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

Phase 3

Completed

• Conditions: Dentin Hypersensitivity
• Interventions: Drug: Xeno V+; Drug: Bifluorid 12; Drug: Single Bond Universal

• Registration Number: NCT04225247
• Lead Sponsor: Dow University of Health Sciences

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.

Study Timeline

• Study Start: 2018-03-07
• Primary Completion: 2018-10-07
• Study Completion: 2018-10-07
• Study First Submitted: 2019-12-27
• Status Verified: 2020-01
• Study First Submitted QC: 2020-01-08
• Study First Posted: 2020-01-13
• Last Update Submitted: 2020-01-15
• Last Update Posted: 2020-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group-II Xeno V+	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-III Bifluorid 12	Bifluorid 12	it is a fluoride varnish used as desensitizer, manufactured by VOCO. applied on the affected surface of the group-III participants.
Group-I Single Bond Universal	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.

Primary Outcome Measures

Name	Time	Method
Schiff Cold Air Sensitivity Scale Score	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.
Discomfort Internal Scale score	1 month	0 - No Pain; 1. - Mild; 2. - Moderate; 3. - Severe; 4. - Intolerable Pain

Trial Locations

Locations (1)

Dow University of health Sciences; 🇵🇰 Karachi, Sindh, Pakistan