Efficacy of Seventh Generation Bonding Agents as Short-Term Desensitizers Among Patients With Hypersensitivity
Primary Purpose
Dentin Hypersensitivity
Status
Completed
Phase
Phase 3
Locations
Pakistan
Study Type
Interventional
Intervention
Single Bond Universal
Bifluorid 12
Xeno V+
Sponsored by
About this trial
This is an interventional treatment trial for Dentin Hypersensitivity focused on measuring Dentin hypersensitivity, Gingival Recession, Bonding Agents
Eligibility Criteria
Inclusion Criteria:
- Healthy males or females of 18 to 45 years of age
- Hypersensitive teeth to air and tactile stimultaion
- Gingival recession of Miller Class I and II
- Score 1 of Silness and Loe Plaque index
- Participants who have no sysytemic illness
- Patients who agree to give consent were included in the study.
Exclusion Criteria:
- Carious teeth
- Fractured restoration or cracked teeth
- Teeth undergoing orthodontic or periodontal treatment at sensitive site
- Patients who had dental bleaching in last 03 months
- Patients taking pain killers
- Smokers
- Pregnant and nursing females were excluded from the study
Sites / Locations
- Dow University of health Sciences
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Group-I Single Bond Universal
Group-II Xeno V+
Group-III Bifluorid 12
Arm Description
it is a seventh generation bonding agent used as desensitizer, manufactured by 3M ESPE. applied on the affected surface of the group-I participants.
it is a seventh generation bonding agent used as desensitizer, manufactured by Dentsply. applied on the affected surface of the group-II participants.
it is a fluoride varnish used as desensitizer, manufactured by VOCO. applied on the affected surface of the group-III participants.
Outcomes
Primary Outcome Measures
Discomfort Internal Scale score
0 - No Pain
- Mild
- Moderate
- Severe
- Intolerable Pain
Schiff Cold Air Sensitivity Scale Score
Grade 0 - Subject does not respond to air stimulus. Grade 1 - Subject responds to air stimulus does not request discontinuation of stimulus.
Grade 2- Subject responds to air stimulus and requests discontinuation or moves away from stimulus.
Grade 3 - Subject responds to air stimulus, considers stimulus to be painful and requests discontinuation of stimulus.
Secondary Outcome Measures
Full Information
NCT ID
NCT04225247
First Posted
December 27, 2019
Last Updated
January 15, 2020
Sponsor
Dow University of Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04225247
Brief Title
Efficacy of Seventh Generation Bonding Agents as Short-Term Desensitizers Among Patients With Hypersensitivity
Official Title
Efficacy of Seventh Generation Bonding Agents as Short-Term Desensitizers Among Patients With Hypersensitivity A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
March 7, 2018 (Actual)
Primary Completion Date
October 7, 2018 (Actual)
Study Completion Date
October 7, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dow University of Health Sciences
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.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The world lacks a gold standard treatment for treating dentin hypersensitivity. Fluoride varnish is most commonly used as a treatment but it causes temporary discoloration of tooth structure and may cause irritation or burning of gums when it comes in contact with gums. Seventh generation bonding agents are less technique sensitive and are easy to use. The present study aims to find out the better seventh generation bonding agent as a treatment option for sensitivity.
A total of 105 patients with dentin hypersensitivity are randomized into three groups. Scaling and root debridement are performed for all the groups. This study compares two seventh generation bonding agents and taking fluoride varnish as control group.
Detailed Description
Dentin hypersensitivity is a painful condition resulting from external stimulation of exposed vital dentin. Dentin gets exposed to the oral environment by multiple factors like gingival recession, erosion, attrition, abrasion, fractures, caries, and many more. The intra-tubular fluid movement of exposed tubules is believed to be the mechanism of hypersensitivity. Dentin bonding agents acts by occluding patent tubules, thus reducing hypersensitivity. Seventh generation combines etchant, primer and bonding agent into one solution and makes it easy to use.
After diagnosis of dentin hypersensitivity, the patients signed a consent form stating their voluntary participation in the research. The discomfort internal scale score and Schiff cold air sensitivity scale scores are recorded at baseline, immediately after the intervention, after 01 week and after 01 month. Discomfort internal scale score are recorded for every participant using dental explorer in the mesial and distal direction on the exposed surface of the affected teeth for tactile stimulation. For schiff cold air sensitivity scale scores an air syringe system was used to check the evaporative response on the affected teeth of the participants and the scores are recorded.
All the patients received scaling and root debridement as a standard protocol treatment. Dentin bonding agents and fluoride varnish are applied to the participants. All the participants are instructed to fast for two hours after the treatment. All the records are made on subjective response of patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dentin Hypersensitivity
Keywords
Dentin hypersensitivity, Gingival Recession, Bonding Agents
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
105 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group-I Single Bond Universal
Arm Type
Active Comparator
Arm Description
it is a seventh generation bonding agent used as desensitizer, manufactured by 3M ESPE.
applied on the affected surface of the group-I participants.
Arm Title
Group-II Xeno V+
Arm Type
Active Comparator
Arm Description
it is a seventh generation bonding agent used as desensitizer, manufactured by Dentsply.
applied on the affected surface of the group-II participants.
Arm Title
Group-III Bifluorid 12
Arm Type
Placebo Comparator
Arm Description
it is a fluoride varnish used as desensitizer, manufactured by VOCO. applied on the affected surface of the group-III participants.
Intervention Type
Drug
Intervention Name(s)
Single Bond Universal
Intervention Description
Single bond universal (by 3M ESPE) is a seventh generation bonding agents used as desensitizers in the present study.
Intervention Type
Drug
Intervention Name(s)
Bifluorid 12
Intervention Description
it is a fluoride varnish by VOCO.
Intervention Type
Drug
Intervention Name(s)
Xeno V+
Intervention Description
Xeno V+ (by Dentsply) is a seventh generation bonding agents used as desensitizers in the present study.
Primary Outcome Measure Information:
Title
Discomfort Internal Scale score
Description
0 - No Pain
- Mild
- Moderate
- Severe
- Intolerable Pain
Time Frame
1 month
Title
Schiff Cold Air Sensitivity Scale Score
Description
Grade 0 - Subject does not respond to air stimulus. Grade 1 - Subject responds to air stimulus does not request discontinuation of stimulus.
Grade 2- Subject responds to air stimulus and requests discontinuation or moves away from stimulus.
Grade 3 - Subject responds to air stimulus, considers stimulus to be painful and requests discontinuation of stimulus.
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy males or females of 18 to 45 years of age
Hypersensitive teeth to air and tactile stimultaion
Gingival recession of Miller Class I and II
Score 1 of Silness and Loe Plaque index
Participants who have no sysytemic illness
Patients who agree to give consent were included in the study.
Exclusion Criteria:
Carious teeth
Fractured restoration or cracked teeth
Teeth undergoing orthodontic or periodontal treatment at sensitive site
Patients who had dental bleaching in last 03 months
Patients taking pain killers
Smokers
Pregnant and nursing females were excluded from the study
Facility Information:
Facility Name
Dow University of health Sciences
City
Karachi
State/Province
Sindh
ZIP/Postal Code
74200
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
20533627
Citation
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Results Reference
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PubMed Identifier
10649916
Citation
Ferrari M, Cagidiaco MC, Kugel G, Davidson CL. Clinical evaluation of a one-bottle bonding system for desensitizing exposed roots. Am J Dent. 1999 Oct;12(5):243-9.
Results Reference
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PubMed Identifier
24720265
Citation
Torres CR, Silva TM, Fonseca BM, Sales AL, Holleben P, Di Nicolo R, Borges AB. The effect of three desensitizing agents on dentin hypersensitivity: a randomized, split-mouth clinical trial. Oper Dent. 2014 Sep-Oct;39(5):E186-94. doi: 10.2341/13-057. Epub 2014 Apr 10.
Results Reference
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PubMed Identifier
28808633
Citation
Hajizadeh H, Nemati-Karimooy A, Majidinia S, Moeintaghavi A, Ghavamnasiri M. Comparing the effect of a desensitizing material and a self-etch adhesive on dentin sensitivity after periodontal surgery: a randomized clinical trial. Restor Dent Endod. 2017 Aug;42(3):168-175. doi: 10.5395/rde.2017.42.3.168. Epub 2017 Jul 21.
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PubMed Identifier
11874519
Citation
Panduric V, Knezevic A, Tarle Z, Sutalo J. The efficiency of dentine adhesives in treating non-caries cervical lesions. J Oral Rehabil. 2001 Dec;28(12):1168-74. doi: 10.1046/j.1365-2842.2001.00779.x.
Results Reference
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PubMed Identifier
17037886
Citation
Bartold PM. Dentinal hypersensitivity: a review. Aust Dent J. 2006 Sep;51(3):212-8; quiz 276.
Results Reference
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PubMed Identifier
16973252
Citation
Polderman RN, Frencken JE. Comparison between effectiveness of a low-viscosity glass ionomer and a resin-based glutaraldehyde containing primer in treating dentine hypersensitivity--a 25.2-month evaluation. J Dent. 2007 Feb;35(2):144-9. doi: 10.1016/j.jdent.2006.06.005. Epub 2006 Sep 14.
Results Reference
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PubMed Identifier
8534380
Citation
Schiff T, Dotson M, Cohen S, De Vizio W, McCool J, Volpe A. Efficacy of a dentifrice containing potassium nitrate, soluble pyrophosphate, PVM/MA copolymer, and sodium fluoride on dentinal hypersensitivity: a twelve-week clinical study. J Clin Dent. 1994;5 Spec No:87-92.
Results Reference
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Efficacy of Seventh Generation Bonding Agents as Short-Term Desensitizers Among Patients With Hypersensitivity
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