Condition category
Oral Health
Date applied
27/08/2008
Date assigned
09/10/2008
Last edited
05/01/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof António Mata

ORCID ID

Contact details

Faculdade de Medicina Dentária
Universidade de Lisboa
Cidade Universitária
Lisboa
1649-003 LX
Portugal
admata2@yahoo.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Effects of gustatory stimulants of salivary secretion on the pH and stimulation of saliva: a two arm parallel single centre randomised controlled trial

Acronym

Study hypothesis

Gustatory stimulants of salivary secretion (GSSS) are sold over the counter in wide number of European countries and used to stimulate salivary secretion. The acidic nature of these lozenges suggests that they may increase the risk for dental erosion. However, clinical studies on this issue are lacking. More recently a new class of these products has been marketed with the claim that its lower acid content and addition of fluoride and xylitol diminishes the risk for dental erosion.

The research questions addressed by this study were to find out if this new class of gustatory stimulants of salivary secretion has comparable efficiency in stimulating salivary secretion and do in fact represent a lower risk for dental erosion. The study hypotheses were:
1. There is a significant difference in the salivary pH variation elicited by the two gustatory stimulants of salivary secretion
2. There is a significant difference in the salivary secretion stimulation capacity elicited by the two gustatory stimulants of salivary secretion

Ethics approval

Ethical Committee at the Higher Institute of Health Sciences Egas Moniz (Instituto Superior de Ciências da Saúde Egas Moniz) approved in October 2006

Study design

Two-arm parallel single centre triple-blind randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Quality of life

Patient information sheet

Condition

Xerostomia

Intervention

Salivary buffering capacity was assessed in all participants at baseline. The participants were randomly allocate to the control and intervention arms in equal numbers (60 in each arm):
1. Intervention arm: Gustatory stimulant of salivary secretion with xylitol and fluoride - one lozenge of Xerodent® (Alpharma, Sweden)
2. Control arm: Traditional, citric acid based gustatory stimulant of salivary secretion - one lozenge of SST® (Sinclair, UK)

Salivary secretion rate and pH changes were recorded at defined time intervals (minute 0, 1, 2, 3, 5, 8, 10, 15 and 20) to determine the efficacy of saliva stimulation and dental erosion potential of these lozenges.

Intervention type

Drug

Phase

Not Applicable

Drug names

Xerodent®, SST®

Primary outcome measures

The following were assessed based on the salivary secretion rate and pH changes recorded at minute 0, 1, 2, 3, 5, 8, 10, 15 and 20 during the interventions (see interventions section):
1. GSSS induced salivary pH variations
2. Time of GSSS induced pH drop below 5.5
3. Absolute risk reduction (ARR) and number needed to treat (NNT), based on the pH variations (see primary outcomes 1 and 2 above)
4. GSSS stimulated salivary flow

Secondary outcome measures

Salivary secretion capacity defined as the difference between mechanically stimulated and basal salivary flow, expressed as ml/min.

Overall trial start date

02/09/2007

Overall trial end date

02/05/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Participants (both males and females) aged over 18 years
2. Students of a Portuguese University through
3. Healthy

Recruitment was supervised by research assistants.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

120

Participant exclusion criteria

1. Presence of systemic pathology
2. Currently taking xerostomic medication

Recruitment start date

02/09/2007

Recruitment end date

02/05/2008

Locations

Countries of recruitment

Portugal

Trial participating centre

Faculdade de Medicina Dentária
Lisboa
1649-003 LX
Portugal

Sponsor information

Organisation

University of Lisbon (Portugal)

Sponsor details

Unidade de Investigação em Ciências Orais e Biomédicas (UICOB)
Faculdade de Medicina Dentária
Universidade de Lisboa
Cidade Universitária
Lisboa
1649-003 LX
Portugal

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

University of Lisbon (Portugal) - Oral and Biomedical Sciences Research Unit (Unidade de Investigação em Ciências Orais e Biomédicas)

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

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19220764

Publication citations

  1. Results

    da Mata AD, da Silva Marques DN, Silveira JM, Marques JR, de Melo Campos Felino ET, Guilherme NF, Effects of gustatory stimulants of salivary secretion on salivary pH and flow: a randomized controlled trial., Oral Dis, 2009, 15, 3, 220-228, doi: 10.1111/j.1601-0825.2009.01513.x.

Additional files

Editorial Notes