NCT07394842

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 long-term oral complications of radiotherapy and to support improved preventive and supportive dental care for cancer patients.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2025

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2026

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 6, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2026

Completed
Last Updated

February 6, 2026

Status Verified

January 1, 2026

Enrollment Period

1 year

First QC Date

January 31, 2026

Last Update Submit

January 31, 2026

Conditions

Head & Neck CancerHead & Neck Squamous Cell CarcinomaPeriodontal DiseaseXerostomia

Keywords

Head and neck radiotherapyperiodontal healthradiation-induced oral complicationsdental cariessalivary dysfunctionoral health quality of life

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Change in Probing Pocket Depth (PPD)

    Baseline, end of radiotherapy, and 3, 6, 9, and 12 months post-radiotherapy

  • Change in Bleeding on Probing (BOP)

    Baseline, end of radiotherapy, and 3, 6, 9, and 12 months post-radiotherapy

  • Change in Decayed, Missing, and Filled Teeth (DMFT) Index

    Baseline, end of radiotherapy, and 3, 6, 9, and 12 months post-radiotherapy

  • Change in Xerostomia Inventory Score

    Baseline, end of radiotherapy, and 3, 6, 9, and 12 months post-radiotherapy

  • Change in Unstimulated Salivary Flow Rate

    Baseline, end of radiotherapy, and 3, 6, 9, and 12 months post-radiotherapy

  • +1 more secondary outcomes

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmed Maher Teaching Hospital

Cairo, Egypt

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsSquamous Cell Carcinoma of Head and NeckPeriodontal DiseasesXerostomiaDental Caries

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeMouth DiseasesStomatognathic DiseasesSalivary Gland DiseasesTooth DemineralizationTooth Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

January 31, 2026

First Posted

February 6, 2026

Study Start

February 1, 2025

Primary Completion

February 1, 2026

Study Completion

April 25, 2026

Last Updated

February 6, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)