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Dentin HypersensitivityPhase 3NCT04225247

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

A Phase 3 study testing Single Bond Universal, Bifluorid 12 and Xeno V+ in people with Dentin Hypersensitivity, run by Dow University of Health Sciences at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Dentin Hypersensitivity
What is being tested?
Single Bond Universal, Bifluorid 12 and Xeno V+
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
105 participants
Where
1 sitePakistan
Study dates
7 Mar 2018to 7 Oct 2018
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Dow University of health Sciences

    Karachi, Sindh, 74200

Other trials in Pakistan

About this study

Official title: 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.

Read the 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.

Being tested
Single Bond Universal, Bifluorid 12, Xeno V+
Keywords
Dentin hypersensitivity, Gingival Recession, Bonding Agents
Medical subject headings
Dentin Sensitivity, Gingival Recession

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Single Bond UniversalDrug

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

  • Bifluorid 12Drug

    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.

Study groups in NCT04225247
Study groupRoleWhat they receive
Group-I Single Bond UniversalActive comparatorit is a seventh generation bonding agent used as desensitizer, manufactured by 3M ESPE. applied on the affected surface of the group-I participants.
Receives: Drug: Single Bond Universal
Group-II Xeno V+Active comparatorit is a seventh generation bonding agent used as desensitizer, manufactured by Dentsply. applied on the affected surface of the group-II participants.
Receives: Drug: Xeno V+
Group-III Bifluorid 12Placebo comparatorit is a fluoride varnish used as desensitizer, manufactured by VOCO. applied on the affected surface of the group-III participants.
Receives: Drug: Bifluorid 12

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Discomfort Internal Scale score

    0 - No Pain

    1. - Mild
    2. - Moderate
    3. - Severe
    4. - Intolerable Pain

    Measured: 1 month

  2. 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.

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2020
  2. Study start7 Mar 2018
  3. Primary completion7 Oct 2018
  4. Study completion7 Oct 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
105 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04225247
Sponsor's protocol ID
2358847
Status last verified
Jan 2020
First submitted
27 Dec 2019
Last updated
18 Jan 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 20533627

  • 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.

    PubMed 10649916

  • 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.

    PubMed 24720265

  • 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.

    PubMed 28808633

  • 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.

    PubMed 11874519

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

    PubMed 17037886

  • 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.

    PubMed 16973252

  • 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.

    PubMed 8534380

  • 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.

    PubMed 38745306

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Single Bond Universal, Bifluorid 12 and Xeno V+ in people with Dentin Hypersensitivity, run by Dow University of Health Sciences at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Discomfort Internal Scale score (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04225247, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.

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