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

NCT02698371 | Completed Results DMC

• 2 other identifiers: FCS-UFP-2014-04-2015-07-19EC/011/2015
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Adhesives/Restorations Performance

Keywords

composite resins; dental restoration; adhesives; non-carious cervical lesions; clinical effectiveness; Adhese universal; Futurabond U; Futurabond DC; self-etch; multimode/universal; clinical trial

Outcome Measures

Primary Outcomes (3)

• 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

  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.

  24 months

• 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

  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.

  24 months

• FDI or USPHS Criteria Evaluation Outcomes for Esthetic, Functional and Biological Parameters, at 24th Month Follow-up.

  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.

  24 months

Secondary Outcomes (16)

• Surface Luster, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall

  24 months

• Staining Margin, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall

  24 months

• Colour Stability and Translucency, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall

  24 months

• Fractures and Retention, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall

  24 months

• Marginal Adaptation, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall

  24 months

Study Arms (6)

FBDC-SE (G1; Control)

ACTIVE COMPARATOR

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)

FBDC-SE-EE (G2; Control )

ACTIVE COMPARATOR

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

FBU-ER (G3)

OTHER

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)

FBU-SE (G4)

OTHER

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)

ADU-ER (G5)

OTHER

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)

ADU-SE (G6)

OTHER

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)

Interventions

G1-Control: Futurabond®DC-SE (FBDC_SE) DEVICE

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.

Also known as: Futurabond®DC_Self-etch mode (FBDC_SE)

FBDC-SE (G1; Control)

G2-Control: Futurabond®DC_SE_EE DEVICE

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.

Also known as: Futurabond®DC_selective Enamel Etching (FBDC_SE_EE)

FBDC-SE-EE (G2; Control )

G3: Futurabond® U - ER (FBU_ER) DEVICE

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.

Also known as: Futurabond® U_Etch-and-Rinse mode (FBU_ER)

FBU-ER (G3)

G4: Futurabond® U - SE (FBU_SE) DEVICE

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.

Also known as: Futurabond® U - Self-Etch mode (FBU_SE)

FBU-SE (G4)

G5: Adhese® Universal - ER (ADU_ER) DEVICE

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.

Also known as: Adhese® Universal - Etch-and-rinse mode (ADU_ER)

ADU-ER (G5)

G6: Adhese® Universal - SE (ADU_SE) DEVICE

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.

Also known as: Adhese® Universal - Self-Etch mode (ADU_SE)

ADU-SE (G6)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Fernando Pessoa: lead

Study Sites (1)

University Fernando Pessoa

Porto, 4200-150, Portugal

Location

Related Publications (9)

• Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. Int J Surg. 2011;9(8):672-7. doi: 10.1016/j.ijsu.2011.09.004. Epub 2011 Oct 13. No abstract available.

  PMID: 22019563 BACKGROUND

• Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010 Mar 23;340:c332. doi: 10.1136/bmj.c332.

  PMID: 20332509 BACKGROUND

• World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013 Nov 27;310(20):2191-4. doi: 10.1001/jama.2013.281053. No abstract available.

  PMID: 24141714 BACKGROUND

• Perdigao J, Kose C, Mena-Serrano AP, De Paula EA, Tay LY, Reis A, Loguercio AD. A new universal simplified adhesive: 18-month clinical evaluation. Oper Dent. 2014 Mar-Apr;39(2):113-27. doi: 10.2341/13-045-C. Epub 2013 Jun 26.

  PMID: 23802645 BACKGROUND

• Ritter AV, Heymann HO, Swift EJ Jr, Sturdevant JR, Wilder AD Jr. Clinical evaluation of an all-in-one adhesive in non-carious cervical lesions with different degrees of dentin sclerosis. Oper Dent. 2008 Jul-Aug;33(4):370-8. doi: 10.2341/07-128.

  PMID: 18666493 BACKGROUND

• Hickel R, Roulet JF, Bayne S, Heintze SD, Mjor IA, Peters M, Rousson V, Randall R, Schmalz G, Tyas M, Vanherle G. Recommendations for conducting controlled clinical studies of dental restorative materials. Clin Oral Investig. 2007 Mar;11(1):5-33. doi: 10.1007/s00784-006-0095-7. Epub 2007 Jan 30.

  PMID: 17262225 BACKGROUND

• Hickel R, Roulet JF, Bayne S, Heintze SD, Mjor IA, Peters M, Rousson V, Randall R, Schmalz G, Tyas M, Vanherle G. Recommendations for conducting controlled clinical studies of dental restorative materials. Science Committee Project 2/98--FDI World Dental Federation study design (Part I) and criteria for evaluation (Part II) of direct and indirect restorations including onlays and partial crowns. J Adhes Dent. 2007;9 Suppl 1:121-47.

  PMID: 18341239 BACKGROUND

• Cvar JF, Ryge G. Reprint of criteria for the clinical evaluation of dental restorative materials. 1971. Clin Oral Investig. 2005 Dec;9(4):215-32. doi: 10.1007/s00784-005-0018-z. No abstract available.

  PMID: 16315023 BACKGROUND

• Manarte-Monteiro P, Domingues J, Teixeira L, Gavinha S, Manso MC. Multi-Mode adhesives performance and success/retention rates in NCCLs restorations: randomised clinical trial one-year report. Biomater Investig Dent. 2019 Nov 6;6(1):43-53. doi: 10.1080/26415275.2019.1684199. eCollection 2019.

  PMID: 31998871 DERIVED

Related Links

• University Fernando Pessoa

Results Point of Contact

• Title: Prof. Patricia Manarte-Monteiro; Associate Professor
• Organization: University Fernando Pessoa

patmon@ufp.edu.pt

+351 225 071 300

Study Officials

• Patrícia Manarte-Monteiro, PhD

  University Fernando Pessoa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 3, 2016
• First Posted: March 3, 2016
• Study Start: November 1, 2015
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: September 13, 2019
• Results First Posted: September 13, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)