NCT02766127|CompletedDMC
Effect of a Self-adhering Material in Dental Hypersensitivity
A Comparative Study of a Self-adhering Material in Dental Hypersensitivity in Xerostomic Patients Due to Radiotherapy
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A Comparative Study of a Self-adhering Material in Dental Hypersensitivity in Xerostomic Patients Due to Radiotherapy
Sponsor study identifier
interventional
17
1 country
1
Study Start
March 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2014
Actual (reported)Study Completion
December 2015
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2015
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2012
Date type not reportedThis date has not been verified as actual or estimated.
June 2014
Actual (reported)December 2015
Actual (reported)April 21, 2016
Actual (reported)May 9, 2016
Actual (reported)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).
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.
Self-adhering composite
non-polymerizable, high molecular weight resin sealant
Complex Operative Unit of Dentistry
Sassari, Sassari, 07100, Italy
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.
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.
Egle Milia, Prof
Università degli Studi di Sassari
17 participants (actual enrollment reported by the registry).
First Submitted
April 21, 2016
First Posted
May 9, 2016
Study Start
March 2012
Date type not reportedThis date has not been verified as actual or estimated.
A Study to Evaluate the Dentinal Hypersensitivity Efficacy of Two Experimental Mouthwash Formulations
methacrylate-based resin, self-etching adhesive system
fluoride-based varnish
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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.
Primary Completion
June 2014
Actual (reported)Study Completion
December 2015
Actual (reported)Last Updated
March 24, 2017
Record last verified: 2017-03
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