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Clinical evaluation of two restorative approach for non-carious cervical lesions

Clinical evaluation of Class V restorations using a semi direct technique - a randomized controlled clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-2s5bhm
Enrollment
Unknown
Registered
2018-06-20
Start date
2015-10-01
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Dental abrasion

Interventions

Participants with non-carious cervical lesions will receive class V restorations. Sixty restorations will be performed, and randomly divided into two groups (n = 30) regarding the testing restorative
Procedure/surgery
E06.323.428
D05.750.716.822.308

Sponsors

Instituto de Ciência e Tecnologia de São José dos Campos (ICT/SJC) - Universidade Estadual Paulista (UNESP)
Lead Sponsor
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior - CAPES
Collaborator

Eligibility

Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: • Be at least 18 years of age; • Provide good general health; • Do not introduce active decay or periodontal disease; • Class V lesions, non-carious in canines premolars or with a minimum depth of 1 mm.

Exclusion criteria

Exclusion criteria: Medical condition that might interfere with the safety of the volunteer during the study period, or allergic reaction to substances and/or products used in the study; use of removable prosthesis with clamp resting on the study tooth; presence of caries or periodontal disease; patients under orthodontic treatment; tooth with endodontic treatment; smoking patients, patients with parafunctional habits

Design outcomes

Primary

MeasureTime frame
"Expected outcome 1" Retention failure of resin composite restorations by means of clinical assessment (visual inspection), considering a minimum 5% variation in the measurements, after the periods of 7 days, 6 months, 1 and 2 years of the intervention;"Observed outcome 1" Regarding retention, the cumulative success rate was 99%, 93.1%, 88.5%, and 88.5% at 7 days, 6 months, 1 and 2 years, respectively. For the semi-direct technique, the cumulative success was 100%, 92.8%, 88.4%, and 83.7% at 7 days, 6 months, 1 and 2 years, respectively—

Secondary

MeasureTime frame
"Expected outcome 2" Presence of fractures, marginal disadaptation, marginal discoloration, post-operative sensitivity and recurrence of caries by means of clinical assessment (visual inspection), considering a minimum 5% variation in the measurements, after the periods of 7 days, 6 months, 1 and 2 years of the intervention;"Observed outcome 2" No secundar outcome led to treatment failure. Post-operative sensitivity reduced in both treatments from 13% to 10.5 - 11%—

Countries

Brazil

Contacts

Public ContactEduardo Bresciani

Instituto de Ciência e Tecnologia de São José dos Campos (ICT/SJC) - Universidade Estadual Paulista (UNESP)

eduardo.bresciani@unesp.br+55-12-39479403

Outcome results

None listed

Source: REBEC (via WHO ICTRP)