Skip to content

Study assesses whether the type of restorative material used in tooth restorations influences the durability of treatments for tooth wear

Does the consistency of fluid or regular resin influence clinical performance when restoring non-carious cervical lesions? Randomized clinical study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-2mp4w9m
Enrollment
Unknown
Registered
2025-09-11
Start date
2025-09-03
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 Sensitivity

Interventions

This is a randomized, controlled, split-mouth, double-blind (evaluator and participant) clinical study that aims to evaluate the clinical performance of composite resins with different consistencies (
E06.323.562.280

Sponsors

Universidade Tuiuti do Paraná
Lead Sponsor
Universidade Tuiuti do Paraná
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Adult participants aged 18 years or older; presence of at least two non-carious cervical lesions (NCCLs) in vital teeth, preferably in homologous teeth, allowing for a split-mouth design; lesions must be non-retentive, with a depth of up to 2 mm, and without pulp involvement; good general and oral health; ability and willingness to attend follow-up visits; signed informed consent form prior to participation; participants of both sexes will be recruited

Exclusion criteria

Exclusion criteria: Teeth with active caries, restorations or fractures in the cervical region; non-vital teeth or teeth with endodontic treatment; severe gingival inflammation or periodontal disease in the area of interest; presence of parafunctional habits such as bruxism or severe occlusal interferences; use of orthodontic appliances or retainers in the regions to be treated; known allergy or hypersensitivity to any of the materials used in the study; pregnant or breastfeeding women; individuals unable or unwilling to attend follow-up visits; systemic conditions or medications that may interfere with healing or oral health

Design outcomes

Primary

MeasureTime frame
We expect to identify differences in the fracture rate and retention of restorative material in non-carious cervical lesions (NCCLs), verified through direct clinical evaluation using the modified USPHS system criteria, observing the total or partial loss of the restoration during the 12-month period

Secondary

MeasureTime frame
It is expected to identify differences in marginal adaptation between restorative materials, verified by clinical inspection with an explorer probe and mirror, using the FDI criteria, with observation of changes in the level of continuity of the tooth-restoration interface. ;It is expected to identify changes in the marginal and superficial discoloration of the restorations, visually verified under operative lighting, using the FDI criteria, based on the presence of noticeable discoloration on the margins or on the surface of the restoration. ;It is expected to identify differences in the anatomical shape of the restorations, evaluated by visual and tactile inspection, using the FDI criteria, observing loss or maintenance of the original contour and shape of the restoration. ;It is expected to observe changes in the color stability of the restorations over time, verified by direct visual comparison with the initial color, using the FDI criteria, observing noticeable variations in the shade of the composite resin. ;It is expected to detect postoperative sensitivity reported by participants after the restorations were performed, verified by means of a standardized questionnaire applied in the follow-up visits, with a record of the presence and intensity of pain or discomfort ;It is expected to identify the recurrence of caries adjacent to the restoration, verified by clinical inspection associated with transillumination or probing, with a record of the presence of new caries lesions around the restoration ;It is expected to evaluate the periodontal response in the area around the restored teeth, verified by clinical inspection and periodontal probing, with observation of inflammatory signs such as bleeding on probing, edema or change in gingival coloration ;It is expected to obtain the subjective perception of the operator regarding the handling of restorative materials, verified by means of a structured questionnaire applied immediately after the procedure,

Countries

Brazil

Contacts

Public ContactThalita Bronholo

Universidade Tuiuti do Paraná

thalitamatos@live.com+55 (41) 3331-7668

Outcome results

None listed

Source: REBEC (via WHO ICTRP)