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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group LA | Experimental | INTERVENTION: to apply Laser (780 nm and 70mW) at the cementum-enamel junction fat the teeth affected by sensitivity |
|
| Group LA-P | Placebo Comparator | 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 |
|
| Group DE | Experimental | INTERVENTION: to brush teeth with a blinded dentifrice with 0,45% of stannous fluoride and a soft-bristled manual toothbrush (Johnson & Johnson®). |
|
| Group DE-P | Placebo Comparator | INTERVENTION: to brush teeth with a blinded dentifrice with 1500 ppm of available fluoride and a soft-bristled manual toothbrush (Johnson & Johnson®). |
|
| Group RGI | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental: • Group LA | Device | to apply Laser (780 nm and 70mW) at the cementum-enamel junction fat the teeth affected by sensitivity |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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); |
| 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 |
| pain from dentin hypersensitivity (DH) |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Takami Hirono Hotta, PhD | USP | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Sao Paulo -Ribeirao Preto Campus | Ribeirão Preto | São Paulo | 14040904 | Brazil |
individual participant data (IPD) available to other researchers will be not available for other researchers
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| ID | Term |
|---|---|
| D003807 | Dentin Sensitivity |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D028022 | Low-Level Light Therapy |
| D019279 | Resin Cements |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |
| D012117 | Resins, Synthetic |
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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
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|
| Group RX | Experimental | INTERVENTION: to apply Adper Single Bond Plus Adhesive in accordance with the manufacturer instructions, at the teeth affected by sensitivity |
|
| Placebo Comparator: • Group LA-P | Device | 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 |
|
|
| Experimental: • Group DE | Other | 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 | Other | to brush teeth with a blinded dentifrice with 1500 ppm of available fluoride and a soft-bristled manual toothbrush (Johnson & Johnson®). |
|
|
| Experimental: • Group RGI | Other | 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 | Other | to apply Adper Single Bond Plus Adhesive in accordance with the manufacturer instructions, at the teeth affected by sensitivity product for 20 seconds. |
|
|
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) | 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) | 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 |
| D010969 |
| Plastics |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D003738 | Dental Cements |
| D003764 | Dental Materials |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |