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Sensitivity after posterior restorations: clinical trial using a Glutaraldeyhe-based desensitizer

Post-operative sensitivity in posterior composite restorations: a double-blind randomized clinical trial of a Glutaraldeyhe-based desensitizer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-6qzktx
Enrollment
Unknown
Registered
2019-09-25
Start date
2018-08-15
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

Based on pre-established criteria, 60 volunteers seeking care at the dental clinics of Ponta Grossa State University will be selected. Volunteers should have at least 4 cavities to be restored, and th
Group 2: Conditioning with 37% phosphoric acid, followed by applying the universal adhesive system and making the resin restoration using the Bulk-Fill technique (60 restorations)
Group 3: Application of glutaraldehyde-based desensitizing agent prior to the adhesive system, leaving it on the surface for 30-60s. Air dry the surface and then rinse with plenty of water, followed b
Group 4: Conditioning with 37% phosphoric acid, followed by application of glutaraldehyde-based desensitizing agent prior to the adhesive system, leaving it on the surface for 30-60s. Air dry the surf
Other
E06.323.428

Sponsors

Universidade Estadual de Ponta Grossa
Lead Sponsor
Universidade Estadual de Ponta Grossa
Collaborator

Eligibility

Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Age: between 18-50 years old; have at least four carious lesions and / or indications for restoration replacement (fracture, secondary caries, provisional restoration), with a depth higher than or equal to 3 mm measured from the central sulcus; the teeth to be restored must be vital and in occlusion with the antagonist

Exclusion criteria

Exclusion criteria: Severe or chronic periodontitis; parafunctional habits; continued use of medication that may alter pain perception (analgesic, anti-inflammatory); patient under whitening treatment; pregnant women.

Design outcomes

Primary

MeasureTime frame
Expected Outcome: Number of patients reporting spontaneous pain after the restorative procedure through self-report. This number will be transformed into percentage of patients with pain and will be called absolute risk of dental sensitivity.;The intensity of dental sensitivity will be assessed by 5-point numerical scale (NRS 0-4) and visual analog scale (VAS 0-10) and will be presented as mean and standard deviation during 7 days after restorative treatment.

Secondary

MeasureTime frame
Expected Outcome 2: The patient will return 7, 14, 21 and 30 days and 6 months after the restoration to evaluate the sensitivity caused by air application, vertical percussion, cold stimulation, in a yes and no evaluation.;Expected Outcome 3: The patient will return at 7, 14, 21, and 30 days and 6, 12, and 18 months after restorations to evaluate modified USPHS (1-5) and FDI (1-3) criteria for marginal discoloration, marginal adaptation, retention and recurrence of caries.

Countries

Brazil

Contacts

Public ContactAlessandro Loguercio

Universidade Estadual de Ponta Grossa

aloguercio@hotmail.com+55423220-3740

Outcome results

None listed

Source: REBEC (via WHO ICTRP)