Comparative Evaluation of Non-Invasive Caries Detection methodsin Adolescents: Conventional Methods versus Intraoral Scanner Technology

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00037003

Enrollment

Registered

2025-11-26

Start date

2025-12-03

Completion date

Unknown

Last updated

2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

K02.1

Interventions

Group 1: Shortly before the start of the Multiband(MB) phase or aligner therapy, adolescents aged between 12 and 17 receive an intraoral scan with iTero Element 5D Plus, an intraoral scan with Trios 4

Eligibility

Sex/Gender

All

Age

12 Years to 18 Years

Inclusion criteria

Inclusion criteria: •Adolescents aged 12 years up to completion of 17 years (early permanent dentition). •Adolescents shortly before the start of the MB phase or undergoing orthodontic treatment. •Adolescents with ICDAS II Code 3 on at least one tooth and/or •Adolescents requiring minimally invasive/non-invasive dental treatment (e.g. initial carious lesions, active carious lesions).

Exclusion criteria

Exclusion criteria: •Adolescents with a severe systemic disease. •Adolescents with low caries risk (ICDAS II Code 0, ICDAS II Code 1, ICDAS II Code 2). •Adolescents whose native language is not German. •Structural anomalies of the teeth. •Trauma to the teeth and/or late consequences of dental trauma. •Objection or refusal of consent by the legal guardians.

Design outcomes

Primary

Measure	Time frame
The primary endpoint measures how accurately (sensitivity, specifity) intraoral scanners detect caries in adolescents compared with clinical examination. When (time of assessment): Assessed once during the same examination (T0). How: Conventional clinical examination including ICDAS (International Caries Detection and Assessment System) scoring and intraoral scanner diagnostics (Trios 4/5, iTero and Emerald S)	—

Measure

Time frame

The primary endpoint measures how accurately (sensitivity, specifity) intraoral scanners detect caries in adolescents compared with clinical examination. When (time of assessment): Assessed once during the same examination (T0). How: Conventional clinical examination including ICDAS (International Caries Detection and Assessment System) scoring and intraoral scanner diagnostics (Trios 4/5, iTero and Emerald S)

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Secondary

Measure	Time frame
Agreement of diagnoses between the different intraoral scanners as well as between scanner-based diagnostics and conventional diagnostics. Assessment of patient comfort using a standadized questionnaire with a numerical scale (1 =very comfortable, 5 =very uncomfortable). When: Collected during the same examination session (T0). How: Comparison of scanner vs. scanner and scanner vs. ICDAS. Patient comfort is recorded using a questionnaire.	—

Measure

Time frame

Agreement of diagnoses between the different intraoral scanners as well as between scanner-based diagnostics and conventional diagnostics. Assessment of patient comfort using a standadized questionnaire with a numerical scale (1 =very comfortable, 5 =very uncomfortable). When: Collected during the same examination session (T0). How: Comparison of scanner vs. scanner and scanner vs. ICDAS. Patient comfort is recorded using a questionnaire.

—

Countries

Germany

Contacts

Public ContactSimona Schick

Poliklinik für Zahnerhaltungskunde, Universitätsklinikum heidelberg

simona.schick@med.uni-heidelberg.de+4962215636827

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026