering.
Metal fused porcelain FDPs: before adjustment
Using Intraoral Scanner, occlusal relationship assessment of the metal fused to porcelain FDPs before the occlusal adjustment.
Metal fused porcelain FDPs: after adjustment
Using Intraoral Scanner, occlusal relationship assessment of the metal fused to porcelain FDPs after the occlusal adjustment. Receives: Other: Monolithic FDPs: before adjustment; Other: Monolithic FDPs: after adjustment; Other: Metal fused porcelain FDPs: before adjustment; Other: Metal fused porcelain FDPs: after adjustment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The evaluation of effectiveness of workflows by assesing the occlusal registration accuracy of 3-unit FDPs that were fabricated with two different work-flows
The occlusal registration accuracy and effectiveness of both analog and digital workflows by means of comparing quantitatively the occlusal adjustment requirement of 3-unit tooth supported metal-ceramic and Zr FDPs produced by analog work-flow use of semi-adjustable articulators with face-bow transfer and complete digital workflow, respectively
Measured: At the baseline, the same day of delivery
Secondary outcomes (1)
Operator and Patient reported outcomes
The patient and operator reported outcomes will be evaulated by means of visual analog scales (VAS). The patients and operator will be asked to rate from 0 to 10 their experience of impression and overall treatment procedure.
(0: inconvenient, 10 very convenient)
Measured: Impression visit and baseline visit (restoration delivery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start24 May 2018
- Primary completion7 Aug 2018
- Study completion27 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth-lossStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A non-randomized one-control group study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duygu Karasan
- Sponsor type
- University, hospital or other
- Collaborators
- Hacettepe University
- Responsible party
- Sponsor-investigator, Duygu Karasan, Hacettepe University
- Investigators
- Duygu Karasan, PhD, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04855084
- Sponsor's protocol ID
- KA-180043
- Status last verified
- Apr 2021
- First submitted
- 18 Apr 2021
- Last updated
- 22 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Occlusal Relationship Assesment of Monolithic Zirconia Fixed Dental Prosthesis
- ClinicalTrials.gov ID
- NCT04855084
- Acronym / sponsor ID
- KA-180043
- Conditions
- Tooth-loss
- Keywords
- Occlusal Relationship, Complete Digital Work-flow, Fixed Partial Denture, Fixed Dental Prosthesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Duygu KarasanUniversity, hospital or other
- Collaborators
- Hacettepe University
- Study start
- 24 May 2018 (actual)
- Primary completion
- 7 Aug 2018 (actual)
- Study completion
- 27 Aug 2018 (actual)
- First posted
- 22 Apr 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.
To analyze in vivo occlusal accuracy and occlusal adjustment requirement, a cross-over clinical trial was designed. Two 3-unit tooth-supported posterior FDPs were planned to be made for each patient's single missing tooth gap, one with complete analog workflow (control group) and the other complete digital workflow (test group). The analog workflow aims for a porcelain fused to metal (PFM) FDP whereas the digital workflow aims for 3-unit monolithic Zr FDP. PFor half of the restorations, digital impression was planned to be taken first and to be followed by analog impression. As for the occlusal adjustment, in half of the study sites monolithic Zr FDPs were planned to be tried-in first, followed by metal-ceramic FDP and vice versa.
One investigator (DK) was assigned to prepare the restoration sites and deliver the FDPs. All monolithic Zr and all metal-ceramic FDPs were designed and fabricated by the same experienced dental technician. One investigator (HL), that was not involved in the treatment intervention was assigned to make the 3D analysis of the volumetric occlusal adjustment amount.
Detailed description
All teeth preparations will be carried out ensuring the minimum material thickness for monolithic FDPs (0.8-1 mm margin thickness, 1 mm occlusal thickness) by one experienced investigator (DK). To prevent any possible carry-over effect, the impression acquisition order will be randomized.
The control group FDPs (metal-ceramic) will be fabricated with a complete analog workflow. Accordingly, a polyether dual-phase impression (Impregum Penta Soft Quick and Soft Quick, 3M) will be taken from the restoration arch and a Polyvinylsiloxane (PVS) impression material will be used for the impression of the antagonist arch. Face bow transfer (Whip Mix Face bow0 will be done. Following the stone master model (Type IV dental rock, Fuji) obtention, the maxillary models will be mounted to a semi-adjustable articulator based on the face bow record and mandibular models will be then mounted with the aid of laterotrusive and MI records. The MI and laterotrusive records will be taken with a PVS bite registration material. The Cr-Ni frameworks will be fabricated with lost-wax technique (Brand?), manually layered with feldspathic veneering porcelain (Vita), and glazed by one experienced dental technician.
The test group FDPs (high translucent monolithic Zr) (Aidite Multilayer 3D) will be fabricated by a complete/model-free digital workflow. The digital quadrant impressions of the preparation, antagonist as well as bite registration will be obtained by the use of an IOS (Trios 3, 3Shape). The files will be sent to a CAD software (Dental System, 3Shape) directly via the communication tool (3 Shape Communicate, 3Shape). Following CAD, the high translucent monolithic Zr 3-unit FDPs will be computer-aided manufactured (CORITEC 350i Loader, imes-icore GmbH). FDPs will be high-gloss polished, glazed, and sent to the dental clinic for the try-in session. Monolithic Zr design and manufacturing process will be completed by one dental technician that is highly experienced in CAD/CAM.
Clinical occlusal adjustment:
A standardized occlusal adjustment strategy will be adopted and executed by one investigator for both control and test group FDPs. In half of the restoration sites, monolithic Zr restorations will be the ones to have been tried first whereas in the other half metal-ceramic FDPs were the first. Initially, distal and mesial approximal contact areas, then the internal fit will be checked and adjusted to eliminate any interferences in order to ensure the optimal fitting of the restorations. For the occlusal adjustment amount calculation, the FDPs will be fixed on the prepared teeth provisionally and scanned by an IOS (Trios 3, 3Shape) to record the pre-adjustment FDP volume. The occlusal contacts and adjustment needs were assessed while still the restorations are fixed. The occlusal adjustment strategy will be as follows: Under normal occlusal forces, 40-micron articulation paper (Arti-Check micro-thin, Bausch, Cologne, Germany) will be used and followed by 12-micron articulation foil (Shimstock-foil, Bausch, Cologne, Germany) under strong occlusal force. The FDPs' occlusal contact design will be ensured to hold the articulation foil under strong occlusal force. Thereafter, once ensuring the FDPs to remain fixed, intraoral digital quadrant impressions (Trios 3, 3 Shape) will be taken by the same investigator in order to record the post-adjustment volume of the FDPs. After chairside finishing and polishing of the adjustment areas, Monolithiz Zr FDPs will be adhesively luted by a composite cement as the definitive restoration.
2.4. Quantitative analysis Both .stl files (pre-and-post adjustment) will be exported in order to process in an inspection software (Gom Inspect 2019, GOM GmbH, Braunschweig, Germany). The pre-and post-adjustment .stl files will be superimposed with the surface of restorations excluding occlusal adjusted area. After that, they will be sectioned from the same planes, mesial, distal, and 3mm apical to occlusal plane. The total volume of the sections that will be analyzed will be measured and the quantitative volume difference of the sectioned parts then was Calculated three-dimensionally (3Matic, Materialise NV, Leuven, Belgium). The total volumetric difference in mm3 between pre-and post-adjustment .stl files will be calculated for each 3-unit FDP
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- A non-randomized one-control group study
| Arm | Type | Receives |
|---|---|---|
| Complete Digital Fixed Dental Prosthesis | Experimental | Other: Monolithic FDPs: before adjustment, Other: Monolithic FDPs: after adjustment, Other: Metal fused porcelain FDPs: before adjustment, Other: Metal fused porcelain FDPs: after adjustmentFollowing the Digital Impression using 3 Shape Trios Intraoral scanner, digital design, and manufacturing of the Monolithic Zirconia FDPs. Monolithic FDPs: before adjustment Using Intraoral Scanner, occlusal relationship assessment of the Monolithic FDPs before the occlusal adjustment. Monolithic FDPs: after adjustment Using Intraoral Scanner, occlusal relationship assessment of the Monolithic FDPs after the occlusal adjustment. |
| Analog Fixed Dental Prosthesis | Active comparator | Other: Monolithic FDPs: before adjustment, Other: Monolithic FDPs: after adjustment, Other: Metal fused porcelain FDPs: before adjustment, Other: Metal fused porcelain FDPs: after adjustmentFollowing the Conventional Impression, transfer to the articulator with Face bow. Manufacturing of the FDPs with lost wax technique and veneering. Metal fused porcelain FDPs: before adjustment Using Intraoral Scanner, occlusal relationship assessment of the metal fused to porcelain FDPs before the occlusal adjustment. Metal fused porcelain FDPs: after adjustment Using Intraoral Scanner, occlusal relationship assessment of the metal fused to porcelain FDPs after the occlusal adjustment. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The individuals with the mandibular or maxillary single missing occlusal unit (2nd premolar, 1st molar) adjacent to a premolar and/or molar tooth
- Participants over 20 years old with no contradiction of dental treatment.
- Good oral hygiene habits, healthy periodontal status, no sign of bruxism (e.g. attrition score >2 according to Wigdorowicz-Makowerowa, and/or muscle pain), and no self-reported grinding and/or clenching.
- No visible periapical lesion
- Presence of minimum 1:1 crown/root ratio
Key exclusion criteria (1 listed)
- Patients and teeth that are not fulfilling the inclusion criteria
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 |
|---|---|---|
| Monolithic FDPs: before adjustmentBefore the occlusal adjustment, Occlusal relationship recording of the 3-unit monolithic FDPs which was fabricated following the complete digital work-flow. | Other | Analog Fixed Dental Prosthesis, Complete Digital Fixed Dental Prosthesis |
| Monolithic FDPs: after adjustmentAfter the occlusal adjustment, Occlusal relationship recording of the 3-unit monolithic FDPs which was fabricated following the complete digital work-flow. | Other | Analog Fixed Dental Prosthesis, Complete Digital Fixed Dental Prosthesis |
| Metal fused porcelain FDPs: before adjustmentBefore the occlusal adjustment, Occlusal relationship recording of the 3-unit metal fused porcelain FDPs which was fabricated following the complete conventional manufacturing procedure. | Other | Analog Fixed Dental Prosthesis, Complete Digital Fixed Dental Prosthesis |
| Metal fused porcelain FDPs: after adjustmentAfter the occlusal adjustment, digital occlusal relationship recording was done of the 3-unit metal fused porcelain FDPs which was fabricated following the complete conventional manufacturing procedure. | Other | Analog Fixed Dental Prosthesis, Complete Digital Fixed Dental Prosthesis |
Primary outcome
The evaluation of effectiveness of workflows by assesing the occlusal registration accuracy of 3-unit FDPs that were fabricated with two different work-flows
Time frame: At the baseline, the same day of delivery
The occlusal registration accuracy and effectiveness of both analog and digital workflows by means of comparing quantitatively the occlusal adjustment requirement of 3-unit tooth supported metal-ceramic and Zr FDPs produced by analog work-flow use of semi-adjustable articulators with face-bow transfer and complete digital workflow, respectively
1 secondary outcome
Operator and Patient reported outcomes
Time frame: Impression visit and baseline visit (restoration delivery)
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 22 Apr 2021.
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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.
Duygu Karasan, PhD principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monolithic FDPs: before adjustment, Monolithic FDPs: after adjustment and Metal fused porcelain FDPs: before adjustment in people with Tooth-loss, run by Duygu Karasan at 1 site in Turkey (Türkiye).
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 1 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 22 Apr 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 Turkey (Türkiye). 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?
The evaluation of effectiveness of workflows by assesing the occlusal registration accuracy of 3-unit FDPs that were fabricated with two different work-flows (time frame: At the baseline, the same day of delivery). 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 22 Apr 2021.