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CTRI Number  CTRI/2025/03/082220 [Registered on: 12/03/2025] Trial Registered Prospectively
Last Modified On: 16/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   A study to compare the early bone to implant contact between photofunctionalized and non photofunctionalized titanium dental implant in the mandibular region – A randomized controlled trial 
Scientific Title of Study   A study to compare the early osseiontegration between photofunctionalized and non photofunctionalized titanium dental implant in the mandibular region – A randomized controlled trial 
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 Aditi Shreya 
Designation  Postgraduate 
Affiliation  Bapuji Dental College and Hospital, Davangere, Karnataka 
Address  Department of prosthodontics crown and bridge, room no -07, Bapuji Dental College and hospital, Davangere, Karnataka

Davanagere
KARNATAKA
577004
India 
Phone  7206943552  
Fax    
Email  shreyaaditi99@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr khinnavar poonam  
Designation  professor 
Affiliation  Bapuji Dental College and Hospital, Davangere, Karnataka 
Address  Department of prosthodontics crown and bridge, room no -07, Bapuji Dental College and hospital, Davangere, Karnataka

Davanagere
KARNATAKA
577004
India 
Phone  7206943552  
Fax    
Email  kpoonamk2000@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Aditi Shreya 
Designation  Postgraduate 
Affiliation  Bapuji Dental College and Hospital, Davangere, Karnataka 
Address  Department of prosthodontics crown and bridge, room no -07, Bapuji Dental College and hospital, Davangere, Karnataka

Davanagere
KARNATAKA
577004
India 
Phone  7206943552  
Fax    
Email  shreyaaditi99@gmail.com  
 
Source of Monetary or Material Support  
bapuji dental college and hospital,MCC B Block, Davanagere, Karnataka 577004, India 
 
Primary Sponsor  
Name  Self funded 
Address  Dr. ADITI SHREYA Room number 7 Department of Prosthodontics and Crown Bridge Bapuji Dental College and Hospital Davangere Mobile number 7206943552 
Type of Sponsor  Other [Self funded ] 
 
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 kinnavar poonam k  bapuji dental college, davangere  bapuji implant center , room number -10, bapuji dental college and hospital , davangere
Davanagere
KARNATAKA 
7206943552

kpoonamk2000@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
the institututional review board, bapuji dental college and hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Total or partially edentulous area in mandibular region who are advised for implant placement. Patients aged 25-40 years.  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1.Total or partially edentulous area in mandibular region who are advised for implant placement.
2.Patient between 25-40 years 
 
ExclusionCriteria 
Details  1.Systemic illnesses or metabolic conditions that may affect research
2. Pregnant women, or nursing mothers.
3.Two adjacent teeth with uncontrolled periodontal disease, caries, or radiographic or clinical symptoms of infection.
4.Conditions requiring bone graft.
5.Smokers.
6.Parafunctional habits (bruxism)
7.Current radiation, chemotherapy, or medications that interfere with the study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
clinical and radiographic outcome  4 weeks , 8 weeks, 4 months 
 
Secondary Outcome  
Outcome  TimePoints 
Implant stability quotient and reverse torque  4 months 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
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)   20/03/2025 
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="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

Patients fulfilling the eligibility criteria will be chosen for the study. All the patients will be explained about the procedures involved and those willing to be part of the study will be enrolled. A written voluntary informed consent will be obtained from the willing subjects. A case proforma will be made to record the history the associated signs and symptoms.

 

The subjects will be equally divided in 2 groups on the basis of age 25 to 32 years and 33 to 40 years. 6 patients from each group will further be divided equally into 3 male and 3 female subgroups. The subjects will be sent to control and experiment group randomly. In order to pre decide the appropriate length and diameter of the implants, participants have to undergo a CBCT scan prior to the surgery. The patients will also be divided on the basis of grayscale value which will be used in future to stratify the patient according to bone density. The surgical site will be classified into three bone quality groups (2,3,4) on the basis of the objective evaluation of the grayscale value measured on CBCT scans. The grayscale value above 500 will be classified as bone quality group 2, between 300 to 500 as group 3, and below300 as group 4. The clinician will receive implant fixture/fixtures which is selected for each surgical case. The procedure will be conducted for each patient. The fixture for a participant who needs multiple implant placement will be included in the same group. Hence, the study is implant-based rather than patient-based.

In case of the photofunctionalized group the implant fixtures will be irradiated with a UV machine (DIO UVirradiator) for 20 seconds, so that the desired condition as per the manufacturer’s recommendation is achieved. After that, the implants will be delivered to the clinician. The placement of implant will be conducted according to the conventional procedures. Immediately after the surgery, the implant site will be evaluated using the Intra Oral Periapical radiograph.

The stability of the implant will be assessed using the resonance frequency analysis device (OSSTELL MENTOR), and the Implant stability quotient value (ISQ) will be recorded. The ISQ will be measured immediately after placing the implant, 4 weeks ,8 weeks and 4 months post operatively.

 

The intra oral periapical radiograph will be taken immediately after placing the implant, 8 weeks and 4 months post operatively using the paralleling technique (70KV, 6mA, 120millisecond). The digital radiograph sensor will be placed parallel to the long axis of the implant and the x-ray beam is directed perpendicular to the receptor to visualize the pitches and platform of the fixtures on the radiograph. A specialist who is trained in dental radiography will then evaluate the marginal bone level of the implants in each intraoral periapical radiograph. At first, the whole length of the fixtures will be measured for magnification calibration of the radiographs. After that, the distance from the platform of the fixture to the marginal bone crest is recorded both mesially and distally. The difference between the measured value as compared to the initial value (the value obtained immediately after the surgery) will be calculated for each case and will be considered as bone loss. The mesial and distal bone loss will be calculated separately and will be recorded as mesial and distal marginal bone loss separately for each implant. At 4 months, a reverse torque of 30N will be given to both photofunctionalized and non photofunctionalized implant using torque wrench and implant resistance will be checked. Peri-implant soft tissue evaluation will be done at 8 weeks and 4 months after placement of implants. The soft tissue evaluation will be done using mouth mirror and plastic probe around using Mombelli et al (mGI).

procedures. Immediately after the surgery, the implant site will be evaluated using the Intra Oral Periapical radiograph.

The stability of the implant will be assessed using the resonance frequency analysis device (OSSTELL MENTOR), and the Implant stability quotient value (ISQ) will be recorded. The ISQ will be measured immediately after placing the implant, 4 weeks ,8 weeks and 4 months post operatively.

 

The intra oral periapical radiograph will be taken immediately after placing the implant, 8 weeks and 4 months post operatively using the paralleling technique (70KV, 6mA, 120millisecond). The digital radiograph sensor will be placed parallel to the long axis of the implant and the x-ray beam is directed perpendicular to the receptor to visualize the pitches and platform of the fixtures on the radiograph. A specialist who is trained in dental radiography will then evaluate the marginal bone level of the implants in each intraoral periapical radiograph. At first, the whole length of the fixtures will be measured for magnification calibration of the radiographs. After that, the distance from the platform of the fixture to the marginal bone crest is recorded both mesially and distally. The difference between the measured value as compared to the initial value (the value obtained immediately after the surgery) will be calculated for each case and will be considered as bone loss. The mesial and distal bone loss will be calculated separately and will be recorded as mesial and distal marginal bone loss separately for each implant. At 4 months, a reverse torque of 30N will be given to both photofunctionalized and non photofunctionalized implant using torque wrench and implant resistance will be checked. Peri-implant soft tissue evaluation will be done at 8 weeks and 4 months after placement of implants. The soft tissue evaluation will be done using mouth mirror and plastic probe around using Mombelli et al (mGI).

 
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