To Decrease Dentin HypersensitivityNCT04813848

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

A study testing Application of varnish fluoride desensitizing agent on buccal surfaces of exposed dentin and Application of bonding agent desensitizing agent on buccal surfaces of exposed dentin in people with To Decrease Dentin Hypersensitivity, run by University of Roma La Sapienza at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: To Decrease Dentin Hypersensitivity
What is being tested?: Application of varnish fluoride desensitizing agent on buccal surfaces of exposed dentin and Application of bonding agent desensitizing agent on buccal surfaces of exposed dentin
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 38 participants
Where: 1 siteItaly
Study dates: 7 Jan 2020to 1 Feb 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Italy1 site

Department of Oral and Maxillo-Facial Sciences, Sapienza University of Rome
Rome, RM, 00161

Other trials in Italy

About this study

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

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
Being tested: Application of varnish fluoride desensitizing agent on buccal surfaces of exposed dentin, Application of bonding agent desensitizing agent on buccal surfaces of exposed dentin
Keywords: dentin hypersensitivity, bonding agent, fluoride varnish
Medical subject headings: Dentin Sensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Application of varnish fluoride desensitizing agent on buccal surfaces of exposed dentinProcedure or surgery
Also called Bifluorid, Voco GmbH
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 dentinProcedure or surgery
Also called Futurabond U, Voco GmbH
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.

Study groups in NCT04813848
Study group	Role	What they receive
Varnish fluoride	Experimental	Varnish fluoride to be applied on the surface of exposed dentin Receives: Procedure: Application of varnish fluoride desensitizing agent on buccal surfaces of exposed dentin
Bonding agent	Active comparator	Bonding agent to be applied on the surface of exposed dentin Receives: Procedure: Application of bonding agent desensitizing agent on buccal surfaces of exposed dentin

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: All study participants were asked to record the pain intensity score at the baseline, before the application of the desensitizing agents
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.
Measured: All study participants were asked to record the pain intensity score at seven days after the application of the desensitizing agents
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.
Measured: All study participants were asked to record the pain intensity score at one month after the application of the desensitizing agents
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.
Measured: All study participants were asked to record the pain intensity score at two months after the application of the desensitizing agents
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.
Measured: All study participants were asked to record the pain intensity score at six months after the application of the desensitizing agents

Secondary outcomes (5)

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.
Measured: All study participants were asked to record the pain intensity score at the baseline, before the application of the desensitizing agents
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.
Measured: All study participants were asked to record the pain intensity score at seven days after the application of the desensitizing agents
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.
Measured: All study participants were asked to record the pain intensity score at one month after the application of the desensitizing agents
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.
Measured: All study participants were asked to record the pain intensity score at two months after the application of the desensitizing agents
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.
Measured: All study participants were asked to record the pain intensity score at six months after the application of the desensitizing agents

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Jan 20201 Feb 2021

First posted24 Mar 2021
Study start7 Jan 2020
Primary completion10 Sep 2020
Study completion1 Feb 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for To Decrease Dentin HypersensitivityStudies of the same condition, open and under way.
More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: A randomized, slit-mouth, double blind clinical trial
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 38 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04813848
Sponsor's protocol ID: 5877/2020
Status last verified: Mar 2021
First submitted: 21 Mar 2021
Last updated: 24 Mar 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 34066300

Study at a glance

From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness of a Bonding and a Fluoride Varnish for Long-term Dentin Hypersensitivity Treatment: a Split-mouth Randomized Clinical Trial
ClinicalTrials.gov ID: NCT04813848
Acronym / sponsor ID: 5877/2020
Conditions: To Decrease Dentin Hypersensitivity
Keywords: dentin hypersensitivity, bonding agent, fluoride varnish
Study type: Interventional
Recruitment status: Completed
Enrolment: 38 participants (actual)
Lead sponsor: University of Roma La SapienzaUniversity, hospital or other
Study start: 7 Jan 2020 (actual)
Primary completion: 10 Sep 2020 (actual)
Study completion: 1 Feb 2021 (actual)
First posted: 24 Mar 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Objectives:

Materials and Methods:

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2
Model description: A randomized, slit-mouth, double blind clinical trial

Arm	Type	Receives
Varnish fluoride	Experimental	Procedure: Application of varnish fluoride desensitizing agent on buccal surfaces of exposed dentinVarnish fluoride to be applied on the surface of exposed dentin
Bonding agent	Active comparator	Procedure: Application of bonding agent desensitizing agent on buccal surfaces of exposed dentinBonding agent to be applied on the surface of exposed dentin

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Application of varnish fluoride desensitizing agent on buccal surfaces of exposed dentinAlso: Bifluorid, Voco GmbHVarnish 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.	Procedure or surgery	Varnish fluoride
Application of bonding agent desensitizing agent on buccal surfaces of exposed dentinAlso: Futurabond U, Voco GmbHBonding 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.	Procedure or surgery	Bonding agent

Primary outcome

Level of Pain assessment with the Schiff Sensitivity Scale
Time frame: All study participants were asked to record the pain intensity score at the baseline, before the application of the desensitizing agents
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.
Level of Pain assessment with the Schiff Sensitivity Scale
Time frame: All study participants were asked to record the pain intensity score at seven days after the application of the desensitizing agents
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.
Level of Pain assessment with the Schiff Sensitivity Scale
Time frame: All study participants were asked to record the pain intensity score at one month after the application of the desensitizing agents
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.
Level of Pain assessment with the Schiff Sensitivity Scale
Time frame: All study participants were asked to record the pain intensity score at two months after the application of the desensitizing agents
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.
Level of Pain assessment with the Schiff Sensitivity Scale
Time frame: All study participants were asked to record the pain intensity score at six months after the application of the desensitizing agents
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.

5 secondary outcomes

Level of Pain assessment with the Visual Analogue Scale (VAS)
Time frame: All study participants were asked to record the pain intensity score at the baseline, before the application of the desensitizing agents
Level of Pain assessment with the Visual Analogue Scale (VAS)
Time frame: All study participants were asked to record the pain intensity score at seven days after the application of the desensitizing agents
Level of Pain assessment with the Visual Analogue Scale (VAS)
Time frame: All study participants were asked to record the pain intensity score at one month after the application of the desensitizing agents
Level of Pain assessment with the Visual Analogue Scale (VAS)
Time frame: All study participants were asked to record the pain intensity score at two months after the application of the desensitizing agents
Level of Pain assessment with the Visual Analogue Scale (VAS)
Time frame: All study participants were asked to record the pain intensity score at six months after the application of the desensitizing agents

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2021.
Derived from this study: PubMed 34066300Mazur 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.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Livia Ottolenghi, DDS,PhD principal investigator

University of Roma La Sapienza

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Level of Pain assessment with the Schiff Sensitivity Scale (time frame: All study participants were asked to record the pain intensity score at the baseline, before the application of the desensitizing agents). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04813848, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2021.