Dentin HypersensitivityPhase 4NCT07669818
Efficacy of Dissolvable Mineral Loaded Starch Particles Strips in Providing Rapid Relief of Dentin Hypersensitivity: A Randomized Clinical Trial
A Phase 4 study testing dissolvable mineral-loaded starch particle strips and Novamin containing toothpaste in people with Dentin Hypersensitivity, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Dentin Hypersensitivity
- What is being tested?
- dissolvable mineral-loaded starch particle strips and Novamin containing toothpaste
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Mar 2026to 20 May 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- dissolvable mineral-loaded starch particle strips, Novamin containing toothpaste
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dissolvable mineral-loaded starch particle stripsOther
dissolvable strips containing mineral-loaded starch particles applied according to the study protocol for the management of dentin hypersensitivity.
Novamin containing toothpasteOther
Toothpaste containing calcium sodium phosphosilicate (NovaMin) used twice daily for the management of dentin hypersensitivity.
| Study group | Role | What they receive |
|---|---|---|
| NovaMin-based toothpaste group | Active comparator | Participants brush twice daily with NovaMin-containing toothpaste according to the study protocol. Receives: Other: Novamin containing toothpaste |
| CrystLCare Strip Group | Experimental | Participants receive dissolvable mineral-loaded starch particle strips according to the study protocol. Receives: Other: dissolvable mineral-loaded starch particle strips |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, after 2 weeks, after 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start10 Mar 2026
- Primary completion10 Apr 2026
- Study completion20 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dentin HypersensitivityStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Abdel Fattah Mahmoud Edrees, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07669818
- Sponsor's protocol ID
- 2312334
- Status last verified
- Jun 2026
- First submitted
- 21 Jun 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Publications
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.
PubMed 31150729
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Dissolvable Mineral Loaded Starch Particles Strips in Providing Rapid Relief of Dentin Hypersensitivity: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07669818
- Acronym / sponsor ID
- 2312334
- Conditions
- Dentin Hypersensitivity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Mar 2026 (actual)
- Primary completion
- 10 Apr 2026 (actual)
- Study completion
- 20 May 2026 (actual)
- First posted
- 25 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NovaMin-based toothpaste group | Active comparator | Other: Novamin containing toothpasteParticipants brush twice daily with NovaMin-containing toothpaste according to the study protocol. |
| CrystLCare Strip Group | Experimental | Other: dissolvable mineral-loaded starch particle stripsParticipants receive dissolvable mineral-loaded starch particle strips according to the study protocol. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dissolvable mineral-loaded starch particle stripsdissolvable strips containing mineral-loaded starch particles applied according to the study protocol for the management of dentin hypersensitivity. | Other | CrystLCare Strip Group |
| Novamin containing toothpasteToothpaste containing calcium sodium phosphosilicate (NovaMin) used twice daily for the management of dentin hypersensitivity. | Other | NovaMin-based toothpaste group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Results publication: PubMed 31150729Bahal 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.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing dissolvable mineral-loaded starch particle strips and Novamin containing toothpaste in people with Dentin Hypersensitivity, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in dentin hypersensitivity intensity (time frame: baseline, after 2 weeks, after 4 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07669818, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.