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CTRI Number  CTRI/2024/02/062855 [Registered on: 19/02/2024] Trial Registered Prospectively
Last Modified On: 24/10/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   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 
Scientific Title of Study   Prospective observational study to determine optimal time to achieve osseointegration after dental implant installation in irradiated jaw bones in head neck cancer patients 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sandeep Gurav 
Designation  Professor 
Affiliation  Tata Memorial Hospital 
Address  Department of Dental and Prosthetic Surgery, Tata Memorial Hospital, Dr. E Borges Road, Parel, Mumbai, Maharashtra

Mumbai
MAHARASHTRA
400012
India 
Phone  02224177000  
Fax    
Email  drsandeepgurav@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Madhumaitri Patra 
Designation  Fellow 
Affiliation  Tata Memorial Hospital 
Address  Department of Dental and Prosthetic Surgery, Tata Memorial Hospital, Dr. E Borges Road, Parel, Mumbai, Maharashtra

Mumbai
MAHARASHTRA
4000012
India 
Phone  7908337544  
Fax    
Email  89patra.madhumaitri@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Madhumaitri Patra 
Designation  Fellow 
Affiliation  Tata Memorial Hospital 
Address  Department of Dental and Prosthetic Surgery, Tata Memorial Hospital, Dr. E Borges Road, Parel, Mumbai, Maharashtra

Mumbai
MAHARASHTRA
4000012
India 
Phone  7908337544  
Fax    
Email  89patra.madhumaitri@gmail.com  
 
Source of Monetary or Material Support  
Tata Memorial Hospital, E Borges Road, Parel, Mumbai, Maharashtra, 400012 
 
Primary Sponsor  
Name  Tata Memorial Centre 
Address  Tata Memorial Hospital,Jerbai Wadia Road, Parel, Mumbai, Maharashtra- 400012 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Madhumaitri Patra  Tata Memorial Hospital  Dept. of Dental Prosthetic Surgery, Homi Bhaba Block-217, Tata Memorial Hosital, E. Borges Road, Parel
Mumbai
MAHARASHTRA 
7908337544

89patra.madhumaitri@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Tata Memorial Centre Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  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 
 
ExclusionCriteria 
Details  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.) 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Implant stability quotient (ISQ) should be 70±5, using resonance frequency analyzing (RFA) device (PENGUIN) when measured monthly at 3rd month and 6th month.  3months, 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Implant stability quotient (ISQ) should be 70±5, using resonance frequency analyzing (RFA) device (PENGUIN) when measured monthly at 3rd month and 6th month.  6 months 
 
Target Sample Size   Total Sample Size="35"
Sample Size from India="35" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/02/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

After-surgery of head and neck cancers, patients have missing teeth that often leads in problems of eating, speech and compromised esthetics. Dental implants are titanium screws like fixtures which supports artificial teeth and useful to restore and rehabilitate the missing teeth and surrounding structure.

However, many of the head and neck cancer patients undergo radiation therapy after surgery. Radiotherapy results in problem in bone healing hence osseointegration gets delayed. (Osseointegration- defined as a direct structural and functional connection between living bone and placed implant). Usually, dental implant placement and the process of rehabilitation takes place after one year of radiotherapy to reduce the effect of radiation on healing. While sufficient literatures are available highlighting the need to delay dental implant placement by at least a year in radiated patients but there is no clinical proof that justifies any need to delay in the placement of artificial teeth on osseointegrated implants (termed as loading of implants). Conventionally, placement of artificial teeth in non-irradiated bones takes place at 3 months after implant placement. Empirically, artificial teeth is carried out at 6 months after dental implant surgery in irradiated jaw bones is mainly based on assumption that radiated bone regenerates at slower rate than non radiated jaw bones.

The objective of this research is to investigate if earlier osseointegration (less than 6 months) of dental implants is achievable in radiated bone. This would directly impact the speed of the rehabilitation process and thus, the quality of life of the patients.

During the study, at three months it will be started checking whether the implants that are placed are integrating to the bone in an expected way or there is any deviation from the normal. For that it is needed to measure the stability of the implant by using an instrument. This instrument measures Implant Stability Quotient (ISQ) i.e level of stability and integration of dental implants with the jaw bone. This ISQ measurement will be done immediately after placement of implants and at 3,6 months. This protocol will be followed for half of the placed implants in the jaw (those will be categorized as study implants), while the rest of the implants will be left undisturbed as it is done conventionally (those will be categorized as control implants) and ISQ will be measured after 6 months.

At the end of 6 months, a prosthesis will be placed in case all the implants have attained an ISQ comparable to the control implants or more than desired value (65±10).

The study will be conducted at Tata Memorial Hospital with the implant surgery aimed to be completed by 18 months. 

0 to 12 Months: Patient screening, consenting, recruitment and dental implant placement. 06-18 Months: Prosthetic rehabilitation (placement of artificial teeth)

At present, there are lack of studies that justifies any need to delay the placement of prosthesis on osseointegrated implants (termed as loading of implants).This would directly impact the speed of rehabilitation process and thus, the quality of life of the patients. Hence we can give teeth / denture early to patient. It will also help the clinician to assess the impact of different factors (dose of radiation and type of bone) on the osseointegration of the dental implant.

 
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