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Clinical Trial NCT07394842 (HN-ORAL-RT) for Head & Neck Cancer, Head & Neck Squamous Cell Carcinoma, Periodontal Disease, Xerostomia is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Longitudinal Oral Health Changes After Head and Neck Radiotherapy (HN-ORAL-RT) 100 Observational Preventive

Active, not recruiting
Clinical Trial NCT07394842 (HN-ORAL-RT) is an observational study for Head & Neck Cancer, Head & Neck Squamous Cell Carcinoma, Periodontal Disease, Xerostomia that is active, not recruiting. It started on February 1, 2025 with plans to enroll 100 participants. Led by Ain Shams University, it is expected to complete by April 25, 2026. The latest data from ClinicalTrials.gov was last updated on February 6, 2026.
Brief 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. 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 ...Show More
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 ...

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Official Title

Longitudinal Effects of Head and Neck Radiotherapy on Periodontal and Dental Oral Health: A Prospective Cohort Study

Conditions
Head & Neck CancerHead & Neck Squamous Cell CarcinomaPeriodontal DiseaseXerostomia
Other Study IDs
  • HN-ORAL-RT
  • HAMO0223
NCT ID Number
NCT07394842
Start Date (Actual)
2025-02-01
Last Update Posted
2026-02-06
Completion Date (Estimated)
2026-04-25
Enrollment (Estimated)
100
Study Type
Observational
Status
Active, not recruiting
Keywords
Head and neck radiotherapy
periodontal health
radiation-induced oral complications
dental caries
salivary dysfunction
oral health quality of life
Arms / Interventions
Participant Group/ArmIntervention/Treatment
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.
N/A
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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.
Baseline, end of radiotherapy, and 3, 6, 9, and 12 months post-radiotherapy
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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.
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.
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.
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.
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.
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.
Baseline, end of radiotherapy, and 3, 6, 9, and 12 months post-radiotherapy
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 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

  • 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
Ain Shams University logoAin Shams University344 active studies to explore
Study Responsible Party
Fatma ElSayed, Principal Investigator, assistant professor, Ain Shams University
No contact data.
1 Study Locations in 1 Countries
Ahmed Maher Teaching Hospital, Cairo, Egypt