| 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
|
|
|
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
|
|
|
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. |