Home » Trials » SLCTR/2023/024


Quality of life in children with molar incisor hypomineralization (MIH) in permanent anterior teeth treated with infiltrative resins: a quasi experimental study.

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SLCTR Registration Number

SLCTR/2023/024


Date of Registration

21 Dec 2023

The date of last modification

Dec 21, 2023



Application Summary


Scientific Title of Trial

Quality of life in children with molar incisor hypomineralization (MIH) in permanent anterior teeth treated with infiltrative resins: a quasi experimental study.


Public Title of Trial

Comparison of the impact on quality of life in Mexican children with molar incisor hypomineralisation (HIM) in anterior teeth treated with infiltrative resin and/or bleaching compared to standard care: a quasi-experimental study.


Disease or Health Condition(s) Studied

Molar incisor hypomineralisation


Scientific Acronym

None


Public Acronym

None


Brief title

None


Universal Trial Number

U1111_1287-1742


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

Autonomous University of the State of Hidalgo.ERC - Comiteei.icsa/ICSa146a/2023


Trial Details


What is the research question being addressed?

What non-invasive treatment to improve aesthetics in children with MIH with affected anterior teeth improve quality of life the most, infiltrative resin or the combination of infiltrative resin with bleaching compared to the standard of care?


Type of study

Interventional


Study design

Allocation

Non-randomized controlled trial


Masking

Masking not used : Outcome assessors


Control

Standard therapy/practice


Assignment

Parallel


Purpose

Treatment


Study Phase

Not Applicable


Intervention(s) planned

The participants will be divided in three groups based on the researcher view that resin infiltration alone should improve the aesthetic appearance of their incisors. OR would benefit from bleaching and resin infiltration to improve the aesthetic appearance of the incisors OR Participants who have teeth with defects that are not suitable for infiltration treatment due to partial eruption, rendering them unsuitable for resin infiltration treatment at this stage.

Intervention:

Group A: Participants for whom it is estimated by the researchers that resin infiltration alone should improve the aesthetic appearance of their incisors.

The intervention with Icon infiltration clinical kit (DMG, Hamburg, Germany) will be according to the manufacturer’s instructions with modifications according to Marouane and Manton (2021). The teeth will be isolated with rubber dam (Nic Tone; MDC Dental, México City, México) and gingival protector will be applied around the gingival cuff to prevent gel leakage (Optradam; Ivoclar,Products Inc., Utah, USA), then 15% hydrochloric acid gel (Icon etch; DMG, Hamburg, Germany) will be applied to the lesion for 120 s, the tooth washed for 30 s using triplex water spray; ethanol applied for 30 s to desiccate the lesion (Icon Dry; DMG, Hamburg, Germany), the effect of the ethanol on lesion translucence will be evaluated (positive or negative), then the infiltrant resin will be applied to the hypomineralised lesion by means of a sponge tipped applicator (Icon; DMG Hamburg, Germany), the resin will be light-cured (40 s) one minute after the lesion has ceased improving in translucence – this is estimated at 3 - 4 min for Type 1 lesions or 9 – 10 min for Type 2 and 3 lesions (Manton and Marouane 2021). Another application of resin will be placed on the lesion and after 120 s, light-cured for 40 s. If the lesion surface still appears porous, a further application of infiltrant shall be placed.

Group B: Participants who would benefit from bleaching and resin infiltration to improve the aesthetic appearance of the incisors as estimated by the researchers.

For participants who, according to the researcher/clinician, an experienced paediatric dentist, would benefit from bleaching before resin infiltration due to the colour of the lesion, a custom-fabricated bleaching tray will be manufactured and ‘take home’ bleaching gel containing 10% carbamide peroxide will be used as the active ingredient (Opalescence PF, Ultradent Products Inc., Utah, USA). Bleaching trays (custom fitted, covering from canine to canine only), vacuum formed from 0.35 mm soft acrylic and finished at the gingival margin, will be manufactured. Instructions for bleaching gel use shall be provided and demonstrated in person and written instructions will also be provided – the bleaching tray should be worn two hours-a-day after dinner and tooth brushing and before going to sleep. Parents will be asked to supervise the procedure and only one syringe of gel will be kept at home to prevent gel overuse. Precautions will be taken to prevent postoperative sensitivity, parents and participants will be instructed to alternate use of bleaching tray one night and MI Paste (10% CPP-ACP; GC Corp., Japan) on the alternate night (Night on, night off method, Ng and Manton, 2007), and so on until a suitable result is obtained.

The bleaching effectiveness will be reviewed and assessed at two weeks, and if further aesthetic improvement is desired, a further two weeks of bleaching will be undertaken; if it is necessary, this period may be extended until the participant, parents and researcher are satisfied with the visual results.

If bleaching is required, two weeks after completing the bleaching treatment, the resin infiltration procedure will be performed. The intervention with Icon infiltration clinical kit (DMG, Hamburg, Germany) will be according to the manufacturer’s instructions with modifications according to Marouane and Manton (2021). The teeth will be isolated with rubber dam (Nic Tone; MDC Dental, México City, México) and gingival protector will be applied around the gingival cuff to prevent gel leakage (Optradam; Ivoclar,Products Inc., Utah, USA), then 15% hydrochloric acid gel (Icon etch; DMG, Hamburg, Germany) will be applied to the lesion for 120 s, the tooth washed for 30 s using triplex water spray; ethanol applied for 30 s to desiccate the lesion (Icon Dry; DMG, Hamburg, Germany), the effect of the ethanol on lesion translucence will be evaluated (positive or negative), then the infiltrant resin will be applied to the hypomineralised lesion by means of a sponge tipped applicator (Icon; DMG Hamburg, Germany), the resin will be light-cured (40 s) one minute after the lesion has ceased improving in translucence – this is estimated at 3 - 4 min for Type 1 lesions or 9 – 10 min for Type 2 and 3 lesions (Manton and Marouane 2021). Another application of resin will be placed on the lesion and after 120 s, light-cured for 40 s. If the lesion surface still appears porous, a further application of infiltrant shall be placed.

Group C (control group): Participants who have teeth with defects that are not suitable for infiltration treatment due to partial eruption, rendering them unsuitable for resin infiltration treatment at this stage. For control group, they will receive a preventive standard therapy, with means, age-appropriate toothbrush, sodium fluoride toothpaste 1450 ppm, brushing tecnique instruction and dietary advice.


Inclusion criteria

o Children (male and female) aged from 6 to 13 years. o At least one MIH-affected permanent incisor according to EAPD MIH criteria. o Children who view their teeth as unattractive and wish for aesthetic improvement (at least one permanent incisor that is affecting dental aesthetics)


Exclusion criteria

o Other developmental defects of enamel such as fluorosis, diffuse opacities, hypoplasia or 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.

To evaluate the impact of this condition on oral health quality-of-life (OHQoL), using the Parental-caregiver perceptions of child OHQoL P-CPQ (for ages 6 to 14 years; Jokovic et al., 2003, Peruvian Spanish version 2013) This questionnaire has 31 items divided into four sub-scales: oral symptoms (6 items), functional limitations (8 items), emotional wellbeing (7 items) and social wellbeing (10 items). A five-point Likert scale will be used, 0 – never; 1 - once/twice; 2 – sometimes; 3 – often; 4 - every day/almost every day. For the 31 items, the final score ranges from 0 to 124, for which a higher score will indicate a greater degree of the impact of oral conditions on quality of life of the child. (Jokovic et al., 2003, Peruvian Spanish version 2013)

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it will be measured before treatment, one week, one month and 3 months after treatment

]
2.

Participant and parental/guardian direct visual perception of the lesions will be measured using the Extended Visual Rating Scale for Appearance Match (EVRSAM) Rating Scale. (Ostervemb 2011)

[

Before, immediately after treatment and 1 and 3 months later

]
3.

Digital photographic images will be taken under standardised camera and lighting settings. These images will be inspected and rated by a panel consisting of four dentists (two specialist paediatric dentists with experience in MIH (including the student researcher), one general dentist with experience in MIH, one paediatric postgraduate student in training (with limited experience in MIH) and one layperson with no dental training or MIH experience. The examiners, blinded regarding the timepoint at which the image was taken and whether the teeth were bleached before resin infiltration, will grade aesthetic appearance according to EVRSAM. The three images of the treated tooth will be displayed side-by-side in a single Powerpoint® (Microsoft Inc., WA, USA) slide, in randomised order, under standardised lighting and screen brightness settings. Tooth images will be graded using the EVRSAM criteria as outlined below, to evaluate the aesthetic match of hypomineralised enamel lesions to the surrounding sound enamel.

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Before treatment (T1), immediately after infiltration (T2), immediately after bleaching (T2), 1 week (T3), 4 weeks (T4), 8 weeks (T5), 12 weeks (T6) and 26 weeks (T7) after treatment

]

Secondary outcome(s)

1.

None

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Target number/sample size

Sample size 57, 19 participants per group.


Countries of recruitment

Mexico


Anticipated start date

2024-01-01


Anticipated end date

2024-11-01


Date of first enrollment


Date of study completion


Recruitment status

Pending


Funding source

DMG Company, Hamburg, Germany.


Regulatory approvals

None



State of Ethics Review Approval


Status

Approved


Date of Approval

2022-11-24


Approval number

Comiteei.icsa/ICSa146a/2023


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, Universitair Medisch Centrum Groningen
Universitair Medisch Centrum Groningen, A. Deusinglaan 1, FB-21, Postbus 196, 9700 AD Groningen, Nederland
+31 050 3610665


d.j.manton@umcg.nl


Primary study sponsor/organization

DMG Corporation (Germany)





Secondary study sponsor (If any)

GC Corporation (Japan)





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