Clinical trial NCT03177109: Comparison of Different Desensitizers in Reducing Dentinal Hypersensitivity
Official title: Comparison of Fluoride Varnish With Two Different Desensitizers in Reducing Dentinal Hypersensitivity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Dentine Hypersensitivity
Keywords: Dentine Hypersensitivity
Fluoride varnish
Desensitizing agents
Lead sponsor: Aga Khan University
Sponsor class: OTHER
First posted: 2017-06-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This is a single center, randomized control. Sixty eligible subjects will be recruited into 3 study treatment groups (n=20 per group) through computerized randomization. Subjects in group 1 will be treated with 8% arginine containing paste(Colgate® Sensitive Pro-Relief™), group 2 with 5% topical fluoride varnish (Acclean) and group 3 with self-adhesive resin (Seal and protect, Dentsply). The subjects in the study will be evaluated for tactile and air-blast hypersensitivity criteria at baseline, two and four weeks.

Detailed description: The aim of the present study is to evaluate the efficacy of three common professionally applied desensitizing agents in the reduction of dentine hypersensitivity over a period of 4 weeks. Patients presenting to the dental clinic with Dentine hypersensitivity and fulfilling the inclusion criteria will be included in the study after taking informed consent. Participants will be divided into three groups. Sixty eligible subjects will be recruited into 3 study treatment groups (n=20 per group) through computerized randomization. Subjects in group 1 will be treated with 8% arginine containing paste(Colgate® Sensitive Pro-Relief™), group 2 with 5% topical fluoride varnish (Acclean) and group 3 with self-adhesive resin (Seal and protect, Dentsply). the subjects in the study will be evaluated for tactile and air-blast hypersensitivity criteria at baseline, two and at four weeks by another dentist who would be a blind assessor.

Eligibility criteria: Inclusion Criteria:

* Patients with age 18 and above with dentine hypersensitivity will be selected.
* At least two hypersensitive teeth which will be sensitive to air blast (Schiff air sensitivity scores of 2 or 3) and positive tactile sensitivity assessed clinically with explorer
* Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.

Exclusion Criteria:

* • Patients who would have undergone any periodontal procedure or gotten any professionally applied desensitizers in the last three months.

  * Patients having generalized sensitivity in all teeth
  * Chronic use of anti-inflammatory and analgesic medications
  * Pregnant or lactating females;
  * Any denture bridgework; active cervical caries or deep abrasion requiring Class V fillings;
  * Fractured, crowned or root filled teeth and teeth with large restorations
  * Carious teeth or cracked teeth assessed on the basis of clinical judgment

Primary outcomes:
measure: Reduction of hypersensitivity
timeFrame: Reduction of hypersensitivity will be assessed at 2 weeks and 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Aga Khan University Hospital
state: Sindh
Study officials:
affiliation: Aga Khan University
name: Muhammad Hasan Hameed, BDS
role: PRINCIPAL_INVESTIGATOR
References: