Frequency of Periodontal Disease in Head and Neck Cancer Patients After Radiation Therapy

NCT06667362 | Completed

• 1 other identifier: HAM00212
• Study Type: observational
• Target: 189
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective cross-sectional study evaluates the frequency and risk factors of periodontal disease in head and neck cancer patients who have undergone radiotherapy. 189 patients from three radiation centers in Cairo Governorate, Egypt will be included in the study. Periodontal status will be assessed according to the 2017 classification of periodontal diseases. Data will be collected through interviews, clinical examinations, and medical records. Potential risk factors, including tumor characteristics, treatment modalities, and oral health behaviors, will be analyzed. The findings aim to provide insights into the oral health challenges faced by these patients and inform better clinical management strategies.

Conditions

Periodontal Diseases; Periodontitis

Keywords

periodontitis; head and neck cancer; radiotherapy

Outcome Measures

Primary Outcomes (6)

• Clinical Attachment Loss (CAL)

  The distance from the cementoenamel junction (CEJ) to the bottom of the periodontal pocket. It indicates the amount of attachment loss due to periodontal disease. Measured with a periodontal probe at six sites per tooth.

  Measured once during the study.

• Probing Depth (PD)

  The distance from the gingival margin to the bottom of the periodontal pocket. Measured with a periodontal probe at six sites per tooth.

  Measured once during the study.

• Bleeding on Probing (BOP)

  Presence or absence of bleeding from the gingival sulcus 10 seconds after probing with a standardized force. Assessed at six sites per tooth.

  Assessed once during the study.

• Plaque Index (PI)

  A score reflecting the thickness of dental plaque present at the gingival margin. Assessed using a Williams periodontal probe and scored on a scale of 0 to 3 (0=no plaque, 3=dense plaque).

  Assessed once during the study.

• Tooth Loss due to Periodontitis

  Tooth Loss due to Periodontitis

  Assessed through patient history, so it covers the period prior to the study.

• Radiographic Bone Loss

  Assessed through radiographic examination to determine the extent of bone loss around the teeth. Used in conjunction with CAL to stage periodontitis.

  Radiographs taken once during the study.

Secondary Outcomes (3)

• Clinical Oral Dryness Score (CODS)

  Assessed once during the study.

• Unstimulated Salivary Flow Rate

  Saliva collected once during the study, between 8:00 AM and 11:00 AM.

• Oral Mucositis (OM)

  Assessed once during the study

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will include 189 participants recruited from three radiation centers in Cairo Governorate, Egypt.

You may qualify if:

• Over 18 years of age Any gender At least six remaining teeth Undergoing head and neck radiotherapy with or without chemotherapy for 6-7 weeks Head and neck malignancy including squamous cell carcinoma of the tongue, buccal mucosa, hard palate, soft palate, and base of tongue.
• Both mandible and maxilla included in the radiation field

You may not qualify if:

• Major surgical intervention (major hard tissue resection) Psychiatric disorders Distant metastatic disease Bone-related disorders Active untreated infection Palliative care Pregnancy Smokers

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ahmed Maher teaching Hospital

Cairo, Egypt

Location

Related Publications (2)

• 1. Petersen PE: Oral cancer prevention and control--the approach of the World Health Organization. Oral Oncol 2009, 45(4-5):454-460 10.1016/j.oraloncology.2008.05.023. 2. Mehrotra R, Singh M, Gupta RK, Singh M, Kapoor AK: Trends of prevalence and pathological spectrum of head and neck cancers in North India. Indian Journal of Cancer 2005, 42(2). 3. Hancock PJ, Epstein JB, Sadler GR: Oral and dental management related to radiation therapy for head and neck cancer. J Can Dent Assoc 2003, 69(9):585-590. 4. Dreizen S, Daly TE, Drane JB, Brown LR: Oral complications of cancer radiotherapy. Postgrad Med 1977, 61(2):85-92 10.1080/00325481.1977.11712115. 5. Marx RE: Osteoradionecrosis: a new concept of its pathophysiology. J Oral Maxillofac Surg 1983, 41(5):283-288 10.1016/0278-2391(83)90294-x. 6. Silverman Jr S, Chierici G: Radiation Therapy of Oral Carcinoma I. Effects on Oral Tissues and Management of the Periodontium. The Journal of Periodontology 1965, 36(6):478-484 https://doi.org/10.1902/jop.1965.36.6.478. 7. Yusof ZW, Bakri MM: Severe progressive periodontal destruction due to radiation tissue injury. J Periodontol 1993, 64(12):1253-1258 10.1902/jop.1993.64.12.1253. 8. Kassim N, Sirajuddin S, Biswas S, Rafiuddin S, Apine A: Iatrogenic Damage to the Periodontium Caused by Radiation and Radiotherapy. The Open Dentistry Journal 2015, 9:182-186 10.2174/1874210601509010182. 9. Marx RE, Johnson RP: Studies in the radiobiology of osteoradionecrosis and their clinical significance. Oral Surg Oral Med Oral Pathol 1987, 64(4):379-390 10.1016/0030-4220(87)90136-8. 10. Epstein JB, Corbett T, Galler C, Stevenson-Moore P: Surgical periodontal treatment in the radiotherapy-treated head and neck cancer patient. Spec Care Dentist 1994, 14(5):182-187 10.1111/j.1754-4505.1994.tb01129.x. 11. Llory H, Dammron A, Gioanni M, Frank RM: Some population changes in oral anaerobic microorganisms, Streptococcus mutans and yeasts following irradiation of the salivry glands. Caries Res 19

  BACKGROUND

• Abou-Bakr A, Ahmed E, William H, Hassanein FEA. Frequency of periodontal disease in head and neck cancer patients after radiation therapy: a cross-sectional study. BMC Oral Health. 2025 Jul 2;25(1):1008. doi: 10.1186/s12903-025-06391-7.

  PMID: 40604898 DERIVED

MeSH Terms

Conditions

Periodontal Diseases; Periodontitis; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Neoplasms by Site; Neoplasms

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2024
• First Posted: October 31, 2024
• Study Start: September 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: October 15, 2024
• Last Updated: October 31, 2024

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)