AzTrials
AzTrials

Dentin SensitivityNCT02766127

Effect of a Self-adhering Material in Dental Hypersensitivity

A study testing Veritise Flow, Universal Dentin Sealant and Clearfil Protect Bond in people with Dentin Sensitivity and Xerostomia, run by Università degli Studi di Sassari at 1 site in Italy.

Completed

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

Official record
Search all trials

Trial summary

Aim: To compare the desensitizing capacity of Vertise Flow™ (VF), a new self adhering material, in the treatment of dentine hypersensitivity (DH) in patients who are xerostomic due to radiotherapy for head and neck cancer. Methods: A total of 17 patients were selected for the study. Read more about this study

Who is it for?
Any age
Conditions the study is for
Dentin Sensitivity, Xerostomia
What is being tested?
Veritise Flow, Universal Dentin Sealant and Clearfil Protect Bond
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
1 siteItaly
Study dates
Mar 2012to Dec 2015
Phase
Interventional
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Generally good health despite the seriousness of their illness;
  • A clinical reduction of salivary flow;
  • The presence of two or three teeth which were hypersensitive to stimulation with a blast of air.
  • In addition, patients were considered suitable for the study if they had sensitive teeth showing abrasion, erosion or recession with the exposure of the cervical dentine.

Who cannot join

  • teeth with subjective or objective evidence of carious lesions, pulpitis, restorations, premature contact, cracked enamel, active periapical infection or that had received periodontal surgery or root-planning up to 6 months prior to the investigation;
  • patients who had received professional desensitizing therapy during the previous 3 months;
  • patients who had used desensitizing toothpaste in the last 6 weeks. Patients were also excluded if they were under significant medication that could have interfered with pain perception (e.g., antidepressants, anti-inflammatory drugs, sedatives, and muscle relaxants).

Trial locations and contacts

1 site in 1 country.

Italy1 site
  • Complex Operative Unit of Dentistry

    Sassari, Sassari, 07100

Other trials in Italy

About this study

Official title: A Comparative Study of a Self-adhering Material in Dental Hypersensitivity in Xerostomic Patients Due to Radiotherapy

Aim: To compare the desensitizing capacity of Vertise Flow™ (VF), a new self adhering material, in the treatment of dentine hypersensitivity (DH) in patients who are xerostomic due to radiotherapy for head and neck cancer.

Methods: A total of 17 patients were selected for the study. The study was conducted as a split-mouth randomized clinical trial comparing: 1) VF 2) Universal Dentin Sealant (UDS), 3) Clearfil Protect Bond (CPB) and 4) Flor-Opal® Varnish (FOV). Basal and stimulated salivary flow was recorded for each patient according to the method described by Sreebny. The pain experience was generated by a cold stimulus directly to a sensitive tooth surface and assessed using the Visual Analogue Scale (VAS). The response was recorded before the application of the materials (PRE-1), immediately after (POST-1), at 1-week (POST-2), 4-weeks (POST-3) and 12-week controls (POST-4).

Read the detailed description

Participants The study was designed as a split-mouth randomized clinical trial. The protocol and informed consent forms were approved by the ethics committee at the University of Sassari (n° 1000/CE).

To participate in the study, all the subjects were carefully informed about the study's purpose, risks and benefits.

The study inclusion criteria were the following:

  • Generally good health despite the seriousness of their illness;
  • A clinical reduction of salivary flow;
  • The presence of two or three teeth which were hypersensitive to stimulation with a blast of air.

In addition, patients were considered suitable for the study if they had sensitive teeth showing abrasion, erosion or recession with the exposure of the cervical dentine.

The study exclusion criteria were:

  • teeth with subjective or objective evidence of carious lesions, pulpitis, restorations, premature contact, cracked enamel, active periapical infection or that had received periodontal surgery or root-planning up to 6 months prior to the investigation;
  • patients who had received professional desensitizing therapy during the previous 3 months;
  • patients who had used desensitizing toothpaste in the last 6 weeks. Patients were also excluded if they were under significant medication that could have interfered with pain perception (e.g., antidepressants, anti-inflammatory drugs, sedatives, and muscle relaxants).

Clinical Procedure

Saliva collection

All salivary assessments were performed in the absence of acute sialadenitis. All assessments were performed by the same observer. The flow rate was determined in every person according to the method described by Sreebny. Saliva was collected in a standardised manner. Patients were instructed not to eat, drink, or smoke for 90 minutes before the sialometric assessment. All assessments were performed at a fixed time of the day, between 10 am and 1 pm, in order to minimise fluctuations related to a circadian rhythm of salivary secretion and composition. The whole saliva sample was collected in pre-weighed plastic tubes using electronic scales.

Unstimulated salivary secretions were collected for 5 min with the patient seated in an upright position, with the head tilted forward . When possible the tongue, cheek and lip movements were limited during the procedure. At the end of the collection period the patient had to expectorate saliva into the test-tube. Stimulated whole saliva samples were collected by asking patients to chew a small block of paraffin wax or chewing gum. All the saliva secreted for 5 min was then collected in the test-tube. Measuring vessels were weighed after each collection using an electronic scales, and salivary flow rate was expressed in ml/min, which is nearly equivalent to g/min (31). A secretion rate < 0.1-0.2 ml/min for unstimulated flow and < 0.5-0.7 ml/min for stimulated flow was considered as an objective sign of hyposalivation.

Assessment of hypersensitivity and application of desensitizing agents.

A week before the experiment, patients received oral prophylaxis. Non-fluoride toothpaste (Biorepair, Coswell), a soft toothbrush (Oral-B Sensitive Advantage, Procter \& Gamble) and oral hygiene instructions were also provided. The level of sensitivity experienced by each patient was considered as independent of the position of the hypersensitive tooth in the oral cavity. The pain experience was assessed by a Visual Analogue Scale (VAS) using the methodology described in our previous study. The pain experience was measured using a VAS graded from 1 to 10. The pain stimulus was given by one examiner with the same equipment yielding similar air pressure each time, while another one performed the treatments. The same operator carried out the sensitivity test evaluating the subject's response before the application of the materials (PRE-1), immediately after (POST-1), after 1 week (POST-2), 4 weeks (POST-3), and 12 weeks (POST-4) .

The following dental materials were used following the manufacturers' instructions: Verities Flow™ (VF) (Kerr Corporation, Orange, CA, USA), a self-adhering composite; Universal Dentin Sealant (UDS) (Ultradent Products Inc., South Jordan, UT, USA), a biocompatible, non-polymerizable, high molecular weight resin sealant in alcohol solvent; Clearfil Protect Bond (CPB), (Kuraray Noritake Dental, Osaka, Japan) a methacrylate-based resin, self-etching adhesive system, and Flor-Opal® Varnish (FOV), (Ultradent Products Inc., South Jordan, UT, USA), a fluoride-based varnish.

In view of the treatment with the desensitizing agents, teeth were randomly assigned into four groups (N = per group).

Being tested
Veritise Flow, Universal Dentin Sealant, Clearfil Protect Bond, Flor-Opal® Varnish
Keywords
radiotherapy
Medical subject headings
Dentin Sensitivity, Xerostomia

What participants receive

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

  • Veritise FlowOther

    Also called Kerr Corporation, USA; Batch no. 3391829

    Self-adhering composite

  • Universal Dentin SealantOther

    Also called Ultradent Products Inc., USA; Batch no. 052809

    non-polymerizable, high molecular weight resin sealant

  • Clearfil Protect BondOther

    Also called Kuraray Noritake Dental, Japan; Batch no. 041212

    methacrylate-based resin, self-etching adhesive system

  • Flor-Opal® VarnishOther

    Also called Ultradent Products Inc., USA; Batch no. 122005

    fluoride-based varnish

Study groups in NCT02766127
Study groupRoleWhat they receive
Xerostomic PatientsExperimentalPatients with evident clinical signs of xerostomia who experienced dentinal hypersensitivity after undergoing radiation therapy due to head and neck cancer. The following dental materials will be used following the manufacturers' instructions: Veritise Flow; Universal Dentin Sealant; Clearfil Protect Bond, and Flor-Opal® Varnish. In view of the treatment with the desensitizing agents, teeth were randomly assigned into four groups. the application of the materials will be made only once. The effectiveness will be evaluated: immediately after application and after 1, 4, 12 weeks.
Receives: Other: Veritise Flow; Other: Universal Dentin Sealant; Other: Clearfil Protect Bond; Other: Flor-Opal® Varnish

What is being measured

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

  1. Evaluation of change of dentinal hypersensitivity after treatment

    The pain experience was assessed by a Visual Analogue Scale (VAS) using the methodology. The VAS scale consisted of a horizontal line that was 100 mm long, on which 'no pain' was marked on the right-hand extremity and 'unbearable pain' on the other. The patients expressed the intensity of the pain experienced by placing a mark at any point along the continuum. The distance, expressed in millimetres, from the right edge of 'no pain' was used as the VAS score. Each patient was asked to rate the perception of discomfort after the application of air via a dental syringe at 45-60 psi, 1 cm at the cervical third of the tooth after removing supragingival plaque with a low- speed handpiece with pumice powder and without fluoride. The adjacent teeth were covered by cotton rolls. The stimulus was delivered until reaction or up to a maximum duration of 10 s by the same examiner with the same equipment yielding similar air pressure each time.

    Measured: before the treatment (PRE-1), immediately after (POST-1), after 1 week (POST-2), 4 weeks (POST-3), and 12 weeks (POST-4).

Timeline

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

  1. First posted9 May 2016 (estimated)
  2. Study startMar 2012
  3. Primary completionJun 2014
  4. Study completionDec 2015

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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02766127
Sponsor's protocol ID
1000/CE
Status last verified
Mar 2017
First submitted
21 Apr 2016
Last updated
24 Mar 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No: Not a plan for data sharing has been established. But, for anyone researcher would like to have this information, simply they may request them to us directly.

Publications

  • Pinna R, Campus G, Cumbo E, Mura I, Milia E. Xerostomia induced by radiotherapy: an overview of the physiopathology, clinical evidence, and management of the oral damage. Ther Clin Risk Manag. 2015 Feb 4;11:171-88. doi: 10.2147/TCRM.S70652. eCollection 2015.

    PubMed 25691810
  • Pinna R, Bortone A, Sotgiu G, Dore S, Usai P, Milia E. Clinical evaluation of the efficacy of one self-adhesive composite in dental hypersensitivity. Clin Oral Investig. 2015 Sep;19(7):1663-72. doi: 10.1007/s00784-014-1390-3. Epub 2015 Jan 23.

    PubMed 25609032
  • Milia E, Castelli G, Bortone A, Sotgiu G, Manunta A, Pinna R, Gallina G. Short-term response of three resin-based materials as desensitizing agents under oral environmental exposure. Acta Odontol Scand. 2013 May-Jul;71(3-4):599-609. doi: 10.3109/00016357.2012.700063. Epub 2012 Aug 15.

    PubMed 22891890

Questions about this trial

What is this clinical trial studying?

A study testing Veritise Flow, Universal Dentin Sealant and Clearfil Protect Bond in people with Dentin Sensitivity and Xerostomia, run by Università degli Studi di Sassari at 1 site in Italy.

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 4 inclusion and 3 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 24 Mar 2017. 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 Italy. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

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?

Evaluation of change of dentinal hypersensitivity after treatment (time frame: before the treatment (PRE-1), immediately after (POST-1), after 1 week (POST-2), 4 weeks (POST-3), and 12 weeks (POST-4).). 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 NCT02766127, which also lists 3 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 24 Mar 2017.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in