Back to resultsComparison of Different Desensitizers in Reducing Dentinal Hypersensitivity
Primary Purpose
Dentine Hypersensitivity
Status
Unknown status
Phase
Phase 3
Locations
Pakistan
Study Type
Interventional
Intervention
5% fluoride varnish
8% arginine containing paste
Self-adhesive resin
Sponsored by
About this trial
This is an interventional treatment trial for Dentine Hypersensitivity focused on measuring Dentine Hypersensitivity, Fluoride varnish, Desensitizing agents
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
Sites / Locations
- Aga Khan University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Fluoride Varnish Group
Arginine paste Group
Adhesive Resin Group
Arm Description
5% fluoride varnish (Acclean) applied topically
8% arginine containing paste (Colgate® Sensitive Pro-Relief™) applied topically
Self-adhesive resin (Seal and Protect, Dentsply) applied topically
Outcomes
Primary Outcome Measures
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,
Subject responds to air stimulus but does not request discontinuation of stimulus
Subject responds to air stimulus and requests discontinuation or moves from stimulus
Subject responds to air stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03177109
Brief Title
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
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 3, 2017 (Actual)
Primary Completion Date
December 20, 2018 (Anticipated)
Study Completion Date
December 20, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aga Khan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dentine Hypersensitivity
Keywords
Dentine Hypersensitivity, Fluoride varnish, Desensitizing agents
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Fluoride Varnish Group
Arm Type
Active Comparator
Arm Description
5% fluoride varnish (Acclean) applied topically
Arm Title
Arginine paste Group
Arm Type
Active Comparator
Arm Description
8% arginine containing paste (Colgate® Sensitive Pro-Relief™) applied topically
Arm Title
Adhesive Resin Group
Arm Type
Active Comparator
Arm Description
Self-adhesive resin (Seal and Protect, Dentsply) applied topically
Intervention Type
Drug
Intervention Name(s)
5% fluoride varnish
Other Intervention Name(s)
Acclean
Intervention Description
Applied topically as a coating at single point in time
Intervention Type
Drug
Intervention Name(s)
8% arginine containing paste
Other Intervention Name(s)
Colgate® Sensitive Pro-Relief™
Intervention Description
Applied topically as a coating at single point in time
Intervention Type
Drug
Intervention Name(s)
Self-adhesive resin
Other Intervention Name(s)
Seal and Protect, Dentsply
Intervention Description
Applied topically as a coating at single point in time and light cured for 20 seconds
Primary Outcome Measure Information:
Title
Reduction of hypersensitivity
Description
• 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,
Subject responds to air stimulus but does not request discontinuation of stimulus
Subject responds to air stimulus and requests discontinuation or moves from stimulus
Subject responds to air stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus
Time Frame
Reduction of hypersensitivity will be assessed at 2 weeks and 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robia Ghafoor, BDS,FCPS
Phone
02133106467
Ext
6467
Email
robia.ghafoor@aku.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad Hasan Hameed, BDS
Organizational Affiliation
Aga Khan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aga Khan University Hospital
City
Karachi
State/Province
Sindh
ZIP/Postal Code
74800
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robia Ghafoor, BDS,FCPS
Phone
02133106467
Email
robia.ghafoor@aku.edu
First Name & Middle Initial & Last Name & Degree
Muhammad Hasan Hameed
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of Different Desensitizers in Reducing Dentinal Hypersensitivity
We'll reach out to this number within 24 hrs