Long-term clinical evaluation of prolonged application of Universal Adhesives for the restoration of non-carious cervical lesions: A 5-year randomized controlled clinical trial

Effect of prolonged application of Universal Adhesives on non-carious cervical lesions: a 5-year prospective, randomized, controlled clinical trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

REBEC

Registry ID

RBR-355f358

Enrollment

200

Registered

2026-07-27

Start date

2026-08-03

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Root Caries

Interventions

This is a clinical study, double-blind (patient and evaluator), randomized in blocks of 4, with four experimental groups. For this, 200 restorations will be performed on 200 teeth according to the fol

esthetic criteria such as marginal discoloration, surface discoloration, color stability, and anatomical form

and biological considerations such as postoperative sensitivity, recurrence of caries, periodontal response, and oral health.

Eligibility

Age

18 Years to 59 Years

Inclusion criteria

Inclusion criteria: 604 Participants aged 18 to 59 years; classified as ASA I (healthy) or ASA II (with mild systemic disease, without significant functional limitations); with good oral hygiene and absence of periodontal disease according to the Simplified Oral Hygiene Index (OHI-S); presenting at least 20 teeth in occlusion and a minimum of four non-retentive non-carious cervical lesions (NCCLs) deeper than 1 mm and involving both enamel and dentin; located on vital, non-mobile teeth, with a cavosurface margin involving no more than 50% enamel

Exclusion criteria

Exclusion criteria: Participants with poor oral hygiene; orthodontic appliances; severe periodontitis; severe bruxism; known allergy to any materials used in the study; pregnant or breastfeeding women; and individuals receiving chronic treatment with anti-inflammatory drugs, analgesics, or psychotropic medications will be excluded

Design outcomes

Primary

Measure	Time frame
A 30% increase in restoration retention and a lower incidence of restoration fractures are expected for restorations performed using the prolonged application of universal adhesives, as assessed by clinical evaluation according to the FDI World Dental Federation criteria at the 6-, 12-, 24-, 36-, 48-, and 60-month follow-up evaluations.	—

Secondary

Measure	Time frame
It is expected that restorations subjected to prolonged application of the universal adhesives will show better marginal adaptation, less surface wear, less marginal and surface discoloration, better maintenance of color and anatomical form, less postoperative sensitivity, and a lower incidence of recurrent caries and periodontal changes, along with adequate preservation of oral health, as verified through clinical evaluation according to the criteria of the Fédération Dentaire Internationale (FDI), in the assessments performed at 6, 12, 24, 36, 48, and 60 months.	—

Measure

Time frame

It is expected that restorations subjected to prolonged application of the universal adhesives will show better marginal adaptation, less surface wear, less marginal and surface discoloration, better maintenance of color and anatomical form, less postoperative sensitivity, and a lower incidence of recurrent caries and periodontal changes, along with adequate preservation of oral health, as verified through clinical evaluation according to the criteria of the Fédération Dentaire Internationale (FDI), in the assessments performed at 6, 12, 24, 36, 48, and 60 months.

—

Countries

Contacts

Public ContactAndres Cardenas

Universidade Federal do Maranhão

andresfelipemillancardenas@hotmail.com+55(98)985074270

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Aug 10, 2026