Clinical Effectiveness of Episodic Use of Bioactive Silica Based Versus in Management of Dentin Hypersensitivity (A 6m Randomized Clinical Trial)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: episodic use of the desensitizing toothpaste, continuous use of the conventional desensitizing toothpaste.
- Who it may be relevant to
- Registry conditions: Dentin Hypersensitivity. Basic parameters: 22 years — 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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)
Overview
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
- Procedure episodic 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 - Procedure continuous 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.
Primary outcome measures
- Degree of Dentin hypersensitivity [Time frame: change from the baseline, 1month, 2months, 4 months, 6 months after treatment]
Secondary outcome measures (2)
- Examiner Assessment to level of patient pain [Time frame: change from the baseline, 1month, 2months, 4 months, 6 months after treatment]
- Patient satisfaction with the Treatment [Time frame: change from the baseline, 1month, 2months, 4 months, 6 months after treatment]
Eligibility criteria
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.
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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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Cairo University — Cairo
Identifiers
NCT: NCT07120139 · CONS2R