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

NCT05748067 | Completed

• 1 other identifier: 623-2021
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Molar Incisor Hypomineralization

Outcome Measures

Primary Outcomes (3)

• Successful restoration

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

  After 1 year

• Functional tooth clinically

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

  After 1 year

• Healthy periapical region radiographically

  No signs of periapical pathology on radiograph

  After 1 year

Study Arms (3)

Group 1: SDF, HVGIC & SSC

ACTIVE COMPARATOR

Silver diamine fluoride (SDF) will be clinically applied in the first visit. After 1 week of caries arrest, the tooth will be restored with a high viscosity glass ionomer (HVGIC) and stainless steel crown (SSC).

Procedure: SDF; Procedure: HVGIC restoration; Procedure: SSC

Group 2: SDF & SSC

ACTIVE COMPARATOR

Silver diamine fluoride (SDF) will be clinically applied in the first visit. After 1 week of caries arrest, the tooth will be restored with a SSC only.

Procedure: SDF; Procedure: SSC

Group 3: HVGIC & SSC

ACTIVE COMPARATOR

The tooth will be restored in a similar fashion to atraumatic restorative treatment (ART technique) and restored with a high viscosity glass ionomer (HVGIC) and stainless steel crown (SSC).

Procedure: HVGIC restoration; Procedure: SSC

Interventions

SDF PROCEDURE

Silver diamine fluoride

Group 1: SDF, HVGIC & SSC; Group 2: SDF & SSC

HVGIC restoration PROCEDURE

High viscosity glass ionomer restoration

Group 1: SDF, HVGIC & SSC; Group 3: HVGIC & SSC

SSC PROCEDURE

Stainless steel crown

Group 1: SDF, HVGIC & SSC; Group 2: SDF & SSC; Group 3: HVGIC & SSC

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Jordan University of Science and Technology

Irbid, 22110, Jordan

Location

Related Publications (8)

• Ghanim A, Silva MJ, Elfrink MEC, Lygidakis NA, Marino RJ, Weerheijm KL, Manton DJ. Molar incisor hypomineralisation (MIH) training manual for clinical field surveys and practice. Eur Arch Paediatr Dent. 2017 Aug;18(4):225-242. doi: 10.1007/s40368-017-0293-9. Epub 2017 Jul 18.

  PMID: 28721667 BACKGROUND

• Ozgul BM, Saat S, Sonmez H, Oz FT. Clinical evaluation of desensitizing treatment for incisor teeth affected by molar-incisor hypomineralization. J Clin Pediatr Dent. 2013 Winter;38(2):101-5.

  PMID: 24683770 BACKGROUND

• Steffen R, Kramer N, Bekes K. The Wurzburg MIH concept: the MIH treatment need index (MIH TNI) : A new index to assess and plan treatment in patients with molar incisior hypomineralisation (MIH). Eur Arch Paediatr Dent. 2017 Oct;18(5):355-361. doi: 10.1007/s40368-017-0301-0. Epub 2017 Sep 14.

  PMID: 28913739 BACKGROUND

• Jalevik B, Klingberg GA. Dental treatment, dental fear and behaviour management problems in children with severe enamel hypomineralization of their permanent first molars. Int J Paediatr Dent. 2002 Jan;12(1):24-32.

  PMID: 11853245 BACKGROUND

• Zhao IS, Gao SS, Hiraishi N, Burrow MF, Duangthip D, Mei ML, Lo EC, Chu CH. Mechanisms of silver diamine fluoride on arresting caries: a literature review. Int Dent J. 2018 Apr;68(2):67-76. doi: 10.1111/idj.12320. Epub 2017 May 21.

  PMID: 28542863 BACKGROUND

• Grossi JA, Cabral RN, Ribeiro APD, Leal SC. Glass hybrid restorations as an alternative for restoring hypomineralized molars in the ART model. BMC Oral Health. 2018 Apr 18;18(1):65. doi: 10.1186/s12903-018-0528-0.

  PMID: 29669561 BACKGROUND

• Horst JA, Ellenikiotis H, Milgrom PL. UCSF Protocol for Caries Arrest Using Silver Diamine Fluoride: Rationale, Indications and Consent. J Calif Dent Assoc. 2016 Jan;44(1):16-28.

  PMID: 26897901 BACKGROUND

• Crystal YO, Marghalani AA, Ureles SD, Wright JT, Sulyanto R, Divaris K, Fontana M, Graham L. Use of Silver Diamine Fluoride for Dental Caries Management in Children and Adolescents, Including Those with Special Health Care Needs. Pediatr Dent. 2017 Sep 15;39(5):135-145.

  PMID: 29070149 BACKGROUND

MeSH Terms

Conditions

Molar Hypomineralization

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

Study Officials

• Ola B. Al-Batayneh

  Jordan University of Science and Technology

  PRINCIPAL INVESTIGATOR

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: February 5, 2023
• First Posted: February 28, 2023
• Study Start: November 29, 2021
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)