Clinical trial NCT03403088: Non-carious Cervical Lesions and Treatments
Official title: Non-carious Cervical Lesions: Clinical Comparison of Different Strategies to Treat Dentin Hypersensitivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Sensitivity
Keywords: Non-carious cervical lesions
dentin hypersensitivity
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2018-01-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: pain from dentin hypersensitivity (DH)
timeFrame: pre-treatment
measure: pain from dentin hypersensitivity (DH)
timeFrame: immediately after the end of the treatment (S1);
measure: pain from dentin hypersensitivity (DH)
timeFrame: one weeks (1S) after the end of the treatments
measure: pain from dentin hypersensitivity (DH)
timeFrame: two weeks (2S) after the end of the treatments
measure: pain from dentin hypersensitivity (DH)
timeFrame: One month (1M) after the end of the treatments
measure: pain from dentin hypersensitivity (DH)
timeFrame: Two months (2M) after the end of the treatments
Secondary outcomes:
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: University of Sao Paulo -Ribeirao Preto Campus
state: São Paulo
Study officials:
affiliation: USP
name: Takami Hirono Hotta, PhD
role: STUDY_DIRECTOR
References: