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NCT Number: NCT05748067

Minimally Invasive Treatment for Permanent Molars Affected With Molar-incisor Hypomineralization Defects

In this prospective randomized clinical trial, the is aim to compare the clinical and radiographic success of 3 minimally invasive treatment protocols on permanent first molars affected with MIH over 24 months. A total of 73children/120molar teeth (N=40 molars per group) between the ages of 6-16 years with MIH will be recruited at the post-graduate clinics at Jordan University of Science and Technology (JUST).

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Key information

Age range

6 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jordan University of Science and Technology

Irbid, 22110, Jordan

About this study

Background: The term molar-incisor hypomineralization (MIH) is defined as 'hypomineralization of systemic origin, presenting as demarcated, qualitative defects of enamel of one to four first permanent molars (FPMs) frequently associated with affected incisors. There are no clinical studies on use of minimally invasive techniques as restorative treatments for molars affected by MIH.

Aim: The aim of this clinical trial is to compare the clinical and radiographic success of 3 minimally invasive treatment protocols on permanent first molars affected with MIH over 24 months.

Methods: A total of 73 children/120 molar teeth (N=40 molars per group) between the ages of 6-16 years with MIH will be recruited for this prospective randomized clinical trial in the post-graduate clinics at JUST. Clinical and radiographic examination will be done. Participants will be randomly allocated to one of the three treatment modalities: For groups 1 and 2, silver diamine fluoride (SDF) will be clinically applied using cotton roll isolation on the first visit for three minutes after cleaning the tooth with gauze. After 1 week, the carious lesion will be examined for signs of caries arrest using two criteria: the color turning darker black and increased hardness of the lesion rather than soft texture (assessed using an excavator), if the criteria are met, the tooth will be restored with high viscosity glass ionomer (HVGIC) and stainless steel crown (SSC) for group 1, or only with a SCC for group 2. If not met, the carious lesion will be assumed to be still active, and a reapplication of SDF will be done before restoring the tooth with HVGIC and SCC. In group 3, the tooth will be restored in a similar fashion to atraumatic restorative treatment (ART technique) and restored with HVGIC and a SCC. Follow up will be done for all groups at 3 months, 6 months, 12 months, and 24 months to record specified clinical and radiographic criteria as outcome measures of success.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Permanent molars with MIH with the following MIH indices (2a, 2b, 3, 4a, 4b) affected by caries (ICDAS 3 or 4) or post eruptive breakdown.
  • Restorable teeth
  • Permanent molars with MIH with NO clinical/radiographic signs and symptoms of irreversible pulpitis or pulpal necrosis.
  • Clear band of dentine radiographically between the carious lesion and the pulp.

Exclusion criteria

  • Medically compromised patients.
  • Permanent molars with MIH with the following indices (1, 2c, 4c, 0, 1).
  • Permanent molars with MIH with severe post eruptive breakdown therefore, unrestorable.
  • Permanent molars with MIH with clinical/radiographic signs and symptoms of irreversible pulpitis or pulpal necrosis.
  • No clear band of dentine radiographically between the carious lesion and the pulp.

Treatment and study plan

SDF

Procedure

Silver diamine fluoride

HVGIC restoration

Procedure

High viscosity glass ionomer restoration

SSC

Procedure

Stainless steel crown

Primary outcomes

  1. Successful restoration

    Time frame: After 1 year

    SSC is clinically intact (not perforated), retentive (not lost), in proper occlusion, with no gingival inflammation

  2. Functional tooth clinically

    Time frame: After 1 year

    Tooth should have no symptoms of pain, mobility or tenderness to percussion

  3. Healthy periapical region radiographically

    Time frame: After 1 year

    No signs of periapical pathology on radiograph

Sponsors and collaborators

Lead sponsor

King Abdullah University Hospital

Other

Collaborators

  • Jordan University of Science and Technology

Registry information

Official study title

Outcome of Minimally Invasive Treatment for Permanent Molars Affected With Molar-incisor Hypomineralization Defects: a Randomized Clinical Trial

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Feb 28, 2023
Registry last updated
May 15, 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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