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

NCT07056855 | Not Yet Recruiting DMC

• 1 other identifier: 1444
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

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 Dentin Hypersensitivity in MIH-affected teeth.

Conditions

Dentine Hypersensitivity

Outcome Measures

Primary Outcomes (2)

• Dentin Hypersensitivity

  Face scale: scores from 0-4. the higher the score the worse the sensitivity

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

• Dentin Hypersensitivity

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

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

Secondary Outcomes (1)

• Oral hygiene

  baseline, 2-, and 4- week post-op

Study Arms (3)

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

EXPERIMENTAL

Intervention group (1)

Drug: nano hydroxy apatite varnish Intervention (1)

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

EXPERIMENTAL

Intervention group (2)

Drug: Potassium Nitrate Gel

5% fluoride varnish Control group

ACTIVE COMPARATOR

Drug: Varnishes, Fluorid

Interventions

nano hydroxy apatite varnish Intervention (1) DRUG

Fygg's professional strength, Fygg, USA

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

Potassium Nitrate Gel DRUG

Ultradent UltraEZ Desensitizing Gel, Ultradent Inc., USA

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

Varnishes, Fluorid DRUG

DentKist Charm Varnish 5% Sodium Fluoride Varnish

5% fluoride varnish Control group

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may not qualify if:

• Participants related criteria:
• Children with severe behavioral or emotional disabilities.
• Children who received analgesics within the last 24 hours before the procedure.
• Patients who are using chlorhexidine-based gels or mouthwashes.
• Tooth related criteria:
• A tooth with signs and symptoms of irreversible pulpitis.
• A tooth with signs and symptoms of necrotic pulp.
• Sealing therapy or application of desensitizing agent on the MIH teeth within one month before participation in the study.
• Presence of dental caries on the MIH-affected permanent tooth.
• Presence of restoration(s) on MIH-affected permanent tooth.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Dentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Central Study Contacts

Mennat Allah A. A. Abd Elsabour, PhD student

CONTACT

+201026022605; mennatallah.ashraf@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer, Pediatric Dentistry Department, Ahram Canadian University. PhD student, Pediatric Dentistry and Dental Public Health Department, Cairo University. Affiliation: Cairo University

Study Record Dates

• First Submitted: June 29, 2025
• First Posted: July 9, 2025
• Study Start: July 10, 2025
• Primary Completion: July 20, 2025
• Study Completion: July 20, 2025
• Last Updated: July 9, 2025

Record last verified: 2025-03