A Clinical Trial to Compare the Safety and Performance of Two Different Curing Modes in the Direct Filling Therapy in Deciduous Teeth

NCT07212660 | Recruiting

• 1 other identifier: OTCS 369512033
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

Brief Summary

The overall aim of this clinical investigation is to assess the clinical performance and safety of composite restorations cured with fast curing mode (5 seconds with 2000 mW/cm²) in primary molars.

Conditions

Insufficient Dental Filling; Dental Caries

Outcome Measures

Primary Outcomes (1)

• Postoperative pain

  The assessment of postoperative pain will be done by using the Wong-Baker Faces Pain rating Scale and includes questions about type and duration of pain, intensity of pain and the type of stimulus causing the pain. Values of 0 and 2 in the Wong-Baker Faces Pain Rating Scale are considered as no pain and values \>2 as pain.

  4-10 days after placement of the dental fillings

Study Arms (2)

Fast curing mode

EXPERIMENTAL

Composite restoration is cured with Turbo mode (5 seconds with 2000 mW/cm²).

Device: Fast curing mode

Conventional curing mode

OTHER

Composite restoration is cured with High mode (10 seconds with 1200 mW/cm²).

Device: Conventional curing mode

Interventions

Fast curing mode DEVICE

Composite restoration is cured with Turbo mode (5 seconds with 2000 mW/cm²).

Fast curing mode

Conventional curing mode DEVICE

Composite restoration is cured with High mode (10 seconds with 1200 mW/cm²).

Conventional curing mode

Eligibility Criteria

• Age: 4 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Consent of a legal representative (usually parents)
• deciduous molars in the need of direct filling therapy class I and/or II in different quadrants (primary or secondary caries, filling loss)
• Classification of caries: caries of all sizes in deciduous molars are included unless they can be treated with fissure sealing (ICDAS 3, 4, 5)
• Sufficient language skills of legal representative and children
• Teeth in the need of indirect pulp capping if necessary (Operator decision)

You may not qualify if:

• Cognitive impairment not age-appropriate
• Sensitive tooth (pain at night, irritation-persistent pain, buccal swelling, percussion sensitivity)
• Teeth with severely resorbed roots (anormal tooth mobility)
• Direct pulp capping
• Pulpotomy of an adjacent tooth in the same appointment
• Noncompliant child
• Allergies to material or anaesthetics used in the study
• Sufficient isolation not possible

Sponsors & Collaborators

• Ivoclar Vivadent AG: lead

Study Sites (2)

N|DENT Zahnarztpraxis

Herzogenbuchsee, Canton of Bern, 3360, Switzerland

RECRUITING

Zahnarztpraxis Chrüzhof

Willisau, Canton of Lucerne, 6130, Switzerland

RECRUITING

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Split-mouth design: each patient receives 2 dental fillings (test and control treatment in the same patient)

Study Record Dates

• First Submitted: October 1, 2025
• First Posted: October 8, 2025
• Study Start: December 18, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (2)