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Effect of Nano Hydroxy Apatite Varnish and Potassium Nitrate Gel on the MIH-affected Permanent Teeth

ConditionMolar Incisor Hypomineralisation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-10
SponsorCairo University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Children aged from six to ten years old.

Medically free children according to the history taken from their parents.

Children who are categorized as Class I or II according to the American Society of Anaesthesiologists (ASA).

Children whom their parents accept to comply with the follow-up visits.

Disqualifiers

Children with severe behavioral or emotional disabilities.

Children who received analgesics within the last 24 hours before the procedure.15

Patients who are using chlorhexidine-based gels or mouthwashes.

A tooth with signs and symptoms of irreversible pulpitis.

Trial design

Design model

Parallel

Treatments tested in this trial

  • nano hydroxy apatite varnish

    Drug

    Intervention (1)

  • Potassium Nitrate Gel

    Drug

    Intervention (2)

  • Varnishes, Fluoride

    Drug

    Control

Treatment groups

48 Participants
are divided into 3 treatment groups
Group A: 8.6% nano-hydroxy apatite crystals varnish.Experimental treatment 1 intervention
Group B: Potassium Nitrate gelExperimental treatment 1 intervention
Group C: 5% fluoride varnishActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Dentin Hypersensitivity

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.
2

Dentin Hypersensitivity

Measured by: Schiff Cold Air Blasting Sensitivity Scale: scores from 0-3. The higher the score the worse the sensitivity.

Time frame
Baseline, 15 miutes pot-op, 2 weeks post-op, and 4 weeks post op.

Secondary outcomes

1

Post-eruptive enamel breakdown

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.
2

Caries incidence

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, 3-, 6-, 9-, and 12- month post-op.
3

Oral hygiene

Measured by Plaque Control Record: Percentage.

Time frame
baseline, 2-, and 4- week post-op.
4

Oral health-related quality of life

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
baseline, 6-, and 12- month post-op.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: