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

NCT07142629 | Enrolling By Invitation DMC

• 2 other identifiers: 413 - 202420240457 .
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Molar Incisor Hypomineralisation; Dental Caries

Keywords

Molar Incisor Hypomineralisation; Selective caries removal; Non-selective caries removal

Outcome Measures

Primary Outcomes (2)

• Rate of Radiographic Success

  No radiographic evidence of periapical changes indicative of apical periodontitis

  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.

  6,12 months

Secondary Outcomes (3)

• Patient acceptance of treatment

  immediately following intervention, and at 6 and 12 months recall

• Time taken for intervention

  Perioperative/Periprocedural: from the time the child sits on the dental chair and until the intervention is completed.

• Child pain score

  preoperatively and one week following the intervention

Study Arms (2)

Selective caries removal

EXPERIMENTAL

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

Non-Selective caries removal

EXPERIMENTAL

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

Interventions

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.

Selective caries removal

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.

Non-Selective caries removal

Eligibility Criteria

• Age: 6 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Abdullah University Hospital: lead
• Jordan University of Science and Technology: collaborator

Study Sites (1)

Jordan University of Science and Technology

Irbid, Jordan

Location

MeSH Terms

Conditions

Molar Hypomineralization; Dental Caries

Condition Hierarchy (Ancestors)

Dental Enamel Hypomineralization; Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Tooth Demineralization

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: August 26, 2025
• Study Start: September 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: August 26, 2025

Record last verified: 2025-08

Locations

JO (1)