Condition category
Musculoskeletal Diseases
Date applied
03/01/2010
Date assigned
16/03/2010
Last edited
16/03/2010
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 Antonio Mata

ORCID ID

Contact details

Grupo de Investigação em Biologia e Bioquímica Oral
Faculdade de Medicina Dentária da Universidade de Lisboa
Cidade Universitária
Lisbon
1649-003
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 of Sjögren’s syndrome patients: 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.

The rationale for this study being to find out if the use of the Dentaid GSSS increases salivary secretion and is safer regarding dental erosion.

The study hypotheses are:
1.There is a significant difference in the salivary pH variation elicited by the new GSSS in patients with Sjögren’s syndrome
2.There is a significant difference in the stimulation of whole saliva secretion capacity elicited by the new GSSS with patients with Sjögren’s syndrome

Ethics approval

Ethical Committee at the Faculty of Dentistry of the University of Lisbon and the Portuguese Institute for Rheumathological Diseases approved in December 2009

Study design

Two-arm parallel single centre triple-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

Primary Sjögren's syndrome

Intervention

Salivary buffering capacity will be assessed in all participants at baseline. The participants will randomly be allocated to the control and intervention arms in equal numbers (40 in each arm):
1. Intervention arm: New Gustatory stimulant of salivary secretion - one lozenge of Dentaid® (Dentaid, Spain)
2. Control arm: Traditional, citric acid based gustatory stimulant of salivary secretion - one lozenge of SST® (Sinclair, UK)

Salivary secretion rate and pH changes will be 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

Dentaid®, SST®

Primary outcome measures

Time of GSSS induced pH drop below 5.5 expressed in minutes as the mean ± 95% confidence interval. In order to better quantify risk differences of GSSS induced pH drop below 5.5 a contingency table compiling the counts of subjects with pH drops below 5.5 for over one minute will be obtained. Additional analyses will be done to calculate association measures like the absolute risk reduction (ARR) and number needed to treat (NNT).

Secondary outcome measures

1. GSSS induced salivary pH variations expressed as the mean ± 95% confidence interval of the three pH measures obtained from salivary samples at defined time points
2. GSSS stimulated salivary flow expressed in ml/min as the mean ± 95% confidence interval of stimulated salivary flow obtained at different time points
3. Overall stimulated salivary flow will also be calculated and expressed in ml/min as the mean ± 95% confidence interval of the total volume of stimulated saliva divided by the total time of each experiment which will be 20 minutes
4. Salivary stimulation output defined as the difference between GSSS and basal salivary flow, expressed as ml/min

Overall trial start date

07/01/2010

Overall trial end date

07/10/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Participants (both males and females) above 18 years
2. Suffering from primary Sjögren's syndrome
3. An unstimulated whole saliva flow less than 0.1 mL/min, and a stimulated whole saliva flow greater than 0.2 mL/min

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

80

Participant exclusion criteria

1. Currently taking xerostomic medication
2. Pregnant

Recruitment start date

07/01/2010

Recruitment end date

07/10/2010

Locations

Countries of recruitment

Portugal

Trial participating centre

Grupo de Investigação em Biologia e Bioquímica Oral
Lisbon
1649-003
Portugal

Sponsor information

Organisation

Dentaid, S.L. (Spain)

Sponsor details

Oficinas centrales
Ronda Can Fatjó
10
Parc Tecnologic Del Valles
Cerdanyola
Barcelona
08290
Spain
dentaid@dentaid.es

Sponsor type

Industry

Website

http://www.dentaid.com/

Funders

Funder type

Industry

Funder name

Dentaid, S.L. (Spain)

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