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NCT Number: NCT04225247

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

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.

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Key information

Conditions

Dentin Hypersensitivity Dentin Sensitivity Gingival Diseases Gingival Recession Mouth Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases Tooth Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Dow University of health Sciences

Karachi, Sindh, 74200, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Single Bond Universal

Drug

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

Bifluorid 12

Drug

it is a fluoride varnish by VOCO.

Xeno V+

Drug

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

Primary outcomes

  1. Discomfort Internal Scale score

    Time frame: 1 month

    0 - No Pain

    • - Mild
    • - Moderate
    • - Severe
    • - Intolerable Pain

  2. 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.

Sponsors and collaborators

Lead sponsor

Dow University of Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 13, 2020
Registry last updated
Jan 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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