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

Not Applicable

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

• Registration Number: CTRI/2024/02/062855
• Lead Sponsor: Tata Memorial Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

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.)

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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