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NCCL Direct Composite Restoration Performance With Self-Etch and Multimode Adhesives (SEMMAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02698371
Recruitment Status : Completed
First Posted : March 3, 2016
Results First Posted : September 13, 2019
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
Patrícia Manarte Monteiro, University Fernando Pessoa

Brief Summary:

The purpose is to evaluate/compare clinical effectiveness of dual cure (DC) all-in-one Self-Etch (Futurabond® DC (FBDC)) adhesive and multimode/universal (Futurabond® U (FU) and Adhese® Universal (AU)) adhesives, with or without selective enamel etching, in non-carious cervical lesions (NCCL), during 24th months, using Word Dental Federation (FDI) and United States Public Health Services (USPHS) criteria.

The null hypotheses are:

H0 - Bonding to NCCLs with DC-SE and SE-Universal adhesives with SE strategies will result in similar (no significant differences) clinical (aesthetic, functional and biologic) behaviour/performance in a period of 24th month evaluation; H0 - Bonding to NCCLs with DC-SE and SE-Universal adhesives with SE strategies will result in similar restorations (aesthetic, functional and biologic) success rates over 24th month evaluation; H0 - Bonding to NCCLs with DC-SE and SE-Universal adhesives with SE strategies will result in similar restoration retention rates in a period of 24th month evaluation; H0 - Bonding to NCCLs DC-SE with enamel pre-etching and Universal adhesives with ER adhesive strategy will result in similar (no significant differences) clinical (aesthetic, functional and biologic) behaviour/performance in a period of 24thmonth evaluation; H0 - Bonding to NCCLs DC-SE with enamel pre-etching and Universal adhesives with ER adhesive strategy will result in similar restorations (aesthetic, functional and biologic) success rates over 24th month evaluation; H0 - Bonding to NCCLs DC-SE with enamel pre-etching and Universal adhesives with ER adhesive strategy will result in similar restoration retention rates in a period of 24th month evaluation; H0 - Bonding to NCCLs with FBDC or FU (DC adhesives) and AU (Light-curing adhesive) with SE or ER adhesive strategies will result in similar (no significant differences) clinical (aesthetic, functional and biologic) behaviour/performance in a period of 24th month evaluation; H0 - Bonding to NCCLs with FBDC or FU (DC adhesives) and AU (Light-curing adhesive) with SE or ER adhesive strategies will result in similar restorations (aesthetic, functional and biologic) success rates over 24th month evaluation; H0 - Bonding to NCCLs with FBDC or FU (DC adhesives) and AU (Light-curing adhesive) with SE or ER adhesive strategies will result in similar restoration retention rates in a period of 24th month evaluation; H0 - FDI or USPHS criteria evaluation outcomes not differ for the same data.


Condition or disease Intervention/treatment Phase
Dental Adhesives/Restorations Performance Device: G1-Control: Futurabond®DC-SE (FBDC_SE) Device: G2-Control: Futurabond®DC_SE_EE Device: G3: Futurabond® U - ER (FBU_ER) Device: G4: Futurabond® U - SE (FBU_SE) Device: G5: Adhese® Universal - ER (ADU_ER) Device: G6: Adhese® Universal - SE (ADU_SE) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Other
Official Title: NCCL Direct Composite Restoration Performance With Self-Etch and Multimode Adhesives Clinical Trial
Actual Study Start Date : November 2015
Actual Primary Completion Date : May 2018
Actual Study Completion Date : May 2018

Arm Intervention/treatment
Active Comparator: FBDC-SE (G1; Control)
Futurabond DC (single dose blister) will be applied as thickness to the enamel/dentine and rub into the tooth surface for 20s; FBDC drying layer for at least 5s with an air syringe; This adhesive layer will be light-cured with a light emitting diode unit (LED light), with an intensity of 1000mW/cm2, during 20s.
Device: G1-Control: Futurabond®DC-SE (FBDC_SE)
Futurabond®DC (FBDC) adhesive by self-etch (SE) mode bonding in NCCls restorations, was randomly assigned to premolar or molar teeth ensuring that this adhesive/mode is only apllied once in each participant.
Other Name: Futurabond®DC_Self-etch mode (FBDC_SE)

Active Comparator: FBDC-SE-EE (G2; Control )
Etch with 36% phosphoric acid, during 30s in enamel structures. Remove the 36% phosphoric acid with water during 1 minute. The remove of water excess will be done with weak air spray, not to dry the dentine completely. The dentine surface must slightly remain wet. Application of Futurabond DC (FBDC) as self-etch mode simultaneously in dentin and enamel, and the light-cured (LED light; 1000mW/cm2), during 20s.
Device: G2-Control: Futurabond®DC_SE_EE
Futurabond®DC adhesive by self-etch mode with selective enamel etching (FBDC-SE-EE) bonding in NCCls restorations, was randomly assigned to premolar or molar teeth ensuring that this adhesive/mode is only apllied once in each participant.
Other Name: Futurabond®DC_selective Enamel Etching (FBDC_SE_EE)

FBU-ER (G3)
FuturabondU® (FBU) apply in enamel and dentin as etch-and-rinse (ER) mode. Etching of the dental hard tissue phosphoric acid (15s in dentin and 30s in enamel) and then rinse with water for 1 min. Dry off excess moisture with a gentle stream of air. Activating FBU SingleDose. FBU adhesive will be homogeneously applied to all cavity surfaces and rub in for 20s using the Single Tim; This adhesive layer will be light-cured with a light emitting diode unit, with an intensity of 1000mW/cm2 during 20s.
Device: G3: Futurabond® U - ER (FBU_ER)
FuturabondU® (FBU) adhesive by etch-and-rinse (ER) mode, bonding in NCCls restorations, was randomly assigned to premolar or molar teeth ensuring that this adhesive/mode is only apllied once in each participant.
Other Name: Futurabond® U_Etch-and-Rinse mode (FBU_ER)

FBU-SE (G4)
FuturabondU® (FBU) apply in enamel and dentin as SE mode. Activating FBU SingleDose. FBU adhesive will be homogeneously apply to all cavity surfaces and rub in for 20 s using the Single Tim; Dry off the adhesive layer with dry, oil-free air for at least 5 s in order to remove any solvents. This adhesive layer will be light-cured with a light emitting diode unit (LED light), with an intensity of 1000mW/cm2, during 20 seconds.
Device: G4: Futurabond® U - SE (FBU_SE)
FuturabondU® (FBU) adhesive by self-etch (SE) mode, bonding in NCCls restorations, was randomly assigned to premolar or molar teeth ensuring that this adhesive/mode is only apllied once in each participant.
Other Name: Futurabond® U - Self-Etch mode (FBU_SE)

ADU-ER (G5)
Adhese®Universal (ADU) apply by etch-and-rinse (ER) mode. Etching of the dental hard tissue phosphoric acid (15 seconds in dentin and 30 seconds in enamel); Etch agent rinse with water for 1 minute. Dry off excess moisture with a gentle stream of air. Keep dentin dry, do not over dry; Adhesive ADU will be scrubbed into the tooth surface (enamel and dentin) for at least 20 seconds. Adhesive will be dispersed with compressed air until a glossy, immobile film layer results.Light-curing for 10 s with a light emitting diode unit (LED light), with an intensity of 1000mW/cm2 for 20s.
Device: G5: Adhese® Universal - ER (ADU_ER)
Adhese®Universal (ADU) adhesive by etch-and-rinse (ER) mode, bonding in NCCls restorations, was randomly assigned to premolar or molar teeth ensuring that this adhesive/mode is only apllied once in each participant.
Other Name: Adhese® Universal - Etch-and-rinse mode (ADU_ER)

ADU-SE (G6)
Adhese®Universal (ADU)apply by self-etch (SE) mode. Starting with the enamel, thoroughly coat the tooth surfaces (enamel and dentin) to be treated with ADU; Adhesive will be scrubbed into the tooth surface for at least 20 seconds. Adhesive will be dispersed with compressed air until a glossy, immobile film layer results.Light-curing for 20 s with a light emitting diode unit (LED light), with an intensity of 1000mW/cm2.
Device: G6: Adhese® Universal - SE (ADU_SE)
Adhese®Universal (ADU) adhesive by self-etch (SE) mode, bonding in NCCls restorations, was randomly assigned to premolar or molar teeth ensuring that this adhesive/mode is only apllied once in each participant.
Other Name: Adhese® Universal - Self-Etch mode (ADU_SE)




Primary Outcome Measures :
  1. Esthetic, Functional and Biological Clinical Performance Adhesive/Adhesion Mode of NCCLs Restoration, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall [ Time Frame: 24 months ]
    Clinical Performance Acceptance was expressed as the number of NCCls restorations scored as "1-Clinically excellent/ very good", "2-Clinically good (after correction, very good)", "3-Clinically sufficient/ satisfactory (minor shortcomings with no adverse effects but not adjustable without damage to the tooth)", "4-Clinically unsatisfactory (repair for prophylactic reasons)". NCCls restorations with not acceptable performance were scored as "5-Clinically poor (replacement necessary)" for clinical properties. NCCLs restorations not observed due to retention/marginal integrity lost were scored as "missing" for other categories.

  2. Esthetic, Functional and Biological Clinical Performance Adhesive/Adhesion Mode of NCCLs Restoration, Graded on a 4-point Scale, Using USPHS Criteria at 24 Month Follow-up Recall [ Time Frame: 24 months ]
    Clinical Performance Acceptance was expressed as the number of NCCls restorations scored as "Alfa" and "Bravo". NCCls restorations with not acceptable performance were scored as "Charlie" for Esthetic properties, for Retention criteria and for Biological properties, and also scored "Delta" for Marginal Adaptation criteria. NCCLs restorations not observed due to retention/marginal integrity lost were scored as "missing" for other categories.

  3. FDI or USPHS Criteria Evaluation Outcomes for Esthetic, Functional and Biological Parameters, at 24th Month Follow-up. [ Time Frame: 24 months ]
    FDI or USPHS criteria evaluation outcomes for Esthetic, Functional and Biological parameters, at 24th month follow-up were expressed as the number os NCCLs With Clinical Acceptance for each parameter. NCCLs restorations not observed due to retention/marginal integrity lost were scored as "missing" for other categories.


Secondary Outcome Measures :
  1. Surface Luster, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall [ Time Frame: 24 months ]
    Surface Luster Clinical Acceptance was expressed as the number of NCCls restorations classified as "(11)-Luster comparable to enamel", "(12)-Slightly dull, not noticeable from speaking distance", "(13)-Dull surface but acceptable if covered with film of saliva", "(14)- Rough surface, cannot be masked by saliva film, simple polishing is not sufficient. Further intervention necessary". NCCls restorations with not acceptable Surface Luster were classified as "(15)-Quite rough, unacceptable plaque retentive surface". NCCLs restorations not observed due to retention lost were scored as "missing" for other categories.

  2. Staining Margin, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall [ Time Frame: 24 months ]
    Staining Margin Clinical Acceptance was expressed as the number of NCCls restorations classified as "(21)-No surface staining", "(22)-Minor staining, easily removable", "(23)-Moderate surface staining, also present on other teeth, not aesthetically unacceptable", "(24)-Surface staining present on the restoration and is unacceptable; major intervention necessary for improvement". NCCls restorations with not acceptable Staining Margin were classified as "(25)-Severe staining and/or subsurface staining (generalized or localized); not accessible for intervention". NCCLs restorations not observed due to retention lost were scored as "missing" for other categories.

  3. Colour Stability and Translucency, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall [ Time Frame: 24 months ]
    Colour Stability and Translucency Clinical Acceptance was expressed as the number of NCCls restorations classified as "(31)-Good colour match no difference in shade and translucency", "(32)-Minor deviations", "(33)-Clear deviation but acceptable. Does not affect aesthetics", "(34)-(Localised) clinically unsatisfactory but can be corrected by repair". NCCls restorations with not acceptable Colour Stability and Translucency were classified as "(35)-Unacceptable. Replacement necessary". NCCLs restorations not observed due to retention lost were scored as "missing" for other categories.

  4. Fractures and Retention, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall [ Time Frame: 24 months ]
    Fractures and Retention Clinical Acceptance was expressed as the number of NCCls restorations classified as "(41)-Restoration retained, no fractures/cracks", "(42)-Small hairline crack", "(43)-Two or more or larger hairline cracks and/or chipping (not affecting the marginal integrity or proximal contact", "(44)-Chipping fractures which damage marginal quality or proximal contacts; bulk fractures with or without partial loss(less than half of the restoration)". NCCls restorations with not acceptable Fractures and Retention were classified "(45)-Partial or complete loss of restoration".

  5. Marginal Adaptation, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall [ Time Frame: 24 months ]
    Marginal Adaptation Clinical Acceptance was expressed as the number of NCCls restorations classified as "(51)-Harmonious outline, no gaps, no discoloration", "(52)-Marginal gap (50 µm) or Small marginal fracture removable by polishing", "(53)-Gap< 150 µm not removable or Severe small enamel or dentin fractures", "(54)- Gap> 250 µm or dentine exposed or Chip fracture damaging margins or Notable enamel or dentine wall fracture", "(55)-Filling is loose but in situ". NCCLs restorations not observed due to retention lost were scored as "missing" for other categories.

  6. Postoperative Hypersensibility, Tooth Vitality, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall [ Time Frame: 24 months ]
    Postoperative Hypersensibility, Tooth Vitality Clinical Acceptance was expressed as the number of NCCls restorations classified as "(61)-No hypersensitivity, normal vitality", "(62)-Low hypersensitivity for a limited period of time, normal vitality", "(63)-Premature/slightly more intense or Delayed/weak sensitivity; no subjective complaints, no treatment needed", "(64)-Premature/very intense or Extremely delayed/weak with subjective complaints or Negative sensitivity intervention necessary but not replacement". NCCls restorations with not acceptable Postoperative Hypersensibility, Tooth Vitality criteria were classified as (65)-Very intense, acute pulpitis or no vital; Endodontic treatment is necessary and restoration has to be replaced".NCCLs restorations not observed due to retention/marginal integrity lost were scored as "missing" for other categories.

  7. Recurrence of Caries, Erosion, Abfraction, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall [ Time Frame: 24 months ]
    Recurrence of Caries, Erosion, Abfraction Clinical Acceptance was expressed as the number of NCCls restorations classified as "(71)-No secondary or primary caries", "(72)-Very small and localized. No operative treatment required", "(73)-Larger areas of: Demineralisation or Erosion or Abrasion/abfraction in dentine, localized and accessible and can be repaired", "(74)-Caries with cavitation or Erosion in dentine or Abrasion/abfraction in dentine Localized and accessible and can be repaired". NCCls restorations with not acceptable Recurrence of Caries, Erosion, Abfraction criteria were classified as "(75)-Deep secondary caries or exposed dentine that is not accessible for repair of restoration". NCCLs restorations not observed due to retention/marginal integrity lost were scored as "missing" for other categories.

  8. Tooth Integrity (Enamel Cracks), Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall [ Time Frame: 24 months ]
    Tooth Integrity (enamel cracks) Clinical Acceptance was expressed as the number of NCCls restorations classified as "(81)-Complete integrity", "(82)-Small margin enamel(<150 µm) or Hairline crack in enamel (<150 µm not probable)", "(83)-Enamel split(<250 µm) or Crack< 250 µm, no adverse effects", "(84)-Major enamel split (gap>250 µm or dentine or base exposed) or Crack>250 µm (probe penetrates)". NCCls restorations with not acceptable Tooth Integrity (enamel cracks) criteria were classified as "(85)-Cusp or tooth fracture". NCCLs restorations not observed due to retention/marginal integrity lost were scored as "missing" for other categories.

  9. Surface Staining, Graded on a 3-point Scale, Using USPHS Criteria at 24 Month Follow-up Recall [ Time Frame: 24 months ]
    Surface Staining Clinical Acceptance was expressed as the number of NCCls restorations classified as "(Alfa)- No staining in the restoration and/or the tooth" or "(Bravo)-Slight staining in the restoration and/or the tooth". NCCls restorations with not acceptable Surface Staining were classified as "(Charlie)-The staining penetrated in the restoration and/or the tooth in a pulpal direction". NCCLs restorations not observed due to retention/marginal integrity lost were scored as "missing" for other categories.

  10. Marginal Discoloration, Graded on a 3-point Scale, Using USPHS Criteria at 24 Month Follow-up Recall [ Time Frame: 24 months ]
    Marginal Discoloration Clinical Acceptance was expressed as the number of NCCls restorations classified as "(Alfa)-No discoloration along the margin between the restoration and adjacent tooth" or "(Bravo)-Slight discoloration along the margin between the restoration and the adjacent tooth (removable, usually localized)". NCCls restorations with not acceptable Marginal Discoloration were classified as "(Charlie)-Deep staining cannot be polished away". NCCLs restorations not observed due to retention/marginal integrity lost were scored as "missing" for other categories.

  11. Color Match, Graded on a 3-point Scale, Using USPHS Criteria at 24 Month Follow-up Recall [ Time Frame: 24 months ]
    Color Match Clinical Acceptance was expressed as the number of NCCls restorations classified as "(Alfa)-Restoration matches the adjacent tooth structure in color and translucency" or "(Bravo)-Light mismatch in color, shade or translucency between the restoration and the adjacent tooth". NCCls restorations with not acceptable Color Match were classified as "(Charlie)-The mismatch in color and translucency is outside the acceptable range of tooth color and translucency". NCCLs restorations not observed due to retention/marginal integrity lost were scored as "missing" for other categories.

  12. Retention, Graded on a 3-point Scale, Using USPHS Criteria at 24 Month Follow-up Recall [ Time Frame: 24 months ]
    Retention Clinical Acceptance was expressed as the number of NCCls restorations classified as "(Alfa)-Retained" or "(Bravo)-Partially retained". NCCls restorations with not acceptable Retention were classified as "(Charlie)-Missing".

  13. Marginal Integrity, Graded on a 4-point Scale, Using USPHS Criteria at 24 Month Follow-up Recall [ Time Frame: 24 months ]
    Marginal Integrity Clinical Acceptance was expressed as the number of NCCls restorations classified as "(Alfa)-No visible evidence of crevice along the margin", "(Bravo)-Visible evidence of a crevice along the margin into which the explorer will penetrate"or "(Charlie)-Dentin or the base is exposed". NCCls restorations with not acceptable Marginal Integrity were classified as "(Delta)-Restoration is fractured, mobile or missing".

  14. Postoperative Sensitivity, Graded on a 2-point Scale, Using USPHS Criteria at 24 Month Follow-up Recall [ Time Frame: 24 months ]
    Postoperative Sensitivity Clinical Acceptance was expressed as the number of NCCls restorations classified as "(A)-No evidence of postoperative sensitivity". NCCls restorations with not acceptable Postoperative Sensitivity were classified as "(B)-Experience of postoperative sensitivity. NCCLs restorations not observed due to retention/marginal integrity lost were scored as "missing" for other categories.

  15. Secondary Caries, Graded on a 2-point Scale, Using USPHS Criteria at 24 Month Follow-up Recall [ Time Frame: 24 months ]
    Secondary Caries Clinical Acceptance was expressed as the number of NCCls restorations classified as "(A)-No evidence of caries". NCCls restorations with not acceptable Secondary Caries criteria were classified as "(B)-Evidence of caries along the margin of the restoration. NCCLs restorations not observed due to retention/marginal integrity lost were scored as "missing" for other categories.

  16. Gingival Bleeding, Graded on a 2-point Scale, Using USPHS Criteria at 24 Month Follow-up Recall [ Time Frame: 24 months ]
    Gingival Bleeding Clinical Acceptance was expressed as the number of NCCls restorations classified as "(A)-No evidence of gingival bleeding adjacent to Class II restoration". NCCls restorations with not acceptable Gingival Bleeding criteria were classified as "(B)-Evidence of gingival bleeding adjacent to Class II restoration". NCCLs restorations not observed due to retention/marginal integrity lost were scored as "missing" for other categories.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients of both genders
  • ages up to 18 years old and less than 65 years old
  • Patients with diagnosis and treatment required of dental structure loss in cervical vestibular surfaces with non-bacterial or chemical origin, which is non-carious cervical lesions (NCCL) in premolar/molar teeth (These lesions have to be non-carious, non-retentive, deeper than 1 mm, and involve both the enamel and dentin of vital teeth without mobility. The cavo-surface margin cannot involve more that 50% of enamel.)

Exclusion Criteria:

  • Patients with a number of teeth inferior than 20 in occlusion;
  • If the tooth is not vital;
  • Chronic periodontal disease;
  • Incapacity to return to follow-up;
  • To participate in another clinical evaluation in course at that time;
  • Medical, psychiatric history or pharmacotherapy to compromise the protocol
  • Pregnancy;
  • Allergies and idiosyncratic answers to the ingredients of the products;
  • Fixed orthodontic treatment;
  • Teeth support for fixed prosthodontic treatments;
  • Teeth or structures of support with pulpa injury in transition phase;
  • Periodontal surgery in the 3 previous months;
  • Severe bruxism;
  • Extremely poor oral hygiene;
  • Patient refuse to voluntary participate in the trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02698371


Locations
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Portugal
University Fernando Pessoa
Porto, Portugal, 4200-150
Sponsors and Collaborators
University Fernando Pessoa
Investigators
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Principal Investigator: Patrícia Manarte-Monteiro, PhD University Fernando Pessoa
  Study Documents (Full-Text)

Documents provided by Patrícia Manarte Monteiro, University Fernando Pessoa:
Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Patrícia Manarte Monteiro, Associate Professor, University Fernando Pessoa
ClinicalTrials.gov Identifier: NCT02698371    
Other Study ID Numbers: FCS-UFP-2014-04-2015-07-19
EC/011/2015 ( Other Identifier: INFARMED )
First Posted: March 3, 2016    Key Record Dates
Results First Posted: September 13, 2019
Last Update Posted: September 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Patrícia Manarte Monteiro, University Fernando Pessoa:
composite resins
dental restoration
adhesives
non-carious cervical lesions
clinical effectiveness
Adhese universal
Futurabond U
Futurabond DC
self-etch
multimode/universal
clinical trial