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Forward-looking observational study to find out the ideal time frame for integration of implants with jaw bones which underwent radiation treatment for head and neck cancer patients

Prospective observational study to determine optimal time to achieve osseointegration after dental implant installation in irradiated jaw bones in head neck cancer patients - NIL

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/02/062855
Enrollment
35
Registered
2024-02-19
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Health Condition 1: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx

Interventions

Intervention1: NIL: NIL

Sponsors

Tata Memorial Centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patient underwent radiation to the head and neck region in an adjuvant/ definitive setting. 2. Undergoingdental implant placement for replacement of missing teeth in maxillary/mandibular/ reconstructed jaw as per the protocol of hospital. 3. Present with an insertion torque of =25 at the time of dental implant placement 4. Patients should have sufficient bone dimensions allowing standard sized dental implant placement 5. Willing to report for monthly follow-ups from 3 months to 6 months 6. Willing and able to complete study interventions, assessments, and other requirements. 7. Ready to provide with Signed, written, informed consent

Exclusion criteria

Exclusion criteria: 1. Non-radiated head and neck cancer patients. 2. Who have received radiation more than once to the head and neck region, prior to the dental implant placement 3. Local/ systemic factors which may contribute to delayed osseointegration (including those patients who are currently on oral metronomic therapy and bone-modifying agents including bisphosphonates, denosumab and tyrosine kinase inhibitors.)

Design outcomes

Primary

MeasureTime frame
Implant stability quotient (ISQ) should be 70±5, using resonance frequency analyzing (RFA) device (PENGUIN) when measured monthly at 3rd month and 6th month.Timepoint: 3months, 6 months

Secondary

MeasureTime frame
Implant stability quotient (ISQ) should be 70±5, using resonance frequency analyzing (RFA) device (PENGUIN) when measured monthly at 3rd month and 6th month.Timepoint: 6 months

Countries

India

Contacts

Public ContactDr Madhumaitri Patra

Tata Memorial Hospital

89patra.madhumaitri@gmail.com7908337544

Outcome results

None listed

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