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

NCT07669818 | Completed Phase 4 FDA Drug

• 1 other identifier: 2312334
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dentin Hypersensitivity

Outcome Measures

Primary Outcomes (1)

• Reduction in dentin hypersensitivity intensity

  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.

Study Arms (2)

NovaMin-based toothpaste group

ACTIVE COMPARATOR

Participants brush twice daily with NovaMin-containing toothpaste according to the study protocol.

Other: Novamin containing toothpaste

CrystLCare Strip Group

EXPERIMENTAL

Participants receive dissolvable mineral-loaded starch particle strips according to the study protocol.

Other: dissolvable mineral-loaded starch particle strips

Interventions

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.

CrystLCare Strip Group

Novamin containing toothpaste OTHER

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

NovaMin-based toothpaste group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

King Salman International University

Cairo, Other, 223453, Egypt

Location

Related Publications (1)

• Bahal P, He T, Zou Y, Davies M, Chapman N, Seong J, West N. A randomised controlled trial to investigate the efficacy of an oxalate strip for the management of dentine hypersensitivity pain. J Dent. 2019 Jul;86:95-101. doi: 10.1016/j.jdent.2019.05.031. Epub 2019 May 29.

  PMID: 31150729 RESULT

MeSH Terms

Conditions

Dentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of conservative dentistry

Study Record Dates

• First Submitted: June 21, 2026
• First Posted: June 25, 2026
• Study Start: March 10, 2026
• Primary Completion: April 10, 2026
• Study Completion: May 20, 2026
• Last Updated: June 25, 2026

Record last verified: 2026-06

Locations

EG (1)