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NCT Number: NCT02807519

Salivary Cytokines as Biomarker for Oral Health

Oral complications during and after cancer treatment are common. A key role in maintaining oral health plays saliva. In the last decade numerous studies have investigated immunological biomarkers such as cytokines in saliva samples. In children, the few studies have investigated salivary cytokines (sCK) suggesting that these are associated with oral health (sCK). One study investigating sCK in adult oncology patients showed an association between Interleukin-6 (IL-6) and severity of oral chronic graft-versus-host disease (GVHD) in survivors of hematopoietic stem cell transplantation. Therefore determination of sCK concentrations may also be helpful for assessment of GVHD activity and other inflammatory processes in cancer patients. In pediatric oncology patients, to the investigators' knowledge, no study has so far investigated sCK concentrations as markers for oral or systemic health.

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Key information

Conditions

Age range

4 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Schulzahlklinik Basel, Basel, Canton of Basel-City, Switzerland

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About this study

Oral complications are common during and after cancer treatment. Oral mucositis typically occurs during or immediately after chemotherapy and may lead to pain, oral and systemic infection, and nutritional compromise. Late effects of oral mucositis as a result of cancer treatment include an increased risk for dental caries, xerostomia and osteonecrosis. It has been recognised, that regular assessment of oral health, prevention and early treatment of oral mucositis decreases early and late complication rates.

Saliva plays a key role in maintaining oral health and reduced salivary flow contributes to acute disorders and long-term sequelae in oral health. Saliva is a complex fluid secreted by the salivary glands and the gingiva. In the last decade numerous studies have investigated immunological biomarkers such as cytokines in saliva samples. These studies included individuals with various oral and systemic diseases including oral cancer, oral caries, autoimmune and endocrine diseases, metabolic syndrome, chronic kidney disease and psychiatric illnesses.

In children, the few studies that have investigated salivary cytokines (sCK) suggest that these are associated with oral health (sCK). For example, one study in 114 healthy adolescent girls aged 11-17 years showed that sCK concentrations were generally not associated with levels in the serum . In addition this study also suggested that the sCK concentrations are age dependent.

However, a number of other studies suggest that sCK may also reflect systemic diseases such as shown in a study including 20 children aged 9-17 with allergies (including asthma, allergic rhinitis and eosinophilic esophagitis) showing that Th-2 cytokines were detectable in sCK.

One study investigating sCK in adult oncology patients showed an association between IL-6 and severity of oral chronic GVHD in survivors of a hematopoietic stem cell transplantation. Therefore determination of sCK concentrations may also be helpful for assessment of GVHD activity and other inflammatory processes in cancer patients. In paediatric oncology patients, to the investigators' knowledge, no study has so far investigated sCK concentrations as markers for oral or systemic health.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children with confirmed haematological/oncological disease and necessity for radio-or chemotherapy
  • Age > 4 and < 18 years.

Exclusion criteria

  • patients, who already were treated with radio- or chemotherapy
  • patients with current or previous (last 7 days) symptoms of a respiratory infection, rhinitis, bronchitis and tonsillitis
  • children with an autoimmune disease
  • Use of systemic antibiotics within the last 2 weeks.
  • Use of antimicrobial mouth rinsing solution within the last 12 hours,
  • any vaccination within the last 48 hours
  • known allergy to paraffin.

Treatment and study plan

collection of salivary cytokines

Genetic

Collection of the saliva will be done following this procedure: The collection will be done prior to any other dental manipulation. The test person is sitting with its head tilted slightly forward. Initially, any saliva present in the mouth must be swallowed or spit out completely. Then, a paraffin gum is given to the test person. This paraffin gum must be chewed for minimally 2 and maximally up to 5 minutes. During the time period that the test person is chewing the paraffin gum, the saliva must be spitted into a cup repeatedly, or the saliva can also be let run passively into the cup. The amount of saliva is then weighted (1g equivalent to 1 ml) and a saliva flow rate (ml/min) is calculated and noted.

Primary outcomes

  1. mucositis (clinical oral finding)

    Time frame: 18 months

    clinical oral finding as mucositis in children with a hematological/oncological disease and healthy control children

  2. salivary cytokine (sCK) levels

    Time frame: 18 months

    salivary cytokine (sCK) levels in children with a hematological/oncological disease and healthy control children

  3. aphthous ulcer (clinical oral finding)

    Time frame: 18 months

    clinical oral finding as aphthous ulcer in children with a hematological/oncological disease and healthy control children

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • Schulzahnklinik Basel
  • Volkszahnklinik Basel

Registry information

Official study title

Salivary Cytokines in Paediatric Oncology Patients and Healthy Persons - A Pilot Study to Investigation of Biomarkers for Oral Health

Acronym: Cytosal

Important dates

Study start
2016
Primary completion
2020
Study completion
2021
First posted
Jun 21, 2016
Registry last updated
Feb 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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