nano hydroxy apatite varnish
DrugIntervention (1)
Other names: Fygg's professional strength, Fygg, USA
NCT Number: NCT06896565
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.
Trial opening soon.
Get Notified6 year–10 year
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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:
Tooth related criteria:
The child will be confirmed to have MIH if any of the following characteristics are apparent:
Participants related criteria:
Tooth related criteria:
Intervention (1)
Other names: Fygg's professional strength, Fygg, USA
Intervention (2)
Other names: Ultradent UltraEZ Desensitizing Gel, Ultradent Inc., USA
Control
Other names: DentKist Charm Varnish 5% Sodium Fluoride Varnish
Time frame: 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.
Time frame: Baseline, 15 miutes pot-op, 2 weeks post-op, and 4 weeks post op.
Measured by:
Schiff Cold Air Blasting Sensitivity Scale: scores from 0-3. The higher the score the worse the sensitivity.
Time frame: : 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.
Time frame: 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.
Time frame: baseline, 2-, and 4- week post-op.
Measured by Plaque Control Record: Percentage.
Time frame: 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.
Time frame: 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
Contact information is provided by the study sponsor or research team.
Cairo University
Other
Comparative Evaluation of Three Different Topically Applied Materials as Non-invasive Treatment of Permanent Teeth With Molar Incisor Hypo-mineralization: Randomized Clinical Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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