Assessment of Oral Health Status of Patients in Pediatric Intensive Care UnitsPICUNCT05656950
Assessment of Oral Health Status of Patients in Pediatric Intensive Care Units
An observational study of Assessment of Oral Health Status of Patients in Pediatric Intensive Care Units, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial summary
The research is a descriptive study designed to evaluate the oral health status of hospitalized children in pediatric intensive care units. The research was conducted between June 2021 and September 2021 in pediatric intensive care units in Izmir province. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Assessment of Oral Health Status of Patients in Pediatric Intensive Care Units
- What is being tested?
- Assessment
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 88 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jun 2021to 15 Sep 2021
- 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 Up to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Under 18 years old patients who are therapy in PICU
Who may be able to join
- Being treated in the PICU
- Parent's consent to participate in the study
Who cannot join
- Applying non-invasive ventilation therapy
Trial locations and contacts
1 site in 1 country.
About this study
The research is a descriptive study designed to evaluate the oral health status of hospitalized children in pediatric intensive care units. The research was conducted between June 2021 and September 2021 in pediatric intensive care units in Izmir province. The patients were included in the study by using the cluster sampling method in the selection of the sample (n=88). Patient Identification Information Form and Oral Assessment Guide (OAG) were used for oral health assessment of patients. It was taken written consents from the hospitals where the research was carried out and from the relatives of the patients
- Being tested
- Assessment
- Keywords
- Pediatric intensive care unit, Oral health, Oral care, Oral health assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AssessmentProcedure or surgery
Oral health of the patient was evaluated by the researcher using a flashlight, tongue depressor and Oral Evaluation Guide.
| Study group | Role | What they receive |
|---|---|---|
| Observed | Oral health of the patient was evaluated by the researcher using a flashlight, tongue depressor and Oral Evaluation Guide. Patient's age, gender, day of hospitalization in pediatric intensive care units, medical diagnosis/diagnoses, presence of chronic disease, state of consciousness, body temperature, oral care application method, oral care application frequency, oral care product used, amount taken/extracted, drugs used, albumin and haemoglobin data on values were obtained from the observation form of the patient. Receives: Procedure: Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing oral status of children in pediatric intensive care unit
Oral health of the patient was evaluated using a flashlight and tongue depressor
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start20 Jun 2021
- Primary completion30 Aug 2021
- Study completion15 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (53)Papers the sponsor has linked to this study.
- Other trials for Assessment of Oral Health Status of Patients in Pediatric Intensive Care UnitsStudies of the same condition, open and under way.
- More trials run by Sakarya UniversityThe sponsor's other registered studies.
- 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Collaborators
- Ege University
- Responsible party
- Principal investigator, RAMAZANBOZKURT, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05656950
- Sponsor's protocol ID
- oral assessment pediatric
- Acronym
- PICU
- Status last verified
- Dec 2022
- First submitted
- 10 Dec 2022
- Last updated
- 19 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Akkaş, I., Toptaş, O., ve Özan, F. (2014). Ağız kuruluğu. Acta Odontol Turc, 31(1), 54-60.
Barbosa de Castro Piau CG, Azevedo TD, de Castro Piau AG, Miranda AF, Pinheiro JA, Bezerra AC. Oral Microbial Colonization in Pediatric Intensive Care Unit Patients. J Dent Child (Chic). 2016;83(2):53-9.
PubMed 27620514Labeau SO, Blot SI. Toothbrushing for preventing ventilator-associated pneumonia. Crit Care. 2013 Mar 5;17(2):417. doi: 10.1186/cc12511. No abstract available.
PubMed 23462424Maeda K, Akagi J. Oral care may reduce pneumonia in the tube-fed elderly: a preliminary study. Dysphagia. 2014 Oct;29(5):616-21. doi: 10.1007/s00455-014-9553-6. Epub 2014 Jul 18.
PubMed 25034303Nederfors T. Xerostomia and hyposalivation. Adv Dent Res. 2000 Dec;14:48-56. doi: 10.1177/08959374000140010701.
PubMed 11842923Hocherman S, Yirmiya R. Neuronal activity in the medial geniculate nucleus and in the auditory cortex of the rhesus monkey reflects signal anticipation. Brain. 1990 Dec;113 ( Pt 6):1707-20. doi: 10.1093/brain/113.6.1707.
PubMed 2276042Walls AW, Steele JG. The relationship between oral health and nutrition in older people. Mech Ageing Dev. 2004 Dec;125(12):853-7. doi: 10.1016/j.mad.2004.07.011.
PubMed 15563930Abidia RF. Oral care in the intensive care unit: a review. J Contemp Dent Pract. 2007 Jan 1;8(1):76-82.
PubMed 17211508Ames NJ, Sulima P, Yates JM, McCullagh L, Gollins SL, Soeken K, Wallen GR. Effects of systematic oral care in critically ill patients: a multicenter study. Am J Crit Care. 2011 Sep;20(5):e103-14. doi: 10.4037/ajcc2011359.
PubMed 21885453Berry AM, Davidson PM. Beyond comfort: oral hygiene as a critical nursing activity in the intensive care unit. Intensive Crit Care Nurs. 2006 Dec;22(6):318-28. doi: 10.1016/j.iccn.2006.04.003. Epub 2006 Jun 27.
PubMed 16806933Berry AM, Davidson PM, Nicholson L, Pasqualotto C, Rolls K. Consensus based clinical guideline for oral hygiene in the critically ill. Intensive Crit Care Nurs. 2011 Aug;27(4):180-5. doi: 10.1016/j.iccn.2011.04.005.
PubMed 21684164Celik GG, Eser I. Examination of intensive care unit patients' oral health. Int J Nurs Pract. 2017 Dec;23(6). doi: 10.1111/ijn.12592. Epub 2017 Sep 28.
PubMed 28960619Chang I, Schibler A. Ventilator Associated Pneumonia in Children. Paediatr Respir Rev. 2016 Sep;20:10-16. doi: 10.1016/j.prrv.2015.09.005. Epub 2015 Sep 25.
PubMed 26527358Cheng KK. Children's acceptance and tolerance of chlorhexidine and benzydamine oral rinses in the treatment of chemotherapy-induced oropharyngeal mucositis. Eur J Oncol Nurs. 2004 Dec;8(4):341-9. doi: 10.1016/j.ejon.2004.04.002.
PubMed 15550364Çiftcioğlu, Ş., ve Efe, E. (2017). Validity and reliability of the oral assessment guide for children and young people receiving chemotherapy. Turk Onkoloji Dergisi, 32(4), 133-140. https://doi.org/10.5505/tjo.2017.1671
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Oral Health Status of Patients in Pediatric Intensive Care Units
- ClinicalTrials.gov ID
- NCT05656950
- Acronym / sponsor ID
- PICU / oral assessment pediatric
- Keywords
- Pediatric intensive care unit, Oral health, Oral care, Oral health assessment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Collaborators
- Ege University
- Study start
- 20 Jun 2021 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 15 Sep 2021 (actual)
- First posted
- 19 Dec 2022 (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.
The research is a descriptive study designed to evaluate the oral health status of hospitalized children in pediatric intensive care units. The research was conducted between June 2021 and September 2021 in pediatric intensive care units in Izmir province. The patients were included in the study by using the cluster sampling method in the selection of the sample (n=88). Patient Identification Information Form and Oral Assessment Guide (OAG) were used for oral health assessment of patients. It was taken written consents from the hospitals where the research was carried out and from the relatives of the patients
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observed | – | Procedure: AssessmentOral health of the patient was evaluated by the researcher using a flashlight, tongue depressor and Oral Evaluation Guide. Patient's age, gender, day of hospitalization in pediatric intensive care units, medical diagnosis/diagnoses, presence of chronic disease, state of consciousness, body temperature, oral care application method, oral care application frequency, oral care product used, amount taken/extracted, drugs used, albumin and haemoglobin data on values were obtained from the observation form of the patient. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Under 18 years old patients who are therapy in PICU
Key inclusion criteria (2 listed)
- Being treated in the PICU
- Parent's consent to participate in the study
Key exclusion criteria (1 listed)
- Applying non-invasive ventilation therapy
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 |
|---|---|---|
| AssessmentOral health of the patient was evaluated by the researcher using a flashlight, tongue depressor and Oral Evaluation Guide. | Procedure or surgery | Observed |
Primary outcome
Assessing oral status of children in pediatric intensive care unit
Time frame: 3 months
Oral health of the patient was evaluated using a flashlight and tongue depressor
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 19 Dec 2022.
- BackgroundAkkaş, I., Toptaş, O., ve Özan, F. (2014). Ağız kuruluğu. Acta Odontol Turc, 31(1), 54-60.
- Background: PubMed 27620514Barbosa de Castro Piau CG, Azevedo TD, de Castro Piau AG, Miranda AF, Pinheiro JA, Bezerra AC. Oral Microbial Colonization in Pediatric Intensive Care Unit Patients. J Dent Child (Chic). 2016;83(2):53-9.
- Background: PubMed 23462424Labeau SO, Blot SI. Toothbrushing for preventing ventilator-associated pneumonia. Crit Care. 2013 Mar 5;17(2):417. doi: 10.1186/cc12511. No abstract available.
- Background: PubMed 25034303Maeda K, Akagi J. Oral care may reduce pneumonia in the tube-fed elderly: a preliminary study. Dysphagia. 2014 Oct;29(5):616-21. doi: 10.1007/s00455-014-9553-6. Epub 2014 Jul 18.
- Background: PubMed 11842923Nederfors T. Xerostomia and hyposalivation. Adv Dent Res. 2000 Dec;14:48-56. doi: 10.1177/08959374000140010701.
- Background: PubMed 2276042Hocherman S, Yirmiya R. Neuronal activity in the medial geniculate nucleus and in the auditory cortex of the rhesus monkey reflects signal anticipation. Brain. 1990 Dec;113 ( Pt 6):1707-20. doi: 10.1093/brain/113.6.1707.
- Background: PubMed 15563930Walls AW, Steele JG. The relationship between oral health and nutrition in older people. Mech Ageing Dev. 2004 Dec;125(12):853-7. doi: 10.1016/j.mad.2004.07.011.
- Results publication: PubMed 17211508Abidia RF. Oral care in the intensive care unit: a review. J Contemp Dent Pract. 2007 Jan 1;8(1):76-82.
- Results publication: PubMed 21885453Ames NJ, Sulima P, Yates JM, McCullagh L, Gollins SL, Soeken K, Wallen GR. Effects of systematic oral care in critically ill patients: a multicenter study. Am J Crit Care. 2011 Sep;20(5):e103-14. doi: 10.4037/ajcc2011359.
- Results publication: PubMed 16806933Berry AM, Davidson PM. Beyond comfort: oral hygiene as a critical nursing activity in the intensive care unit. Intensive Crit Care Nurs. 2006 Dec;22(6):318-28. doi: 10.1016/j.iccn.2006.04.003. Epub 2006 Jun 27.
- Results publication: PubMed 21684164Berry AM, Davidson PM, Nicholson L, Pasqualotto C, Rolls K. Consensus based clinical guideline for oral hygiene in the critically ill. Intensive Crit Care Nurs. 2011 Aug;27(4):180-5. doi: 10.1016/j.iccn.2011.04.005.
- Results publication: PubMed 28960619Celik GG, Eser I. Examination of intensive care unit patients' oral health. Int J Nurs Pract. 2017 Dec;23(6). doi: 10.1111/ijn.12592. Epub 2017 Sep 28.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Assessment of Oral Health Status of Patients in Pediatric Intensive Care Units, run by Sakarya University at 1 site in Turkey (Türkiye).
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 2 inclusion and 1 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 19 Dec 2022. 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 Turkey (Türkiye). 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?
Assessing oral status of children in pediatric intensive care unit (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05656950, which also lists 53 linked publications.
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 19 Dec 2022.