Effect of Saliva Substitutes on Dental Hard Tissues in Situ

NCT01165970 | Terminated Phase 2 DMC

• 2 other identifiers: T-01/2008-005451-232008-005451-23
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 2

Brief 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). 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.

Conditions

Hyposalivation

Keywords

enamel; dentin; saliva substitute; demineralization; remineralization

Outcome Measures

Primary Outcomes (1)

• 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.

  15 weeks

Secondary Outcomes (1)

• general and oral well being

  15 weeks

Study Arms (2)

Glandosane

ACTIVE COMPARATOR

After in situ exposition the enamel and dentin samples will demineralize with Glandosane.

Drug: Glandosane

Saliva natura

EXPERIMENTAL

After in situ exposition the enamel and dentin samples will remineralize with Saliva natura

Device: Saliva natura

Interventions

Glandosane DRUG

according to the german law the sued saliva substitute is a drug (Glandosane) whereas Saliva natura is a medical product

Also known as: Glandosane, Cell Pharm, Germany

Glandosane

Saliva natura DEVICE

Saliva substitute without restriction to be used

Also known as: Saliva natura, Medac, Germany

Saliva natura

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (2)

Charite, Berlin, Germany

Berlin, State of Berlin, 14197, Germany

Location

Charité - Universitätsmedizin Berlin

Berlin, State of Berlin, 14197, Germany

Location

Related Publications (1)

• 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.

  PMID: 21477333 DERIVED

Related Links

• please check the science subsite
• 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.

MeSH Terms

Conditions

Xerostomia

Interventions

Glandosane

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Peter Tschoppe, Dr

  Department of Operative Dentistry and Periodontology, School of Dental Medicine, CharitéCentrum 3, Charité - Universitätsmedizin Berlin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: June 30, 2010
• First Posted: July 20, 2010
• Study Start: January 1, 2009
• Primary Completion: March 1, 2012
• Study Completion: December 1, 2012
• Last Updated: November 15, 2011

Record last verified: 2011-11

Locations

DE (2)