NCT07142629

Selective Versus Non-selective Caries Excavation in MIH Affected Teeth.

Selective Versus Non-selective Caries Excavation in MIH Affected Teeth: A Randomized Clinical Trial

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: King Abdullah University Hospital · Academic / Other
• Sex: All
• Age: 6 Years – 13 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to compare the clinical and radiographic outcomes of selective versus nonselective caries removal in MIH affected teeth with deep carious lesions using enhanced clinical protocols.

Detailed description

The aim of this study is to compare the clinical and radiographic outcomes of selective versus nonselective caries removal in MIH affected teeth with deep carious lesions using enhanced clinical protocols.Cases will be collected from the undergraduate and postgraduate clinics over a 6 months\' period according to predetermined inclusion criteria. Preoperative clinical and radiographic assessment will be conducted to MIH affected molars. MIH molars with deep caries (assymptomatic/ with symptoms of reversible pulpitis) will be randomly allocated for the choice of treatment with selective or non -selective caries excavation. Randomization of teeth between the 2 treatment groups will be performed using an online block randomization technique (block of 6) with the tooth as unit of randomization. Time taken for each procedure will be recorded by the research assistant each visit prospectively after achieving local anaesthesia till the end of procedure. Patients will be asked to rate their satisfaction with the received treatment on the end of treatment visit using a designed questionnaire. Clinical and radiographic success, and patient satisfaction will be evaluated at 6 and 12 months follow up.

Conditions

• Molar Incisor Hypomineralisation
• Dental Caries

Interventions

Type	Name	Description
PROCEDURE	Selective caries removal	Selective carious removal to firm dentine. Subsequently, 2 mm of Biodentine will be placed as a liner over the pulpal wall leaving the peripheries of the cavity available for bonding of the subsequent restoration.
PROCEDURE	Non-Selective caries removal	Complete caries excavation will be done to hard scratchy dentine, with the aid of caries detector dye.If no pulp exposure is evident 2 mm of Biodentine will be placed and the cavity will be restored. If pulp exposure occurred, and it is bleeding normally and uniformly red with no zones of degeneration or necrosis then direct pulp capping will be attempted with Biodentine as a capping material. If no hemostasis is achieved, then the procedure will be modified to either partial pulpotomy, full pulpotomy or RCT depending on the clinical assessment.

Timeline

• Start date: 2024-09-01
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2025-08-26
• Last updated: 2025-08-26

Locations

1 site across 1 country: Jordan