Monolithic CAD/CAM Single Tooth Ceramic Crowns

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.

Study Overview

• Status: Completed
• Conditions: Crowns (MeSH Unique ID: D003442), Single Tooth; Dental Porcelain (MeSH Unique ID: D003776)
• Intervention / Treatment: Other: Zirconium-reinforced glass ceramics(ZRGC),Lithium disilicate glass ceramics(LGC), Resin infiltrated glass ceramics(RIGC)

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Diagnosed patients with temporomandibular joint problems
• Insufficient supportive tooth tissue for restoration

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Zirconium-reinforced glass ceramics (ZRGC); 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.	Other: Zirconium-reinforced glass ceramics(ZRGC),Lithium disilicate glass ceramics(LGC), Resin infiltrated glass ceramics(RIGC)
Active Comparator: Lithium disilicate glass ceramics (LGC); 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.	Other: Zirconium-reinforced glass ceramics(ZRGC),Lithium disilicate glass ceramics(LGC), Resin infiltrated glass ceramics(RIGC)
Active Comparator: 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.	Other: Zirconium-reinforced glass ceramics(ZRGC),Lithium disilicate glass ceramics(LGC), Resin infiltrated glass ceramics(RIGC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 (%).	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).	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).	1 year (Baseline to 12 months)

Collaborators and Investigators

• Sponsor: Hacettepe University
• Investigators: Principal Investigator: Diler DENİZ, DDS, MSD, Clinical Instructor; Study Director: Güliz AKTAŞ, DDS,PhD, Associate Professor; Study Chair: M.Barış GÜNCÜ, DDS,PhD, Associate Professor; Study Chair: Güliz N. GÜNCÜ, DDS,PhD, Professor

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2016
• Primary Completion (Actual): November 1, 2018
• Study Completion (Actual): November 1, 2018

Study Registration Dates

• First Submitted: July 2, 2020
• First Submitted That Met QC Criteria: July 15, 2020
• First Posted (Actual): July 16, 2020

Study Record Updates

• Last Update Posted (Actual): July 16, 2020
• Last Update Submitted That Met QC Criteria: July 15, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Zirconium-reinforced glass ceramics(ZRGC); Lithium disilicate glass ceramics(LGC); Resin infiltrated glass ceramics(RIGC); Monolithic single tooth restoration
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Tranquilizing Agents; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Dopamine Agents; Antimanic Agents; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Sympathomimetics; Adrenergic Uptake Inhibitors; Methamphetamine; Lithium Carbonate
• Other Study ID Numbers: KA-16029; THD-2016-11741 (Other Identifier: ( Other Grant/Funding Number: HacettepeU Scientific Research Projects Coordination Unit ))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No