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A double-blind randomized clinical evaluation of a bulk-fill resin composite in posterior restorations

Clinical evaluation of a fast and high-power curing bulk-fill resin composite in posterior restorations: a double-blind randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-7fgjdxb
Enrollment
51
Registered
2026-03-09
Start date
2026-05-03
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Dental Caries

Interventions

This is a randomized, double-blind study that will follow the CONSORT guidelines. The aim of this study will be to evaluate the clinical performance of a rapid, high-intensity photoactivation restorat

Sponsors

Universidade Estadual de Ponta Grossa
Lead Sponsor
Universidade Estadual de Ponta Grossa
Collaborator

Eligibility

Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Participants aged 18–70 years; participants clinically healthy; participants presenting at least 20 teeth in occlusion and an acceptable level of oral hygiene; each participant must require at least two Class I or II restorations in vital teeth with cavities of similar horizontal and vertical dimensions; the selected teeth must present functional occlusion with the natural antagonist tooth and proximal contact with adjacent teeth; pulp vitality will be confirmed by means of a thermal test using a cold spray and periapical radiography; a positive response will be considered when it occurs within 10 seconds after stimulus application and is characterized by mild, short-lasting pain, consistent with a vital pulp

Exclusion criteria

Exclusion criteria: Participants that present unsatisfactory oral hygiene characterized by a Simplified Oral Hygiene Index greater than 3; participants diagnosed with chronic or advanced periodontitis, defined as probing depth greater than 4 mm, presence of bleeding on probing, participants with clinical attachment loss greater than 3 mm in more than four teeth; participants with fixed orthodontic appliances; participants that present significant occlusal wear in more than 10 posterior teeth; participants that require endodontic treatment; participants that presente hypersensitivity to resin-based composite materials or to any other materials used in this study

Design outcomes

Primary

MeasureTime frame
To compare the clinical performance of a rapid, high intensity photoactivation restorative system in posterior teeth using a bulkfill composite resin.

Secondary

MeasureTime frame
To evaluate the functional properties (fracture and retention, marginal adaptation, wear, proximal contact, radiographic evaluation [when necessary], and patient-reported outcomes) of posterior restorations using Tetric N-PowerFill 2 composite resin, lightcured for 3 s at 3050 mW/cm² versus lightcured for 10 s at 1069 mW/cm², at baseline, 6 months, and at 1, 2, 3, 4, and 5 years;To evaluate the esthetic properties (marginal discoloration, surface discoloration, surface gloss, color stability, and anatomical form) of posterior restorations using Tetric N-PowerFill 2 composite resin, lightcured for 3 s at 3050 mW/cm² versus lightcured for 10 s at 1069 mW/cm², at baseline, 6 months, and at 1, 2, 3, 4, and 5 years.;To evaluate the biological properties (postoperative sensitivity, secondary caries, tooth integrity, periodontal response, and oral health) of posterior restorations using Tetric N-PowerFill 2 composite resin, lightcured for 3 s at 3050 mW/cm² versus lightcured for 10 s at 1069 mW/cm², at baseline, 6 months, and at 1, 2, 3, 4, and 5 years.

Countries

BR

Contacts

Public ContactCamila Falconi

Universidade Estadual de Ponta Grossa

camila-falconi@hotmail.es+55 (42) 3220-3154

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Apr 4, 2026