Vital and Non-vital Posterior Teeth Restored With Onlays and Single Crowns Using Three Different Restorative Materials.

Dr. med. dent. Malin Strasding

Status: Completed

Conditions: Decayed Teeth

Treatments: Procedure: Onlay preparation; Procedure: Crown preparation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07259265

GTC Study

Details and patient eligibility

About

The objective of this study is to assess the survival rate and the biological and technical outcomes of onlays and single crowns made out of different restorative materials on vital and non-vital teeth. The onlays are made either out of a lithium-disilicate glass ceramic (E.max CAD, Ivoclar Vivadent), hybrid ceramic (VITA ENAMIC, VITA Zahnfabrik) or out of a lithium aluminosilicate glass ceramic reinforced with lithium disilicate (N!ce, Straumann). The crowns are made either out of lithium aluminosilicate glass ceramic reinforced with lithium disilicate (N!ce, Straumann), hybrid ceramic (VITA ENAMIC, VITA Zahnfabrik) or lithium-disilicate glass ceramic (E.max CAD, Ivoclar Vivadent).

Enrollment: 120 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• • Subjects with the need for a fixed reconstruction in premolar and molar region with indication for either crown or onlay.

  • min. 18 years of age and ≤ 80 years
  • Patient with physical status PS1 and PS2 (according to Physical Status Classification System of the American Society of Anesthesiologists; Attachment 5)
  • Capable of providing written informed consent
  • Absence of any active periodontal and pulpal disease

Exclusion criteria

• Presence of conditions requiring chronic routine prophylactic use of antibiotics or prolonged use of steroids e.g. history of rheumatic heart disease, bacterial endocarditis, cardiac vascular anomalies, prosthetic joint replacements, etc.
• Patients with history of renal failure, bleeding disorders, metabolic bone disorder, uncontrolled endocrine disorders, HIV infection, Hepatitis
• History of neoplastic disease requiring the use of radiation or chemotherapy
• Inability to perform adequate oral hygiene
• Significant reduced saliva flow rate
• Unable or unwilling to cooperate for the trial period
• Allergy to any components of the reconstruction materials and cements
• Alcohol or drug abuse
• Pregnant or lactating women

Specific criteria:

• Root caries / root canal caries
• Extreme short dental arch (eSDA)
• Severe bruxism or clenching habits

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Crown restoration

Active Comparator group

Description:

The tooth is restored with a conventional, full-coverage crown.

Treatment:

Procedure: Crown preparation

Onlay restoration

Experimental group

Description:

The tooth is restored with a defect-oriented onlay.

Treatment:

Procedure: Onlay preparation