Clinical evaluation of flowable composite materials in small Class I restorations: 3-year randomized trial

Clinical evaluation of flowable composite materials in small Class I restorations: 3-year randomized trial - Clinical evaluation of flowable composite

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00017616

Enrollment

103

Registered

2019-07-23

Start date

2013-02-23

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

K00-K14 K02

Interventions

Group 1: Group Grandio Flow: Inorganic glass ceramic fillers, Bis-GMA, TEGDMA, HEDMA, inorganic filler 80% loading by weight. Bis-GMA, HEMA, BHT, acetone, organic acids. Carious lesions were analyzed

Eligibility

Sex/Gender

All

Age

12 Years to 18 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria for patients in the study included the following: a) minimum two active occlusal caries lesions on permanent molars confined to occlusal pits and fissures; b) natural teeth antagonists and contact with opposite tooth; c) buccolingual width of each restoration not greather that ? the distance between the cusp tips as measured with periodontal probe; d) a minimum of 1.5mm in depth and e) 20 or more teeth present.

Exclusion criteria

Exclusion criteria: The exclusion criteria included a) severe medical complications; b) xerostomia; c) advanced untreated periodontal disease; e) severe bruxing, clenching, or temporomandibular joint disorder; d) known sensitivity to acrylates or related materials; e) deep carious defects with frank occlusal cavitation or proximal caries; and f) poor oral hygiene.

Design outcomes

Primary

Measure	Time frame
The restorations were blindly evaluated by another examiner (M.M.) according to the modified criteria from the United States Public Health Services (USPHS) at baseline (one week), 12, 24, and 36 months. For each criterion, a score of A indicated the highest degree of clinical acceptability, and B scores indicated clinically acceptable scores, while C and D meant clinically insufficient and unacceptable scores. Evaluation was done by the operator using the mirror, dental probe, and 3-in-1 dental syringe from the dental unit. The operator calibration was performed prior, to a predetermined level of intra-examiner agreement with at least 95% per each criterion. At the end of 3-year study, 80 children were available for analysis.	—

Measure

Time frame

The restorations were blindly evaluated by another examiner (M.M.) according to the modified criteria from the United States Public Health Services (USPHS) at baseline (one week), 12, 24, and 36 months. For each criterion, a score of A indicated the highest degree of clinical acceptability, and B scores indicated clinically acceptable scores, while C and D meant clinically insufficient and unacceptable scores. Evaluation was done by the operator using the mirror, dental probe, and 3-in-1 dental syringe from the dental unit. The operator calibration was performed prior, to a predetermined level of intra-examiner agreement with at least 95% per each criterion. At the end of 3-year study, 80 children were available for analysis.

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Countries

Croatia

Contacts

Public ContactSilvana Jukic Krmek

Vice Dean for Science at School of Dental Medicine University of Zagtreb

jukic@sfzg.hr+38514802126

Outcome results

None listed

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