Efficacy of Seventh Generation Bonding Agents as Short-Term Desensitizers Among Patients With Hypersensitivity

NCT ID: NCT04225247

Last Updated: 2020-01-18

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-07

Study Completion Date

2018-10-07

Brief Summary

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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

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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.

Conditions

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Dentin Hypersensitivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Group-I Single Bond Universal

it is a seventh generation bonding agent used as desensitizer, manufactured by 3M ESPE.

applied on the affected surface of the group-I participants.

Group Type ACTIVE_COMPARATOR

Single Bond Universal

Intervention Type DRUG

Single bond universal (by 3M ESPE) is a seventh generation bonding agents used as desensitizers in the present study.

Group-II Xeno V+

it is a seventh generation bonding agent used as desensitizer, manufactured by Dentsply.

applied on the affected surface of the group-II participants.

Group Type ACTIVE_COMPARATOR

Xeno V+

Intervention Type DRUG

Xeno V+ (by Dentsply) is a seventh generation bonding agents used as desensitizers in the present study.

Group-III Bifluorid 12

it is a fluoride varnish used as desensitizer, manufactured by VOCO. applied on the affected surface of the group-III participants.

Group Type PLACEBO_COMPARATOR

Bifluorid 12

Intervention Type DRUG

it is a fluoride varnish by VOCO.

Interventions

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Single Bond Universal

Single bond universal (by 3M ESPE) is a seventh generation bonding agents used as desensitizers in the present study.

Intervention Type DRUG

Bifluorid 12

it is a fluoride varnish by VOCO.

Intervention Type DRUG

Xeno V+

Xeno V+ (by Dentsply) is a seventh generation bonding agents used as desensitizers in the present study.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dow University of Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Sumaiya Shabbir

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dow University of health Sciences

Karachi, Sindh, Pakistan

Site Status

Countries

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Pakistan

References

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Yu X, Liang B, Jin X, Fu B, Hannig M. Comparative in vivo study on the desensitizing efficacy of dentin desensitizers and one-bottle self-etching adhesives. Oper Dent. 2010 May-Jun;35(3):279-86. doi: 10.2341/09-346-C.

Reference Type BACKGROUND
PMID: 20533627 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10649916 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24720265 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28808633 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11874519 (View on PubMed)

Bartold PM. Dentinal hypersensitivity: a review. Aust Dent J. 2006 Sep;51(3):212-8; quiz 276.

Reference Type BACKGROUND
PMID: 17037886 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16973252 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8534380 (View on PubMed)

Shabbir S, Ahmed S, Zaidi SJA, Riaz S, Sarwar H, Taqi M, Rahman Khan ZU. Efficacy of seventh generation bonding agents as desensitizers in patients with dentin hypersensitivity: a randomized clinical trial. BMC Oral Health. 2024 May 14;24(1):562. doi: 10.1186/s12903-024-04352-0.

Reference Type DERIVED
PMID: 38745306 (View on PubMed)

Other Identifiers

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2358847

Identifier Type: -

Identifier Source: org_study_id

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