NCT04474093|Completed
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Sponsor study identifier
Secondary identifiers
OTHER · ( Other Grant/Funding Number: HacettepeU Scientific Research Projects Coordination Unit )
interventional
36
0 countries
N/A
Study Start
August 24, 2016
Actual (reported)Primary Completion
November 2018
Actual (reported)Study Completion
November 2018
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2018
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 24, 2016
Actual (reported)November 2018
Actual (reported)November 2018
Actual (reported)July 2, 2020
Actual (reported)July 16, 2020
Actual (reported)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).
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Diler DENİZ, DDS, MSD
Clinical Instructor
Güliz AKTAŞ, DDS,PhD
Associate Professor
M.Barış GÜNCÜ, DDS,PhD
Associate Professor
Güliz N. GÜNCÜ, DDS,PhD
Professor
36 participants (actual enrollment reported by the registry).
First Submitted
July 2, 2020
First Posted
July 16, 2020
Study Start
August 24, 2016
Actual (reported)1 year (Baseline to 12 months)
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.
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Primary Completion
November 2018
Actual (reported)Study Completion
November 2018
Actual (reported)Last Updated
July 16, 2020
Record last verified: 2020-07
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Source: ClinicalTrials.gov.
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