Comparison of two minimally invasive methods for removing tooth decay in children with molar–incisor hypomineralization

A randomized controlled clinical trial comparing the efficacy, treatment time, and patient-reported pain perception of BRIX-3000 and sodium hypochlorite gel for chemo-mechanical caries removal in molars affected by molar–incisor hypomineralization

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN16136853

Enrollment

Registered

2025-10-08

Start date

2024-10-01

Completion date

Unknown

Last updated

2025-10-20

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

Conditions

Severe molar–incisor hypomineralization (MIH) in children, leading to post-eruptive enamel breakdown, hypersensitivity, and carious lesions in first permanent molars Oral Health

Interventions

1. BRIX-3000® Chemo-Mechanical Caries Removal Agent: BRIX-3000® Application: Applied to the carious lesion for 2 minutes according to manufacturer instructions. Procedure: Carious dentin softened by B

caries detector applied to confirm removal. Restoration: Same as above (bulk-fill resin composite). Participants were randomized using a computer-generated block randomization table (block size = 6).

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Health status: Healthy and cooperative children 2. Diagnosis: Presence of first permanent molars affected by severe molar–incisor hypomineralization (MIH). 3. Lesion characteristics: Localized enamel opacity with post-eruptive enamel breakdown. 4. Restorable carious lesion on the occlusal surface 5. Radiographic depth not exceeding two-thirds of dentin thickness. Symptoms: Spontaneous or persistent hypersensitivity affecting function (e.g., brushing or chewing). 6. Pulp status: Teeth must be vital, and without clinical or radiographic signs of pulp necrosis (no fistula, abscess, mobility, periapical lesion, or internal/external root resorption).

Exclusion criteria

Exclusion criteria: 1. Presence of other developmental enamel defects, such as amelogenesis imperfecta. 2. Mild MIH in first permanent molars. 3. Teeth with pulpal pathology, including spontaneous or prolonged pain, abscess, fistula, tooth mobility, periapical lesions, or internal/external root resorption. 4. Children with systemic health conditions or behavioral issues that prevent safe dental treatment. 5. Previous restorative treatment on the target tooth.

Design outcomes

Primary

Measure	Time frame
The completeness of caries removal will be assessed using the Ericson et al. scoring system by two blinded investigators. The endpoint is achieved when all carious dentin is removed, leaving firm dentin with no soft or infected tissue, confirmed by visual inspection and probing with a sharp dental explorer. Scores range from 0 (complete removal) to 5 (residual caries at base and margins of the cavity and =2 walls).	—

Measure

Time frame

The completeness of caries removal will be assessed using the Ericson et al. scoring system by two blinded investigators. The endpoint is achieved when all carious dentin is removed, leaving firm dentin with no soft or infected tissue, confirmed by visual inspection and probing with a sharp dental explorer. Scores range from 0 (complete removal) to 5 (residual caries at base and margins of the cavity and =2 walls).

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Secondary

Measure	Time frame
1. Pain will be assessed using the Wong-Baker FACES Pain Rating Scale (child self-report) and the FLACC scale (observer-reported) . Scores range from 0–10, with higher scores indicating greater pain or discomfort 2. Total time required to remove carious dentin will be measured using a digital timer. This will allow comparison of procedure duration among BRIX-3000®, sodium hypochlorite gel, and conventional rotary instrumentation 3. The need for supplemental local anesthesia will be recorded as yes/no, based on patient-reported discomfort or pain during caries removal	—

Measure

Time frame

1. Pain will be assessed using the Wong-Baker FACES Pain Rating Scale (child self-report) and the FLACC scale (observer-reported) . Scores range from 0–10, with higher scores indicating greater pain or discomfort 2. Total time required to remove carious dentin will be measured using a digital timer. This will allow comparison of procedure duration among BRIX-3000®, sodium hypochlorite gel, and conventional rotary instrumentation 3. The need for supplemental local anesthesia will be recorded as yes/no, based on patient-reported discomfort or pain during caries removal

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Countries

Syria

Contacts

Public ContactHasan Alzoubi

hasan.alzoubi@damascusuniversity.edu.sy+963 943647659

Outcome results

None listed

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