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

Dentin Hypersensitivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04225247
• Other study ID #: 2358847
• Status: Completed
• Phase: Phase 3
• Start date: March 7, 2018
• Est. completion date: October 7, 2018

Study information

• Verified date: January 2020
• Source: Dow University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: October 7, 2018
• Est. primary completion date: October 7, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Dentin Hypersensitivity
• Dentin Sensitivity
• Hypersensitivity

Intervention

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

Locations

Country	Name	City	State
Pakistan	Dow University of health Sciences	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Dow University of Health Sciences

Country where clinical trial is conducted

Pakistan, 

References & Publications (8)

Bartold PM. Dentinal hypersensitivity: a review. Aust Dent J. 2006 Sep;51(3):212-8; quiz 276. Review. — View 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. — View 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. — View 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. — View 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. Epub 2006 Sep 14. — View 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. — View 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Discomfort Internal Scale score	0 - No Pain; - Mild; - Moderate; - Severe; - Intolerable Pain	1 month
Primary	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.	1 month