Minimally Invasive Treatment for Permanent Molars Affected With Molar-incisor Hypomineralization Defects
NCT ID: NCT05748067
Last Updated: 2025-05-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
73 participants
INTERVENTIONAL
2021-11-29
2025-05-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Group 1: SDF, HVGIC & SSC
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).
SDF
Silver diamine fluoride
HVGIC restoration
High viscosity glass ionomer restoration
SSC
Stainless steel crown
Group 2: SDF & SSC
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.
SDF
Silver diamine fluoride
SSC
Stainless steel crown
Group 3: HVGIC & SSC
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).
HVGIC restoration
High viscosity glass ionomer restoration
SSC
Stainless steel crown
Interventions
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SDF
Silver diamine fluoride
HVGIC restoration
High viscosity glass ionomer restoration
SSC
Stainless steel crown
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
6 Years
16 Years
ALL
Yes
Sponsors
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Jordan University of Science and Technology
OTHER
King Abdullah University Hospital
OTHER
Responsible Party
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Principal Investigators
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Ola B. Al-Batayneh
Role: PRINCIPAL_INVESTIGATOR
Jordan University of Science and Technology
Locations
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Jordan University of Science and Technology
Irbid, , Jordan
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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623-2021
Identifier Type: -
Identifier Source: org_study_id
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