Effect of adhesive usage in complete denture wearers

• Register: REBEC
• Last refreshed on: 29 April 2013
• Main ID: RBR-9bwgr9
• Date of registration: 30/11/2012
• Primary sponsor: Universidade Estadual Paulista Júlio de Mesquita Filho - SP, Brazil
• Public title: Effect of adhesive usage in complete denture wearers
• Scientific title: Effect of using an adhesive in conventional complete denture wearers
• Date of first enrolment: 10/08/2011
• Target sample size: 50
• Recruitment status: recruitment completed
• URL: http://www.ensaiosclinicos.gov.br/rg/RBR-9bwgr9/
• Study design: Clinical trial, two sequences, double-blinded (researcher and patient), randomized controlled

Countries of recruitment

Brazil

Contacts

• Name: Ana Pero
• Affiliation: Universidade Estadual Paulista Júlio de Mesquita Filho

• Name: Ana Pero
• Affiliation: Universidade Estadual Paulista Júlio de Mesquita Filho

Key inclusion & exclusion criteria

Inclusion criteria: Adults; mentally agile and responsive; with resilience and alveolar volume normal; absence of dysfunctions in the stomatognathic system and the absence of debilitating systemic changes
Exclusion criteria: Debilitating neurological or systemic diseases and the need for pre-prosthetic surgery

Age minimum: 40Y
Age maximum: 80Y
Gender: -

Health Condition(s) or Problem(s) studied

Edentulous patients, complete denture wearers
E06.780.345.760.290
N04.452.822.360.600

Intervention(s)

Clinical trial on the effects of using a denture adhesive. Two arms, double-blind (researcher and patient), randomized controlled trial. The sample consisted of 50 patients of both genders, 32 women and 18 men, between 40 and 80 years. The patients received new conventional dentures, and after the adjustment period after the installation of those were included or excluded from the study according to the criteria of inclusion and exclusion. The study included 29 patients, randomized into two arms with using the computer program BioEstat. Arm 1 (15 patients) = utilization of the adhesive during the first 15 day trial, followed by not using any kind of adhesive over the next 15 days; Arm 2 (14 patients) = not using any type of adhesive for the first 15 day trial, followed by use of adhesive over the next 15 days. To use the adhesive, the patients were instructed according to the manufacturer's recommendations for use of the product (GlaxoSmithKline Brazil Ltda.) No the use of placebo. After each 15 day period, the biofilm formed on the internal surface of the dentures were stained and quantitated by means of a photographic method using a software. Samples of material from the palatal and the inner surface of the dentures were obtained using a sterile swab. Microbiological material was diluted and plated on a culture medium nonselective. After incubation (48 ° C houors/37ºC), the number of colony forming units (cfu / mL) was calculated. In addition, a questionnaire was applied to assess satisfaction with the dentures and average daily cost of the product will be estimated through mathematical formulas

Primary Outcome(s)

Patients’ satisfaction with denture adhesive evaluated by answering the questionnaire to assess subjectively patients satisfaction with and without use of denture adhesive after each period of assessment

Secondary Outcome(s)

Influence of denture adhesive, evaluated by means of the colony counts of microorganisms collected from palatal mucosa and maxillary denture in new denture wearers

Influence of denture adhesive, evaluated by means of the percentage of biofilm formed on the inner surface of maxillary denture in new denture wearers

Secondary ID(s)

CAAE: 0003.0.199.000-10

Protocolo CEP: 04/10

Source(s) of Monetary Support

Fundação de Amparo a Pesquisa do Estado de São Paulo - São Paulo, SP, Brazil

Universidade Estadual Paulista Júlio de Mesquita Filho - SP, Brazil

Secondary Sponsor(s)

Fundação de Amparo a Pesquisa do Estado de São Paulo - São Paulo, SP, Brazil