Crowns (MeSH Unique ID: D003442), Single ToothNCT04474093
Monolithic CAD/CAM Single Tooth Ceramic Crowns
A study testing Zirconium-reinforced glass ceramics(ZRGC),Lithium disilicate glass ceramics(LGC), Resin infiltrated glass ceramics(RIGC) in people with Crowns (MeSH Unique ID: D003442), Single Tooth and Dental Porcelain (MeSH Unique ID: D003776), run by Hacettepe University.
Trial summary
With the development of Computer Aided Design and Computer Aided manufacturing (CAD / CAM) systems, all ceramic restorations have been used with high success rates during the past 30 years in order to eliminate the disadvantages of metal ceramic restorations. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Crowns (MeSH Unique ID: D003442), Single Tooth, Dental Porcelain (MeSH Unique ID: D003776)
- What is being tested?
- Zirconium-reinforced glass ceramics(ZRGC),Lithium disilicate glass ceramics(LGC), Resin infiltrated glass ceramics(RIGC)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 24 Aug 2016to Nov 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years old
- Individuals who have signed the informed consent form
- Periodontally stable patients
- Having devital teeth need to be restored in the posterior region
- Having natural dentition or minimally invasive restoration against the restored tooth.
Who cannot join
- Diagnosed patients with temporomandibular joint problems
- Insufficient supportive tooth tissue for restoration
About this study
Official title: Monolithic CAD/CAM Single Tooth Crowns Made From Different Ceramics: One Year Preliminary Results of a Randomized Clinical Trial
With the development of Computer Aided Design and Computer Aided manufacturing (CAD / CAM) systems, all ceramic restorations have been used with high success rates during the past 30 years in order to eliminate the disadvantages of metal ceramic restorations. Based on these developments, in every passing days new ceramic materials has been added to dental market. The aim of the present study was evaluating clinical results of single-tooth ceramic crowns in the posterior region produced from three different monolithic ceramic materials.
- Conditions
- Crowns (MeSH Unique ID: D003442), Single Tooth, Dental Porcelain (MeSH Unique ID: D003776)
- Being tested
- Zirconium-reinforced glass ceramics(ZRGC),Lithium disilicate glass ceramics(LGC), Resin infiltrated glass ceramics(RIGC)
- Keywords
- Zirconium-reinforced glass ceramics(ZRGC), Lithium disilicate glass ceramics(LGC), Resin infiltrated glass ceramics(RIGC), Monolithic single tooth restoration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zirconium-reinforced glass ceramics(ZRGC),Lithium disilicate glass ceramics(LGC), Resin infiltrated glass ceramics(RIGC)Other
| Study group | Role | What they receive |
|---|---|---|
| Zirconium-reinforced glass ceramics (ZRGC) | Active comparator | 12 posterior single tooth crowns made from monolithic zirconium-reinforced glass ceramics(ZRGC). Restorations were evaluated prosthetic and periodontal criteria at baseline, after 6 and 12 months. While prosthetic evaluation was performed according to Modified US Public Health Service criteria; probing depth(PD), clinical attachment level(CAL), gingival bleeding time index(GBTI), gingival(GI) and periodontal index(PI) were used in periodontal evaluation. Receives: Other: Zirconium-reinforced glass ceramics(ZRGC),Lithium disilicate glass ceramics(LGC), Resin infiltrated glass ceramics(RIGC) |
| Lithium disilicate glass ceramics (LGC) | Active comparator | Group 2: 12 posterior single tooth crowns made from monolithic lithium disilicate glass ceramics(LGC). Restorations were evaluated prosthetic and periodontal criteria at baseline, after 6 and 12 months. While prosthetic evaluation was performed according to Modified US Public Health Service criteria; probing depth(PD), clinical attachment level(CAL), gingival bleeding time index(GBTI), gingival(GI) and periodontal index(PI) were used in periodontal evaluation. Receives: Other: Zirconium-reinforced glass ceramics(ZRGC),Lithium disilicate glass ceramics(LGC), Resin infiltrated glass ceramics(RIGC) |
| Resin infiltrated glass ceramics (RIGC) | Active comparator | 12 posterior single tooth crowns made from monolithic resin infiltrated glass ceramics(RIGC). Restorations were evaluated prosthetic and periodontal criteria at baseline, after 6 and 12 months. While prosthetic evaluation was performed according to Modified US Public Health Service criteria; probing depth(PD), clinical attachment level(CAL), gingival bleeding time index(GBTI), gingival(GI) and periodontal index(PI) were used in periodontal evaluation. Receives: Other: Zirconium-reinforced glass ceramics(ZRGC),Lithium disilicate glass ceramics(LGC), Resin infiltrated glass ceramics(RIGC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate and success (changes over time)
12 crowns were made from each group of three different ceramics: ZRGC, LDGC and RIGC. Thereafter, the restorations was evaluated in terms of any failure or loss of the restoration at any follow-up (6th and 12th months) periods. The results were obtained proportionally in percent (%).
Measured: 1 year (Baseline to 12 months)
Prosthetic evaluation changes
As recorded at the baseline (0), each restoration was assessed according to the modified the United States Public Health Service (USPHS) Ryge Criteria for prosthetic evaluation by a calibrated prosthodontics.USPHS criteria is based on the following ratings: Color match (Alpha,Bravo, Charlie), cavosurface marginal discoloration (Alpha,Bravo, Charlie), secondary caries (Alpha,Bravo), anatomic contour (Alpha,Bravo, Charlie), marginal integrity (Alpha,Bravo, Charlie), surface texture (Alpha,Bravo, Charlie) and gross fracture (Alpha,Bravo, Charlie).
Measured: 1 year (Baseline to 12 months)
Periodontal evaluation changes
Probing depth(PD): Probing depth is defined as the distance from the free gingival margin to the bottom of the periodontal pocket (mm).
Clinical attachment level(CAL): The loss of CAL were measured and calculated by measuring recession and subtracting the periodontal probing depth (mm).
Gingival bleeding time index(GBTI): The probe were swiped at apical portion of the gingival crevice from line angle interproximally and after 10 seconds assessed if there was bleeding or no bleeding on the mesial and distal (unit/tooth).
Plaque index(PI, according to Silness and Löe, 1964): The total mean PI is the sum of the individual scores divided by the number of investigated sites. The thickness and extension of plaque were assessed (unit/tooth).
Gingival index(GI, according to Löe, 1967): The total mean GI is the sum of the individual scores divided by the number of investigated sites. The GI for each tooth is the sum of the 4 individual scores divided by 4 (unit/tooth).
Measured: 1 year (Baseline to 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2020
- Study start24 Aug 2016
- Primary completionNov 2018
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crowns (MeSH Unique ID: D003442), Single ToothStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diler Deniz, Hacettepe University
- Investigators
- Diler DENİZ, DDS, MSD, Principal investigator, Clinical InstructorGüliz AKTAŞ, DDS,PhD, Study director, Associate ProfessorM.Barış GÜNCÜ, DDS,PhD, Study chair, Associate ProfessorGüliz N. GÜNCÜ, DDS,PhD, Study chair, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04474093
- Sponsor's protocol ID
- KA-16029
- Other IDs
- THD-2016-11741
- Status last verified
- Jul 2020
- First submitted
- 2 Jul 2020
- Last updated
- 16 Jul 2020
- Results posted
- No
- 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 16 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monolithic CAD/CAM Single Tooth Crowns Made From Different Ceramics: One Year Preliminary Results of a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04474093
- Acronym / sponsor ID
- KA-16029
- Conditions
- Crowns (MeSH Unique ID: D003442), Single Tooth, Dental Porcelain (MeSH Unique ID: D003776)
- Keywords
- Zirconium-reinforced glass ceramics(ZRGC), Lithium disilicate glass ceramics(LGC), Resin infiltrated glass ceramics(RIGC), Monolithic single tooth restoration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 24 Aug 2016 (actual)
- Primary completion
- Nov 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 16 Jul 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.
With the development of Computer Aided Design and Computer Aided manufacturing (CAD / CAM) systems, all ceramic restorations have been used with high success rates during the past 30 years in order to eliminate the disadvantages of metal ceramic restorations. Based on these developments, in every passing days new ceramic materials has been added to dental market. The aim of the present study was evaluating clinical results of single-tooth ceramic crowns in the posterior region produced from three different monolithic ceramic materials.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Zirconium-reinforced glass ceramics (ZRGC) | Active comparator | Other: Zirconium-reinforced glass ceramics(ZRGC),Lithium disilicate glass ceramics(LGC), Resin infiltrated glass ceramics(RIGC)12 posterior single tooth crowns made from monolithic zirconium-reinforced glass ceramics(ZRGC). Restorations were evaluated prosthetic and periodontal criteria at baseline, after 6 and 12 months. While prosthetic evaluation was performed according to Modified US Public Health Service criteria; probing depth(PD), clinical attachment level(CAL), gingival bleeding time index(GBTI), gingival(GI) and periodontal index(PI) were used in periodontal evaluation. |
| Lithium disilicate glass ceramics (LGC) | Active comparator | Other: Zirconium-reinforced glass ceramics(ZRGC),Lithium disilicate glass ceramics(LGC), Resin infiltrated glass ceramics(RIGC)Group 2: 12 posterior single tooth crowns made from monolithic lithium disilicate glass ceramics(LGC). Restorations were evaluated prosthetic and periodontal criteria at baseline, after 6 and 12 months. While prosthetic evaluation was performed according to Modified US Public Health Service criteria; probing depth(PD), clinical attachment level(CAL), gingival bleeding time index(GBTI), gingival(GI) and periodontal index(PI) were used in periodontal evaluation. |
| Resin infiltrated glass ceramics (RIGC) | Active comparator | Other: Zirconium-reinforced glass ceramics(ZRGC),Lithium disilicate glass ceramics(LGC), Resin infiltrated glass ceramics(RIGC)12 posterior single tooth crowns made from monolithic resin infiltrated glass ceramics(RIGC). Restorations were evaluated prosthetic and periodontal criteria at baseline, after 6 and 12 months. While prosthetic evaluation was performed according to Modified US Public Health Service criteria; probing depth(PD), clinical attachment level(CAL), gingival bleeding time index(GBTI), gingival(GI) and periodontal index(PI) were used in periodontal evaluation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years old
- Individuals who have signed the informed consent form
- Periodontally stable patients
- Having devital teeth need to be restored in the posterior region
- Having natural dentition or minimally invasive restoration against the restored tooth.
Key exclusion criteria (2 listed)
- Diagnosed patients with temporomandibular joint problems
- Insufficient supportive tooth tissue for restoration
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 |
|---|---|---|
| Zirconium-reinforced glass ceramics(ZRGC),Lithium disilicate glass ceramics(LGC), Resin infiltrated glass ceramics(RIGC) | Other | Lithium disilicate glass ceramics (LGC), Resin infiltrated glass ceramics (RIGC), Zirconium-reinforced glass ceramics (ZRGC) |
Primary outcome
Survival rate and success (changes over time)
Time frame: 1 year (Baseline to 12 months)
12 crowns were made from each group of three different ceramics: ZRGC, LDGC and RIGC. Thereafter, the restorations was evaluated in terms of any failure or loss of the restoration at any follow-up (6th and 12th months) periods. The results were obtained proportionally in percent (%).
Prosthetic evaluation changes
Time frame: 1 year (Baseline to 12 months)
As recorded at the baseline (0), each restoration was assessed according to the modified the United States Public Health Service (USPHS) Ryge Criteria for prosthetic evaluation by a calibrated prosthodontics.USPHS criteria is based on the following ratings: Color match (Alpha,Bravo, Charlie), cavosurface marginal discoloration (Alpha,Bravo, Charlie), secondary caries (Alpha,Bravo), anatomic contour (Alpha,Bravo, Charlie), marginal integrity (Alpha,Bravo, Charlie), surface texture (Alpha,Bravo, Charlie) and gross fracture (Alpha,Bravo, Charlie).
Periodontal evaluation changes
Time frame: 1 year (Baseline to 12 months)
Probing depth(PD): Probing depth is defined as the distance from the free gingival margin to the bottom of the periodontal pocket (mm). Clinical attachment level(CAL): The loss of CAL were measured and calculated by measuring recession and subtracting the periodontal probing depth (mm). Gingival bleeding time index(GBTI): The probe were swiped at apical portion of the gingival crevice from line angle interproximally and after 10 seconds assessed if there was bleeding or no bleeding on the mesial and distal (unit/tooth). Plaque index(PI, according to Silness and Löe, 1964): The total mean PI is the sum of the individual scores divided by the number of investigated sites. The thickness and extension of plaque were assessed (unit/tooth). Gingival index(GI, according to Löe, 1967): The total mean GI is the sum of the individual scores divided by the number of investigated sites. The GI for each tooth is the sum of the 4 individual scores divided by 4 (unit/tooth).
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 16 Jul 2020.
- 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.
Diler DENİZ, DDS, MSD principal investigator
Clinical Instructor
Güliz AKTAŞ, DDS,PhD study director
Associate Professor
M.Barış GÜNCÜ, DDS,PhD study chair
Associate Professor
Questions about this trial
What is this clinical trial studying?
A study testing Zirconium-reinforced glass ceramics(ZRGC),Lithium disilicate glass ceramics(LGC), Resin infiltrated glass ceramics(RIGC) in people with Crowns (MeSH Unique ID: D003442), Single Tooth and Dental Porcelain (MeSH Unique ID: D003776), run by Hacettepe University.
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 5 inclusion and 2 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 16 Jul 2020. 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?
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?
Survival rate and success (changes over time) (time frame: 1 year (Baseline to 12 months)). The study lists 3 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 16 Jul 2020.