Monolithic CAD/CAM Single Tooth Ceramic Crowns

NCT04474093 | Completed

• 2 other identifiers: KA-16029THD-2016-11741
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief 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. 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)

Keywords

Zirconium-reinforced glass ceramics(ZRGC); Lithium disilicate glass ceramics(LGC); Resin infiltrated glass ceramics(RIGC); Monolithic single tooth restoration

Outcome Measures

Primary Outcomes (3)

• 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)

Study Arms (3)

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.

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.

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.

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

Interventions

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hacettepe University: lead

Study Officials

• Diler DENİZ, DDS, MSD

  Clinical Instructor

  PRINCIPAL INVESTIGATOR

• Güliz AKTAŞ, DDS,PhD

  Associate Professor

  STUDY DIRECTOR

• M.Barış GÜNCÜ, DDS,PhD

  Associate Professor

  STUDY CHAIR

• Güliz N. GÜNCÜ, DDS,PhD

  Professor

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Instructor, Prosthetic Dentistry

Study Record Dates

• First Submitted: July 2, 2020
• First Posted: July 16, 2020
• Study Start: August 24, 2016
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: July 16, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share