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CTRI Number  CTRI/2018/08/015521 [Registered on: 29/08/2018] Trial Registered Prospectively
Last Modified On: 20/01/2020
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Evaluation of implant stability in head and neck cancer patients.  
Scientific Title of Study   Assessment of dental implant stability following oral rehabilitation of head and neck cancer patients. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr K P Dholam 
Designation  Professor and Head of Department 
Affiliation  Tata Memorial Hospital 
Address  Dept of dental and prosthetic surgery, Tata Memorial Hospital, Dr E Borges Marg Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  02224177000  
Fax  02224146937  
Email  kdholam@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Aishwarya Chatterjee 
Designation  Fellow - 1 
Affiliation  Tata Memorial Hospital 
Address  Dept of dental and prosthetic surgery, Tata Memotial Hospital, Dr. E Borges Marg, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  02224177224  
Fax  02224146937  
Email  aishwarjo@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Aishwarya Chatterjee 
Designation  Fellow - 1 
Affiliation  Tata Memorial Hospital 
Address  Dept of dental and prosthetic surgery, Tata Memotial Hospital, Dr. E Borges Marg, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  02224177224  
Fax  02224146937  
Email  aishwarjo@gmail.com  
 
Source of Monetary or Material Support  
Tata Memorial Hospital Dr E Borges Marg Parel Mumbai 400012 Maharashtra India 
 
Primary Sponsor  
Name  Tata Memorial Hospital 
Address  Dr E Borges Marg Parel Mumbai 400012 Maharashtra India 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  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 K P Dholam  217, Second floor,Dept of Dental and Prosthetic Surgery, Homi Bhaba Block  Tata Memorial Hospital, Dr. E. Borges Marg, Parel, Mumbai
Mumbai
MAHARASHTRA 
02224177224
02224146937
kdholam@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instutional Ethics Committee, Tata Memorial Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C031||Malignant neoplasm of lower gum,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1) Consenting patients with head and neck carcinoma who have undergone dental implant rehabilitation.
2) Patients who have completed 6 months since implant retained prosthetic rehabilitation.
 
 
ExclusionCriteria 
Details  1) Patients below the age of 18 years.
2) Patients who have recurrences.
3) Implants which cannot be loaded due to various reasons (buccal placement of implant, implant submerged under the submucosa, tilted implants not amenable to prosthetic loading).
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess implant stability after completion of minimum of 6 months since prosthetic rehabilitation and at the next follow up after 6 months  6 months after prosthetic rehabilitation and at the next follow up after 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
i. To compare implant stability in native bone and fibula reconstructed jaw.
ii. To compare implant stability in irradiated and non-irradiated subjects after prosthetic loading of implant.
iii. To assess crestal bone loss (if any) after loading of implants.
 
6 months after prosthetic rehabilitation and at the next follow up after 6 months 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" 
Phase of Trial   N/A 
Date of First Enrollment (India)   31/08/2018 
Date of Study Completion (India) 02/08/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Results will be published in peer reviewed journal 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  
A study is planned to assess the stability of osseointegrated dental implant which has been under prosthetic functional loading in head and neck cancer patients.
Aims: assess implant stability after minimum of 6 months of prosthetic loading and at follow-up after 6 months.
Primary objective: to assess implant stability after completion of minimum of 6 months since prosthetic rehabilitation and at next follow up after 6 months.
Secondary objective: i. to compare implant stability in native bone and fibula reconstructed jaw. ii. to compare implant stability in irradiated and non irradiated subjects after prosthetic loading. iii. to assess crestal bone loss after loading of implant.
Consenting patients who fulfill inclusion and exclusion criteria will be taken up for the study after ethics committee approval. All these patients will have received dental implant rehabilitation and completed a minimum of 6 months of prosthetic loading. The Periotest device will be used to evaluate the implant stability after a minimum of 6 months of prosthetic loading stage and after 6 months at follow up visits. Periotest is a device designed to evaluate mobility of implant by detecting the damping capacity of surrounding bone. It consists of a tapping metal slug. Periotest requires the time required for the tapping metal slug to make contact with an implant using an accelerometer. It can detect bone resorption and reflects the degree of bone implant contact.
 Recording Periotest values:  the measurement of implant stability with Periotest will be done by a single operator. The patient will be seated on a dental chair, with his/her back straight such that the mandible is parallel to the floor. The implant abutment seen in the patients mouth should be at right angles to the floor. The Periotest device will be held by the operator so that it is parallel to the floor and the percussing tip is just away from the implant abutment. Three readings will be recorded for the Periotest values and average of the readings will be taken into account. Panaromic radiographs OPG and intra oral periapical radiographs will be taken as standard protocol for all patients.
Assessment of crestal bone loss: An intra oral periapical radiograph with intraoral x-ray grid will be recorded. This grid in the radiograph will enable measurement of bone levels surrounding the crest of the dental implants.
Evaluation and assessment: first assessment will be done at the time of follow-up of minimum 6 months after loading of the implants (prosthetic rehabilitation). Second assessment will be done again after 6 months at followup. Variables to be studied are: i) Periotest values ii) Radiographic assessment of crestal bone loss if any after loading of dental implants.
Analysis of variables: data will be presented as mean, median (range) and frequency. Continuous variables will be analyzed using independant t test or Mann Whitney test as per distribution. Categorical data will be analysed using Chi-square test or Fisher Exact tesr (for binary data). Paired comparison will be done using Paired t tesr/Wilcoxon signed rank test as per the distribution. Repeated measures ANOVA will be used to compare data at different time points. Data will  analyzed using descriptive statistic using IBM SPSS 24.0 (Armonk, NY). P - value < 0.05 will be considered statistically significant.
50 patients were recruited in the study, of which 40 were males and 10 were females.The age ranged from 18 – 76 years with a mean of 55.55 years.Dental implants were placed in the free fibula flap in 24 patients and in native jaw in 26 patients.In the native jaw, dental implants were placed in 13 maxilla and 41mandibles.With respect to radiation, 37 patients were radiated and 13 patients not radiated. 34 patients had a habit of usage of some form of tobacco (smoking, chewing, paan with arecanut, khaini and masheri).
Most of the patients registered PTV ranging from -8 to 0.This suggests optimum osseointegration after prosthetic loading of the implants.There was imperceptible change overtime between the PTV at follow-up.The outcome of the comparision within the groups at the two time points was not significant. A comparison of the PTV with respect to time i.e. at 6 months and 12 month follow-up showed a similar result (p > 0.05).
5 patients recorded PTV more than +10 which mean insufficient osseointegration.Of the 5 patients 3 showed worsening of the PTV and 2 showed improvement overtime at the follow up readings, though the PTV was more than +8 after improvement. Of the 50 patients 1 dental implant was lost in 1 patient, 1 was submerged in 1 and 1 patient developed recurrence around an implant during the study period.
 
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