A clinical trail to study the effects of three different desensitising toothpastes on dental hypersensitivity

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2015/08/006091
• Date of registration: 13-08-2015
• Prospective Registration: No
• Primary sponsor: Self Funded
• Public title: A clinical trail to study the effects of three different desensitising toothpastes on dental hypersensitivity
• Scientific title: EFFICACY OF DESENSITIZING DENTIFRICES ON DENTINAL HYPERSENSITIVITY: A RANDOMIZED CLINICAL TRAIL
• Date of first enrolment: 13-03-2015
• Target sample size: 60
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=11437
• Study type: Interventional
• Study design: Randomized, Parallel Group, Multiple Arm Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Pre-numbered or coded identical Containers Blinding and masking:Participant, Investigator and Outcome Assessor Blinded
• Phase: Post Marketing Surveillance

Countries of recruitment

India

Contacts

• Name: CHANDRASEKHARA REDDY
• Affiliation: NARAYANA DENTAL COLLEGE AND HOSPITAL

• Name: DEEPTHI ATHULURU
• Affiliation: NARAYANA DENTAL COLLEGE AND HOSPITAL

Key inclusion & exclusion criteria

Inclusion criteria: 1. The individuals aged 18 to 75 years with a history of dentinal hypersensitivity.

2. Subjects with at least 20 natural permanent teeth and at least two teeth with a VAS score of >= 4.
Exclusion criteria: 1. Teeth with caries, defective restorations, chipped teeth, deep periodontal pockets, periodontal surgery within the previous six months.

2. Subjects with orthodontic appliances or bridge work that would interfere with evaluation will be excluded.

3. Subjects will also be excluded if there was presence of occlusal overload or occlusal adjustment recently made in the tooth to be studied.

4. Subjects who had undertaken treatment with any product that could influence the dentinal hypersensitivity of the patient in the 30 days prior to baseline will be excluded.

5. Subjects will also be excluded if they were allergic to ingredients used in the study or exhibited any gross oral pathology, eating disorders, chronic diseases, pregnancy and lactation.

6. Medically compromised patients.

7. Poor oral hygiene and to failure to comply with protocol.

Age minimum:
Age maximum:
Gender:

Intervention(s)

Intervention1: Novamin
: Calcium sodium phosphosilicate, used in the form of tooth paste, twice daily for 12 weeks
Intervention2: Amine Fluoride: Used in Dentifrice
Intervention3: Potassium Nitrate: 5% in dentifrice
Intervention4: Amine Fluoride: Amine fluoride, used in the form of tooth paste, twice daily for 12 weeks
Control Intervention1: Calcium sodium phosphosilicate
Amine fluoride
Potassium nitrate: Used in three different dentifrices
Control Intervention2: Not Applicable: Not Applicable
Control Intervention3: Potassium Nitrate: Potassium Nitrate, used in the form of tooth paste, twice daily for 12 weeks
Control Intervention4: Sodium Fluoride: Sodium Fluoride, used in the form of tooth paste, twice daily for 12 weeks

Primary Outcome(s)

1. Clinical assessment: To measure the visual analogue scale score for Dentinal hypersensitivity in all three groups

2. Biochemical: pH and Buffering capacity of saliva in all three groups.Timepoint: base line, 6 weeks, 12 weeks

Secondary Outcome(s)

nilTimepoint: nil

Secondary ID(s)

NIL

Source(s) of Monetary Support

Self funded

Ethics review

Status: Approved
Approval date: 27/03/2014
Contact:

Institutional Ethical Committee (IEC), Narayana Dental College and Hospital