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ORA-FEBRIS
Sponsor study identifier
observational
94
1 country
1
Study Start
December 2015
Actual (reported)Primary Completion
December 31, 2020
Actual (reported)Study Completion
January 2021
Actual (reported)Febrile neutropenia (FN) is a clinically important adverse effect of myelosuppressive chemotherapy. If patients present with FN, attention is focussed on well-recognized sites of origin of infection: the airways, urinary tracts, and skin. However, infections can be only documented clinically in about two-third of febrile episodes, whereas a causative microbial pathogen cannot be identified in the majority (\>70%) of cases. Pre-treatment oral evaluation aimed to identify and eliminate oral/dental foci is only routinely used in patients at high risk for oral complications (i.e. head and neck cancer patients and stem cell transplantation recipients). However, any patient treated with myelosuppressive chemotherapy, be it for cure or palliation, is at risk of developing infection in and/or originating from the oral cavity. Nevertheless, in these patients dental screening is somewhat randomly employed at the oncologist's discretion. More insight into the pre-treatment oral condition and its potential role in FN is mandatory, particularly considering the growing numbers of older patients retaining their natural dentition and the increase of dental diseases and cancer incidence with age. In addition, oral diseases may aggravate chemotherapy-induced oral mucositis (OM). OM is associated with an inflammatory response, which together with ulcerations providing a portal of entry for bacteria, can result in FN and systemic inflammatory syndrome (SIRS) and/or sepsis. Evidence suggests that microorganisms are involved in the pathobiology of OM, but no longitudinal studies using open-end sequencing are available. Furthermore, comparing bacteria identified in blood cultures in febrile patients with those of the oral cavity will expand the knowledge on the role of the oral cavity as a potential source of bacteremia. The investigators expect that the results will provide a scientific base for subsequent intervention studies on the efficacy of dental screening and elimination of foci, and other interventions aimed at modifying the oral environment before and during chemotherapy.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2021
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2015
Actual (reported)February 22, 2016
Actual (reported)March 8, 2016
Actual (reported)December 31, 2020
Actual (reported)January 2021
Actual (reported)Dutch Periodontal Screening Index
Score Clinical criteria for the score per sextant (note site per sextant with the highest score) 0 No pockets \>3mm in depth, no calculus, no overhanging restorations and no bleeding on probing to the bottom of the pocket 1. No pockets \>3mm in depth, no calculus, no overhangs of restorations, but presence of bleeding on probing to the bottom of the pocket 2. No pockets \>3mm in depth, presence of bleeding on probing to the bottom of the pocket, and presence of calculus or overhanging restorations 3. Presence of pathological pockets of 4-5mm without gingival recession 4. Presence of pathological pockets of 4-5mm with gingival recession 5. Presence of pathological pockets of 6mm or more. Ref: Van der Velden U, (2009) J Clin Periodontol. 2009 Dec;36(12):1018-24. doi: 10.1111/j.1600-051X.2009.01495.x. The Dutch periodontal screening index validation and its application in The Netherlands.
1 day
Caries-screening
1. no caries 2. caries in enamel 3. caries \<50% in dentin 4. caries \>50% in dentin 5. caries in rootcanal
1 day
Adult patients treated with myelosuppressive chemotherapy with a 10-20% estimated risk to develop febrile neutropenia.
Academic Medical Center
Amsterdam, North Holland, 1105 AZ, Netherlands
Oral rinsing samples Saliva samples
L. Smeele, Professor, MD
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
94 participants (actual enrollment reported by the registry).
First Submitted
February 22, 2016
First Posted
March 8, 2016
Study Start
December 2015
Actual (reported)Impacted (wisdom) teeth
1. not impacted 2. partially impacted 3. impacted
1 day
Plaque index in percentages
The plaque index is calculated via the amount of plaque on the mesiobuccal+buccal+distobuccal+mesiopalatinal or mesiolingual+palatinal or lingual+distopalatinal or distolingual of every tooth, given in percentages.
1 day
Radiographically (X-OPT) calculated bone loss in millimeters
Bone loss is measured on a X-OPT and the average bone loss is noted in millimeters.
1 day
Peri-apical radiolucency
Peri-apical radiolucency is diagnosed on a X-OPT or intraoral radiograph and will be noted as 1. yes 2. no
1 day
Radix relicta
The presence of radix relicta is noted as 1. yes 2. no
1 day
NCI CTCAE V3.0 mucositis/stomatitis
100 days
Contact the study team to confirm eligibility.
Primary Completion
December 31, 2020
Actual (reported)Study Completion
January 2021
Actual (reported)Last Updated
November 29, 2021
Record last verified: 2021-11
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Source: ClinicalTrials.gov.
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