Effect of a Self-adhering Material in Dental Hypersensitivity

NCT02766127 | Completed DMC

• 1 other identifier: 1000/CE
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Dentin Sensitivity; Xerostomia

Keywords

radiotherapy

Outcome Measures

Primary Outcomes (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.

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

Study Arms (1)

Xerostomic Patients

EXPERIMENTAL

Patients 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.

Other: Veritise Flow; Other: Universal Dentin Sealant; Other: Clearfil Protect Bond; Other: Flor-Opal® Varnish

Interventions

Veritise Flow OTHER

Self-adhering composite

Also known as: Kerr Corporation, USA; Batch no. 3391829

Xerostomic Patients

Universal Dentin Sealant OTHER

non-polymerizable, high molecular weight resin sealant

Also known as: Ultradent Products Inc., USA; Batch no. 052809

Xerostomic Patients

Clearfil Protect Bond OTHER

methacrylate-based resin, self-etching adhesive system

Also known as: Kuraray Noritake Dental, Japan; Batch no. 041212

Xerostomic Patients

Flor-Opal® Varnish OTHER

fluoride-based varnish

Also known as: Ultradent Products Inc., USA; Batch no. 122005

Xerostomic Patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Università degli Studi di Sassari: lead

Study Sites (1)

Complex Operative Unit of Dentistry

Sassari, Sassari, 07100, Italy

Location

Related Publications (3)

• 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.

  PMID: 25691810 BACKGROUND

• 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.

  PMID: 25609032 BACKGROUND

• 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.

  PMID: 22891890 BACKGROUND

MeSH Terms

Conditions

Dentin Sensitivity; Xerostomia

Interventions

universal dentin sealant; Clearfil Protect Bond

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Salivary Gland Diseases; Mouth Diseases

Study Officials

• Egle Milia, Prof

  Università degli Studi di Sassari

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: April 21, 2016
• First Posted: May 9, 2016
• Study Start: March 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: December 1, 2015
• Last Updated: March 24, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)