Dental Caries, Hypomineralization of Enamel, Molar Incisor Hypomineralization
Conditions
Keywords
molar incisor hypomineralization, silver diamine fluoride, deproteinizing agent
Brief summary
Molar incisor hypomineralization (MIH) is a developmental defect of enamel affecting the first permanent molar and frequently the incisors with a prevalence of 16-16.9% in Malaysia. They presented with many problems such as hypersensitivity, increase susceptibility of caries, need for recurrent complex dental treatment, and difficulty to achieve pain control. Silver Diamine Fluoride is a new form of topical fluoride that has been extensively used and recommended for the management of caries in children and adolescents. The influence of organic material removal from artificial dentine lesions by means of surface pre-treatment with deproteinizing agent show favoring result of its use on subsequent remineralization with and without fluoride. The purpose of this trial is to study the clinical outcome of SDF and papain based gel on hypomineralized teeth restored with HVGIC.
Detailed description
This is a three-arm parallel randomized controlled trial and will be performed in participants between the age of 5 to 15 years presented with hypomineralised molar of MIH in origin. Clinical assessment, radiograph, and photographs will be taken for assessment. Patients that fulfilled the inclusion criteria will be invited to the study. After that, the patient will be explained and a Patient Information Sheet (PIS) will be given. Once consent obtained and the patient randomly allocated for the treatment group, treatment will be done as below: For group 1, any caries if present will be removed using a hand instrument. The tooth then will be filled with High Viscous Glass Ionomer Cement (HVGIC) following the manufacturer's instruction. If the participant is assigned to group 2, after caries has been removed using a hand instrument, silver diamine fluoride (SDF) will be applied for 1 minute on the affected area prior to restoration with HVGIC following the manufacturer's instruction. If the participant is assigned to group 3, papain-based gel (Papacare Duo) will be applied as a deproteinizing agent, caries will be removed using a hand instrument if present. Then, silver diamine fluoride will be applied for 1 minute on the affected area prior to restoration with HVGIC following the manufacturer's instruction. The patient will be followed up after 6 and 12 months. The teeth and restoration will be assessed clinically by an assessor that is not involved in the provision of treatment. Sign and symptom of pain, tenderness to percussion, presence of swelling or fistula, the scale of sensitivity using Schiff Cold Air Sensitivity Scale (SCASS), quality if restorative assessment using Atraumatic Restorative Treatment (ART) Index
Interventions
DEVICESilver Diamine Fluoride
A single application of SDF 38% (Riva Star) on dry affected molar for 1 minute and immediately restored using HVGIC
DEVICEPapain-Based Gel
Papain based Gel (Papacare Duo) will be applied to the MIH affected molar for 60 seconds and repeated if required. The molar will be treated with SDF and restored using HVGIC
DEVICEHigh Viscosity Glass Ionomer Cement (HVGIC)
The molar will be restored with HVGIC
Sponsors
University of Malaya
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participant were not informed regarding intervention given
Eligibility
Sex/Gender
ALL
Age
5 Years to 15 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy with ability to comprehend instruction and perform oral hygiene care independently 2. Hypomineralised First Permanent Molar with: 2.1 Post Eruptive Breakdown (Code 3) 2.2 Atypical restoration (Code 4) which is unsatisfactory or with secondary caries that require replacement 2.3 Atypical caries (Code 5) with enamel breakdown
Exclusion criteria
1. Patient with silver allergy 2. First Permanent Molar with: 2.1 Non-MIH defect 2.2 White, creamy demarcated yellow or brown opacities (Code 2) 2.3 Good satisfactory atypical restoration (Code 4) 2.4 Atypical caries (Code 5) with pulpal involvement -Irreversible pulpitis and pulpal necrosis 2.5 Extensive coronal breakdown (Code 7)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Outcome Based on Success After Intervention on MIH Affected Molar at 6 Months | 6 month | Treated MIH affected molars must fulfilled all criteria for success in order to be reported as success. Criteria of 'Successful' on treated MIH affected molars include 1. Absence of pain related to the treated tooth/teeth 2. Absence of tenderness to percussion (TTP) 3. No evidence of swelling of supporting soft tissue or presence of a sinus tract 4. Absence of enamel breakdown and caries along margin of restoration 5. Scale 0 and 1 for Schiff Cold Air Sensitivity Scale |
| Clinical Outcome Based on Success After Intervention on MIH Affected Molar at 12 Months | 12 month | Treated MIH affected molars must fulfilled all criteria for success in order to be reported as successful. Criteria of 'Successful' on treated MIH affected molars include 1. Absence of pain related to the treated tooth/teeth 2. Absence of tenderness to percussion (TTP) 3. No evidence of swelling of supporting soft tissue or presence of a sinus tract 4. Absence of enamel breakdown and caries along margin of restoration 5. Scale 0 and 1 for Schiff Cold Air Sensitivity Scale |
Countries
Malaysia
Participant flow
Recruitment details
Recruitment period : 1st December 2019 to 6th October 2020 Location: Paediatric Dental Clinic, Faculty of Dentistry, University of Malaya, Kuala Lumpur, Malaysia
Pre-assignment details
For this study, Molar Incisor Hypomineralisation (MIH) affected molar was used as unit prior assignment to intervention groups. The reason for this, data collections were affected by the peak of Coronavirus disease (COVID-19) pandemic with movement control orders enforcement for months in Malaysia. Due to this problem, one participants may had one to four molars (teeth) affected with MIH and be assigned into more than 1 intervention groups. Total participants for this study was 38 participants.
Participants by arm
| Arm | Count |
|---|---|
| High Viscosity GIC (HVGIC) High Viscosity GIC
High Viscosity Glass Ionomer Cement: The molar will be restored with HVGIC | 18 |
| High Viscosity GIC (HVGIC) High Viscosity GIC
High Viscosity Glass Ionomer Cement: The molar will be restored with HVGIC | 21 |
| Silver Diamine Fluoride (SDF) + HVGIC SDF and High Viscosity GIC
Silver Diamine Fluoride: A single application of SDF 38% (Riva Star) on dry affected molar for 1 minute and immediately restored using HVGIC | 19 |
| Silver Diamine Fluoride (SDF) + HVGIC SDF and High Viscosity GIC
Silver Diamine Fluoride: A single application of SDF 38% (Riva Star) on dry affected molar for 1 minute and immediately restored using HVGIC | 21 |
| Papain Based Gel + SDF + HVGIC SDF, Papain-Based Gel and High Viscosity GIC
Papain-Based Gel: Papain based Gel (Papacare Duo) will be applied to the MIH affected molar for 60 seconds and repeated if required. The molar will be treated with SDF and restored using HVGIC | 20 |
| Papain Based Gel + SDF + HVGIC SDF, Papain-Based Gel and High Viscosity GIC
Papain-Based Gel: Papain based Gel (Papacare Duo) will be applied to the MIH affected molar for 60 seconds and repeated if required. The molar will be treated with SDF and restored using HVGIC | 21 |
| Total | 120 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 7 | 6 | 5 |
Baseline characteristics
| Characteristic | High Viscosity GIC (HVGIC) | Total | Papain Based Gel + SDF + HVGIC | Silver Diamine Fluoride (SDF) + HVGIC |
|---|---|---|---|---|
| Age, Customized | 10.1 years STANDARD_DEVIATION 2.8 | 9.2 years STANDARD_DEVIATION 2.43 | 9.2 years STANDARD_DEVIATION 2.44 | 7.9 years STANDARD_DEVIATION 1.5 |
| MIH affected molars | 18 Participants | 57 Participants | 20 Participants | 19 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 18 Participants | 57 Participants | 20 Participants | 19 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex/Gender, Customized Female | 12 participants | 35 participants | 11 participants | 12 participants |
| Sex/Gender, Customized Male | 9 participants | 28 participants | 10 participants | 9 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 19 | 0 / 20 |
| other Total, other adverse events | 0 / 18 | 0 / 19 | 0 / 20 |
| serious Total, serious adverse events | 0 / 18 | 0 / 19 | 0 / 20 |
Outcome results
Primary
Clinical Outcome Based on Success After Intervention on MIH Affected Molar at 12 Months
Treated MIH affected molars must fulfilled all criteria for success in order to be reported as successful. Criteria of 'Successful' on treated MIH affected molars include 1. Absence of pain related to the treated tooth/teeth 2. Absence of tenderness to percussion (TTP) 3. No evidence of swelling of supporting soft tissue or presence of a sinus tract 4. Absence of enamel breakdown and caries along margin of restoration 5. Scale 0 and 1 for Schiff Cold Air Sensitivity Scale
Time frame: 12 month
Population: Descriptive analysis of frequency was used. MIH affected molars represent as participants in this analysis. This is because one participants may have more than 1 tooth assigned into one or more intervention groups.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| High Viscosity GIC (HVGIC) | Clinical Outcome Based on Success After Intervention on MIH Affected Molar at 12 Months | 14 number of successful MIH affected molars |
| Silver Diamine Fluoride (SDF) + HVGIC | Clinical Outcome Based on Success After Intervention on MIH Affected Molar at 12 Months | 13 number of successful MIH affected molars |
| Papain Based Gel + SDF + HVGIC | Clinical Outcome Based on Success After Intervention on MIH Affected Molar at 12 Months | 15 number of successful MIH affected molars |
p-value: <0.05t-test, 2 sided
p-value: <0.05t-test, 2 sided
Primary
Clinical Outcome Based on Success After Intervention on MIH Affected Molar at 6 Months
Treated MIH affected molars must fulfilled all criteria for success in order to be reported as success. Criteria of 'Successful' on treated MIH affected molars include 1. Absence of pain related to the treated tooth/teeth 2. Absence of tenderness to percussion (TTP) 3. No evidence of swelling of supporting soft tissue or presence of a sinus tract 4. Absence of enamel breakdown and caries along margin of restoration 5. Scale 0 and 1 for Schiff Cold Air Sensitivity Scale
Time frame: 6 month
Population: Descriptive analysis of frequency was used. MIH affected molars represents as participants. This is because one participants may have more than 1 tooth assigned into one or more intervention groups.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| High Viscosity GIC (HVGIC) | Clinical Outcome Based on Success After Intervention on MIH Affected Molar at 6 Months | 17 number of Successful MIH affected molars |
| Silver Diamine Fluoride (SDF) + HVGIC | Clinical Outcome Based on Success After Intervention on MIH Affected Molar at 6 Months | 18 number of Successful MIH affected molars |
| Papain Based Gel + SDF + HVGIC | Clinical Outcome Based on Success After Intervention on MIH Affected Molar at 6 Months | 17 number of Successful MIH affected molars |