Non-carious Cervical Lesions and Treatments

Tooth Sensitivity Clinical Trial

— NCCL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03403088
• Other study ID #: 04969312.6.0000.5419
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: October 10, 2018

Study information

• Verified date: October 2018
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 10, 2018
• Est. primary completion date: October 9, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dentin Sensitivity
• Hypersensitivity
• Tooth Sensitivity

Intervention

Device:
• Experimental: • Group LA
to apply Laser (780 nm and 70mW) at the cementum-enamel junction fat the teeth affected by sensitivity
• 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:
• Experimental: • Group DE
to brush teeth with a blinded dentifrice with 0,45% of stannous fluoride and a soft-bristled manual toothbrush (Johnson & Johnson®).
• 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®).
• 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.
• 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.

Locations

Country	Name	City	State
Brazil	University of Sao Paulo -Ribeirao Preto Campus	Ribeirão Preto	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	pre-treatment
Primary	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	immediately after the end of the treatment (S1);
Primary	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	one weeks (1S) after the end of the treatments
Primary	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	two weeks (2S) after the end of the treatments
Primary	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	One month (1M) after the end of the treatments
Primary	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	Two months (2M) after the end of the treatments