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Effect of radiotherapy dose at implant site on implant survival: a prospective study of "dual dose" digital guided implant repair in head and neck radiotherapy patients based on radiotherapy dose and bone mass

Effect of radiotherapy dose at implant site on implant survival: a prospective study of "dual dose" digital guided implant repair in head and neck radiotherapy patients based on radiotherapy dose and bone mass

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400094319
Enrollment
Unknown
Registered
2024-12-20
Start date
2025-01-01
Completion date
Unknown
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dentition defects

Interventions

0~40Gy group:0~40Gy
40~45Gy group:40~45Gy
45~50Gy group:45~50Gy

Sponsors

Shanghai Ninth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) The age of the patient must be >=18 years; 2) Receiving radiotherapy for the head and neck alone or postoperative radiotherapy, with or without chemotherapy; 3) Partially or completely edentulous, with implant restoration needs and meeting the indications for implant restoration; 4) The dose of potential dental implant is not more than 50Gy and 12 months or more after radiotherapy; 5) Subjects voluntarily sign the informed consent form prior to the implementation of any study-related trial steps.

Exclusion criteria

Exclusion criteria: 1) The potential dental implant is reconstructed after partial removal of the jaw; 2) Absolute and relative contraindications to implant surgery, systemic diseases affecting osseointegration, wound healing and dental implant treatment: such as uncontrolled and stable diabetes mellitus and hypertension; Grade II and above cardiac disease; Patients with abnormal liver and kidney function; Immunocompromised; obese patients; Patients taking drugs that affect the effectiveness of treatment: such as patients on long-term high-dose steroid therapy; Patients who have been treated with drugs (such as bisphosphonates) that may affect or promote bone metabolism within the past 3 months, etc.; 3) Smoking/tobacco equivalents/chewing tobacco more than 10 per day; 4) Other special populations: such as physical or mental impairments that affect oral health care; Patients with product allergies; Female patients who are pregnant or breastfeeding, etc.; 5) Patients who are considered by the investigator to have poor compliance and cannot participate in the trial.

Design outcomes

Primary

MeasureTime frame
Survival rate;

Countries

China

Contacts

Public ContactYu Dedong

Shanghai Ninth People's Hospital

15862203588@163.com+86 159 2183 0591

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026