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

To Decrease Dentin Hypersensitivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04813848
• Other study ID #: 5877/2020
• Status: Completed
• Phase: N/A
• Start date: January 7, 2020
• Est. completion date: February 1, 2021

Study information

• Verified date: March 2021
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: February 1, 2021
• Est. primary completion date: September 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dentin Sensitivity
• Hypersensitivity
• To Decrease Dentin Hypersensitivity

Intervention

Procedure:
• 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.
• 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.

Locations

Country	Name	City	State
Italy	Department of Oral and Maxillo-Facial Sciences, Sapienza University of Rome	Rome	RM

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of Pain assessment with the Schiff Sensitivity Scale	A 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.	All study participants were asked to record the pain intensity score at the baseline, before the application of the desensitizing agents
Primary	Level of Pain assessment with the Schiff Sensitivity Scale	A 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.	All study participants were asked to record the pain intensity score at seven days after the application of the desensitizing agents
Primary	Level of Pain assessment with the Schiff Sensitivity Scale	A 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.	All study participants were asked to record the pain intensity score at one month after the application of the desensitizing agents
Primary	Level of Pain assessment with the Schiff Sensitivity Scale	A 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.	All study participants were asked to record the pain intensity score at two months after the application of the desensitizing agents
Primary	Level of Pain assessment with the Schiff Sensitivity Scale	A 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.	All study participants were asked to record the pain intensity score at six months after the application of the desensitizing agents
Secondary	Level of Pain assessment with the Visual Analogue Scale (VAS)	The 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.	All study participants were asked to record the pain intensity score at the baseline, before the application of the desensitizing agents
Secondary	Level of Pain assessment with the Visual Analogue Scale (VAS)	The 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.	All study participants were asked to record the pain intensity score at seven days after the application of the desensitizing agents
Secondary	Level of Pain assessment with the Visual Analogue Scale (VAS)	The 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.	All study participants were asked to record the pain intensity score at one month after the application of the desensitizing agents
Secondary	Level of Pain assessment with the Visual Analogue Scale (VAS)	The 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.	All study participants were asked to record the pain intensity score at two months after the application of the desensitizing agents
Secondary	Level of Pain assessment with the Visual Analogue Scale (VAS)	The 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.	All study participants were asked to record the pain intensity score at six months after the application of the desensitizing agents