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

Effectiveness of a Bonding and a Fluoride Varnish for Long-term Dentin Hypersensitivity Treatment: a Split-mouth Randomized Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04813848
Enrollment
38
Registered
2021-03-24
Start date
2020-01-07
Completion date
2021-02-01
Last updated
2021-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

To Decrease Dentin Hypersensitivity

Keywords

dentin hypersensitivity, bonding agent, fluoride varnish

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.

Interventions

PROCEDUREApplication 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.

PROCEDUREApplication 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.

Sponsors

University of Roma La Sapienza
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

A randomized, slit-mouth, double blind clinical trial

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Level of Pain assessment with the Schiff Sensitivity ScaleAll study participants were asked to record the pain intensity score at the baseline, before the application of the desensitizing agentsA score of 0, 1, 2 or 3 was given by the participant. 0 = No subject response to stimulus, 1 = Subject response but will continue, 2 = Subject responds and moves or requests discontinuation, 3 = Painful response to stimulus, discontinuation requested. The lower the score, the lower the hypersensitivity. Air-blast stimulus was used: the response to a jet of cold air was rated by the examiner.

Secondary

MeasureTime frameDescription
Level of Pain assessment with the Visual Analogue Scale (VAS)All study participants were asked to record the pain intensity score at the baseline, before the application of the desensitizing agentsThe level of pain was evaluated on a visual scale from 0 (no pain) to 10 (maximum pain). The lower the score, the lower the hypersensitivity. Air-blast stimulus was used: the response to a jet of cold air was rated by the examiner.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026