Head & Neck CancerHN-ORAL-RTNCT07394842
Longitudinal Oral Health Changes After Head and Neck Radiotherapy
An observational study of Head & Neck Cancer and Head & Neck Squamous Cell Carcinoma, run by Ain Shams University at 1 site in Egypt.
Trial summary
This prospective observational study evaluates how head and neck radiotherapy affects oral health over time. Patients with head and neck cancer undergoing standard radiotherapy are followed from before treatment through multiple post-treatment visits. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head & Neck Cancer, Head & Neck Squamous Cell Carcinoma, Periodontal Disease
- Type of treatment
- Pill or oral medicine
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2025to 25 Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with head and neck cancer receiving external beam radiotherapy at a tertiary referral hospital who are followed longitudinally for oral and periodontal health outcomes.
Who may be able to join
- Age ≥18 years
- Histologically confirmed head and neck malignancy
- Planned radiotherapy dose ≥50 Gy
- Presence of at least 20 natural teeth
- No periodontal treatment during the preceding 6 months
- Ability to comply with the scheduled follow-up visits
Who cannot join
- Previous head and neck radiotherapy
- Autoimmune salivary gland disorders
- Current bisphosphonate or anti-resorptive therapy
- Pregnancy
- Uncontrolled systemic disease (HbA1c >9% for diabetic patients)
- Severe periodontal destruction requiring immediate surgical intervention
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Longitudinal Effects of Head and Neck Radiotherapy on Periodontal and Dental Oral Health: A Prospective Cohort Study
This prospective observational study evaluates how head and neck radiotherapy affects oral health over time. Patients with head and neck cancer undergoing standard radiotherapy are followed from before treatment through multiple post-treatment visits. Changes in periodontal health, dental status, salivary function, and patient-reported oral health quality of life are assessed. The study aims to better understand the long-term oral complications of radiotherapy and to support improved preventive and supportive dental care for cancer patients.
Read the detailed description
This prospective longitudinal cohort study investigates the effects of head and neck radiotherapy on periodontal health, dental outcomes, salivary gland function, and oral health-related quality of life.
Adult patients with histologically confirmed head and neck malignancies scheduled to receive external beam radiotherapy are enrolled and followed longitudinally. Clinical assessments are conducted at baseline prior to radiotherapy, at the end of radiotherapy, and at 3, 6, and 12 months post-treatment.
Periodontal evaluation includes clinical attachment level, probing pocket depth, plaque index, gingival index, and bleeding on probing, recorded at six sites per tooth using standardized periodontal examination protocols. Dental outcomes include decayed, missing, and filled teeth index, radiation-associated caries incidence, and tooth mobility. Salivary gland function is assessed using unstimulated whole saliva collection. Patient-reported outcomes include xerostomia severity and oral health-related quality of life using validated questionnaires.
Radiotherapy characteristics including technique, total dose, fractionation schedule, mandibular field involvement, and concurrent chemotherapy are recorded. Longitudinal changes in oral health outcomes are analyzed to identify patterns of disease progression and potential predictors of radiotherapy-related oral complications.
This study aims to generate clinical evidence to improve preventive strategies, early detection, and supportive oral care protocols for patients receiving head and neck radiotherapy.
- Keywords
- Head and neck radiotherapy, periodontal health, radiation-induced oral complications, dental caries, salivary dysfunction, oral health quality of life
- Medical subject headings
- Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck, Periodontal Diseases, Xerostomia, Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Head and Neck Radiotherapy Cohort | Adult patients with head and neck cancer undergoing standard external beam radiotherapy who are followed longitudinally to evaluate periodontal health, dental outcomes, salivary function, and oral health-related quality of life. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Clinical Attachment Level (CAL)
Mean change in clinical attachment level measured in millimeters using a standardized UNC-15 periodontal probe at six sites per tooth. CAL is used as the primary indicator of periodontal tissue loss following radiotherapy.
Measured: Baseline, end of radiotherapy, and 3, 6, 9, and 12 months post-radiotherapy
Secondary outcomes (6)
Change in Probing Pocket Depth (PPD)
Mean probing pocket depth measured in millimeters at six sites per tooth using a standardized UNC-15 periodontal probe as an indicator of periodontal pocket severity.
Measured: Baseline, end of radiotherapy, and 3, 6, 9, and 12 months post-radiotherapy
Change in Bleeding on Probing (BOP)
Percentage of periodontal sites exhibiting bleeding on probing as a measure of periodontal inflammation.
Measured: Baseline, end of radiotherapy, and 3, 6, 9, and 12 months post-radiotherapy
Change in Decayed, Missing, and Filled Teeth (DMFT) Index
Dental caries experience assessed using the Decayed, Missing, and Filled Teeth (DMFT) index to evaluate cumulative dental disease burden.
Measured: Baseline, end of radiotherapy, and 3, 6, 9, and 12 months post-radiotherapy
Change in Xerostomia Inventory Score
Patient-reported xerostomia severity measured using the validated Xerostomia Inventory questionnaire.
Measured: Baseline, end of radiotherapy, and 3, 6, 9, and 12 months post-radiotherapy
Change in Unstimulated Salivary Flow Rate
Unstimulated whole salivary flow rate measured in milliliters per minute using the passive drooling collection method.
Measured: Baseline, end of radiotherapy, and 3, 6, 9, and 12 months post-radiotherapy
Change in Oral Health Impact Profile-14 (OHIP-14) Score
Oral health-related quality of life assessed using the OHIP-14 questionnaire.
Measured: Baseline, end of radiotherapy, and 3, 6, 9, and 12 months post-radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start1 Feb 2025
- Primary completion1 Feb 2026 (estimated)
- Study completion25 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head & Neck CancerStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma ElSayed, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07394842
- Sponsor's protocol ID
- HAMO0223
- Acronym
- HN-ORAL-RT
- Status last verified
- Jan 2026
- First submitted
- 31 Jan 2026
- Last updated
- 6 Feb 2026
- 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 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Effects of Head and Neck Radiotherapy on Periodontal and Dental Oral Health: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07394842
- Acronym / sponsor ID
- HN-ORAL-RT / HAMO0223
- Keywords
- Head and neck radiotherapy, periodontal health, radiation-induced oral complications, dental caries, salivary dysfunction, oral health quality of life
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 25 Apr 2026 (estimated)
- First posted
- 6 Feb 2026 (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.
This prospective observational study evaluates how head and neck radiotherapy affects oral health over time. Patients with head and neck cancer undergoing standard radiotherapy are followed from before treatment through multiple post-treatment visits. Changes in periodontal health, dental status, salivary function, and patient-reported oral health quality of life are assessed. The study aims to better understand the long-term oral complications of radiotherapy and to support improved preventive and supportive dental care for cancer patients.
Detailed description
This prospective longitudinal cohort study investigates the effects of head and neck radiotherapy on periodontal health, dental outcomes, salivary gland function, and oral health-related quality of life.
Adult patients with histologically confirmed head and neck malignancies scheduled to receive external beam radiotherapy are enrolled and followed longitudinally. Clinical assessments are conducted at baseline prior to radiotherapy, at the end of radiotherapy, and at 3, 6, and 12 months post-treatment.
Periodontal evaluation includes clinical attachment level, probing pocket depth, plaque index, gingival index, and bleeding on probing, recorded at six sites per tooth using standardized periodontal examination protocols. Dental outcomes include decayed, missing, and filled teeth index, radiation-associated caries incidence, and tooth mobility. Salivary gland function is assessed using unstimulated whole saliva collection. Patient-reported outcomes include xerostomia severity and oral health-related quality of life using validated questionnaires.
Radiotherapy characteristics including technique, total dose, fractionation schedule, mandibular field involvement, and concurrent chemotherapy are recorded. Longitudinal changes in oral health outcomes are analyzed to identify patterns of disease progression and potential predictors of radiotherapy-related oral complications.
This study aims to generate clinical evidence to improve preventive strategies, early detection, and supportive oral care protocols for patients receiving head and neck radiotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Head and Neck Radiotherapy Cohort | – | –Adult patients with head and neck cancer undergoing standard external beam radiotherapy who are followed longitudinally to evaluate periodontal health, dental outcomes, salivary function, and oral health-related quality of life. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with head and neck cancer receiving external beam radiotherapy at a tertiary referral hospital who are followed longitudinally for oral and periodontal health outcomes.
Key inclusion criteria (6 listed)
- Age ≥18 years
- Histologically confirmed head and neck malignancy
- Planned radiotherapy dose ≥50 Gy
- Presence of at least 20 natural teeth
- No periodontal treatment during the preceding 6 months
Key exclusion criteria (6 listed)
- Previous head and neck radiotherapy
- Autoimmune salivary gland disorders
- Current bisphosphonate or anti-resorptive therapy
- Pregnancy
- Uncontrolled systemic disease (HbA1c >9% for diabetic patients)
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
Change in Clinical Attachment Level (CAL)
Time frame: Baseline, end of radiotherapy, and 3, 6, 9, and 12 months post-radiotherapy
Mean change in clinical attachment level measured in millimeters using a standardized UNC-15 periodontal probe at six sites per tooth. CAL is used as the primary indicator of periodontal tissue loss following radiotherapy.
6 secondary outcomes
Change in Probing Pocket Depth (PPD)
Time frame: Baseline, end of radiotherapy, and 3, 6, 9, and 12 months post-radiotherapy
Change in Bleeding on Probing (BOP)
Time frame: Baseline, end of radiotherapy, and 3, 6, 9, and 12 months post-radiotherapy
Change in Decayed, Missing, and Filled Teeth (DMFT) Index
Time frame: Baseline, end of radiotherapy, and 3, 6, 9, and 12 months post-radiotherapy
Change in Xerostomia Inventory Score
Time frame: Baseline, end of radiotherapy, and 3, 6, 9, and 12 months post-radiotherapy
Change in Unstimulated Salivary Flow Rate
Time frame: Baseline, end of radiotherapy, and 3, 6, 9, and 12 months post-radiotherapy
Change in Oral Health Impact Profile-14 (OHIP-14) Score
Time frame: Baseline, end of radiotherapy, and 3, 6, 9, and 12 months post-radiotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Head & Neck Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
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 Head & Neck Cancer and Head & Neck Squamous Cell Carcinoma, run by Ain Shams University at 1 site in Egypt.
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 6 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: under way, not looking for participants, as of the sponsor's last update on 6 Feb 2026. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in Clinical Attachment Level (CAL) (time frame: Baseline, end of radiotherapy, and 3, 6, 9, and 12 months post-radiotherapy). 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 6 Feb 2026.