Clinical trial NCT03471195: Salivary Cytokine Profile as a Biomarker for Dental Pain
Official title: Salivary Cytokine Profile as Biomarker for Dental Pain in Children With Cerebral Palsy - An Exploratory Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Dental Diseases
Lead sponsor: Riyadh Colleges of Dentistry and Pharmacy
Sponsor class: OTHER
First posted: 2018-03-20
Enrollment: 46
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will comprise of children with cerebral palsy(unable to verbalize pain) who have at least one dental condition that would be considered painful.

The sample will be matched to controls who have similar dental status and can verablize pain

Brief summary: always reliable.Pain is an important diagnostic tool in dentistry. The type of treatment, extent of treatment and, sometimes, even the decision on whether to treat or not is dependent on the pain history obtained from the patient.The absence of an accurate description of dental pain is a factor that severely limits dental treatment planning in children with CP. The aim of this study is to study to evaluate the salivary cytokine profile of children with CP who have severe dental problems and to compare this to verbal children who have a similar dental profile.

Detailed description: The sample with CP will be selected from individuals attending the dental clinics of the Prince Sultan bin Abdulaziz Humanitarian city (SBAHC). The control patients will be selected from the dental clinics of the Riyadh Colleges of Dentistry and Pharmacy and be matched to the CP patients for age, gender and extent of dental problems. The sample will comprise of 20 patients with CP and 20 verbal controls.The oral health of all children will be recorded using WHO examination criteria .The teeth will be examined using WHO category II criteria - clinical examination with lighting and without radiographs.aliva will be collected from the children using the passive drool method and stored in sterile plastics collection tubes. The collected sample will be stored at -600C until they can be analyzed. The cytokine profile of the saliva sample will be analyzed using an ELISA kit for total cytokine profile (Luminex Performance Human Cytokine Panel A, LUH000, R\&D systems) to measure cytokines IL-1 alpha, IL-1 beta, IL-8, and TNF-alpha. The pain perception of the verbal control group will be recorded using the validated Arabic version of the short form of the McGill Pain Questionnaire. The children will also indicate the extent of the pain using the Wong Baker Faces ™ pain perception scale.Normality of the total cytokine levels will be tested using the Shapiro-Wilkes Test. The Mann Whiney U test will be used to compare the cytokine profile the CP and control group. The spearman correlation will be used to explore the relationship between the reported pain and cytokine profile levels. If found to be significant an initial cytokine-pain map will be proposed.

Eligibility criteria: Inclusion Criteria:

* Cerebral Palsy
* At least one tooth with pulpal involvement
* Aged between 8-12 years
* No neurological illness (for Control Group)
* Ability to verbalize pain (for Control Group)
* One dental tooth with pulpal involvement matching the condition of the test group (for Control Group)

Exclusion Criteria:

* confounding neurological disorders
* History of orofacial pain syndromes
* Absence of consent or assent

Primary outcomes:
measure: Salivary Cytokine profile
timeFrame: 0 weeks (baseline)
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: Riyadh Colleges of Dentistry and Pharmacy
Study officials:
affiliation: Riyadh Elm University
name: Hezekiah A Mosadomi, DMD
role: STUDY_CHAIR
References: