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Comparison of Different Desensitizers in Reducing Dentinal Hypersensitivity

NCT ID: NCT03177109

Last Updated: 2018-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-03

Study Completion Date

2018-12-20

Brief Summary

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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

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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.

Conditions

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Dentine Hypersensitivity

Keywords

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Dentine Hypersensitivity Fluoride varnish Desensitizing agents

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Fluoride Varnish Group

5% fluoride varnish (Acclean) applied topically

Group Type ACTIVE_COMPARATOR

5% fluoride varnish

Intervention Type DRUG

Applied topically as a coating at single point in time

Arginine paste Group

8% arginine containing paste (Colgate® Sensitive Pro-Relief™) applied topically

Group Type ACTIVE_COMPARATOR

8% arginine containing paste

Intervention Type DRUG

Applied topically as a coating at single point in time

Adhesive Resin Group

Self-adhesive resin (Seal and Protect, Dentsply) applied topically

Group Type ACTIVE_COMPARATOR

Self-adhesive resin

Intervention Type DRUG

Applied topically as a coating at single point in time and light cured for 20 seconds

Interventions

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5% fluoride varnish

Applied topically as a coating at single point in time

Intervention Type DRUG

8% arginine containing paste

Applied topically as a coating at single point in time

Intervention Type DRUG

Self-adhesive resin

Applied topically as a coating at single point in time and light cured for 20 seconds

Intervention Type DRUG

Other Intervention Names

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Acclean Colgate® Sensitive Pro-Relief™ Seal and Protect, Dentsply

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aga Khan University

OTHER

Sponsor Role lead

Responsible Party

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Muhammad Hasan Hameed

Resident investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Muhammad Hasan Hameed, BDS

Role: PRINCIPAL_INVESTIGATOR

Aga Khan University

Locations

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Aga Khan University Hospital

Karachi, Sindh, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Robia Ghafoor, BDS,FCPS

Role: CONTACT

Phone: 02133106467

Email: [email protected]

Facility Contacts

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Robia Ghafoor, BDS,FCPS

Role: primary

Other Identifiers

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4714-Sur-ERC-17

Identifier Type: -

Identifier Source: org_study_id