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Enrolling by invitation NCT07142629

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

No phase Interventional Molar Incisor Hypomineralisation Dental Caries

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Selective caries removal, Non-Selective caries removal.
Who it may be relevant to
Registry conditions: Molar Incisor Hypomineralisation, Dental Caries. Basic parameters: 6 years — 13 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Jordan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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 pul

Primary outcome measures

  • Rate of Radiographic Success [Time frame: 6,12 months]
  • Rate of Clinical Success [Time frame: 6,12 months]
Secondary outcome measures (3)
  • Patient acceptance of treatment [Time frame: immediately following intervention, and at 6 and 12 months recall]
  • Time taken for intervention [Time frame: Perioperative/Periprocedural: from the time the child sits on the dental chair and until the intervention is completed.]
  • Child pain score [Time frame: preoperatively and one week following the intervention]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Jordan · 1 center
  • Jordan University of Science and Technology — Irbid

Identifiers

NCT: NCT07142629 · 413 - 2024 · 20240457 .

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗