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Completed
NCT07669818
Efficacy of Dissolvable Mineral Loaded Starch Particles Strips in Providing Rapid Relief of Dentin Hypersensitivity: A Randomized Clinical Trial
Conditions: Dentin Hypersensitivity
Sex: All
Ages: 18 Years – 60 Years
Healthy volunteers: No
Phase: PHASE4
Enrollment: 82
Sponsor: Cairo University
Location: King Salman International University Cairo Other
Summary
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07669818). StuddyBuddy aggregates publicly available trial information.