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

June 21, 2026 updated by: Amr Abdel Fattah Mahmoud Edrees, Cairo University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Other
      • Cairo, Other, Egypt, 223453
        • King Salman International University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: NovaMin-based toothpaste group
Participants brush twice daily with NovaMin-containing toothpaste according to the study protocol.
Other: Novamin containing toothpaste
Toothpaste containing calcium sodium phosphosilicate (NovaMin) used twice daily for the management of dentin hypersensitivity.
Experimental: CrystLCare Strip Group
Participants receive dissolvable mineral-loaded starch particle strips according to the study protocol.
Other: dissolvable mineral-loaded starch particle strips
dissolvable strips containing mineral-loaded starch particles applied according to the study protocol for the management of dentin hypersensitivity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline, after 2 weeks, after 4 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2026

Primary Completion (Actual)

April 10, 2026

Study Completion (Actual)

May 20, 2026

Study Registration Dates

First Submitted

June 21, 2026

First Submitted That Met QC Criteria

June 21, 2026

First Posted (Actual)

June 25, 2026

Study Record Updates

Last Update Posted (Actual)

June 25, 2026

Last Update Submitted That Met QC Criteria

June 21, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2312334

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

De-identified individual participant data underlying the results reported in the publication, including baseline characteristics and outcome measures, will be made available to qualified researchers upon reasonable request after publication of the study results. Data will be shared in accordance with institutional policies and applicable ethical and regulatory requirements.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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