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OpenTrials
Completed

NCT Number: NCT07669818

Efficacy of Dissolvable Mineral Loaded Starch Particles Strips in Providing Rapid Relief of Dentin Hypersensitivity: A Randomized Clinical Trial

Dentinal Hypersensitivity is a common condition associated with exposed root surfaces that causes short, sharp pain in response to thermal, evaporative, or tactile stimuli, negatively affecting patients' daily activities and oral hygiene practices. Current treatment approaches mainly focus on occluding dentinal tubules to reduce sensitivity.

NovaMin-based toothpaste is widely used because of its ability to promote mineral deposition and dentinal tubule occlusion. Recently, dissolvable mineral-loaded starch particle strips have been introduced as a novel delivery system that may enhance mineral contact with exposed dentin and improve patient compliance. However, limited evidence exists regarding their clinical effectiveness compared with established desensitizing toothpastes.

Therefore, this study is significant because it aims to evaluate whether these dissolvable strips can provide a comparable therapeutic effect to NovaMin-based toothpaste in managing dentinal hypersensitivity.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

King Salman International University

Cairo, Other, 223453, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged 18-60 years.
  • Presence of at least one permanent tooth exhibiting dentin hypersensitivity due to exposed cervical dentin.
  • Hypersensitive tooth with a Schiff Cold Air Sensitivity Scale score ≥2 and/or a Visual Analog Scale (VAS) score ≥4 following standardized air stimulation.
  • Vital teeth with no signs or symptoms of irreversible pulpitis.
  • Provision of written informed consent.

Exclusion criteria

  • Active carious lesions, defective restorations, cracked teeth, or fractured cusps associated with the test tooth.
  • Teeth with pulp pathology, periapical lesions, or previous endodontic treatment.
  • Current orthodontic appliances involving the test tooth.
  • Periodontal pockets >4 mm or active periodontal disease affecting the test tooth.
  • Use of desensitizing products or professional desensitizing treatment within the previous 4 weeks.
  • Ongoing use of medications that may affect pain perception.
  • Pregnancy or lactation (if applicable).
  • Known allergy or hypersensitivity to any component of the study materials.

Treatment and study plan

dissolvable mineral-loaded starch particle strips

Other

dissolvable strips containing mineral-loaded starch particles applied according to the study protocol for the management of dentin hypersensitivity.

Novamin containing toothpaste

Other

Toothpaste containing calcium sodium phosphosilicate (NovaMin) used twice daily for the management of dentin hypersensitivity.

Primary outcomes

  1. Reduction in dentin hypersensitivity intensity

    Time frame: baseline, after 2 weeks, after 4 weeks.

    Dentin hypersensitivity will be assessed using a Visual Analog Scale (VAS, 0-10) in response to a standardized air-blast stimulus. The change in VAS score from baseline to follow-up visits will be compared between groups.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 25, 2026
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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