Salivary Cytokines as Biomarker for Oral Health

NCT02807519 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 128

Last updated 2021-02-02

No results posted yet for this study

Summary

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.

Conditions

  • Neoplasms

Interventions

GENETIC

collection of salivary cytokines

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.

Sponsors & Collaborators

  • Schulzahnklinik Basel

    collaborator UNKNOWN
  • Volkszahnklinik Basel

    collaborator UNKNOWN
  • University Hospital, Basel, Switzerland

    lead OTHER

Principal Investigators

  • Tamara Diesch, Dr. · University Children's Hospital of Basel

  • Cornelia Filippi, Dr. · University Centre of Dental Medicine Basel

Eligibility

Min Age
4 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2020-08-31
Completion
2021-01-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02807519 on ClinicalTrials.gov