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Treating cavities in weak molar teeth of children: a study comparing three gentle filling methods

Comparison of atraumatic restorative techniques for managing occlusal caries in molars with molar-incisor hypomineralization: a three-arm randomized controlled trial in pediatric patients

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN28596671
Enrollment
75
Registered
2025-07-01
Start date
2025-04-01
Completion date
Unknown
Last updated
2025-09-08

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

Conditions

Molar-incisor hypomineralization (MIH) with occlusal caries, post-eruptive enamel breakdown and hypersensitive Oral Health

Interventions

Permanent molars affected by MIH with occlusal caries, post-eruptive enamel breakdown and hypersensitive from healthy children aged between 6-10 years will be randomly divided into three groups using

Sponsors

Damascus University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Cooperative healthy Children aged 6-10 years. 2. At least a permanent first molar affected by severe Molar Incisor Hypomineralisation (MIH) with 3 to 5 caries according to ICDAS-II. 3. The targeted molar has hypersensitivity 2 or 3 according to (SCASS) and 4a or 4b degree according to (MIH-TNI).

Exclusion criteria

Exclusion criteria: 1. The presence of another enamel defects such as amelogenesis imperfecta. 2. Silver allergy 3. Mouth sores, ulcerative gingivitis. 4. Irreversible pulpitis.

Design outcomes

Primary

MeasureTime frame
Clinical evaluation: Patients will be asked to rate their pain at the time of the procedure (baseline) on the Wong-Baker Faces Scale, where children will set their pain levels by choosing a face; 0 = no hurt, 1 = hurts a little bit, 2 = hurts a little more 3 = hurts even more, 4 = hurts a whole lot, and 5 = hurts worst, and FLACC pain scale (Face, Legs, Activity, Cry, Consolability), and the need for anesthesia. Also, they will be recalled after to assess the restoration survival based on ART restoration criteria and to assess the hypersensitivity using the Schiff Cold Air Sensitivity Scale (SCASS) at 3, 6 and 12 months

Secondary

MeasureTime frame
Radiographical assessment: After restoration is done a control x-ray will be taken to assess the restoration and the pulp condition at baseline, 3, 6, and 12 months after treatment

Countries

Syria

Contacts

Public ContactMarwan;Yasser Alhaji;Alsayed Tolibah

;

Mrwan.2013.55.a@gmail.com;yasseralsayedtolibah@gmail.com+963 (0) 995514119;+963988812044

Outcome results

None listed

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