Different Application Strategies When Using Ambar Universal in Class V Cavities
Condition: Dental Restoration Failure of Marginal Integrity
Study type: Interventional

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.
    

Intervention name(s): Self-Etching Application Strategy; Enamel Etching Application Strategy; Self Etching with Extended time Application Strategy; Self Etching with Extended layers number Strategy
Intervention type(s): Other; Other; Other; Other
Intervention description(s): 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.; 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.; 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; 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: dentin bonding agents; tooth sensitivity; composite resin restoration