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Evaluation of BRIX3000 and Carisolv in chemomechanical caries removal in immature permanent first molars

Comparative evaluation of BRIX3000 and Carisolv in chemomechanical caries removal in immature permanent first molars: A randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN12761284
Enrollment
45
Registered
2024-11-06
Start date
2024-08-03
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

Dental caries Oral Health

Interventions

A total of seventy-five specimens were assigned randomly to five groups with the help of an online randomization tool https://www.randomizer.org/. The total number of sets consisted of 3, with each se

Sponsors

Damascus University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Healthy pediatric patients aged 7-9 years old 2. Pediatric patients were classified as either definitely positive or positive based on Frankel’s behavior rating scale 3. Radiographically, lesions reaching the middle or inner third of the dentine (D2/3) were observed in immature mandibular PFMs 4. Caries lesions fell under ICDAS code 4

Exclusion criteria

Exclusion criteria: 1. Special health care needs for pediatric patients 2. Immature mandibular PFMs were exhibiting pulpal and/or periodontal issues 3. Unintentional pulp exposure occurred during the excavation process 4. Immature mandibular PFMs with dental anomalies

Design outcomes

Primary

MeasureTime frame
The efficacy of caries removal was measured by two blinded examiners (ICC > 0.8) using the Ericson et al. scale by visual-tactile examination and utilizing the caries detector of the Ericson et al. scale after caries excavation

Secondary

MeasureTime frame
1. Objective pain assessment measured using the Sound, Eye, Motor (SEM) scale by two blinded examiners (ICC > 0.8), and SEM scoring criteria during the excavation of caries 2. Subjective pain assessment measured using the Wong-Baker FACES scale during caries excavation 3. Requirement of local anesthesia measured using data collected in the study records during caries excavation

Countries

Syria

Contacts

Public ContactMawia Karkoutly
mawiamaherkarkoutly@hotmail.com+963 (0)992 647 528

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 5, 2026