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NCT Number: NCT07667946

Effect of Different Cavity Designs on the Clinical Performance of 3D- Printed Resin Composite Partial-Coverage Restorations in Vital Molars

This randomized clinical trial aims to evaluate the effect of different cavity designs on the clinical performance of 3D-printed resin composite partial-coverage restorations in vital molars with complex cavities over an 18-month follow-up period.

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Key information

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Despite these material advancements, growing evidence indicates that cavity preparation design exerts a greater influence on the clinical performance of indirect restorations than material selection alone. However, current evidence regarding preparation design is predominantly derived from in vitro studies and remains inadequately validated under clinical conditions, particularly in vital molars. Although recent randomized clinical trials have begun to address this gap, available data remain limited and largely confined to endodontically treated teeth. Therefore, a rigorously designed randomized clinical trial is warranted to evaluate the influence of different cavity preparation designs on the clinical performance of indirect restorations in vital molars.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients aging 20-45 years.
  • Healthy males and females
  • Patients with good oral hygiene
  • Patients presenting with at least one eligible permanent molar requiring a partial-coverage restoration.
  • Patients willing and able to attend scheduled follow-up visits for 18 months.
  • Permanent maxillary or mandibular molars.
  • Vital teeth with a positive response to cold thermal testing.
  • Complex Large or severely compromised cavities resulting from primary or secondary caries (ICDAS 5 or 6) and/or replacement of large defective restorations with at least 2 missing cavity walls requiring overlay restorations
  • Well-formed and fully erupted in normal functional occlusion with natural antagonist and adjacent teeth.
  • Absence of any radiographic, periodontal or periapical changes.

Exclusion criteria

  • Participants with general/systemic illness.
  • Pregnant or lactating females.
  • Concomitant participation in another research study.
  • Inability or unwillingness to comply with study visits and procedures.
  • Heavy bruxism or other parafunctional habits
  • Known allergic reactions against any components of the used materials
  • Patients receiving orthodontic treatment.
  • Poor oral hygiene or high caries activity.
  • Non vital teeth.
  • Hypersensitive teeth.
  • Teeth with prior endodontic treatment.
  • Teeth with spontaneous pain or signs/symptoms of irreversible pulpitis.
  • Teeth with advanced periodontal disease or mobility.
  • Teeth with a history of direct or indirect pulp capping procedure.
  • Teeth with vertical root fractures or cracked tooth syndrome

Treatment and study plan

Anatomical cavity design preparation

Procedure

Cavity preparation design for adhesive restoration

Butt joint cavity design preparation

Procedure

Cavity preparation design for adhesive restoration

Primary outcomes

  1. Fracture

    Time frame: 18 Months

    Modified USPHS Ryge Criteria (Ordinal scoring system)

Secondary outcomes

  1. Retention, marginal integrity, marginal discoloration, wear/anatomic form, secondary caries and surface texture

    Time frame: 18 Months

    Modified USPHS Ryge Criteria (Ordinal scoring system)

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Effect of Different Cavity Designs on the Clinical Performance of 3D- Printed Resin Composite Partial-Coverage Restorations in Vital Molars With Complex Cavities: An 18 Month Randomized Clinical Trial

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 25, 2026
Registry last updated
Jun 25, 2026

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.

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