Effectiveness of denture adhesives in chewing of complete denture wearers

• Register: REBEC
• Last refreshed on: 29 April 2013
• Main ID: RBR-5qrt8h
• Date of registration: 08/05/2012
• Primary sponsor: Universidade Estadual Paulista - UNESP - Araraquara, SP, Brazil
• Public title: Effectiveness of denture adhesives in chewing of complete denture wearers
• Scientific title: Effectiveness of denture adhesives on the kinesiographic records and satisfaction of complete denture wearers
• Date of first enrolment: 10/01/2012
• Target sample size: 50
• Recruitment status: recruiting
• URL: http://www.ensaiosclinicos.gov.br/rg/RBR-5qrt8h/
• Study design: Therapeutic, cross-over, with 2 arms, triple-blinded, randomized clinical trial.

Countries of recruitment

Brazil

Contacts

• Name: Marco Compagnoni
• Affiliation: UNESPUniv Estadual Paulista

• Name: Marco Compagnoni
• Affiliation: UNESPUniv Estadual Paulista

Key inclusion & exclusion criteria

Inclusion criteria: Adults;
Mentally agile and responsive;
Resilience and alveolar volume normal; Absence of dysfunctions in the stomatognathic system;
Absence of debilitating systemic changes.
Exclusion criteria: Debilitating neurological or systemic diseases;
Cardiac pacemaker;
Need for pre-prosthetic surgery.

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

Health Condition(s) or Problem(s) studied

Edentulous patients, complete denture wearers, edentulous arch
C05.500.480

Intervention(s)

Patients will receive new conventional dentures, and after the adjustment period after the insertion of dentures, the sample (n = 50) will be divided in two protocols, and, in sequential and alternating periods of 15 days will be assigned to two types of protocol proposed: protocol 1- denture adhesive application during the first 15 days, followed by the absence of denture adhesive over the next 15 days; protocol 2-absence of denture adhesive during the first 15 days, followed by application of denture adhesive over the next 15 days.

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)

Retention of the denture adhesive on the kinesiographic records(three-dimensional motion of the jaw during chewing and movement of dentures during mastication) in new denture wearers.

Secondary ID(s)

003.0.199.000-10

04/10

Source(s) of Monetary Support

Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP) - São Paulo, SP, Brazil

Secondary Sponsor(s)

Universidade Estadual Paulista - UNESP - Araraquara, SP, Brazil