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NCT Number: NCT07142629

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Selective caries removal

Procedure

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.

Non-Selective caries removal

Procedure

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.

Primary outcomes

  1. Rate of Radiographic Success

    Time frame: 6,12 months

    No radiographic evidence of periapical changes indicative of apical periodontitis

  2. Rate of Clinical Success

    Time frame: 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 outcomes

  1. Patient acceptance of treatment

    Time frame: immediately following intervention, and at 6 and 12 months recall

    Self-reported child acceptance using questionnaire

  2. Time taken for intervention

    Time frame: 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.

  3. Child pain score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

King Abdullah University Hospital

Other

Collaborators

  • Jordan University of Science and Technology

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 26, 2025
Registry last updated
Aug 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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