Three Different Topically Applied Materials as Non-invasive Treatment of Sensitivity in Permanent Teeth With Molar Incisor Hypomineralization

Cairo University (CU)

Status: Not yet enrolling

Conditions: Dentine Hypersensitivity

Treatments: Drug: Potassium Nitrate Gel; Drug: nano hydroxy apatite varnish Intervention (1); Drug: Varnishes, Fluorid

Study type: Interventional

Funder types: Other

Identifiers

NCT07056855

1444

Details and patient eligibility

About

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 Dentin Hypersensitivity in MIH-affected teeth.

Full 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.

Enrollment: 48 estimated patients

Sex: All

Ages: 6 to 10 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

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).
  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.
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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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48 participants in 3 patient groups

8.6% nano-hydroxy apatite crystals varnish (Fygg's professional strength, Fygg, USA).

Experimental group

Description:

Intervention group (1)

Treatment:

Drug: nano hydroxy apatite varnish Intervention (1)

Potassium Nitrate (Ultradent UltraEZ Desensitizing Gel, Ultradent Inc., USA).

Experimental group

Description:

Intervention group (2)

Treatment:

Drug: Potassium Nitrate Gel

5% fluoride varnish Control group

Active Comparator group

Treatment:

Drug: Varnishes, Fluorid