Clinical evaluation of tooth restoration using an agent by only one insertion

• Register: REBEC
• Last refreshed on: 29 May 2023
• Main ID: RBR-2h9qkd
• Date of registration: 27/01/2020
• Prospective Registration: No
• Primary sponsor: Faculdades Integradas Pitágoras de Montes Claros
• Public title: Clinical evaluation of tooth restoration using an agent by only one insertion
• Scientific title: Clinical behavior of single increment composites: randomized controlled longitudinal study
• Date of first enrolment: 01/11/2018
• Recruitment status: Recruitment completed
• URL: http://ensaiosclinicos.gov.br/rg/RBR-2h9qkd
• Study type: Intervention
• Study design: clinical trial of treatment, parallel, blind, randomized and controlled with 6 arms/conditions
• Phase: N/A

Countries of recruitment

Brazil

Contacts

• Name: Daniela Araujo Veloso Popoff
• Affiliation: Universidade de Estadual de Montes Claros

• Name: Daniela Araujo Veloso Popoff
• Affiliation: Universidade de Estadual de Montes Claros

Key inclusion & exclusion criteria

Inclusion criteria: over 18 years old; patients who had posterior teeth with active and / or cavitated caries lesions, requiring restoration with direct restorative material, but free of proximal caries according to interproximal radiographic examination; patients who already had class I restorations within score 5 (Clinically poor: International Dental Federation - IDF) on at least one of the following criteria: surface gloss; surface and margin staining; combination of color and translucency; anatomical form; fracture and retention of material; marginal adaptation; patient satisfaction; postoperative sensitivity; recurrence of caries.
Exclusion criteria: patients contraindicated for dental treatment due to their medical history; xerostomia patients or who were taking medication that significantly reduced salivary flow; patients with parafunctional habits of bruxism and teeth clenching and / or attrition; patients who did not have teeth antagonist to the element indicated for the restorative procedure; patients with endodontically treated teeth.

Age minimum:
Age maximum:
Gender: -

Health Condition(s) or Problem(s) studied

C07.793.720.210

Clinical conditions of tooth restoration (due dental caries)

Intervention(s)

Procedure/surgery

E06.323.428

After identifying the patient who was in the research (having need for class I restoration), the interproximal radiograph (s) were performed and the day was scheduled to be performed.
For each unit
experimental, a draw was made to
determine which of the four treatments the restoration would undergo.
Each group received one of the following restorative treatments:
Group 1 (control): Conventional three-step adhesive system (Adper ™ Scotchbond ™ Multipurpose Adhesive) + Restoration of nanoparticulate compactable resin (Filtek Z350 XT), with 33 restorations.

Group 2 (test): Conventional three-step adhesive system (Adper ™ Scotchbond ™ Multipurpose Adhesive) + Bulk fill flow resin restoration (Filtek Bulk Fill Flow) as a base + nanoparticulate resin (Filtek Z350 XT) for covering, 28 restorations.
Group 3 (test): Conventional three-step adhesive system (Adper ™ Scotchbond ™ Multipurpose Adhesive) + Regular Bulk Fill Resin Restoration (Filtek One Bulk Fill), 23 restorations.

Group 4 (test): Self-etching adhesive system (Universal Single Bond Adhesive - 3M) + Restoration of nanoparticulate compactable resin (Filtek Z350 XT), being 23 restorations.

Group 5 (test): Self-etching system (Universal Single Bond Adhesive - 3M) + Bulk fill flow resin restoration (Filtek Bulk Fill Flow) as a base + nanoparticulate resin (Filtek Z350 XT) for covering, 22 restorations.

Group 6 (test): Self-etching adhesive system (Universal Single Bond Adhesive - 3M) + Regular Bulk Fill Resin Restoration (Filtek One Bulk Fill), being 26 restorations.
Before starting the actual operative procedures, a draw was made to know which group each sample unit belonged to. If the same participant needed restoration on more than one tooth, the draw was made corres

Primary Outcome(s)

Dentin hypersensitivity and patient satisfaction were the primary outcome. The following criteria were evaluated: surface gloss; surface and margin staining; combination of color and translucency; anatomical form; fracture and retention of material; marginal adaptation; patient satisfaction; postoperative sensitivity; caries recurrence being verified by clinical examination and classified according to the
IDF criteria (2) in: clinically
excellent Very Good); clinically good
(very good after polishing); clinically
satisfactory (no adjustments required);
clinically unsatisfactory (needs to be
repair) and clinically poor or poor
(needs replacements).
To assess the primary hypersensitivity outcome, a visual analogue scale was used, as well as a cold sensitivity test. To assess patient satisfaction, an analog scale was also used. These events, evaluated in baseline.

At baseline there was a statistical difference between group 1 (87.9) and the other groups (p = 0.012) for the superficial staining criterion. There were statistical differences for anatomical shape (p <0.001), and the lowest values ??were for group 1 (72.7) and group 3 (95).

Secondary Outcome(s)

As a secondary outcome, the presence of
secondary caries, postoperative
hypersensitivity and marginal staining were
evaluated after a year of assessment (1),
being the parameters evaluated by clinical
examination and classified according to the criteria of FDI (2) in: clinically excellent (very
good); clinically good (very good after
polishing); clinically satisfactory (no
adjustments); clinically unsatisfactory (needs
repair) and clinically poor or bad
(replacements). The assessment was made
by the difference in percentage of teeth
classified as "clinically excellent" after one
year

Source(s) of Monetary Support

Faculdades Integradas Pitágoras de Montes Claros

Secondary Sponsor(s)

Universidade de Estadual de Montes Claros