Condition category
Oral Health
Date applied
20/08/2014
Date assigned
29/09/2014
Last edited
29/09/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Hard direct autopolymerizing reliners (a type of material used to make dentures) are often used to re-establish the fit and improve the stability and retention of complete dentures. One of the main problems in use of acrylic resins is that there are chances that microorganisms (germs) can attach themselves on it due to its rough surface. Therefore, an effective method of cleaning dentures is necessary as these germs can cause infection. Dentures can be cleaned mechanically, chemically, or by a combination of the two. Mechanical procedures include brushing with soap or an abrasive paste and water and are the most used method among elderly patients. The use of chemical cleansers is usually associated with mechanical methods. They have not been seen to consistently reduce the accumulation of germs. Surface roughness is an important factor. A rough surface may contain a number of irregularities that serve as starting points for attachment and provide a place where microorganisms are protected from mechanical forces. During clinical use, the surface roughness of the denture can be modified by continued use of cleansing procedures. Previous studies have reported the effect of surface roughness and accumulation of germs (biofilm formation) on acrylic resin after continuous exposure to chemical disinfection agents. However, no clinical study has compared the effects of these agents in reducing biofilm formation when associated with brushing on chairside hard reline material. The aim of this study was to evaluate the effect of disinfection with sodium perborate or chlorhexidine combined with brushing on the removal of biofilm on relined dentures.

Who can participate?
Patients, aged 50-75, whose dentures need relining.

What does the study involve?
All patients underwent reline and polish of the denture. A biological sample was taken from the denture after 48 hours to check the initial level of microorganisms present. The patients were randomly divided into three groups based on the cleaning method used: the control group brushed with coconut soap and a soft toothbrush; the perborate group brushed and disinfected with warmed sodium perborate solution for 5 minutes once a day for 6 months; and the chlorhexidine group brushed and disinfected with 2% chlorhexidine digluconate for 5 minutes once a day for 6 months. The subjects were told to brush their dentures three times a day. Biofilm formation was analysed and compared in the three groups.

What are the possible benefits and risks of participating?
The material used to reline the dentures is internationally recognized as one of the most suitable for this procedure. In addition, patients will have their dentures again fitted to the support tissues. The advantages are comfort and preservation of tissues and surrounding bone. Moreover, the disinfection solutions and toothbrushes were provided to all patients during the 6 months follow-up. There were no risks to the patients.

Where is the study run from?
School of Dentistry of Araraquara, São Paulo State University (UNESP) (Brazil).

When is the study starting and how long is it expected to run for?
March 2011 to March 2012 with 6 months follow up

Who is funding the study?
1. São Paulo Research Foundation (FAPESP), Brazil
2. Coordination for the Improvement of Higher Level or Education Personnel (CAPES), Brazil

Who is the main contact?
Dr Eunice Giampaolo
eunice@foar.unesp.br

Trial website

Contact information

Type

Scientific

Primary contact

Dr Eunice Giampaolo

ORCID ID

Contact details

Rua Humaitá
1680 - Centro
Departamento de Materiais Odontológicos e Prótese - 4 andar
Araraquara
14801-903
Brazil

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

U1111-1160-1207

Study information

Scientific title

Effectiveness of chemical disinfection on biofilm of relined dentures: a randomized clinical trial

Acronym

Study hypothesis

The aim of this randomized clinical study was to evaluate the effect of disinfection with sodium perborate or chlorhexidine combined with brushing on the removal of biofilm on relined dentures during different time intervals.

Ethics approval

Ethics Committee of the Araraquara Dental School, UNESP – Univ. Estadual Paulista (number 60/2009). UTN: U1111-1160-1207

Study design

Double-blind randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Maxillary denture relining

Intervention

The patients were randomly divided into three groups (n = 15); allocation was concealed with the use of the BioStat program. The dentures were cleansed according to three methods: CG (control group) – brushing with coconut soap and soft toothbrush; PG (perborate group) – brushing according to previous methods and disinfection with warmed sodium perborate solution (Corega Tabs – GlaxoSmithKline Brasil Ltda, Rio de Janeiro – RJ, Brazil) for 5 minutes, according manufacturer’s instructions once a day for 6 months; and ChxG (chlorhexidine group) – brushing according to CG and disinfection with 2% chlorhexidine digluconate (Arte &Ciência, Farmácia de Manipulação, Araraquara – SP, Brazil) for 5 minutes once a day for 6 months.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Microbial growth for each type of denture 48 hours after the reline procedure. Swabs were collected 48 hours after the reline procedure (day 0) and at the follow-up time intervals of 7, 15, 30, 90, and 180 days.
2. The surface roughness (Ra-μm) of each denture as measured using a profilometer with a resolution of 0.01 μm, an interval (cut-off length) of 0.8 mm, a transverse length of 2.4 mm, a stylus speed of 0.5 mm s-1, and a diamond stylus tip radius of 5 μm. One operator recorded all measurements, taken immediately after the relining and after 7, 15, 30, 90, and 180 days of treatment.

Secondary outcome measures

N/A

Overall trial start date

10/03/2011

Overall trial end date

10/03/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age between 50 to 75 years
2. Have attended the School of Dentistry of Araraquara/UNESP
3. Healthy with good manual dexterity whose maxillary dentures required relining

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

45

Participant exclusion criteria

Presence of oral or systemic diseases

Recruitment start date

10/03/2011

Recruitment end date

10/03/2012

Locations

Countries of recruitment

Brazil

Trial participating centre

Rua Humaitá, 1680 - Centro
Araraquara
14801-903
Brazil

Sponsor information

Organisation

São Paulo State University (UNESP) (Brazil)

Sponsor details

c/o Dr Eduardo Moffa
Rua Humaitá
1680
- Centro
Departamento de Materiais Odontológicos e Prótese - 4 Andar
Araraquara
14801-903
Brazil

Sponsor type

University/education

Website

Funders

Funder type

Other

Funder name

FAPESP – São Paulo Research Foundation (Grant 2010/009167) (Brazil)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

CAPES – Coordination for the Improvement of Higher Level or Education Personnel (Brazil)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes