Longitudinal Oral Health Changes After Head and Neck Radiotherapy (HN-ORAL-RT)

January 31, 2026 updated by: Fatma ElSayed, Ain Shams University

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.

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Ahmed Maher Teaching Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, end of radiotherapy, and 3, 6, 9, and 12 months post-radiotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Probing Pocket Depth (PPD)
Time Frame: Baseline, end of radiotherapy, and 3, 6, 9, and 12 months post-radiotherapy
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)
Time Frame: Baseline, end of radiotherapy, and 3, 6, 9, and 12 months post-radiotherapy
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
Time Frame: Baseline, end of radiotherapy, and 3, 6, 9, and 12 months post-radiotherapy
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
Time Frame: Baseline, end of radiotherapy, and 3, 6, 9, and 12 months post-radiotherapy
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
Time Frame: Baseline, end of radiotherapy, and 3, 6, 9, and 12 months post-radiotherapy
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
Time Frame: Baseline, end of radiotherapy, and 3, 6, 9, and 12 months post-radiotherapy
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2025

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

April 25, 2026

Study Registration Dates

First Submitted

January 31, 2026

First Submitted That Met QC Criteria

January 31, 2026

First Posted (Actual)

February 6, 2026

Study Record Updates

Last Update Posted (Actual)

February 6, 2026

Last Update Submitted That Met QC Criteria

January 31, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HAMO0223

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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