ClinicalTrials.gg
Not yet recruitingNCT07120139Updated Aug 13, 2025

Clinical Effectiveness of Episodic Use of Bioactive Silica Based Versus in Management of Dentin Hypersensitivity (A 6m Randomized Clinical Trial)

An interventional study of episodic use of the desensitizing toothpaste and continuous use of the conventional desensitizing toothpaste in Dentin Hypersensitivity, sponsored by Rawda Hesham Abd ElAziz. Not yet recruiting at 1 site in Egypt. Open to participants aged 22 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-13.

Sponsored by Rawda Hesham Abd ElAziz · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Feb 2026, 8 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
22 Years to 45 Years
Sex
All
01

Study summary

The aim of the study to compare the clinical effectiveness of Episodic use of Bioactive Silica Based versus continuous use of fluoride based desensitizing toothpastes in management of dentin hypersensitivity (DH) of adult patients over 6m follow up and evaluating patient satisfaction regarding the treatment provided. Episodic use will be tested as it reflects the effectiveness in a clinical scenario regarding patient compliance and adherence to the treatment where some of the Egyptian patients stop the treatment once improvement occurs due to financial constraints

02

Conditions studied

  • Dentin Hypersensitivity

Browse trials for

Keywords

  • Bioactive Silica Based with calcium booster (Refix technology) toothpaste
  • Dentin hypersensitivity.
03

In context

Dentin Sensitivity

288 studies on the registry are indexed under Dentin Sensitivity; 46 are open to participants now.

This study's planned enrollment of 50 is below the median of 60 across 279 interventional studies indexed under Dentin Sensitivity.

Browse Dentin Sensitivity studies →

Lead sponsor

Rawda Hesham Abd ElAziz is the lead sponsor of 4 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Patients with DH, VAS ≥ 3 and Schiff sensitivity score needed to be ≥2, indicating that application of a jet of air makes the patient respond and move or requests discontinuation of the stimuli application.

  • Teeth with DH related to Non- carious Cervical lesions (abrasion, abfracture, erosion).
  • Teeth with gingival recession and exposed root dentin.

-

Exclusion criteria

Exclusion Criteria:

  • Patients with known allergies or adverse reactions to any ingredient of the tested materials.

Systematic disease and/ or physical disabilities that may affect participation. • Patients who did any periodontal surgeries within the previous 3 months.

  • Patients with orthodontic appliances, or restorative work that might interfere with evaluation.
  • Patient who frequently use analgesics or any drugs that could affect the pain level.
  • Home or in-office bleaching and/ or in office fluoride application for 6 months before beginning of treatment.
  • Pregnant females with frequent vomiting attacks.
  • Smokers.
  • Systemic conditions that cause or predispose patients to develop dentin (for example, gastroesophageal reflux disease, GERD).
  • Excessive dietary or environmental exposure to acids.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Group 1 Episodic use of Refix booster Bioactive Silica with calcium booster toothpaste

    Procedure: episodic use of the desensitizing toothpaste

  • Experimental
    Group 2: Episodic use of Regenerador Sentitive: Bioactive Silica Based toothpaste,

    Procedure: episodic use of the desensitizing toothpaste

  • Experimental
    Group 3: Episodic use of (Sensodyne Rapid action) Fluoride containing desensitizing Toothpaste,

    Procedure: episodic use of the desensitizing toothpaste

  • Active comparator
    Group 4: Continuous use of (Sensodyne Rapid action) Fluoride containing desensitizing Toothpaste

    Procedure: continuous use of the conventional desensitizing toothpaste

Interventions

  • Procedureepisodic use of the desensitizing toothpaste

    subjects assigned to episodic treatment will use the assigned toothpaste with the same previous instructions for two 8-week treatment periods, followed by an 8-week phase in which they will use the conventional fluoride dentifrice (Signal Complete 8 Original, Unilever, Egypt), which has no documented desensitizing efficacy

  • Procedurecontinuous use of the conventional desensitizing toothpaste

    The patients will be instructed to use 1 inch amount of the assigned desensitizing toothpaste and soft bristle toothbrushes with the same brushing technique they will be taught in the intervention visit for 2 minutes twice a day (morning and last thing at night ) without further rinsing, only spitting of the excess material every day along the whole study period for the continuous treatment group.

06

What researchers measure

Primary outcomes

  1. Degree of Dentin hypersensitivity

    Visual analog scale (VAS)

    Time frame: change from the baseline, 1month, 2months, 4 months, 6 months after treatment

Secondary outcomes

  1. Examiner Assessment to level of patient pain

    Schiff sensitivity scale \[SSS\]

    Time frame: change from the baseline, 1month, 2months, 4 months, 6 months after treatment

  2. Patient satisfaction with the Treatment

    4-point Likert scale

    Time frame: change from the baseline, 1month, 2months, 4 months, 6 months after treatment

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07120139
Lead sponsor
Rawda Hesham Abd ElAziz
Responsible party
Rawda Hesham Abd ElAziz (Associate Professor, Conservative dentistry department, Cairo University) — Sponsor-investigator
First posted
Aug 13, 2025
Start date
Aug 20, 2025 (estimated)
Primary completion
Feb 20, 2026 (estimated)
Completion
Feb 28, 2026 (estimated)
Last update
Aug 13, 2025

Study contacts

Rawda Hesham Abd ElAziz
Contact
rawda.hesham@dentistry.cu.edu.eg
+201001097200

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion