Posterior OcclusionNCT04355325
Posterior Implant-Supported Modified Monolithic Zirconia and Metal-Ceramic Single Crowns: 5 Years Study
A study testing modified monolithic zirconia crowns and Metal Ceramic crowns in people with Posterior Occlusion and Fracture, run by Jordan University of Science and Technology at 1 site in Jordan.
Trial summary
The outcome of implant therapy has been presented in the majority of clinical studies by focusing only on implant survival without providing detailed information on the reconstructions . Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Posterior Occlusion, Fracture
- What is being tested?
- modified monolithic zirconia crowns and Metal Ceramic crowns
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteJordan
- Study dates
- 2 Apr 2020to 5 Dec 2024
- 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 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- · Participants will be required to sign informed consents prior to inclusion in the study.
- Aged between 21 to 55 years, with no contraindications to dental treatment.
- Need implant supported single crown in the maxillary and/or mandibular premolar and/or molar area
- No systemic disease.
- No signs of bruxism.
- Full-mouth plaque scores and full-mouth bleeding scores of <25%
Show all 14Show fewer
- Good overall dental health, no active caries, no active periodontal disease, and periodontal pocket depths not greater than 4 mm.
- Adequate bone height and width at areas of proposed implant sites
- Adequate interocclusal distance to accommodate the prosthesis
- Space width with mesial -distal width of at least 6 mm.
- Good oral hygiene and compliance with oral hygiene instructions as determined by the amount of plaque present on tooth surfaces
- Thick or medium gingival biotype.
- Bilateral one missing tooth being a premolar or molar in the maxilla or mandible with adjacent natural teeth.
- Fixed teeth opposing the edentulous area and a full complement of teeth or restored teeth in all other areas.
Who cannot join
- Systemic disease
- Pregnant and lactating women
- Unwilling to receive radiographs
- Presence of clinically active periodontal disease as expressed by probing pocket depths 4 mm in combination with bleeding on probing
- Presence of peri-apical lesions or any other abnormalities in the region as detected on a radiograph.
- Subjects that get diagnosed with any systemic disease, start smoking, or become pregnant during the study period will be excluded from the study
Trial locations and contacts
1 site in 1 country.
esam Alem, Prosthetic contact
Jordan1 site, 1 recruiting
- Recruiting
Jordan University of Science and Technology
Irbid, 21110
Rola a AlHabashneh, Prof, 0796064813, raalhabashneh@just.edu.jo
Esam Alem, Dr, ealem@just.edu.jo
About this study
Official title: Randomized Controlled Clinical Trial to Compare Posterior Implant-Supported Modified Monolithic Zirconia and Metal-Ceramic Single Crowns: 5 Years Study
The outcome of implant therapy has been presented in the majority of clinical studies by focusing only on implant survival without providing detailed information on the reconstructions . However, for decision making, it is important to know the survival rates and the incidence of biological and technical complications not only for the implants but also for the reconstructions. Thus, the selection of restoration materials should be based on proper optical characteristics in addition to biocompatibility and sufficient strength of materials.
Monolithic zirconia has been used in posterior region, especially for single crowns, in order to eliminate the veneer cracking, But Since monolithic zirconia are relatively new, few randomized, controlled clinical studies have evaluated their success. There is only one study identified regarding the performance of monolithic ceramic restorations bonded to Ti inserts, investigating the clinical outcome of using monolithic or modified monolithic zirconia implant-supported single crowns and comparing outcomes and complications of metal-ceramic and monolithic or modified monolithic zirconia implant supported single crowns.
Read more
More clinical studies to evaluate the performance of CAD/CAM monolithic implant-supported restorations bonded to Ti inserts and bases and compare their survival, success and complication rates with other restorative options [with a mean follow-up period of at least 5 years are required for a meaningful interpretation of the survival and complication rate .
So this study aims to investigate outcomes and complications of implant supported modified monolithic zirconia and metal-ceramic single crowns in the posterior region of the mouth.
The null hypothesis is that there is no difference between modified monolithic zirconia and metal-ceramic posterior implant-supported SCs in prosthetic complication rates.
Read the detailed description
Background: Dental implants restored with single crowns (SCs) have been reported to have a comparable survival rate and fewer technical complications compared to multiple-unit implant-supported FDPs. Porcelain-fused to metal restorations were the golden standard option for implant supported reconstructions in the past, but nowadays, the application of all-ceramic restorations in general and specifically zirconia as a restorative material for implant-supported single crowns has increased utilizing the CAD/CAM technology. The continuous technological progress in both the computer-based development and the dental manufacturing process ensures new opportunities in the clinical workflow. A fully digital pathway in a model-free approach or a combination of these workflows is now possible.
Purpose: The purpose of this randomized controlled clinical trial is to investigate the prosthetic outcomes of posterior implant-supported single crowns (SCs) with a modified monolithic zirconia or metal-ceramic design utilizing the digital workflow at 1, 3 and 5 years of loading.
Materials and methods: This single-blind split mouth study will enroll 60 participants, having to receive 120 dental Implants. They will be scheduled for a bilateral posterior single-unit prosthetic rehabilitation supported by one implant in the posterior region of the maxilla or the mandible (premolars, molars). A fully digital pathway will be followed. A CT scan will be performed without any template. An intraoral optical impression using CEREC Omnicam scanner will be made. A virtual set-up of the prosthetic reconstruction, as well as a surgical template with optimal 3-D implant positioning will be designed then printed using a 3-D printer without the need of any physical model. Straumann bone level implants with either a wide diameter (Ø4.8 mm) or regular diameter (Ø4.1 mm) with a minimum length of 8 mm will be inserted. Implants will be loaded after 3 months of submerged healing. A second intraoral optical impression will be made using CEREC Omnicam scanner and Straumann scanbody. The implant-supported prosthetic suprastructure will be designed. Implants will be randomly allocated to either the test group modified monolithic zirconia crowns (MMZ) or the control group metal ceramic crowns (MC), using a computer-generated randomization list. A digital model with movable dies will be 3-D printed, then used to adjust restoration in terms of occlusal and proximal contacts. Prefabricated screw-retained Titanium abutments (Variobase Abutment; Straumann) will be used as the metal substructures of the crowns and will be secured to lab analogues on the digitally printed casts. Metal/ zirconia substructures with a hole for the screw retention will be designed using the CAD software and will be anatomically reduced by 1 mm to allow for porcelain veneering then will be laser-printed/ dry milled. Hand layering of glass ceramic will be made on the surface. Crowns will be cemented extraorally to titanium abutments using dual cure resin cement to make one-piece screw-retained single crown. The screw-retained single crowns and titanium abutments will be inserted intraorally with 35 Ncm torque and screw-access holes will be restored with Teflon and light-polymerized composite resin. The implant-supported SCs will be examined after 1, 3 and 5 years for survival and technical complications.
Clinical significance: to evaluate the survival and prosthetic complication rates of zirconia-ceramic and metal-ceramic implant-supported single crowns at 1, 3 and 5 years of service. In addition to that, the digital workflow for implant supported single crowns will be evaluated for efficiency, accuracy, time and cost compared to conventional workflow.
- Conditions
- Posterior Occlusion, Fracture
- Being tested
- modified monolithic zirconia crowns, Metal Ceramic crowns
- Keywords
- Implant, Zirconia, crown, molar
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified monolithic zirconia crownsDevice
Also called Zirconia
outcomes and complications of implant restoration
Metal Ceramic crownsDevice
Also called Metal-Ceramic
outcomes and complications of implant restoration
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Active comparator | modified monolithic zirconia crowns At the time of the second optical impression, implants will be randomly allocated to either the test group (modified monolithic zirconia crowns) or the control group (metal ceramic crowns), using a computer-generated randomization list. Receives: Device: modified monolithic zirconia crowns; Device: Metal Ceramic crowns |
| control | Placebo comparator | metal ceramic crowns At the time of the second optical impression, implants will be randomly allocated to either the test group (modified monolithic zirconia crowns) or the control group (metal ceramic crowns), using a computer-generated randomization list. Receives: Device: modified monolithic zirconia crowns; Device: Metal Ceramic crowns |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screw loosing
Alpha rating: no screw loosening Bravo rating: loose screw that can be retightened Delta rating: fractured screw that needs replacement
Measured: 5 years
Marginal integrity
Visual inspection with dental explorer to the abutment-restoration interphase under fourfold to fivefold optical magnification. Digital bitewing radiographs with standardized paralleling technique using Ring holders and analogue films will be taken at baseline then at each recall visit and compared together for any misfits or gaps. Alpha rating: no visible or soundable gap Bravo rating: marginal gap slightly soundable Charlie rating: explorer penetrates a significant crevice Delta rating: restoration needs to be replaced
Measured: 5 years
chipping of veneering ceramic
Visual and tactile inspection of the restorations will be made to check for any chippings of the restoration. Fourfold to fivefold optical magnification will be used. Clinical photographs will be taken for crowns and neighboring teeth at delivery stage. Impressions will be made as well and poured into stone. New impressions will be made at each recall visit, poured into stone, then stone casts will be evaluated using a light microscope and compared with surface topography of casts made at prosthetic delivery stage to detect any potential minor chip-off fractures.
- Alpha rating: No fracture
- Bravo rating: minor chipping (polishable)
- Charlie rating: major chipping (up to framework)
- Delta rating: restoration needs to be replaced If chipping rating changes during the observation period, the most severe rating will be recorded
Measured: 5 years
occlusal roughness
Crowns will be dried at each recall visit and visually inspected under fourfold to fivefold optical magnification for any roughness. Alpha rating: no roughness Bravo rating: slight roughness (< 2mm) Charlie rating: obvious roughness (> 2mm) Delta rating: restoration needs to be replaced If roughness rating changes during the observation period, the most severe rating will be recorded
Measured: 5 years
framework fracture
Visual and tactile inspection of the restorations will be made to check for fracture or loss of the restoration. Fourfold to fivefold optical magnification will be used. Clinical photographs will be also taken for crowns and neighboring teeth at delivery stage then at each recall visit and compared together.
- Alpha rating: No fracture
- Delta rating: restoration needs to be replaced If fracture rating changes during the observation period, the most severe rating will be recorded.
Measured: 5 years
Secondary outcomes (2)
Marginal bone loss:
Digital bitewing radiographs with standardized paralleling technique using Ring holders and analogue films will be taken at the days of implant placement, at baseline, at 6, at 12 months, then at each recall visit and compared together for marginal bone loss
Measured: 1 year
Crown de-bonding
Tactile inspection for any loosening of the restoration. History taking from the patient for any incidence of crown loosening, movement upon eating or complete separation from underlying abutment. Alpha rating: no crown de-bonding Bravo rating: crown de-bonding that can be re-bonded Delta rating: de-bonded crown that needs replacement
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2020
- Study start2 Apr 2020
- Primary completion2 May 2024 (estimated)
- Study completion5 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posterior OcclusionStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This single-blind split mouth study will enroll 60 participants, having to receive 120 dental Implants. They will be recruited from 3 dental centers in Jordan .
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jordan University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- ITI International Team for Implantology, Switzerland
- Responsible party
- Principal investigator, Rola Abdelraheem Alhabashneh, Jordan University of Science and Technology
- Investigators
- Rola Alhabshneh, Prof, Principal investigator, JUST
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04355325
- Sponsor's protocol ID
- Jordan
- Status last verified
- Apr 2020
- First submitted
- 7 Feb 2020
- Last updated
- 22 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Clinical Trial to Compare Posterior Implant-Supported Modified Monolithic Zirconia and Metal-Ceramic Single Crowns: 5 Years Study
- ClinicalTrials.gov ID
- NCT04355325
- Acronym / sponsor ID
- Jordan
- Conditions
- Posterior Occlusion, Fracture
- Keywords
- Implant, Zirconia, crown, molar
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Jordan University of Science and TechnologyUniversity, hospital or other
- Collaborators
- ITI International Team for Implantology, Switzerland
- Study start
- 2 Apr 2020 (actual)
- Primary completion
- 2 May 2024 (estimated)
- Study completion
- 5 Dec 2024 (estimated)
- First posted
- 21 Apr 2020 (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 outcome of implant therapy has been presented in the majority of clinical studies by focusing only on implant survival without providing detailed information on the reconstructions . However, for decision making, it is important to know the survival rates and the incidence of biological and technical complications not only for the implants but also for the reconstructions. Thus, the selection of restoration materials should be based on proper optical characteristics in addition to biocompatibility and sufficient strength of materials.
Monolithic zirconia has been used in posterior region, especially for single crowns, in order to eliminate the veneer cracking, But Since monolithic zirconia are relatively new, few randomized, controlled clinical studies have evaluated their success. There is only one study identified regarding the performance of monolithic ceramic restorations bonded to Ti inserts, investigating the clinical outcome of using monolithic or modified monolithic zirconia implant-supported single crowns and comparing outcomes and complications of metal-ceramic and monolithic or modified monolithic zirconia implant supported single crowns.
More clinical studies to evaluate the performance of CAD/CAM monolithic implant-supported restorations bonded to Ti inserts and bases and compare their survival, success and complication rates with other restorative options [with a mean follow-up period of at least 5 years are required for a meaningful interpretation of the survival and complication rate .
So this study aims to investigate outcomes and complications of implant supported modified monolithic zirconia and metal-ceramic single crowns in the posterior region of the mouth.
The null hypothesis is that there is no difference between modified monolithic zirconia and metal-ceramic posterior implant-supported SCs in prosthetic complication rates.
Detailed description
Background: Dental implants restored with single crowns (SCs) have been reported to have a comparable survival rate and fewer technical complications compared to multiple-unit implant-supported FDPs. Porcelain-fused to metal restorations were the golden standard option for implant supported reconstructions in the past, but nowadays, the application of all-ceramic restorations in general and specifically zirconia as a restorative material for implant-supported single crowns has increased utilizing the CAD/CAM technology. The continuous technological progress in both the computer-based development and the dental manufacturing process ensures new opportunities in the clinical workflow. A fully digital pathway in a model-free approach or a combination of these workflows is now possible.
Purpose: The purpose of this randomized controlled clinical trial is to investigate the prosthetic outcomes of posterior implant-supported single crowns (SCs) with a modified monolithic zirconia or metal-ceramic design utilizing the digital workflow at 1, 3 and 5 years of loading.
Materials and methods: This single-blind split mouth study will enroll 60 participants, having to receive 120 dental Implants. They will be scheduled for a bilateral posterior single-unit prosthetic rehabilitation supported by one implant in the posterior region of the maxilla or the mandible (premolars, molars). A fully digital pathway will be followed. A CT scan will be performed without any template. An intraoral optical impression using CEREC Omnicam scanner will be made. A virtual set-up of the prosthetic reconstruction, as well as a surgical template with optimal 3-D implant positioning will be designed then printed using a 3-D printer without the need of any physical model. Straumann bone level implants with either a wide diameter (Ø4.8 mm) or regular diameter (Ø4.1 mm) with a minimum length of 8 mm will be inserted. Implants will be loaded after 3 months of submerged healing. A second intraoral optical impression will be made using CEREC Omnicam scanner and Straumann scanbody. The implant-supported prosthetic suprastructure will be designed. Implants will be randomly allocated to either the test group modified monolithic zirconia crowns (MMZ) or the control group metal ceramic crowns (MC), using a computer-generated randomization list. A digital model with movable dies will be 3-D printed, then used to adjust restoration in terms of occlusal and proximal contacts. Prefabricated screw-retained Titanium abutments (Variobase Abutment; Straumann) will be used as the metal substructures of the crowns and will be secured to lab analogues on the digitally printed casts. Metal/ zirconia substructures with a hole for the screw retention will be designed using the CAD software and will be anatomically reduced by 1 mm to allow for porcelain veneering then will be laser-printed/ dry milled. Hand layering of glass ceramic will be made on the surface. Crowns will be cemented extraorally to titanium abutments using dual cure resin cement to make one-piece screw-retained single crown. The screw-retained single crowns and titanium abutments will be inserted intraorally with 35 Ncm torque and screw-access holes will be restored with Teflon and light-polymerized composite resin. The implant-supported SCs will be examined after 1, 3 and 5 years for survival and technical complications.
Clinical significance: to evaluate the survival and prosthetic complication rates of zirconia-ceramic and metal-ceramic implant-supported single crowns at 1, 3 and 5 years of service. In addition to that, the digital workflow for implant supported single crowns will be evaluated for efficiency, accuracy, time and cost compared to conventional workflow.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This single-blind split mouth study will enroll 60 participants, having to receive 120 dental Implants. They will be recruited from 3 dental centers in Jordan .
| Arm | Type | Receives |
|---|---|---|
| Experimental | Active comparator | Device: modified monolithic zirconia crowns, Device: Metal Ceramic crownsmodified monolithic zirconia crowns At the time of the second optical impression, implants will be randomly allocated to either the test group (modified monolithic zirconia crowns) or the control group (metal ceramic crowns), using a computer-generated randomization list. |
| control | Placebo comparator | Device: modified monolithic zirconia crowns, Device: Metal Ceramic crownsmetal ceramic crowns At the time of the second optical impression, implants will be randomly allocated to either the test group (modified monolithic zirconia crowns) or the control group (metal ceramic crowns), using a computer-generated randomization list. |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- · Participants will be required to sign informed consents prior to inclusion in the study.
Key exclusion criteria (6 listed)
- Systemic disease
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 |
|---|---|---|
| modified monolithic zirconia crownsAlso: Zirconiaoutcomes and complications of implant restoration | Device | Experimental, control |
| Metal Ceramic crownsAlso: Metal-Ceramicoutcomes and complications of implant restoration | Device | Experimental, control |
Primary outcome
Screw loosing
Time frame: 5 years
Alpha rating: no screw loosening Bravo rating: loose screw that can be retightened Delta rating: fractured screw that needs replacement
Marginal integrity
Time frame: 5 years
Visual inspection with dental explorer to the abutment-restoration interphase under fourfold to fivefold optical magnification. Digital bitewing radiographs with standardized paralleling technique using Ring holders and analogue films will be taken at baseline then at each recall visit and compared together for any misfits or gaps. Alpha rating: no visible or soundable gap Bravo rating: marginal gap slightly soundable Charlie rating: explorer penetrates a significant crevice Delta rating: restoration needs to be replaced
chipping of veneering ceramic
Time frame: 5 years
Visual and tactile inspection of the restorations will be made to check for any chippings of the restoration. Fourfold to fivefold optical magnification will be used. Clinical photographs will be taken for crowns and neighboring teeth at delivery stage. Impressions will be made as well and poured into stone. New impressions will be made at each recall visit, poured into stone, then stone casts will be evaluated using a light microscope and compared with surface topography of casts made at prosthetic delivery stage to detect any potential minor chip-off fractures. * Alpha rating: No fracture * Bravo rating: minor chipping (polishable) * Charlie rating: major chipping (up to framework) * Delta rating: restoration needs to be replaced If chipping rating changes during the observation period, the most severe rating will be recorded
occlusal roughness
Time frame: 5 years
Crowns will be dried at each recall visit and visually inspected under fourfold to fivefold optical magnification for any roughness. Alpha rating: no roughness Bravo rating: slight roughness (< 2mm) Charlie rating: obvious roughness (> 2mm) Delta rating: restoration needs to be replaced If roughness rating changes during the observation period, the most severe rating will be recorded
framework fracture
Time frame: 5 years
Visual and tactile inspection of the restorations will be made to check for fracture or loss of the restoration. Fourfold to fivefold optical magnification will be used. Clinical photographs will be also taken for crowns and neighboring teeth at delivery stage then at each recall visit and compared together. * Alpha rating: No fracture * Delta rating: restoration needs to be replaced If fracture rating changes during the observation period, the most severe rating will be recorded.
2 secondary outcomes
Marginal bone loss:
Time frame: 1 year
Crown de-bonding
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2020.
- 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.
esam Alem, Prosthetic contact
Rola Alhabshneh, Prof principal investigator
JUST
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing modified monolithic zirconia crowns and Metal Ceramic crowns in people with Posterior Occlusion and Fracture, run by Jordan University of Science and Technology at 1 site in Jordan.
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 14 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: status not confirmed, as of the sponsor's last update on 22 Apr 2020. 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 Jordan. 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. Some participants in this study may receive a placebo. 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 Rola Alhabshneh, Prof (+962796064813, raalhabashneh@just.edu.jo), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Screw loosing (time frame: 5 years). The study lists 5 primary outcomes in all. 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 2020.