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Sensitivity after composite resin restorations with previous desensitizing application

Postoperative sensitivity in composite resin restorations with prior desensitizing agent application: Randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-7q7cq8
Enrollment
Unknown
Registered
2020-03-16
Start date
2018-12-07
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

20 class I (occlusal) and class II composite resin restorations in molars and premolars will be performed in 74 patients with a universal adhesive and a resin composite under absolute isolation. Each
(B) adhesive restoration using the etch and rinse (ER) technique (control)
(C) adhesive restoration using the self-etching technique with previous application of Gluma desensitizing agent (SE / GL)
(D) adhesive restoration using the etch and rinse technique with the application of Gluma desensitizing agent (ER / GL)
Procedure/surgery

Sponsors

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior - CAPES
Lead Sponsor
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior - CAPES
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Volunteers over 18 years old; presence of 4 class I (occlusal) or class II cavities in the molar or premolar teeth; cavities with medium or deep depth (up to 3 mm) resulting from primary caries or need for restoration replacement; teeth with pulp vitality; Enamel gingival margin in class II preparations; absence of non-carious cervical lesions in the teeth involved in the research; occlusal contact with an antagonist tooth and at least one contact with an adjacent tooth; Patient with good general health; do not have any contraindications for dental treatments.

Exclusion criteria

Exclusion criteria: Present less than 20 teeth; history of spontaneous dentinal sensitivity; periodontal disease; bruxism; teeth with impossibility of absolute isolation; teeth with pulp exposure during cavity preparation; teeth that needed pulp protection in addition to the application of the adhesive system during the restorative procedure; allergy to resinous materials; impossibility to return to reevaluation consultations; fractured or visibly cracked tooth; conducting current desensitization therapy, including desensitizing toothpastes or other desensitizing products; medical, psychiatric or pharmacotherapeutic history that may compromise the protocol, including the chronic use of anti-inflammatory, analgesic and psychotropic drugs; pregnancy or breast-feeding; allergies and idiosyncratic responses to the composition of the products; orthodontic treatment performed within the previous three months; abutment teeth for fixed or removable prosthesis; teeth or support structures with any painful pathology; periodontal surgery within the previous three months; patients under whitening treatment.

Design outcomes

Primary

MeasureTime frame
Expected to find postoperative sensitivity assesed by pain scales: Pain Visual Analog Scale (VAS) and Numeric Rating Scale for Pain (NRS), showing mild, moderate or severe pain scores.

Secondary

MeasureTime frame
It is expected to find, based on assessments of 6, 12 and 18 months, using the FDI (World Dental Federation) and the USPHS (United States Public Health Service) changes in discoloration, roughness, marginal desadaptation, fracture and secondary caries in composite resin restorations, showing alpha, beta or charlie scores.

Countries

Brazil

Contacts

Public ContactGabriela Monteiro

Faculdade de odontologia da Universidade de Pernambuco

gabriela.queiroz@upe.br+55 (81) 3184 7659

Outcome results

None listed

Source: REBEC (via WHO ICTRP)