Randomized clinical trial of five adhesive systems in occlusal posterior restorations

A randomized double-blinded controlled clinical trial comparing the behaviour of one three-step etch-and-rinse (Optibond™FL), one two-step etch-and-rinse (Prime&Bond®NT™) and three self-etch adhesives systems; one two-step (Clearfil™SE Bond), one one-step/two-bottle (Xeno®III) and one one-step/one bottle (Xeno®V+) in the restoration of occlusal posterior cavities based on the FDI evaluation criteria and focusing marginal adaptation as the primary outcome.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN87835631

Enrollment

Registered

2014-08-08

Start date

2011-06-24

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral health Oral Health

Interventions

Carious lesions removal was ensured with drilling and dentin spoon excavators. The restorative procedures were performed by one single operator. After application of the respective randomly assigned a

A2) was placed incrementally and light-cured using a LED-curing unit (Bluephase®) in its low intensity mode emitting around 650 mW/cm2. Experimental groups: 1. Optibond® FL: Apply etchant for 15 s

rinse for 15 s

air-dry for 5 s

scrub surface for 15 s with primer

gentle air-blow for 5 s

apply bonding agent

gentle air-blow for 3 s

light-cure for 20 s. 2. Prime&Bond®NT™: Apply etchant for 15 s

apply adhesive on surface and wait 20 s

light-cure for 10 s

apply second coat

light-cure for 10 s. 3. Clearfil™ SE Bond: Apply primer and leave undisturbed for 20 s

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Agreement to participate in the study 2. In good general and oral health 3. Require class I restorations in their molar or premolar teeth due to primary carious lesions 4. In permanent dentition

Exclusion criteria

Exclusion criteria: Patients with: 1. Systemic diseases, chronic use of anti-inflammatory, analgesic or psychotropic drugs 2. Xerostomy 3. Pregnancy or breastfeeding 4. Periodontal surgery within the previous three months 5. Orthodontic treatment within the previous three months 6. Uncontrolled periodontal disease 7. Bruxism 8. Allergies to specific compounds 9. Uncontrolled oral hygiene 10. Incapacity to undergo rubber dam isolation 11. Inability to attend recall appointments 12. Fewer than 20 teeth Teeth with: 1. Endodontic therapy 2. Function of abutment for fixed or removable prostheses 3. Previous restorations 4. Absence of occlusal contacts with antagonist tooth 5. Fixed or removable prosthetic tooth as antagonist 6. Attrition, abfraction or erosion 7. Fissures or fractures 8. Signs of previous pulp pathology 9. Pathologic mobility 10. Enamel and/or dentin dysplasia 11. Cavities that requires cuspid coverage 12. Cavities involving pulp exposure

Design outcomes

Primary

Measure	Time frame
The FDI evaluation criteria was applied in baseline, 6 months and one year. Marginal adaptation was considered for the primary outcome Score 1: Harmonious outline, no gaps Score 2: Marginal gaps (150 µm and 250 µm or dentin/base exposed; severe marginal fractures Score 5: Restoration lost but in situ; generalized major gaps	—

Secondary

Measure	Time frame
1. The FDI evaluation criteria was applied in baseline, 6 months and one year. 2. Esthetic Properties (surface lustre, marginal and surface staining, anatomical form), 3. Functional Properties (fracture of material and retention, radiographic examination), 4. Biological Properties (postoperative hypersensitivity and tooth vitality; recurrence of caries; tooth integrity; adjacent mucosa)	—

Countries

Portugal

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 21, 2026