Cerebral PalsyNCT03471195
Salivary Cytokine Profile as a Biomarker for Dental Pain
An observational study of Cerebral Palsy and Dental Diseases, run by Riyadh Colleges of Dentistry and Pharmacy at 1 site in Saudi Arabia.
Trial 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… Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy, Dental Diseases
- What is being tested?
- Total Salivary Cytokine profile
- How many people
- 46 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Jan 2018to 1 Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
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
Who may be able to join
- 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)
Who cannot join
- confounding neurological disorders
- History of orofacial pain syndromes
- Absence of consent or assent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Salivary Cytokine Profile as Biomarker for Dental Pain in Children With Cerebral Palsy - An Exploratory Study
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.
Read the 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.
- Conditions
- Cerebral Palsy, Dental Diseases
- Being tested
- Total Salivary Cytokine profile
- Medical subject headings
- Cerebral Palsy, Stomatognathic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Salivary Cytokine profileDiagnostic test
Also called cytokine profile
Saliva will be collected using the passive drool technique and stored in a deep freezerat-60C.
| Study group | Role | What they receive |
|---|---|---|
| CP | A total of 20 children with cerebral palsy and dental decay will undergothe following Collection of Saliva Total Salivary Cytokine Profile Receives: Diagnostic Test: Total Salivary Cytokine profile | |
| Control | A total of 20 verbal children without cerebral palsy matched for age and extent of dental decay will undergo the following Collection of Saliva Total Salivary Cytokine Profile Receives: Diagnostic Test: Total Salivary Cytokine profile |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary Cytokine profile
Salivary IL1alpha in mcg, Salivary IL1beta in mcg, Salivary IL6 in mcg, IL8 in mc , Salivary TNFalpha in mcg
Measured: 0 weeks (baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2018
- Study start1 Jan 2018
- Primary completion1 Jun 2018
- Study completion1 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riyadh Colleges of Dentistry and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Sharat Pani, Riyadh Colleges of Dentistry and Pharmacy
- Investigators
- Hezekiah A Mosadomi, DMD, Study chair, Riyadh Elm University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03471195
- Sponsor's protocol ID
- FPGRP/43635002/175
- Status last verified
- Jul 2018
- First submitted
- 4 Mar 2018
- Last updated
- 23 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Salivary Cytokine Profile as Biomarker for Dental Pain in Children With Cerebral Palsy - An Exploratory Study
- ClinicalTrials.gov ID
- NCT03471195
- Acronym / sponsor ID
- FPGRP/43635002/175
- Conditions
- Cerebral Palsy, Dental Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Riyadh Colleges of Dentistry and PharmacyUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 20 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CP | – | Diagnostic Test: Total Salivary Cytokine profileA total of 20 children with cerebral palsy and dental decay will undergothe following Collection of Saliva Total Salivary Cytokine Profile |
| Control | – | Diagnostic Test: Total Salivary Cytokine profileA total of 20 verbal children without cerebral palsy matched for age and extent of dental decay will undergo the following Collection of Saliva Total Salivary Cytokine Profile |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (3 listed)
- confounding neurological disorders
- History of orofacial pain syndromes
- Absence of consent or assent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total Salivary Cytokine profileAlso: cytokine profileSaliva will be collected using the passive drool technique and stored in a deep freezerat-60C. | Diagnostic test | CP, Control |
Primary outcome
Salivary Cytokine profile
Time frame: 0 weeks (baseline)
Salivary IL1alpha in mcg, Salivary IL1beta in mcg, Salivary IL6 in mcg, IL8 in mc , Salivary TNFalpha in mcg
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hezekiah A Mosadomi, DMD study chair
Riyadh Elm University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy and Dental Diseases, run by Riyadh Colleges of Dentistry and Pharmacy at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Salivary Cytokine profile (time frame: 0 weeks (baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2018.