Non-carious Cervical Lesions and Treatments (NCCL)

October 9, 2018 updated by: Camila Tirapelli, University of Sao Paulo

Non-carious Cervical Lesions: Clinical Comparison of Different Strategies to Treat Dentin Hypersensitivity

This study will compare clinically the efficacy, time to action and duration of different treatments for patients with non-carious cervical lesions (NCCLs) that caused dentin hypersensitivity (DH).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will compare clinically the efficacy, time to action and duration of different treatments for patients with non-carious cervical lesions (NCCLs) that caused dentin hypersensitivity (DH). Casuistic and methods: 60 participants with NCCLs and positive for DH will be enrolled in the study to receive randomly the followed treatments: LA= 780 nm and 70mW GaAlAs Laser/ 4 sessions; LAP= placebo laser/ four sessions; RGI= ClinproTM XT Varnish/ in-office single session; RX= adhesive RelyXTM Arc/ in-office single session; DE= stannous fluoride dentifrice/30-days-home-use; DE-P= placebo dentifrice/30-days-home-use. Pain from DH is measured with visual analogue scale (VAS), pre-treatment and in accordance with each treatment, immediately after the end of the treatment (S1); one and two weeks (1S and 2S) and one and two months (1M and 2M) after the end of the treatments. Strategies of treatments are compared each other in each period of evaluation and along time with pre-treatments values of pain, using Kruskall-Wallis and Friedman Test (p<0.05).

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • Ribeirão Preto, São Paulo, Brazil, 14040904
        • University of Sao Paulo -Ribeirao Preto Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

- (a) male or female between 18 to 60 years old; (b) good general (no diseases that could interfere in the results) and oral health (no alterations in hard or soft tissues); (c) a minimum of 24 permanent teeth; (d) presence of non-carious cervical lesion; and (e) compliment of cervical dentin hypersensitivity

Exclusion Criteria:

-(a) chronic analgesic or anti-inflammatory therapy; (b) orthodontic treatment or dental prosthesis; (c) desensitization therapy in the preceding 3 months; (d) alimentary disorder or acid diet; and (e) pregnant or lactating women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Group LA
INTERVENTION: to apply Laser (780 nm and 70mW) at the cementum-enamel junction fat the teeth affected by sensitivity
Device: Experimental: • Group LA
to apply Laser (780 nm and 70mW) at the cementum-enamel junction fat the teeth affected by sensitivity
Other Names:
  • low laser therapy
PLACEBO_COMPARATOR: Group LA-P
INTERVENTION: to apply Laser (780 nm and 70mW) at the cementum-enamel junction at the teeth affected by sensitivity with the laser device having no effective laser emission, only guided by light
Device: Placebo Comparator: • Group LA-P
to apply Laser (780 nm and 70mW) at the cementum-enamel junction at the teeth affected by sensitivity with the laser device having no effective laser emission, only guided by light
Other Names:
  • low laser therapy
EXPERIMENTAL: Group DE
INTERVENTION: to brush teeth with a blinded dentifrice with 0,45% of stannous fluoride and a soft-bristled manual toothbrush (Johnson & Johnson®).
Other: Experimental: • Group DE
to brush teeth with a blinded dentifrice with 0,45% of stannous fluoride and a soft-bristled manual toothbrush (Johnson & Johnson®).
Other Names:
  • desensitizing dentifrice
PLACEBO_COMPARATOR: Group DE-P
INTERVENTION: to brush teeth with a blinded dentifrice with 1500 ppm of available fluoride and a soft-bristled manual toothbrush (Johnson & Johnson®).
Other: Placebo Comparator: • Group DE-P
to brush teeth with a blinded dentifrice with 1500 ppm of available fluoride and a soft-bristled manual toothbrush (Johnson & Johnson®).
Other Names:
  • placebo desensitizing dentifrice
EXPERIMENTAL: Group RGI
INTERVENTION: to apply a thin layer of resin based glass-ionomer product on the cervical surface of the affected teeth affected by sensitivity following the manufacturer instructions.
Other: Experimental: • Group RGI
to apply a thin layer of resin based glass-ionomer product on the cervical surface of the affected teeth affected by sensitivity following the manufacturer instructions.
Other Names:
  • resin glass ionomer restorarion
EXPERIMENTAL: Group RX
INTERVENTION: to apply Adper Single Bond Plus Adhesive in accordance with the manufacturer instructions, at the teeth affected by sensitivity
Other: Experimental: Group RX
to apply Adper Single Bond Plus Adhesive in accordance with the manufacturer instructions, at the teeth affected by sensitivity product for 20 seconds.
Other Names:
  • selant with resin cement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain from dentin hypersensitivity (DH)
Time Frame: pre-treatment
Examiner assess dentin hypersensitivity (DH) using VAS (visual analogue scale). The selected tooth was thermic stimulated by a cold air (approximately 10°C) from a triple syringe placed 3mm from the buccal surface in the cervical area, perpendicular to the tooth long axis at full blast during 3 seconds. In addition, the selected tooth received a mechanical stimulus by a dental probe n° 05 over the cervical area. Thereby, volunteers were instructed to record the sensitivity perception by placing a mark on the scale from 0 (no pain) to 10 (intolerable pain) while sensitivity test was occurred
pre-treatment
pain from dentin hypersensitivity (DH)
Time Frame: immediately after the end of the treatment (S1);
Examiner assess dentin hypersensitivity (DH) using VAS (visual analogue scale). The selected tooth was thermic stimulated by a cold air (approximately 10°C) from a triple syringe placed 3mm from the buccal surface in the cervical area, perpendicular to the tooth long axis at full blast during 3 seconds. In addition, the selected tooth received a mechanical stimulus by a dental probe n° 05 over the cervical area. Thereby, volunteers were instructed to record the sensitivity perception by placing a mark on the scale from 0 (no pain) to 10 (intolerable pain) while sensitivity test was occurred
immediately after the end of the treatment (S1);
pain from dentin hypersensitivity (DH)
Time Frame: one weeks (1S) after the end of the treatments
Examiner assess dentin hypersensitivity (DH) using VAS (visual analogue scale). The selected tooth was thermic stimulated by a cold air (approximately 10°C) from a triple syringe placed 3mm from the buccal surface in the cervical area, perpendicular to the tooth long axis at full blast during 3 seconds. In addition, the selected tooth received a mechanical stimulus by a dental probe n° 05 over the cervical area. Thereby, volunteers were instructed to record the sensitivity perception by placing a mark on the scale from 0 (no pain) to 10 (intolerable pain) while sensitivity test was occurred
one weeks (1S) after the end of the treatments
pain from dentin hypersensitivity (DH)
Time Frame: two weeks (2S) after the end of the treatments
Examiner assess dentin hypersensitivity (DH) using VAS (visual analogue scale). The selected tooth was thermic stimulated by a cold air (approximately 10°C) from a triple syringe placed 3mm from the buccal surface in the cervical area, perpendicular to the tooth long axis at full blast during 3 seconds. In addition, the selected tooth received a mechanical stimulus by a dental probe n° 05 over the cervical area. Thereby, volunteers were instructed to record the sensitivity perception by placing a mark on the scale from 0 (no pain) to 10 (intolerable pain) while sensitivity test was occurred
two weeks (2S) after the end of the treatments
pain from dentin hypersensitivity (DH)
Time Frame: One month (1M) after the end of the treatments
Examiner assess dentin hypersensitivity (DH) using VAS (visual analogue scale). The selected tooth was thermic stimulated by a cold air (approximately 10°C) from a triple syringe placed 3mm from the buccal surface in the cervical area, perpendicular to the tooth long axis at full blast during 3 seconds. In addition, the selected tooth received a mechanical stimulus by a dental probe n° 05 over the cervical area. Thereby, volunteers were instructed to record the sensitivity perception by placing a mark on the scale from 0 (no pain) to 10 (intolerable pain) while sensitivity test was occurred
One month (1M) after the end of the treatments
pain from dentin hypersensitivity (DH)
Time Frame: Two months (2M) after the end of the treatments
Examiner assess dentin hypersensitivity (DH) using VAS (visual analogue scale). The selected tooth was thermic stimulated by a cold air (approximately 10°C) from a triple syringe placed 3mm from the buccal surface in the cervical area, perpendicular to the tooth long axis at full blast during 3 seconds. In addition, the selected tooth received a mechanical stimulus by a dental probe n° 05 over the cervical area. Thereby, volunteers were instructed to record the sensitivity perception by placing a mark on the scale from 0 (no pain) to 10 (intolerable pain) while sensitivity test was occurred
Two months (2M) after the end of the treatments

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Investigators

  • Study Director: Takami Hirono Hotta, PhD, USP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2017

Primary Completion (ACTUAL)

October 9, 2018

Study Completion (ACTUAL)

October 10, 2018

Study Registration Dates

First Submitted

January 2, 2018

First Submitted That Met QC Criteria

January 17, 2018

First Posted (ACTUAL)

January 18, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 11, 2018

Last Update Submitted That Met QC Criteria

October 9, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04969312.6.0000.5419

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

individual participant data (IPD) available to other researchers will be not available for other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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