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Treatment outcomes of Direct Restorations with Fibers in non-vital front teeth: randomized double-blind clinical trial

Clinical performance of Direct Fiber-Reinforced Restorations in non-vital anterior teeth: a double-blind randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-6wshhsb
Enrollment
Unknown
Registered
2026-01-26
Start date
2026-03-01
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Tooth nonvital

Interventions

This is an equivalence, quantitative, experimental study designed as a randomized, double-blind (participant and evaluator) clinical trial, to be conducted at the clinics of the School of Dentistry of
neither the participant nor the operator will be aware of the group assignment prior to this stage. Initially, participant identification data and medical and dental history will be recorded, followed

Sponsors

Faculdade de Odontologia da Universidade Federal do Amazonas
Lead Sponsor
Universidade Federal do Amazonas
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Participants of both sexes, aged 18 years or older, in good general and oral health, presenting at least one endodontically treated anterior tooth considered satisfactory, with no clinical or radiographic evidence of periapical lesions; participants must require an extensive restoration of the eligible tooth and present an opposing tooth in functional occlusion

Exclusion criteria

Exclusion criteria: Participants presenting parafunctional habits, such as bruxism; pregnant or breastfeeding women; teeth with pathological mobility, internal or external root resorption, or root fractures; cases with dental morphological alterations, such as fluorosis, amelogenesis imperfecta, dentinogenesis imperfecta, or tetracycline staining, as well as the presence of non-carious cervical lesions; patients undergoing orthodontic treatment; those with an indication for periodontal treatment; or with systemic conditions that may interfere with the prognosis of the treatment

Design outcomes

Primary

MeasureTime frame
The primary outcome will be the clinical success of direct restorations in non-vital anterior teeth, assessed by restoration survival, defined as the absence of failures requiring repair or replacement during the follow-up period

Secondary

MeasureTime frame
The secondary outcome will be the assessment of oral health–related quality of life (OHRQoL) and the Psychosocial Impact of Dental Aesthetics Questionnaire (PIDAQ) after restorative therapy

Countries

Brazil

Contacts

Public ContactSheise Silva

Faculdade de Odontologia da Universidade Federal do Amazonas

sheisecerdeiradentista@gmail.com+55(92) 992719886

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Feb 7, 2026