Mucositis OralNCT05224882
Chemotherapy Oral Manifestations and Dental Awareness Among Parents
An observational study of Mucositis Oral and Chemotherapy Effect, run by Cairo University.
Trial summary
The prevention of oral illnesses in children and adolescents undergoing oncological treatment is critical, because oral lesions caused by this therapy significantly exacerbate the clinical condition and increase the risk of infection, as well as making it harder to perform required dental procedures when needed . Read more about this study
- Who is it for?
- Ages 1 year to 14 years
- Conditions the study is for
- Mucositis Oral, Chemotherapy Effect
- How many people
- 441 participants
- Where
- No sites listed yet
- Study dates
- 12 Aug 2023to 25 Jan 2024
- 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 1 year to 14 years
- All sexes
- No healthy volunteers
- Child
Study population: The study will be carried out at the pediatric clinic of the National Cancer Institute ,Egypt. Pediatric patients and their parents at the pediatric clinic will be screened until the target population is achieved. The pediatric patients will be subjected to thorough examination. Once the patient and the parent are potentially eligible for this study, the principal investigator will explain the study and ascertain the patient's and the parents' interest. The legal guardian provides written informed consent for participation in the study.
Who may be able to join
- Children between the age of 1 -14years.
- Children receiving chemotherapy for hematological cancer or solid tumors.
- Parents who are able to understand the aim of the study and willing to participate in the study.
Who cannot join
- Children previously received radiotherapy on head and neck region.
- Children suffering from oral cancer.
- Children presented with other oral disorders such as leukoplakia.
Trial locations and contacts
No sites are listed yet.
Yasmin Yousry, PHD contact
About this study
Official title: Oral Manifestations Of Pediatric Cancer Patients Receiving Chemotherapy And Dental Awareness Among Parents
The prevention of oral illnesses in children and adolescents undergoing oncological treatment is critical, because oral lesions caused by this therapy significantly exacerbate the clinical condition and increase the risk of infection, as well as making it harder to perform required dental procedures when needed .
"The key to success in maintaining a healthy oral cavity during therapy is patient compliance. The child and the parents should be educated regarding the possible acute side effects." Pediatric cancer patients may have a lower quality of life if they have poor dental health. Preventing and treating pre-existing oral illnesses is critical to reduce problems in these people.
Read more
It is critical to raise awareness of the benefits of proper oral health so that this understanding becomes a positive attitude, reducing the discomfort of these children.
The American Academy of Pediatric Dentistry (AAPD) recommends pediatric oncology/hematology that Pediatric dentists must be involved in the treatment process from the moment cancer is diagnosed. This should be carried out by having a preventive and dental care plan developed based on the patient's needs before any cancer treatment is initiated.
The aim of the study is primarily to report oral complications and manifestations during chemotherapy treatment in pediatric cancer patients and raise the awareness of their parents on these manifestations thus proper interventions can be carried out to prevent more serious problems.
Read the detailed description
Childhood cancer is defined here as cancer in children aged 0-14 years and it only accounts for a small portion of the worldwide cancer burden .with an estimated 13.7 million additional cases of cancer in children globally between 2020 and 2050.
Childhood malignancies continue to be a leading source of morbidity and death in children. Cancer is the leading cause of disease-related mortality among children in developed, high-income countries, such as the United States.
With advances in healthcare access and a drop in communicable disease mortality, paediatric cancer is projected to become a significant cause of death even in developing, low- and middle-income nations. Furthermore, because children make up a significant proportion of the population in these countries, the scope of the problem is exacerbated, potentially resulting in a greater burden of childhood malignancy for the healthcare system to address.
Leukaemia accounted for the greatest share of classified childhood cancer burden globally, followed by brain and nervous system cancers.
The Children's Cancer Hospital in Egypt (CCHE) is the country's largest paediatric cancer hospital, enrolling about 3000 children under the age of 18 annually, accounting for an estimated 50% of juvenile cancer cases in a country with a population of around 100,000,000.
The primary mode of treatment for malignancies in children is antineoplastic chemotherapy, either alone or in conjunction with surgery and/or radiation according to the type of neoplasm.
Childhood cancers tend to respond well to chemotherapy as they are fast-growing and thus more susceptible to chemotherapy.This mechanism of treatment usually associated with severe side effects. Moreover, general adverse events that are common among patients treated by chemotherapy include reduced immunity, pancytopenia, muscle atrophy, skin manifestations, hair loss and others.
Chemotherapy includes the administration of injectable pharmaceuticals, which suppresses the immunity .Approximately 15 days after the chemotherapy session, patients usually show immunosuppression. As a result, any change in the integrity of the oral mucosa, carious processes, or outbreaks of odontogenic infection pose a significant risk for the development of additional oral and systemic illnesses.
Complications might be acute (occurring during therapy) or chronic (occurring after therapy) (developing months to years after therapy) Oral problems result from both direct injury to oral tissues as a result of chemotherapy and indirect damage as a result of regional or systemic toxicity.
One of the most common adverse effects of chemotherapy antineoplastic therapy is oral mucositis, which appears as mucosal inflammation followed by tissue degradation caused by chemotherapeutic drug stomatotoxicity. Oral mucositis occurs five to seven days after the start of antineoplastic therapy and lasts for the duration of the treatment.
Also, infections (viral- fungal- bacterial), salivary gland dysfunction, taste impairment, and discomfort are the most frequent oral problems associated with cancer treatments. Secondary problems such as dehydration, dysgeusia, and malnutrition might result from these issues. The mouth cavity can potentially be a source of systemic infection in myelosuppressed cancer patients. Fungal infections and ulceration can be observed with patient on chemotherapy.
Parents of children receiving cancer treatment, particularly chemotherapy, who are in a phase of acute immunosuppression usually neglect dental care. The parents are more concerned about the concurrent disease than the dental care of their kid, as they appeared anxious when presented with a cancer diagnosis, and they inquired about the impact of oral hygiene on cancer therapy and may not see it as a high priority.
- Conditions
- Mucositis Oral, Chemotherapy Effect
- Medical subject headings
- Stomatitis
What is being measured
The primary outcome is the main question the study is designed to answer.
The assessment of the prevalence of oral adverse events induced by chemotherapy in pediatric cancer patients .
Patients will be examined for oral manifestations at the first visit together with intra oral photos will be taken for the patients included in the study.
Voice ,swallow ,tongue, saliva, mucous membrane**, gingiva ,teeth will be measured by Oral Assessment Guide by the principal investigator .
**If oral mucositis is present it will be staged according to the World Health Organization Scale (WHO Oral Toxicity Scale) by the principal investigator.
Measured: Baseline
Secondary outcomes (1)
Assessment of dental awareness among parents of pediatric cancer patients .
Questionnaire (structured questionnaire that is developed and validated by Gupta et al., 2016) Parents of the pediatric cancer patients participating in the study will complete the "Parental dental Awareness Questionnaire" to assess their awareness.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start12 Aug 2023 (estimated)
- Primary completion27 Nov 2023 (estimated)
- Study completion25 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mucositis OralStudies of the same condition, open and under way.
- More trials run by Cairo 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
- 441 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Mohammed Al-Sayed, Cairo University
- Investigators
- Sherif Bahgat, Professor, Study chair, Professor of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Cairo University.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05224882
- Sponsor's protocol ID
- Chemotherapy manifestations
- Status last verified
- Nov 2022
- First submitted
- 25 Jan 2022
- Last updated
- 29 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Al-Sayed AM, El-Tawil SB, Madney Y, Yousry YM. Oral manifestations of pediatric cancer patients receiving chemotherapy and dental awareness among their parents-a cross-sectional study. BMC Oral Health. 2026 Mar 27;26(1):633. doi: 10.1186/s12903-026-07983-7.
PubMed 41896812
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Manifestations Of Pediatric Cancer Patients Receiving Chemotherapy And Dental Awareness Among Parents
- ClinicalTrials.gov ID
- NCT05224882
- Acronym / sponsor ID
- Chemotherapy manifestations
- Conditions
- Mucositis Oral, Chemotherapy Effect
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 441 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 12 Aug 2023 (estimated)
- Primary completion
- 27 Nov 2023 (estimated)
- Study completion
- 25 Jan 2024 (estimated)
- First posted
- 4 Feb 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 prevention of oral illnesses in children and adolescents undergoing oncological treatment is critical, because oral lesions caused by this therapy significantly exacerbate the clinical condition and increase the risk of infection, as well as making it harder to perform required dental procedures when needed .
"The key to success in maintaining a healthy oral cavity during therapy is patient compliance. The child and the parents should be educated regarding the possible acute side effects." Pediatric cancer patients may have a lower quality of life if they have poor dental health. Preventing and treating pre-existing oral illnesses is critical to reduce problems in these people.
It is critical to raise awareness of the benefits of proper oral health so that this understanding becomes a positive attitude, reducing the discomfort of these children.
The American Academy of Pediatric Dentistry (AAPD) recommends pediatric oncology/hematology that Pediatric dentists must be involved in the treatment process from the moment cancer is diagnosed. This should be carried out by having a preventive and dental care plan developed based on the patient's needs before any cancer treatment is initiated.
The aim of the study is primarily to report oral complications and manifestations during chemotherapy treatment in pediatric cancer patients and raise the awareness of their parents on these manifestations thus proper interventions can be carried out to prevent more serious problems.
Detailed description
Childhood cancer is defined here as cancer in children aged 0-14 years and it only accounts for a small portion of the worldwide cancer burden .with an estimated 13.7 million additional cases of cancer in children globally between 2020 and 2050.
Childhood malignancies continue to be a leading source of morbidity and death in children. Cancer is the leading cause of disease-related mortality among children in developed, high-income countries, such as the United States.
With advances in healthcare access and a drop in communicable disease mortality, paediatric cancer is projected to become a significant cause of death even in developing, low- and middle-income nations. Furthermore, because children make up a significant proportion of the population in these countries, the scope of the problem is exacerbated, potentially resulting in a greater burden of childhood malignancy for the healthcare system to address.
Leukaemia accounted for the greatest share of classified childhood cancer burden globally, followed by brain and nervous system cancers.
The Children's Cancer Hospital in Egypt (CCHE) is the country's largest paediatric cancer hospital, enrolling about 3000 children under the age of 18 annually, accounting for an estimated 50% of juvenile cancer cases in a country with a population of around 100,000,000.
The primary mode of treatment for malignancies in children is antineoplastic chemotherapy, either alone or in conjunction with surgery and/or radiation according to the type of neoplasm.
Childhood cancers tend to respond well to chemotherapy as they are fast-growing and thus more susceptible to chemotherapy.This mechanism of treatment usually associated with severe side effects. Moreover, general adverse events that are common among patients treated by chemotherapy include reduced immunity, pancytopenia, muscle atrophy, skin manifestations, hair loss and others.
Chemotherapy includes the administration of injectable pharmaceuticals, which suppresses the immunity .Approximately 15 days after the chemotherapy session, patients usually show immunosuppression. As a result, any change in the integrity of the oral mucosa, carious processes, or outbreaks of odontogenic infection pose a significant risk for the development of additional oral and systemic illnesses.
Complications might be acute (occurring during therapy) or chronic (occurring after therapy) (developing months to years after therapy) Oral problems result from both direct injury to oral tissues as a result of chemotherapy and indirect damage as a result of regional or systemic toxicity.
One of the most common adverse effects of chemotherapy antineoplastic therapy is oral mucositis, which appears as mucosal inflammation followed by tissue degradation caused by chemotherapeutic drug stomatotoxicity. Oral mucositis occurs five to seven days after the start of antineoplastic therapy and lasts for the duration of the treatment.
Also, infections (viral- fungal- bacterial), salivary gland dysfunction, taste impairment, and discomfort are the most frequent oral problems associated with cancer treatments. Secondary problems such as dehydration, dysgeusia, and malnutrition might result from these issues. The mouth cavity can potentially be a source of systemic infection in myelosuppressed cancer patients. Fungal infections and ulceration can be observed with patient on chemotherapy.
Parents of children receiving cancer treatment, particularly chemotherapy, who are in a phase of acute immunosuppression usually neglect dental care. The parents are more concerned about the concurrent disease than the dental care of their kid, as they appeared anxious when presented with a cancer diagnosis, and they inquired about the impact of oral hygiene on cancer therapy and may not see it as a high priority.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 year to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study will be carried out at the pediatric clinic of the National Cancer Institute ,Egypt. Pediatric patients and their parents at the pediatric clinic will be screened until the target population is achieved. The pediatric patients will be subjected to thorough examination. Once the patient and the parent are potentially eligible for this study, the principal investigator will explain the study and ascertain the patient's and the parents' interest. The legal guardian provides written informed consent for participation in the study.
Key inclusion criteria (3 listed)
- Children between the age of 1 -14years.
- Children receiving chemotherapy for hematological cancer or solid tumors.
- Parents who are able to understand the aim of the study and willing to participate in the study.
Key exclusion criteria (3 listed)
- Children previously received radiotherapy on head and neck region.
- Children suffering from oral cancer.
- Children presented with other oral disorders such as leukoplakia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The assessment of the prevalence of oral adverse events induced by chemotherapy in pediatric cancer patients .
Time frame: Baseline
Patients will be examined for oral manifestations at the first visit together with intra oral photos will be taken for the patients included in the study. Voice ,swallow ,tongue, saliva, mucous membrane**, gingiva ,teeth will be measured by Oral Assessment Guide by the principal investigator . **If oral mucositis is present it will be staged according to the World Health Organization Scale (WHO Oral Toxicity Scale) by the principal investigator.
1 secondary outcome
Assessment of dental awareness among parents of pediatric cancer patients .
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2022.
- Derived from this study: PubMed 41896812Al-Sayed AM, El-Tawil SB, Madney Y, Yousry YM. Oral manifestations of pediatric cancer patients receiving chemotherapy and dental awareness among their parents-a cross-sectional study. BMC Oral Health. 2026 Mar 27;26(1):633. doi: 10.1186/s12903-026-07983-7.
- Individual participant dataSharing planned: Undecided
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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.
Yasmin Yousry, PHD contact
Sherif Bahgat, Professor study chair
Professor of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Cairo University.
Questions about this trial
What is this clinical trial studying?
An observational study of Mucositis Oral and Chemotherapy Effect, run by Cairo University.
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 3 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: status not confirmed, as of the sponsor's last update on 29 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amira M Al-Naggar, B.D.S (01125355552 ext. 002, Amira_mohammed@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The assessment of the prevalence of oral adverse events induced by chemotherapy in pediatric cancer patients . (time frame: Baseline). 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 NCT05224882, which also lists 1 linked publication.
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 29 Nov 2022.