NCT04225247

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2018

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 7, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 7, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 7, 2018

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 27, 2019

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 13, 2020

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

7 months

First QC Date

December 27, 2019

Last Update Submit

January 15, 2020

Conditions

Dentin Hypersensitivity

Keywords

Dentin hypersensitivityGingival RecessionBonding Agents

Outcome Measures

Primary Outcomes (2)

  • Discomfort Internal Scale score

    0 - No Pain 1. \- Mild 2. \- Moderate 3. \- Severe 4. \- Intolerable Pain

    1 month

  • 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

Study Arms (3)

Group-I Single Bond Universal

ACTIVE COMPARATOR

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

Group-II Xeno V+

ACTIVE COMPARATOR

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+

Group-III Bifluorid 12

PLACEBO COMPARATOR

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

Drug: Bifluorid 12

Interventions

Single Bond UniversalDRUG

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

Group-I Single Bond Universal
Bifluorid 12DRUG

it is a fluoride varnish by VOCO.

Group-III Bifluorid 12
Xeno V+DRUG

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

Group-II Xeno V+

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dow University of health Sciences

Karachi, Sindh, 74200, Pakistan

Location

Related Publications (9)

  • 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.

    PMID: 20533627BACKGROUND

  • 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.

    PMID: 10649916BACKGROUND

  • 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.

    PMID: 24720265BACKGROUND

  • 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.

    PMID: 28808633BACKGROUND

  • 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.

    PMID: 11874519BACKGROUND

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

    PMID: 17037886BACKGROUND

  • 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.

    PMID: 16973252BACKGROUND

  • 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.

    PMID: 8534380BACKGROUND

  • 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.

    PMID: 38745306DERIVED

MeSH Terms

Conditions

Dentin SensitivityGingival Recession

Interventions

Bifluorid 12Xeno V

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesGingival DiseasesPeriodontal DiseasesMouth DiseasesPeriodontal Atrophy

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 27, 2019

First Posted

January 13, 2020

Study Start

March 7, 2018

Primary Completion

October 7, 2018

Study Completion

October 7, 2018

Last Updated

January 18, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)