Home » Trials » SLCTR/2023/020


Sensitivity in teeth affected by molar incisor hypomineralisation (MIH) in Mexican children: a clinical controlled trial

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SLCTR Registration Number

SLCTR/2023/020


Date of Registration

30 Oct 2023

The date of last modification

Oct 29, 2023



Application Summary


Scientific Title of Trial

Sensitivity in teeth affected by molar incisor hypomineralisation (MIH) in Mexican children: a clinical controlled trial


Public Title of Trial

Comparison of the efficacy of a combination of non-invasive interventions (glass ionomer sealant, fluoride varnish and topical crème with casein phosphopeptide amorphous calcium phosphate) to reduce dental hypersensitivity among Mexican children with sensitivity in teeth due to molar incisor hypomineralisation: randomized controlled study.


Disease or Health Condition(s) Studied

Molar incisor hypomineralisation


Scientific Acronym

MIH


Public Acronym

MIH


Brief title


Universal Trial Number

U1111-1287-1677


Any other number(s) assigned to the trial and issuing authority

Comiteei.icsa/ICSa146/2022


Trial Details


What is the research question being addressed?

What is the most effective combination of non-invasive interventions to reduce hypersensitivity in Mexican children with molars affected by molar incisor hypomineralisation (MIH)?


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Single blinded : Participants


Control

Standard therapy/practice


Assignment

Parallel


Purpose

Treatment


Study Phase

Not Applicable


Intervention(s) planned

The participants will be divided into four intervention groups using a randomisation list generated by a website (http://www.randomization.com) A, B, C and D: Group A: Glass-ionomer sealant 0.30 g (Fuji TRIAGE pink, GC Corp. Japan) placed onto MIH-affected molars that show hypersensitivity and professional topical application of 5% sodium fluoride varnish with casein phosphopeptide amorphous calcium phosphate (CPP-ACP) (MI Varnish, GC Corp., Japan) four applications with a one-week interval between applications. Group B: Glass-ionomer sealant 0.30 g (Fuji TRIAGE pink) placed onto MIH-affected molars that show hypersensitivity and use of topical tooth crème with 10% CPP-ACP (MI Paste; GC Corp., Japan) twice-a-day for 12 weeks. Group C: Glass-ionomer sealant (Fuji TRIAGE pink) placed onto MIH-affected molars that show hypersensitivity, professional topical application of 5% sodium fluoride varnish with CPP-ACP (MI Varnish) four applications with a one- week interval between applications and use of topical tooth crème with 10% CPP-ACP (MI Paste) twice-a-day for 12 weeks. Group D: Professional topical application of 5% sodium fluoride varnish with CPP-ACP (MI Varnish) four applications with a one-week interval between applications and use of topical tooth crème with 10% CPP-ACP (MI Paste) twice-a-day for 12 weeks. In groups A, B and C the MIH-affected molars will be cleaned using a gentle no invasive technique with a wet prophylaxis brush to limit discomfort, isolation using cotton rolls and a four-handed technique. For mixing GIC, the capsule will be activated and triturated according to manufacturer´s instructions. The teeth will be dried with cotton pellets. The GIC will be applied to the MIH lesion(s) and pits and fissures, with the material adapted to the tooth surface using a finger press method. Then exposed to a curing light to speed setting time, and cocoa butter applied to protect the GIC. In Groups A, C and D the teeth will be dried with cotton pellets and NaF varnish applied as a thin, uniform layer over the MIH lesion with a micro-brush. For participants who receive the sealant, the fluoride varnish will be applied one week after sealant application. In Groups B, C and D, a topical tooth crème (MI Paste) will be applied at home twice-a-day for 12 weeks, once in the morning after tooth-brushing and once in the evening after tooth-brushing, before going to bed. A small pea-sized (approx. 1 g) amount of product will be applied across the MIH affected tooth surfaces with a clean finger. For ethical reasons we do not have a separate control group, since we cannot leave any participant without treatment, for this reason all the participants will act as the control at follow-up. Thus, in all, there will be a use of a preventive standard therapy which means, age-appropriate toothbrush, sodium fluoride toothpaste 1450 ppm, brushing technique instruction and dietary advice. All participants will be instructed not to eat anything, or to brush their teeth for at least four hours after the application of MI Paste.


Inclusion criteria

o Children (male and female), aged from 6 to 13 years. o At least one MIH-affected first permanent molar with self-reported hypersensitivity symptoms (to changes in temperature and/or dental brushing) o At least response grade “1” on the Schiff Cold Air Sensitivity Scale SCASS.


Exclusion criteria

o Other developmental defects of enamel such as fluorosis and amelogenesis imperfecta o Teeth of interest with restorations, PEB, or carious lesions classified as score >2 according to the International Caries Detection and Assessment System (ICDAS) o Allergy to milk proteins and/or hydroxybenzoate



Primary outcome(s)

1.

Proportion of patients with pulp sensitivity measured by SybronEndo’s Elements Diagnostic Unit (Electronic pulp tester and apex locator, Kerr Corp., Switzerland). The intensity of the electric current has a range of 0-80; values <25 will be considered hypersensitive, 25-67 sensitive, and >68 will be considered as not sensitive.

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Baseline, 4, 8, 12 and 26 weeks following treatment.

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2.

Visual Analogue Scale (VAS, Ritter 2006): regarding the participants’ perception of the desensitizing treatment.

[

Baseline, 4, 8, 12 and 26 weeks following treatment.

]
3.

Proportion of patients with MIH assessed via the response to stimulation of hypersensitive teeth using a jet of air based on the Schiff Cold Air Sensitivity Scale (SCASS) for 1 s and at a distance of 1 cm and perpendicular to the occlusal surface of the tooth, neighbouring teeth will be shielded with cotton rolls. (Schiff, 2009) The analogue scale scores for the tooth are 0, 1, 2 or 3: “0” – No subjective response to stimulus, “1” – responds but will continue, “2” – responds and moves or requests discontinuation and “3” – Painful response to stimulus, discontinuation requested.

[

Baseline, 4, 8, 12 and 26 weeks following treatment.

]

Secondary outcome(s)

1.

None

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Target number/sample size

148 (4 groups 37 each)


Countries of recruitment

Mexico


Anticipated start date

2023-12-01


Anticipated end date

2024-06-01


Date of first enrollment


Date of study completion


Recruitment status

Pending


Funding source


Regulatory approvals



State of Ethics Review Approval


Status

Approved


Date of Approval

2022-11-24


Approval number


Details of Ethics Review Committee

Name: Autonomous University of Hidalgo State
Institutional Address:Circuito ex Hacienda La Concepción s/n Carretera Pachuca Actopan, San Agustín Tlaxiaca, Hidalgo, Mexico Postcode: 42160
Telephone:52 (771) 7172000 ext 4306
Email: Investigacion_Icsa@uaeh.edu.mx

Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Rivera, Maria
PhD candidate UMCG
Universitair Medisch Centrum Groningen, A. Deusinglaan 1, FB-21, Postbus 196, 9700 AD Groningen, Nederland

+52 7711897631

m.rivera.pacheco@umcg.nl

Contact Person for Public Queries

Manton, David
Professor UMCG
Universitair Medisch Centrum Groningen, A. Deusinglaan 1, FB-21, Postbus 196, 9700 AD Groningen, Nederland
+3150 36 10665


d.j.manton@umcg.nl


Primary study sponsor/organization

Nakao Foundation (Japan)

Foundation Nakao for Worldwide Oral Health Fluhmattweg 13 6004 Luzern, Switzerland



Secondary study sponsor (If any)

GC Corporation (Japan)

GC Corporation 3-2-14 Hongo, Bunkyo-ku Tokyo 113-0033, Japan Tel +81-3-3815-1815



Trial Completion details


Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?

No


IPD sharing plan description


Study protocol available

No


Protocol version and date

Not Available


Protocol URL

Not Available


Results summary available

No


Date of posting results


Date of study completion


Final sample size


Date of first publication


Link to results


Brief summary of results