N/A N=38 Randomized Triple-blind Other

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

Dental Adhesives/Restorations Performance

Bottom Line

View on ClinicalTrials.gov: NCT02698371 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2019

Primary outcome: Primary: 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 — 29; 30; 29; 30 NCCLs restorations — p=0.025

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: 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) (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University Fernando Pessoa
Primary completion: May 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY 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	29; 30; 29; 30; 32; 33	0.025 sig
PRIMARY 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	29; 30; 29; 30; 32; 33	0.025 sig
PRIMARY FDI or USPHS Criteria Evaluation Outcomes for Esthetic, Functional and Biological Parameters, at 24th Month Follow-up.	29; 30; 29; 30; 32; 33	1.000
SECONDARY Surface Luster, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall	28; 30; 29; 30; 32; 32	0.029 sig
SECONDARY Staining Margin, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall	26; 29; 28; 28; 30; 30	0.009 sig
SECONDARY Colour Stability and Translucency, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall	29; 30; 29; 30; 30; 32	<0.001 sig
SECONDARY Fractures and Retention, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall	29; 29; 29; 27; 32; 32	0.006 sig
SECONDARY Marginal Adaptation, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall	21; 29; 24; 24; 27; 27	0.010 sig
SECONDARY Postoperative Hypersensibility, Tooth Vitality, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall	29; 28; 29; 28; 30; 32	0.317
SECONDARY Recurrence of Caries, Erosion, Abfraction, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall	29; 29; 29; 29; 32; 33	0.317
SECONDARY Tooth Integrity (Enamel Cracks), Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall	26; 30; 27; 26; 28; 32	0.020 sig
SECONDARY Surface Staining, Graded on a 3-point Scale, Using USPHS Criteria at 24 Month Follow-up Recall	29; 30; 29; 30; 32; 33	1.000
SECONDARY Marginal Discoloration, Graded on a 3-point Scale, Using USPHS Criteria at 24 Month Follow-up Recall	25; 28; 27; 27; 29; 31	0.011 sig
SECONDARY Color Match, Graded on a 3-point Scale, Using USPHS Criteria at 24 Month Follow-up Recall	29; 30; 29; 30; 31; 33	1.000
SECONDARY Retention, Graded on a 3-point Scale, Using USPHS Criteria at 24 Month Follow-up Recall	29; 29; 29; 29; 32; 33	0.020 sig
SECONDARY Marginal Integrity, Graded on a 4-point Scale, Using USPHS Criteria at 24 Month Follow-up Recall	23; 28; 24; 24; 27; 29	<0.001 sig
SECONDARY Postoperative Sensitivity, Graded on a 2-point Scale, Using USPHS Criteria at 24 Month Follow-up Recall	28; 28; 29; 27; 30; 32	0.102
SECONDARY Secondary Caries, Graded on a 2-point Scale, Using USPHS Criteria at 24 Month Follow-up Recall	29; 29; 29; 28; 32; 33	0.157
SECONDARY Gingival Bleeding, Graded on a 2-point Scale, Using USPHS Criteria at 24 Month Follow-up Recall	28; 29; 28; 29; 30; 32	0.132

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.

Eligibility 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.

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Data sourced from ClinicalTrials.gov (NCT02698371). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.