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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 4
Kontakter og lokationer
Studiesteder
-
-
Other
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Cairo, Other, Egypten, 223453
- King Salman International University
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: NovaMin-based toothpaste group
Participants brush twice daily with NovaMin-containing toothpaste according to the study protocol.
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Toothpaste containing calcium sodium phosphosilicate (NovaMin) used twice daily for the management of dentin hypersensitivity.
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Eksperimentel: CrystLCare Strip Group
Participants receive dissolvable mineral-loaded starch particle strips according to the study protocol.
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dissolvable strips containing mineral-loaded starch particles applied according to the study protocol for the management of dentin hypersensitivity.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Reduction in dentin hypersensitivity intensity
Tidsramme: 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.
|
baseline, after 2 weeks, after 4 weeks.
|
Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2312334
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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