Completed

NCT Number: NCT04474093

Monolithic CAD/CAM Single Tooth Ceramic Crowns

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.

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Key information

Conditions

Crowns (MeSH Unique ID: D003442), Single Tooth Dental Porcelain (MeSH Unique ID: D003776)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zirconium-reinforced glass ceramics(ZRGC),Lithium disilicate glass ceramics(LGC), Resin infiltrated glass ceramics(RIGC)

Other

Primary outcomes

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).

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

Monolithic CAD/CAM Single Tooth Crowns Made From Different Ceramics: One Year Preliminary Results of a Randomized Clinical Trial

Important dates

Study start: 2016
Primary completion: 2018
Study completion: 2018
First posted: Jul 16, 2020
Registry last updated: Jul 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.