NCT03177109

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 3, 2017

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

May 31, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 6, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2018

Completed
Last Updated

June 29, 2018

Status Verified

June 1, 2018

Enrollment Period

1.6 years

First QC Date

May 31, 2017

Last Update Submit

June 28, 2018

Conditions

Dentine Hypersensitivity

Keywords

Dentine HypersensitivityFluoride varnishDesensitizing agents

Outcome Measures

Primary Outcomes (1)

  • Reduction of hypersensitivity

    • Investigators are comparing the effectiveness of three professionally applied desensitizing agents, 8% arginine containing paste (Colgate® Sensitive Pro-Relief™), 5% fluoride varnish (Acclean) and self-adhesive resin (Seal and Protect, Dentsply) in reducing the dentine hypersensitivity immediately after application and at 2 and 4 weeks follow-up.The measurements of sensitivity will be determined by patient's response to air blast stimuli. Subjective responses will be recorded using Schiff Cold Air Sensitivity Scale which is scored as follows: 0 Subject does not respond to air stimulus, 1. Subject responds to air stimulus but does not request discontinuation of stimulus 2. Subject responds to air stimulus and requests discontinuation or moves from stimulus 3. Subject responds to air stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus

    Reduction of hypersensitivity will be assessed at 2 weeks and 4 weeks

Study Arms (3)

Fluoride Varnish Group

ACTIVE COMPARATOR

5% fluoride varnish (Acclean) applied topically

Drug: 5% fluoride varnish

Arginine paste Group

ACTIVE COMPARATOR

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

Drug: 8% arginine containing paste

Adhesive Resin Group

ACTIVE COMPARATOR

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

Drug: Self-adhesive resin

Interventions

5% fluoride varnishDRUG

Applied topically as a coating at single point in time

Also known as: Acclean
Fluoride Varnish Group
8% arginine containing pasteDRUG

Applied topically as a coating at single point in time

Also known as: Colgate® Sensitive Pro-Relief™
Arginine paste Group
Self-adhesive resinDRUG

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

Also known as: Seal and Protect, Dentsply
Adhesive Resin Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aga Khan University Hospital

Karachi, Sindh, 74800, Pakistan

RECRUITING

MeSH Terms

Conditions

Dentin Sensitivity

Interventions

CMW cement

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Officials

  • Muhammad Hasan Hameed, BDS

    Aga Khan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Robia Ghafoor, BDS,FCPS

CONTACT

02133106467robia.ghafoor@aku.edu

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident investigator

Study Record Dates

First Submitted

May 31, 2017

First Posted

June 6, 2017

Study Start

May 3, 2017

Primary Completion

December 20, 2018

Study Completion

December 20, 2018

Last Updated

June 29, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)