Selective Versus Non-selective Caries Excavation in MIH Affected Teeth.
- Conditions
- Molar Incisor HypomineralisationDental Caries
- Registration Number
- NCT07142629
- Lead Sponsor
- King Abdullah University Hospital
- Brief 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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 60
- The patient age <13 years old
- Non -contributory medical history
- Molar affected with MIH as per EAPD diagnostic criteria (White, creamy, or yellow to brownish opacities greater than one millimeter with/without postoperative enamel breakdown).
- Deep caries extending>= 2/3 of dentine but not exposing the pulp on the bitewing radiograph.
- The tooth should give positive response to cold sensibility testing.
- Clinical diagnosis of normal/ reversible pulpitis
- The tooth is restorable, probing pocket depth and mobility are within normal limits.
- No signs of pulpal necrosis including sinus tract or swelling
- No radiographic evidence of periapical changes indicative of apical periodontitis.
- Medically compromised patient.
- Non-restorable tooth.
- Clinical diagnosis of irreversible pulpitis.
- Signs of pulpal necrosis including sinus tract or swelling.
- Teeth indicated for extraction for orthodontic reasons.
- Uncooperative children who could not be treated under local anesthesia.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Rate of Radiographic Success 6,12 months No radiographic evidence of periapical changes indicative of apical periodontitis
Rate of Clinical Success 6,12 months Absence of clinical symptoms of spontaneous pain, pain on percussion, pathologic mobility or abscess formation.,assessed through taking pain history and clinical examination.
- Secondary Outcome Measures
Name Time Method Patient acceptance of treatment immediately following intervention, and at 6 and 12 months recall Self-reported child acceptance using questionnaire
Time taken for intervention Perioperative/Periprocedural: from the time the child sits on the dental chair and until the intervention is completed. Time taken to perform intervention in minutes.
Child pain score preoperatively and one week following the intervention Self-reported Child pain score preoperatively and one week after intervention, recorded on a scale of 0-10.
Trial Locations
- Locations (1)
Jordan University of Science and Technology
🇯🇴Irbid, Jordan
Jordan University of Science and Technology🇯🇴Irbid, Jordan