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

January 15, 2020 updated by: Sumaiya Shabbir, Dow University of Health Sciences

Efficacy of Seventh Generation Bonding Agents as Short-Term Desensitizers Among Patients With Hypersensitivity A Randomized Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

105

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 74200
        • Dow University of Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 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.
Drug: Single Bond Universal
Single bond universal (by 3M ESPE) is a seventh generation bonding agents used as desensitizers in the present study.
ACTIVE_COMPARATOR: 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.
Drug: Xeno V+
Xeno V+ (by Dentsply) is a seventh generation bonding agents used as desensitizers in the present study.
PLACEBO_COMPARATOR: 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.
Drug: Bifluorid 12
it is a fluoride varnish by VOCO.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Discomfort Internal Scale score
Time Frame: 1 month

0 - No Pain

  1. - Mild
  2. - Moderate
  3. - Severe
  4. - Intolerable Pain
1 month
Schiff Cold Air Sensitivity Scale Score
Time Frame: 1 month

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.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dow University of Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 7, 2018

Primary Completion (ACTUAL)

October 7, 2018

Study Completion (ACTUAL)

October 7, 2018

Study Registration Dates

First Submitted

December 27, 2019

First Submitted That Met QC Criteria

January 8, 2020

First Posted (ACTUAL)

January 13, 2020

Study Record Updates

Last Update Posted (ACTUAL)

January 18, 2020

Last Update Submitted That Met QC Criteria

January 15, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2358847

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dentin Hypersensitivity

Clinical Trials on Single Bond Universal

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cambodia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe