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

ConditionDentin Hypersensitivity
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-45
SponsorRawda Hesham Abd ElAziz

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • episodic use of the desensitizing toothpaste

    Procedure/Surgery

    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

  • continuous use of the conventional desensitizing toothpaste

    Procedure/Surgery

    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.

Treatment groups

50 Participants
are divided into 4 treatment groups
Group A: Group 1 Episodic use of Refix booster Bioactive Silica with calcium booster toothpasteExperimental treatment 1 intervention
Group B: Group 2: Episodic use of Regenerador Sentitive: Bioactive Silica Based toothpaste,Experimental treatment 1 intervention
Group C: Group 3: Episodic use of (Sensodyne Rapid action) Fluoride containing desensitizing Toothpaste,Experimental treatment 1 intervention
Group D: Group 4: Continuous use of (Sensodyne Rapid action) Fluoride containing desensitizing ToothpasteActive comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rawda Hesham Abd ElAziz

Lead sponsor

Cairo University

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: