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Non-carious Cervical Lesions and Treatments (NCCL)

Primary Purpose

Tooth Sensitivity

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Experimental: • Group LA
Placebo Comparator: • Group LA-P
Experimental: • Group DE
Placebo Comparator: • Group DE-P
Experimental: • Group RGI
Experimental: Group RX
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth Sensitivity focused on measuring Non-carious cervical lesions, dentin hypersensitivity

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Sao Paulo -Ribeirao Preto Campus

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Experimental

Arm Label

Group LA

Group LA-P

Group DE

Group DE-P

Group RGI

Group RX

Arm Description

INTERVENTION: to apply Laser (780 nm and 70mW) at the cementum-enamel junction fat the teeth affected by sensitivity

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

INTERVENTION: to brush teeth with a blinded dentifrice with 0,45% of stannous fluoride and a soft-bristled manual toothbrush (Johnson & Johnson®).

INTERVENTION: to brush teeth with a blinded dentifrice with 1500 ppm of available fluoride and a soft-bristled manual toothbrush (Johnson & Johnson®).

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.

INTERVENTION: to apply Adper Single Bond Plus Adhesive in accordance with the manufacturer instructions, at the teeth affected by sensitivity

Outcomes

Primary Outcome Measures

pain from dentin hypersensitivity (DH)
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
pain from dentin hypersensitivity (DH)
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
pain from dentin hypersensitivity (DH)
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
pain from dentin hypersensitivity (DH)
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
pain from dentin hypersensitivity (DH)
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
pain from dentin hypersensitivity (DH)
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

Secondary Outcome Measures

Full Information

First Posted
January 2, 2018
Last Updated
October 9, 2018
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT03403088
Brief Title
Non-carious Cervical Lesions and Treatments
Acronym
NCCL
Official Title
Non-carious Cervical Lesions: Clinical Comparison of Different Strategies to Treat Dentin Hypersensitivity
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
October 9, 2018 (Actual)
Study Completion Date
October 10, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Sensitivity
Keywords
Non-carious cervical lesions, dentin hypersensitivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
60 participants with NCCLs and positive for DH are enrolled in the study to receive randomly the followed treatments: LA= 780 nm and 70mW GaAlAs Laser/ 4 sessions; LAP= placebo laser/ four sessions; CP= 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
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group LA
Arm Type
Experimental
Arm Description
INTERVENTION: to apply Laser (780 nm and 70mW) at the cementum-enamel junction fat the teeth affected by sensitivity
Arm Title
Group LA-P
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
Group DE
Arm Type
Experimental
Arm Description
INTERVENTION: to brush teeth with a blinded dentifrice with 0,45% of stannous fluoride and a soft-bristled manual toothbrush (Johnson & Johnson®).
Arm Title
Group DE-P
Arm Type
Placebo Comparator
Arm Description
INTERVENTION: to brush teeth with a blinded dentifrice with 1500 ppm of available fluoride and a soft-bristled manual toothbrush (Johnson & Johnson®).
Arm Title
Group RGI
Arm Type
Experimental
Arm Description
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.
Arm Title
Group RX
Arm Type
Experimental
Arm Description
INTERVENTION: to apply Adper Single Bond Plus Adhesive in accordance with the manufacturer instructions, at the teeth affected by sensitivity
Intervention Type
Device
Intervention Name(s)
Experimental: • Group LA
Other Intervention Name(s)
low laser therapy
Intervention Description
to apply Laser (780 nm and 70mW) at the cementum-enamel junction fat the teeth affected by sensitivity
Intervention Type
Device
Intervention Name(s)
Placebo Comparator: • Group LA-P
Other Intervention Name(s)
low laser therapy
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Experimental: • Group DE
Other Intervention Name(s)
desensitizing dentifrice
Intervention Description
to brush teeth with a blinded dentifrice with 0,45% of stannous fluoride and a soft-bristled manual toothbrush (Johnson & Johnson®).
Intervention Type
Other
Intervention Name(s)
Placebo Comparator: • Group DE-P
Other Intervention Name(s)
placebo desensitizing dentifrice
Intervention Description
to brush teeth with a blinded dentifrice with 1500 ppm of available fluoride and a soft-bristled manual toothbrush (Johnson & Johnson®).
Intervention Type
Other
Intervention Name(s)
Experimental: • Group RGI
Other Intervention Name(s)
resin glass ionomer restorarion
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Experimental: Group RX
Other Intervention Name(s)
selant with resin cement
Intervention Description
to apply Adper Single Bond Plus Adhesive in accordance with the manufacturer instructions, at the teeth affected by sensitivity product for 20 seconds.
Primary Outcome Measure Information:
Title
pain from dentin hypersensitivity (DH)
Description
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
Time Frame
pre-treatment
Title
pain from dentin hypersensitivity (DH)
Description
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
Time Frame
immediately after the end of the treatment (S1);
Title
pain from dentin hypersensitivity (DH)
Description
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
Time Frame
one weeks (1S) after the end of the treatments
Title
pain from dentin hypersensitivity (DH)
Description
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
Time Frame
two weeks (2S) after the end of the treatments
Title
pain from dentin hypersensitivity (DH)
Description
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
Time Frame
One month (1M) after the end of the treatments
Title
pain from dentin hypersensitivity (DH)
Description
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
Time Frame
Two months (2M) after the end of the treatments

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Takami Hirono Hotta, PhD
Organizational Affiliation
USP
Official's Role
Study Director
Facility Information:
Facility Name
University of Sao Paulo -Ribeirao Preto Campus
City
Ribeirão Preto
State/Province
São Paulo
ZIP/Postal Code
14040904
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
individual participant data (IPD) available to other researchers will be not available for other researchers

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Non-carious Cervical Lesions and Treatments

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