HyposalivationPhase 2/3T-01NCT01165970
Effect of Saliva Substitutes on Dental Hard Tissues in Situ
A Phase 2/3 study testing Glandosane and Saliva natura in people with Hyposalivation, run by Charite University, Berlin, Germany at 2 sites in Germany.
Trial summary
Symptomatic hyposalivation is associated not only with Sjögren's syndrome or salivary gland hypofunction in elderly patients, but also with medications containing antimuscarinic drugs, chemo radiotherapy for head and neck carcinomas, and psychiatric disorders (Atkinson \& Ava, 1994, Kielbassa et al., 2006). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyposalivation
- What is being tested?
- Glandosane and Saliva natura
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 2 sitesGermany
- Study dates
- Jan 2009to Dec 2012
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- stimulated salivary flow rate < 0.5 ml/min
- partial denture upper or lower jaw
- radiationtherapy in the head and neck area
- patient age above 18 years
- Signed informed consent (AMG §40 (1) 3b)
Who cannot join
- stimulated salivary flow rate > 0.5 ml/min
- missing partial denture upper or lower jaw
- missing Radiationtherapy in the head and neck area
- paraben allergy
- not signed informed consent (AMG §40 (1) 3b)
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Charite, Berlin, Germany
Berlin, State of Berlin, 14197
Charité - Universitätsmedizin Berlin
Berlin, State of Berlin, 14197
About this study
Official title: Vergleichende, Randomisierte, Kontrollierte Und Doppelblinde In-situ-Studie Zur Wirkung Von Speichelersatzmitteln Auf Schmelz Und Dentin
Symptomatic hyposalivation is associated not only with Sjögren's syndrome or salivary gland hypofunction in elderly patients, but also with medications containing antimuscarinic drugs, chemo radiotherapy for head and neck carcinomas, and psychiatric disorders (Atkinson \& Ava, 1994, Kielbassa et al., 2006).
Human saliva possesses important physiological functions in protecting and moistening the oral hard and soft tissues (Piotrowski et al., 1992, ). Consequently, decreasing salivation causes oral dysfunction and promotes severe oral side effects (reduced antibacterial function, lack of remineralisation, reduced buffer capacity) (Tschoppe et al., 2010a). These have been identified as being responsible for the rapid destruction of the dentition (Willich et al., 1988). Saliva substitutes are frequently applied for relieving the symptoms in patients suffering from hyposalivation (Hahnel et al., 2009, Nieuw Amerongen \& Veerman, 2003, Vissink et al., 2004). Besides the moistening and lubrication of the oral mucosa, these products should also protect dental hard tissues. However, in vitro studies revealed that some marketed products have only a neutral or even a demineralising potential on enamel as well as on dentin (Kielbassa et al., 2001, Meyer-Lueckel et al., 2002, Smith et al., 2001, Tschoppe et al., 2009). Inorganic ions such as calcium, phosphates, and fluorides have been added to saliva substitutes in order to enhance their remineralising property or minimize their demineralising potential (Tschoppe et al., 2009). Furthermore, as most patients suffering from hyposalivation are elderly people, recessions and subsequently exposed dentin surfaces are very common. Since dentin is not as acid resistant as enamel, an earlier and more severe demineralisation can be expected (Saunders \& Meyerowitz, 2005).
Therefore, the current in situ study was performed to assess the effects of a demineralising and a remineralising saliva substitutes on the mineralisation of dental hard tissues. It was hypothesized that storage in Glandosane(cell pharm, Hannover, Germany) would not result in pronounced mineral loss of dentin specimens, and that storage in Saliva natura would not result in enhanced remineralisation when combined with a remineralising artificial saliva (Saliva natura supersaturated with respect to relevant calcium phosphates; medac, Hamburg, Germany) (H0). These null hypotheses were tested against the alternative hypothesis of a difference.
Read the detailed description
see application for the German Federal Institute for Drugs and Medical Devices at Eudra-CT
- Conditions
- Hyposalivation
- Being tested
- Glandosane, Saliva natura
- Keywords
- enamel, dentin, saliva substitute, demineralization, remineralization
- Medical subject headings
- Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlandosaneDrug
Also called Glandosane, Cell Pharm, Germany
according to the german law the sued saliva substitute is a drug (Glandosane) whereas Saliva natura is a medical product
Saliva naturaDevice
Also called Saliva natura, Medac, Germany
Saliva substitute without restriction to be used
| Study group | Role | What they receive |
|---|---|---|
| Glandosane | Active comparator | After in situ exposition the enamel and dentin samples will demineralize with Glandosane. Receives: Drug: Glandosane |
| Saliva natura | Experimental | After in situ exposition the enamel and dentin samples will remineralize with Saliva natura Receives: Device: Saliva natura |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mineral loss and lesion depth of specimens
Evaluation of the mineral loss/lesion depth of the enamel and dentin specimens after in situ exposition evaluated with transversal microradiography. The Unit is the mineral oss as well as lesion depth.
Measured: 15 weeks
Secondary outcomes (1)
general and oral well being
Evaluation of the general and oral well being before and after therapy by questionnaires.
Measured: 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2010 (estimated)
- Study startJan 2009
- Primary completionMar 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyposalivationStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Tschoppe, Charite University, Berlin, Germany
- Investigators
- Peter Tschoppe, Dr, Principal investigator, Department of Operative Dentistry and Periodontology, School of Dental Medicine, CharitéCentrum 3, Charité - Universitätsmedizin Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01165970
- Sponsor's protocol ID
- T-01/2008-005451-23
- Other IDs
- 2008-005451-23, 2008
- Acronym
- T-01
- Status last verified
- Nov 2011
- First submitted
- 30 Jun 2010
- Last updated
- 15 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tschoppe P, Wolf O, Eichhorn M, Martus P, Kielbassa AM. Design of a randomized controlled double-blind crossover clinical trial to assess the effects of saliva substitutes on bovine enamel and dentin in situ. BMC Oral Health. 2011 Apr 9;11:13. doi: 10.1186/1472-6831-11-13.
PubMed 21477333
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vergleichende, Randomisierte, Kontrollierte Und Doppelblinde In-situ-Studie Zur Wirkung Von Speichelersatzmitteln Auf Schmelz Und Dentin
- ClinicalTrials.gov ID
- NCT01165970
- Acronym / sponsor ID
- T-01 / T-01/2008-005451-23
- Conditions
- Hyposalivation
- Keywords
- enamel, dentin, saliva substitute, demineralization, remineralization
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Mar 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 20 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Symptomatic hyposalivation is associated not only with Sjögren's syndrome or salivary gland hypofunction in elderly patients, but also with medications containing antimuscarinic drugs, chemo radiotherapy for head and neck carcinomas, and psychiatric disorders (Atkinson \& Ava, 1994, Kielbassa et al., 2006).
Human saliva possesses important physiological functions in protecting and moistening the oral hard and soft tissues (Piotrowski et al., 1992, ). Consequently, decreasing salivation causes oral dysfunction and promotes severe oral side effects (reduced antibacterial function, lack of remineralisation, reduced buffer capacity) (Tschoppe et al., 2010a). These have been identified as being responsible for the rapid destruction of the dentition (Willich et al., 1988). Saliva substitutes are frequently applied for relieving the symptoms in patients suffering from hyposalivation (Hahnel et al., 2009, Nieuw Amerongen \& Veerman, 2003, Vissink et al., 2004). Besides the moistening and lubrication of the oral mucosa, these products should also protect dental hard tissues. However, in vitro studies revealed that some marketed products have only a neutral or even a demineralising potential on enamel as well as on dentin (Kielbassa et al., 2001, Meyer-Lueckel et al., 2002, Smith et al., 2001, Tschoppe et al., 2009). Inorganic ions such as calcium, phosphates, and fluorides have been added to saliva substitutes in order to enhance their remineralising property or minimize their demineralising potential (Tschoppe et al., 2009). Furthermore, as most patients suffering from hyposalivation are elderly people, recessions and subsequently exposed dentin surfaces are very common. Since dentin is not as acid resistant as enamel, an earlier and more severe demineralisation can be expected (Saunders \& Meyerowitz, 2005).
Therefore, the current in situ study was performed to assess the effects of a demineralising and a remineralising saliva substitutes on the mineralisation of dental hard tissues. It was hypothesized that storage in Glandosane(cell pharm, Hannover, Germany) would not result in pronounced mineral loss of dentin specimens, and that storage in Saliva natura would not result in enhanced remineralisation when combined with a remineralising artificial saliva (Saliva natura supersaturated with respect to relevant calcium phosphates; medac, Hamburg, Germany) (H0). These null hypotheses were tested against the alternative hypothesis of a difference.
Detailed description
see application for the German Federal Institute for Drugs and Medical Devices at Eudra-CT
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glandosane | Active comparator | Drug: GlandosaneAfter in situ exposition the enamel and dentin samples will demineralize with Glandosane. |
| Saliva natura | Experimental | Device: Saliva naturaAfter in situ exposition the enamel and dentin samples will remineralize with Saliva natura |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- stimulated salivary flow rate < 0.5 ml/min
- partial denture upper or lower jaw
- radiationtherapy in the head and neck area
- patient age above 18 years
- Signed informed consent (AMG §40 (1) 3b)
Key exclusion criteria (5 listed)
- stimulated salivary flow rate > 0.5 ml/min
- missing partial denture upper or lower jaw
- missing Radiationtherapy in the head and neck area
- paraben allergy
- not signed informed consent (AMG §40 (1) 3b)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GlandosaneAlso: Glandosane, Cell Pharm, Germanyaccording to the german law the sued saliva substitute is a drug (Glandosane) whereas Saliva natura is a medical product | Drug | Glandosane |
| Saliva naturaAlso: Saliva natura, Medac, GermanySaliva substitute without restriction to be used | Device | Saliva natura |
Primary outcome
Mineral loss and lesion depth of specimens
Time frame: 15 weeks
Evaluation of the mineral loss/lesion depth of the enamel and dentin specimens after in situ exposition evaluated with transversal microradiography. The Unit is the mineral oss as well as lesion depth.
1 secondary outcome
general and oral well being
Time frame: 15 weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2011.
- Derived from this study: PubMed 21477333Tschoppe P, Wolf O, Eichhorn M, Martus P, Kielbassa AM. Design of a randomized controlled double-blind crossover clinical trial to assess the effects of saliva substitutes on bovine enamel and dentin in situ. BMC Oral Health. 2011 Apr 9;11:13. doi: 10.1186/1472-6831-11-13.
- please check the science subsiteLink provided by the sponsor.
- Short review on the main problems in this patient population: Etiologic factors of hyposalivation and consequences for oral health. Quintessence Int. 2010 Apr;41(4):321-33. Review.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Tschoppe, Dr principal investigator
Department of Operative Dentistry and Periodontology, School of Dental Medicine, CharitéCentrum 3, Charité - Universitätsmedizin Berlin
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Glandosane and Saliva natura in people with Hyposalivation, run by Charite University, Berlin, Germany at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mineral loss and lesion depth of specimens (time frame: 15 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01165970, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2011.