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Composite resins restorations in posterior teeth using in association with two materials: bulk-fill resin or glass ionomer cement.

Class II restorations evaluation using bulk-fill resin base or glass ionomer cement: Clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-4rtyfm
Enrollment
Unknown
Registered
2017-09-19
Start date
2017-05-01
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

Dentin caries, compomers, intermediary base in dental cavity

Interventions

Three restorative techniques will be performed on posterior teeth of each participant, according to a split-mouth clinical trial. The teeth that will receive the procedures will be allocated in three
Procedure/surgery

Sponsors

Faculdade de Odontologia da Universidade Federal de Goiás
Lead Sponsor
Faculdade de Odontologia da Universidade Federal de Goiás
Collaborator

Eligibility

Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: older than 18 years; both genders; needed for Class II restorations due to the presence of carious lesions and / or due to replacement of preexisting restorations with caries recurrence, loss or fracture of restorations; presence of at least three vital dental elements to be restored by each participant whose opposing teeth are present; good general health; acceptable level of oral hygiene; presence of at least 20 teeth under occlusion.

Exclusion criteria

Exclusion criteria: high risk of caries and / or periodontal disease; holders of removable or orthodontic appliances; patients with bruxism and / or xerostomia; cavities which, after preparation, do not have a minimum depth of 4 mm in the proximal box; pregnant or breastfeeding.

Design outcomes

Primary

MeasureTime frame
The performance of composite resin restorations at the baseline, 6 months, 12 months and 18 months will be verified through the analysis of the variables proposed by the FDI, comparing the percentages of each score obtained in each time evaluated. The main outcome variable is fracture and retention, which will be evaluated according to scores that include: clinically very good (retained restoration, no fracture / cracks), clinically good (Small fracture line), clinically sufficient / satisfactory (extensive fracture line (Fracture fractures, which cause damage to the marginal quality, fracture volume with or without partial loss - less than half of the restoration) and clinically poor (loss of restoration - partial Or complete).

Secondary

MeasureTime frame
The performance of composite resin restorations at the baseline, 6 months, 12 months and 18 months will be verified through the analysis of the variables proposed by the FDI, comparing the percentages of each score obtained in each time evaluated. The secondary outcomes will be: marginal discolouration, marginal adaptation, postoperative sensitivity and dental vitality and recurrence of caries. The marginal discoloration will be evaluated according to scores that comprise: clinically very good (no marginal discolouration); Clinically good (small marginal discoloration, easily removable with polishing); Clinically sufficient / satisfactory (moderate marginal discolouration, not aesthetically acceptable); Clinically unsatisfactory (pronounced marginal discoloration, necessary intervention for improvement); Clinically poor (deep marginal discolouration not accessible for intervention). The marginal adaptation will be evaluated according to scores that comprise: Clinically very good (harmonious contour, without cracks, without discoloration); Clinically good (small marginal fractures removable by polishing); Clinically sufficient / satisfactory (slits not removable by polishing, minor marginal fractures); Clinically unsatisfactory (cracks or dentin / exposed base, fractures of negative margins, large irregularities, necessary repair); Clinically poor (complete or partial restoration is lost but in situ, generalized major crevices or irregularities). The postoperative sensitivity and dental vitality will be evaluated according to scores that comprise: Clinically very good (at least one sensitivity); Clinically good (low sensitivity for a limited period of time); Clinically sufficient / satisfactory (moderate sensitivity, poor / delayed sensitivity, no patient complaint, no treatment required); Clinically unsatisfactory (severe hypersensitivity, delayed with small symptoms, negative sensitivity, necessary intervention but no substitution); Clinically bad (intense, pulpiti

Countries

Brazil

Contacts

Public ContactJoão de Souza

Faculdade de Odontologia da Universidade Federal de Goiás

jbs.ufg@gmail.com+55 62 32096255

Outcome results

None listed

Source: REBEC (via WHO ICTRP)