The Impact of Adhesion Strategy on the Clinical Performance Of Indirect Dental Restorations

NCT07644676 | Enrolling By Invitation

• 1 other identifier: 2026-03170-01
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this clinical trial is to evaluate whether different cement systems influence the clinical outcome of posterior tooth supported zirconia crowns in adult patients requiring single crown restorations. The main questions it aims to answer are:

• Do glass ionomer cements provide clinical outcomes comparable to those of resin cements for posterior zirconia crowns?
• Do marginal discoloration, marginal integrity, and biological complications differ between the cement systems?
• Do patient reported and clinician reported outcomes differ between the cementation procedures? Researchers will compare zirconia crowns cemented with either a glass ionomer cement or a resin cement to evaluate differences in clinical outcomes. Participants will:
• Receive posterior zirconia crowns fabricated according to standardized clinical procedures
• Be randomized to cementation with either a glass ionomer cement or a resin cement
• Undergo clinical examinations assessing crown survival, marginal adaptation, discoloration, caries, periodontal status, and wear
• Complete questionnaires regarding patient comfort and treatment experience
• Attend baseline and annual follow-up examinations for up to 10 years

Conditions

Healthy Adult Participants; Tooth Fracture

Keywords

crown; zirconia; dental cement; clinical trial

Outcome Measures

Primary Outcomes (4)

• Clinical outcome of tooth-supported zirconia crowns from baseline to 1-year follow up

  Clinical performance of tooth supported zirconia crowns assessed using modified CDA criteria, including survival, success, biological complications, technical complications, marginal integrity, discoloration, and surface morphology.

  Baseline and 1 year.

• Clinical outcome of tooth-supported zirconia crowns from baseline to 3-year follow up

  Clinical performance of tooth supported zirconia crowns assessed using modified CDA criteria, including survival, success, biological complications, technical complications, marginal integrity, discoloration, and surface morphology.

  Baseline and 3 years.

• Clinical outcome of tooth-supported zirconia crowns from baseline to 5-year follow up

  Clinical performance of tooth supported zirconia crowns assessed using modified CDA criteria, including survival, success, biological complications, technical complications, marginal integrity, discoloration, and surface morphology.

  Baseline and 5 years.

• Clinical outcome of tooth-supported zirconia crowns from baseline to 10-year follow up

  Clinical performance of tooth supported zirconia crowns assessed using modified CDA criteria, including survival, success, biological complications, technical complications, marginal integrity, discoloration, and surface morphology.

  Baseline and 10 years.

Secondary Outcomes (2)

• Change from Baseline in "Patient-reported Outcome Measurement" at 1 year

  Baseline and 1 year.

• Change from Baseline in "Patient-reported Outcome Measurement" at 3 year

  Baseline and 3 year.

Study Arms (2)

Resin cement

ACTIVE COMPARATOR

Tooth-supported zirconia crowns cemented with a resin-based cement

Other: Resin cement

Glass-ionomer cement

ACTIVE COMPARATOR

Tooth-supported zirconia crowns cemented with a glass-ionomer cement

Other: Glass-ionomer cement

Interventions

Resin cement OTHER

Zirconia crowns cemented with resin cement

Resin cement

Glass-ionomer cement OTHER

Zirconia crowns cemented with glass-ionomer cement

Glass-ionomer cement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Need of one single crown on vital posterior tooth
• Speak and understand Swedish language
• Free from dental/oral disease; caries, periodontal disease

Sponsors & Collaborators

• Malmö University: lead

Study Sites (2)

Sandin Dentalklinik

Hörby, Skåne County, Sweden

Location

Tandläkare Le

Malmö, Skåne County, 21118, Sweden

Location

MeSH Terms

Conditions

Tooth Fractures

Interventions

Resin Cements; Glass Ionomer Cements

Condition Hierarchy (Ancestors)

Tooth Injuries; Tooth Diseases; Stomatognathic Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Resins, Synthetic; Plastics; Polymers; Macromolecular Substances; Dental Cements; Dental Materials; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Christel Larsson, Ph.D.

  Malmö University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: June 12, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): June 1, 2036
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)