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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07120139
Enrollment
50
Registered
2025-08-13
Start date
2025-08-20
Completion date
2026-02-28
Last updated
2025-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dentin Hypersensitivity

Keywords

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

Brief 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

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.

Sponsors

Rawda Hesham Abd ElAziz
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
22 Years to 45 Years
Healthy volunteers
Yes

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

* 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 hypersensitivity (for example, gastroesophageal reflux disease, GERD). • Excessive dietary or environmental exposure to acids.

Design outcomes

Primary

MeasureTime frameDescription
Degree of Dentin hypersensitivitychange from the baseline, 1month, 2months, 4 months, 6 months after treatmentVisual analog scale (VAS)

Secondary

MeasureTime frameDescription
Examiner Assessment to level of patient painchange from the baseline, 1month, 2months, 4 months, 6 months after treatmentSchiff sensitivity scale \[SSS\]
Patient satisfaction with the Treatmentchange from the baseline, 1month, 2months, 4 months, 6 months after treatment4-point Likert scale

Countries

Egypt

Contacts

Primary ContactRawda Hesham Abd ElAziz
rawda.hesham@dentistry.cu.edu.eg+201001097200

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026