NCT02948686

Different Application Strategies When Using Ambar Universal in Class V Cavities

Clinical Evaluation of Different Application Strategies When Using a Universal Adhesive System in Class V Cavities

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Universidade Federal Fluminense · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

Treatment clinical trial, randomized, controled, parallel, double-blinded, with four groups, that aims to evaluate the best application strategy when using a new Universal Adhesive system, Ambar Universal (FGM, Joinville, Brazil). Volunteers will be selected and recruited,following inclusion criteria and pre-established exclusion. All volunteers will be informed and sign a term of clarification and consent. 38 enrolled patients will receive four Class V dental restorations, made in four different ways, one from each experimental group, using the same universal self-etching adhesive system, which is the tested material in this study. Non-carious cervical lesions will receive the applied adhesive system in 4 different protocols separated by groups. Group Self Etching (SET) (control): no conditioning, the adhesive system will be used in 55 teeth, according to the manufacturer's instructions, in the self-etching mode. The adhesive system will be brushed during 10 seconds in the cavity, will be air-dried during 5 seconds, brushed again during 10 seconds, air-dried during 10 seconds and activated during 10 seconds with Light Emission Diode (LED) light; Group SEE (Selective enamel etching): 37% phosphoric acid will be applied during 15 seconds, only in enamel in 55 teeth. This acid will be removed using water, the cavity will be air-dried, and then, the adhesive will be applied according to the manufacturer's instructions, as described in group SET; Group SETT (Self-Etching with extended time): Similar to Group SET, but during the 2 applications, the adhesive systems will be brushed during 20 seconds, and not during 10 seconds as described in Group SET; Group SETL (Self-Etching with extended number of layers): The adhesive system will be applied as describe in Group SET, but the researchers will apply 4 layers, and not 2 layers, as described in Group SET. After applying the adhesive, the restorations will be made with composite resin, and evaluated every 6 months for pain assessment, shape, staining or recurrent caries, using scores. To determine in which group each tooth will be enrolled, the authors will randomize the teeth.

Detailed description

This is a Treatment clinical trial, randomized, controlled, parallel, double-blinded, with four groups, that aims to evaluate the best application strategy when using a new Universal Adhesive system, Ambar Universal (FGM, Joinville, Brazil). Volunteers will be selected and recruited,following inclusion criteria and pre-established exclusion. All volunteers will be informed and sign a term of clarification and consent. All 38 enrolled patients will receive Class V dental restorations, made in four different ways, one from each experimental group, using the same universal self-etching adhesive system, which is the tested material in this study. All patients must have at only 20 teeth in function, must have at only 4 non carious cervical lesions (NCCL), in different teeth, that need restoration. Those lesions must be non carious, must be more than 1 mm deep, should have exposed dentin, and must have at only 50% of margins in enamel. Teeth should not present periodontal mobility. Firstly, the patient will be anesthetized locally with 3% Mepivacaine solution, followed by prophylaxis with pumice powder and water. All cavities will be washed and dried after these procedures for optimal selection of color, using a color scale. Then, the rubber dam isolation of the teeth to be restored will be held. Non-carious cervical lesions will receive the applied adhesive system in 4 different protocols separated by groups. Group SET (control): no conditioning, the adhesive system will be used in 55 teeth, according to the manufacturer's instructions, in the self-etching mode. The adhesive system will be brushed during 10 seconds in the cavity, will be air-dried during 5 seconds, brushed again during 10 seconds, air-dried during 10 seconds and activated during 10 seconds with LED light; Group SEE (Selective enamel etching): 37% phosphoric acid will be applied during 15 seconds, only in enamel in 55 teeth. This acid will be removed using water, the cavity will be air-dried, and then, the adhesive will be applied according to the manufacturer's instructions, as described in group SET; Group SETT: Similar to Group SET, but during the 2 applications, the adhesive systems will be brushed during 20 seconds, and not during 10 seconds as described in Group SET; Group SETL: The adhesive system will be applied as describe in Group SET, but the researchers will apply 4 layers, and not 2 layers, as described in Group SET. After applying the adhesive, the restorations will be made with composite resin Opallis (FGM, Joinville, Brazil), and evaluated every 6 months for pain assessment, shape, staining or recurrent caries, using scores. To determine in which group each tooth will be enrolled, the authors will randomize the teeth.

Conditions

• Dental Restoration Failure of Marginal Integrity

Interventions

Type	Name	Description
OTHER	Self-Etching Application Strategy	In Group SET, the adhesive system Ambar Universal will be used in 55 teeth, according to the manufacturer's instructions, in the self-etching mode. The adhesive system will be brushed during 10 seconds in the cavity, will be air-dried during 5 seconds, brushed again during 10 seconds, air-dried during 10 seconds and activated during 10 seconds with LED light; After applying the adhesive, the restorations will be made with composite resin Opallis (FGM, Joinville, Brazil), and evaluated every 6 months for pain assessment, shape, staining or recurrent caries, using scores.
OTHER	Enamel Etching Application Strategy	In Group SEE, 37% phosphoric acid will be applied during 15 seconds, only in enamel in 55 teeth. This acid will be removed using water, the cavity will be air-dried, and then, the adhesive system Ambar Universal will be brushed during 10 seconds in the cavity, will be air-dried during 5 seconds, brushed again during 10 seconds, air-dried during 10 seconds and activated during 10 seconds with LED light; After applying the adhesive, the restorations will be made with composite resin Opallis (FGM, Joinville, Brazil), and evaluated every 6 months for pain assessment, shape, staining or recurrent caries, using scores.
OTHER	Self Etching with Extended time Application Strategy	In Group SETT, the adhesive system Ambar Universal will be used in 55 teeth, in the self-etching mode. The adhesive system will be brushed during 20 seconds in the cavity, will be air-dried during 5 seconds, brushed again during 20 seconds, air-dried during 10 seconds and activated during 10 seconds with LED light; After applying the adhesive, the restorations will be made with composite resin Opallis (FGM, Joinville, Brazil), and evaluated every 6 months for pain assessment, shape, staining or recurrent caries, using scores
OTHER	Self Etching with Extended layers number Strategy	In Group SETL, the adhesive system Ambar Universal will be used in 55 teeth, in the self-etching mode. The adhesive system will be brushed during 10 seconds in the cavity, will be air-dried during 5 seconds, brushed again during 10 seconds, air-dried during 5 seconds, brushed again during 10 seconds, air-dried during 5 seconds, brushed again during 10 seconds, air-dried during 5 seconds, and activated during 10 seconds with LED light; After applying the adhesive, the restorations will be made with composite resin Opallis (FGM, Joinville, Brazil), and evaluated every 6 months for pain assessment, shape, staining or recurrent caries, using scores

Timeline

• Start date: 2016-08-01
• Primary completion: 2017-04-01
• Completion: 2023-08-30
• First posted: 2016-10-28
• Last updated: 2023-12-14

Locations

1 site across 1 country: Brazil