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Evaluation of teeth restorations performed inside or outside the mouth

Clinical evaluation of direct and indirect restorations of composite resin in posterior tooth clinical and randomized study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-8pcx5p
Enrollment
Unknown
Registered
2019-08-21
Start date
2018-03-01
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 caries

Interventions

Thirty patients will participate of the study, and each will receive two different treatments, as a split mouth design. Restorative Procedure Direct Restoration For direct restorations, after shade
Other
E06.323.428

Sponsors

Instituto de Ciência e Tecnologia da Universidade Estadual Paulista de São José dos Campos
Lead Sponsor
Instituto de Ciência e Tecnologia da Universidade Estadual Paulista de São José dos Campos
Collaborator

Eligibility

Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: The inclusion criteria will be: patients with age between 18 and 80 year old; presence of adjacent tooth and antagonists to the tooth to be treated; pulp vitality and absence of painful symptomatology; tooth that were never submitted to pulp capping; absence of history of hypersensitivity; isthmus greater than 2/3 of the intercuspide distance; permanent teeth; adequate oral hygiene and absence of periodontal disease; absence of systemic diseases; absence of a removable partial denture that rests on the studied tooth or its antagonist.

Exclusion criteria

Exclusion criteria: The exclusion criteria will be: intense parafunctional habits; exposure to pulp during caries removal; cavities with imminent risk of pulpal exposure; spontaneous pain or sensitivity and percussion.

Design outcomes

Primary

MeasureTime frame
Expected outcome 1 - To evaluate the occurrence fractures or retention loss of the restorations, evaluated by visual direct clinical observation, probing and radiographic examination

Secondary

MeasureTime frame
Expected outcome 2 - To evaluate the changes on the surface brightness of the restorations, evaluated by visual direct clinical observation;Expected outcome 3 - To evaluate the surface staining of the restorations, evaluated by visual direct clinical observation;Expected outcome 4 - To evaluate the marginal staining of the restorations, evaluated by visual direct clinical observation;Expected outcome 5 - To evaluate changes on color and translucency match between the restoration and the remaining tooth structure, evaluated by visual direct clinical observation;Expected outcome 6 - To evaluate changes on anatomical form esthetic of the restoration, evaluated by visual direct clinical observation;Expected outcome 7 - To evaluate occurrence of defects on the marginal adaptation of the restoration, evaluated by visual direct clinical observation and probing of the restoration margins with standardized probes;Expected outcome 8 - To evaluate occlusal contour and wear of the restoration, evaluated by visual direct clinical observation, impression and indirect analysis of epoxy replicas;Expected outcome 9 - To evaluate the proximal contact of the restoration with the neighbor tooth, evaluated by standardized metal blades;Expected outcome 10 - To evaluate the occurrence of post-operative sensitivity, evaluated by anamnesis;Expected outcome 11 - To evaluate the occurrence of secondary caries on restorations margins, evaluated by visual clinical examination, probing of the margins and radiographic examination;Expected outcome 12 - To evaluate the tooth integrity, evaluated by visual clinical examination;Expected outcome 13 - To evaluate the periodontal response around the restoration, evaluated by visual clinical examination and periodontal probing of the crevice;Expected outcome 14 - To evaluate the general health of the patient, evaluated by clinical examination and anamnesis

Countries

Brazil

Contacts

Public ContactCarlos Torres

Instituto de Ciência e Tecnologia da Universidade Estadual Paulista de São José dos Campos

carlosrgt@gmail.com+55-12-39479376

Outcome results

None listed

Source: REBEC (via WHO ICTRP)