An interventional study of Selective caries removal and Non-Selective caries removal in Molar Incisor Hypomineralisation and Dental Caries, sponsored by King Abdullah University Hospital. Enrolling by invitation at 1 site in Jordan. Open to participants aged 6 Years to 13 Years. Per ClinicalTrials.gov, last updated 2025-08-26.
Sponsored by King Abdullah University Hospital · Not applicable, Interventional, and Treatment
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.
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.
121 studies on the registry are indexed under Molar Hypomineralization; 41 are open to participants now.
This study's planned enrollment of 60 is above the median of 52 across 94 interventional studies indexed under Molar Hypomineralization.
Browse Molar Hypomineralization studies →King Abdullah University Hospital is the lead sponsor of 54 studies on the registry; 21 are open to participants now.
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Exclusion Criteria:
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: 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.
Procedure: Non-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.
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.
Rate of Radiographic Success
No radiographic evidence of periapical changes indicative of apical periodontitis
Time frame: 6,12 months
Rate of Clinical Success
Absence of clinical symptoms of spontaneous pain, pain on percussion, pathologic mobility or abscess formation.,assessed through taking pain history and clinical examination.
Time frame: 6,12 months
Patient acceptance of treatment
Self-reported child acceptance using questionnaire
Time frame: immediately following intervention, and at 6 and 12 months recall
Time taken for intervention
Time taken to perform intervention in minutes.
Time frame: Perioperative/Periprocedural: from the time the child sits on the dental chair and until the intervention is completed.
Child pain score
Self-reported Child pain score preoperatively and one week after intervention, recorded on a scale of 0-10.
Time frame: preoperatively and one week following the intervention
Plan to share: Undecided
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King Abdullah University Hospital