Effectiveness of a Bonding and a Fluoride Varnish for Long-term Dentin Hypersensitivity Treatment.

NCT ID: NCT04813848

Last Updated: 2021-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-07
• Study Completion Date: 2021-02-01

Brief Summary

Objectives:

The aim of this in vivo randomized clinical trial with split-mouth design was to evaluate the clinical efficacy of one in-office application of a fluoride containing varnish and in office application of a bonding resin in adult patients presenting with dentin hypersensitivity.

Materials and Methods:

The study cohort consisted of 38 Caucasian outpatients, giving a total of 180 teeth were treated by fluoride varnish (FV) and 160 - by bonding agent (BA). Baseline pain in FV group was slightly higher on both scales (SCHIFF and VAS). Outcome measurements were assessed one or two weeks before product application (enrollment), at baseline at the application days (end of the run-in period: T0a, T0b, T0c), and at 1 week and at 1-2-6 months after first treatment.

Conditions

To Decrease Dentin Hypersensitivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Varnish fluoride

Varnish fluoride to be applied on the surface of exposed dentin

Group Type: EXPERIMENTAL

Application of varnish fluoride desensitizing agent on buccal surfaces of exposed dentin

Intervention Type: PROCEDURE

Varnish fluoride is a single dose transparent varnish with 5 % sodium fluoride (22.600 ppm fluoride) and 5 % calcium fluoride.

The application was performed according to the manufacturer's instructions. The varnish was applied on a clean and dry surface, then after 10-20 seconds to allow the fluoride varnish to be absorbed, was then dried with air.

Bonding agent

Bonding agent to be applied on the surface of exposed dentin

Group Type: ACTIVE_COMPARATOR

Application of bonding agent desensitizing agent on buccal surfaces of exposed dentin

Intervention Type: PROCEDURE

Bonding agent is a single dose dual curing universal adhesive and its application was performed according to the manufacturer's instruction for cases with hypersensitive tooth necks. The bonding was applied without etching, on a clean and dry surface. After 10 s any excess material was removed and then light cured for 30 s.

Interventions

Application of varnish fluoride desensitizing agent on buccal surfaces of exposed dentin

Varnish fluoride is a single dose transparent varnish with 5 % sodium fluoride (22.600 ppm fluoride) and 5 % calcium fluoride.

The application was performed according to the manufacturer's instructions. The varnish was applied on a clean and dry surface, then after 10-20 seconds to allow the fluoride varnish to be absorbed, was then dried with air.

Intervention Type: PROCEDURE

Application of bonding agent desensitizing agent on buccal surfaces of exposed dentin

Bonding agent is a single dose dual curing universal adhesive and its application was performed according to the manufacturer's instruction for cases with hypersensitive tooth necks. The bonding was applied without etching, on a clean and dry surface. After 10 s any excess material was removed and then light cured for 30 s.

Intervention Type: PROCEDURE

Other Intervention Names

Bifluorid, Voco GmbH; Futurabond U, Voco GmbH

Eligibility Criteria

Inclusion Criteria

• absence of systemic pathologies (ASA class I);
• not pregnant or lactating;
• good oral hygiene;
• with ≥1 sensitive tooth with exposed dentin on upper or lower dental arches;
• contemporary presence of exposed dentin both on the left and right counterpart of upper or lower arch.

Exclusion Criteria

• domestic or in-office professional fluoride application and bleaching 6 months before beginning of treatment;
• long-term use of anti-inflammatory, analgesic and psychotropic drugs;
• eating disorders, systemic conditions that cause or predispose patients to develop dentin hypersensitivity (for example, Gastroesophageal reflux disease);
• periodontal surgery and within the previous three months before the study;
• orthodontic treatment within the previous three months before the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Roma La Sapienza

OTHER

Sponsor Role: lead

Responsible Party

Livia Ottolenghi

DDS, PhD, Full Professor, Deputy Dean of the Faculty of Medicine and Dentistry, Dean of the Dental School

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Livia Ottolenghi, DDS,PhD

Role: PRINCIPAL_INVESTIGATOR

University of Roma La Sapienza

Locations

Department of Oral and Maxillo-Facial Sciences, Sapienza University of Rome

Rome, RM, Italy

Countries

Italy

References

Mazur M, Jedlinski M, Ndokaj A, Ardan R, Janiszewska-Olszowska J, Nardi GM, Ottolenghi L, Guerra F. Long-Term Effectiveness of Treating Dentin Hypersensitivity with Bifluorid 10 and Futurabond U: A Split-Mouth Randomized Double-Blind Clinical Trial. J Clin Med. 2021 May 12;10(10):2085. doi: 10.3390/jcm10102085.

Reference Type: DERIVED

PMID: 34066300 (View on PubMed)

Other Identifiers

5877/2020

Identifier Type: -

Identifier Source: org_study_id