Molar Incisor Hypomineralisation
Conditions
Brief summary
This clinical study main goal is to investigate the effectiveness of nano hydroxy apatite crystal varnish and potassium nitrate gel as a non invasive approach in managing MIH-affected teeth.
Detailed description
This randomized clinical trial study aims to investigate the effectiveness of nano-hydroxy apatite crystal varnish, and potassium nitrate gel compared to fluoride varnish, in reducing dentin hypersensitivity, improving a child's oral hygiene, and gingival health, oral health-related quality of life, preventing post-eruptive enamel breakdown, and dental caries, along with economic evaluation.
Interventions
DRUGnano hydroxy apatite varnish
Intervention (1)
Intervention (2)
Control
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
the assessment of outcomes will be performed with two investigators other than the main investigator, who will not be aware of the type of the intervention carried out on the assessed child.
Eligibility
Sex/Gender
ALL
Age
6 Years to 10 Years
Healthy volunteers
No
Inclusion criteria
The research unit of this study will be the MIH-affected permanent tooth, in children aged from six to ten years, from either gender. Inclusion criteria: Participants related criteria: 1. Children aged from six to ten years old. 2. Medically free children according to the history taken from their parents. 3. Children who are categorized as Class I or II according to the American Society of Anaesthesiologists (ASA). 4. Children whom their parents accept to comply with the follow-up visits. 5. Children who accept, and their guardians, to participate in the study by signing the informed consent. 6. Children with no more than four cavitated primary teeth. Tooth related criteria: 1\. The diagnosis of MIH will be done as per the Wurzburg concept, 2023 MIH diagnostic criteria: The child will be confirmed to have MIH if any of the following characteristics are apparent: * affected teeth show a clearly defined opacity at the occlusal and buccal surfaces of a tooth, * defects vary in shape, size, and pattern, * white, cream-colored, or yellow-brown color deviations are recognizable, * defects variably vary in size, * teeth with hypersensitivity are present, * teeth have an atypical restoration, * permanent teeth for (suspected) MIH reasons are missing (extractions), * combinations of the above characteristics are present. 1. MIH-affected permanent teeth, suffering from dentin hypersensitivity, (MIH-TNI 3, 4a). 2. Positive Schiff Cold Airblasting Sensitivity score (score 1, 2, or 3). *
Exclusion criteria
Participants related criteria: 1. Children with severe behavioral or emotional disabilities. 2. Children who received analgesics within the last 24 hours before the procedure.15 3. Patients who are using chlorhexidine-based gels or mouthwashes. Tooth related criteria: 1. A tooth with signs and symptoms of irreversible pulpitis. 2. A tooth with signs and symptoms of necrotic pulp. 3. Sealing therapy or application of desensitizing agent on the MIH teeth within one month before participation in the study. 4. Presence of dental caries on the MIH-affected permanent tooth. 5. Presence of restoration(s) on MIH-affected permanent tooth.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dentin Hypersensitivity | Baseline, 15 miutes pot-op, 2 weeks post-op, and 4 weeks post op. | Measured by: Face scale: scores from 0-4. the higher the score the worse the sensitivity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-eruptive enamel breakdown | : baseline, 3-, 6-, 9-, and 12- month post-op. | Measured by Wurzburg Molar Incisor Hypomineralization - Treatment Need Index (MIH-TNI): ordinal scores: 1,2,3, 4a, 4b, 4c. |
| Caries incidence | baseline, 3-, 6-, 9-, and 12- month post-op. | Measured by International Caries Detection and Assessment System (ICDAS II) criteria: scores from 0-6. The higher the score the worse the caries. |
| Oral hygiene | baseline, 2-, and 4- week post-op. | Measured by Plaque Control Record: Percentage. |
| Oral health-related quality of life | baseline, 6-, and 12- month post-op. | Measured by: Short form Parental-Caregiver Perceptions Questionnaire (P-CPQ): from 0 -32. The higher the score the worse the Oral Health Related Quality of Life. |
| Cost Effectiveness Ratio (CER) and Incremental Cost Effectiveness Ratio (ICER | 12-month- post-op. | Measured by: Equation : CER = C / E, where C is the average direct medical cost calculated for the group, and E is the health effectiveness measure for the same group (change in hypersensitivity score). ICER = (CI - CC) / (EI - EC), where CI is the average direct medical cost of the intervention group CC is the average direct medical cost in the control group, EI is the health effectiveness measure (change in hypersensitivity score) in the intervention group, and EC is the health effectiveness measure in the control group |
Contacts
Primary ContactMennat Allah AA Abd Elsabour, PhD student
Outcome results
None listed