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CTRI Number  CTRI/2026/03/106456 [Registered on: 18/03/2026] Trial Registered Prospectively
Last Modified On: 19/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Evaluation of fully guided, pilot guided and freehand surgical protocols on accuracy of implant position in mandibular posterior partial edentulous region 
Scientific Title of Study   Comparative evaluation of fully guided, pilot guided and freehand surgical protocols on accuracy of implant position in mandibular posterior partial edentulous region: Randomized Control 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 Vaishali Madavi 
Designation  Post Graduate student 
Affiliation  Government Dental College and Hospital, Nagpur 
Address  202, Department of Periodontology, Govt Dental College and Hospital, Nagpur

Nagpur
MAHARASHTRA
440012
India 
Phone  9940296613  
Fax    
Email  vaishalimadavi.18@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vivek Thombre 
Designation  Associate Professor 
Affiliation  Government Dental College and Hospital, Nagpur 
Address  202, Department of Periodontology, Govt Dental College and Hospital, Nagpur

Nagpur
MAHARASHTRA
440003
India 
Phone  9860478817  
Fax    
Email  drvivekthombre@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vivek Thombre 
Designation  Associate Professor 
Affiliation  Government Dental College and Hospital, Nagpur 
Address  202, Department of Periodontology, Govt Dental College and Hospital, Nagpur

Nagpur
MAHARASHTRA
440003
India 
Phone  9860478817  
Fax    
Email  drvivekthombre@gmail.com  
 
Source of Monetary or Material Support  
Government Dental College & Hospital, Medical College Campus, Ajni, Nagpur - 440003, Maharashtra, India 
 
Primary Sponsor  
Name  Dr Vaishali Madavi 
Address  Dept. Of Perioodntology, Government Dental College & Hospital, Medical College Campus, Ajni, Nagpur - 440003, Maharashtra, India 
Type of Sponsor  Other [Self] 
 
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 Vaishali Madavi  Government Dental College and Hospital Nagpur  Government Dental College & Hospital, Medical College Campus, Ajni, Nagpur - 440003, Maharashtra, India
Nagpur
MAHARASHTRA 		 9940296613

vaishalimadavi.18@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K084||Partial loss of teeth,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Freehand   Implants placed with freehand surgical protocol without the help of any surgical guides  
Intervention  Fully guided   Implants placed with fully guided surgical protocol where implants will be placed with the help of digitally 3D fabricated surgical guide from initial drill till final implant placement 
Intervention  Pilot guided  Implants placed with pilot guided surgical protocol with the help of dgitially 3D fabricated surgical guide only for initial pilot drill palcement. 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Age between 25 and 60 years
Good general health with signed informed consent
Good oral hygiene with full mouth plaque score
Systemically healthy subjects requiring and opting dental implants for partial edentulous space of atleast 2 neighbouring teeth in mandibular
posterior region.
Clinical situation fit for implantation as judged by the examining physician
or principal investigator (satisfactory soft and hard tissue conditions and
occlusion).  
 
ExclusionCriteria 
Details  Pregnant or lactating females
Bisphosphonate treatment (either at the time of screening or in the history)
Radiotherapy, irradiation of the mandible or the maxilla (either at the time of screening or in the history)
INR more than 2.5.
Known HIV, Hepatitis B or Hepatitis C infection.
Known allergy to any component of the implant or the implant guide.
Untreated periodontal disease and or caries
Conditions that might render intraoral manipulation impossible (limited
mouth opening, excessive gag reflex  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Angular deviation
2. Linear deviation at coronal (mm)
a.Linear Facio-Lingual deviation at coronal(mm)
b.Linear Mesio-Distal deviation at coronal (mm) c.Linear Apico-Coronal deviation at coronal (mm)
3. Linear deviation at apex (mm)
a.Linear Facio-Lingual deviation at apex (mm)
b.Linear Mesio-Distal deviation at apex (mm)
c.Linear Apico-Coronal deviation at apex (mm)  		 Baaseline and 1 week 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   29/03/2026 
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)   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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  vaishalimadavi.18@gmail.com

  6. For how long will this data be available start date provided 12-01-2026 and end date provided 12-01-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   In this clinical trial, dental implants will be placed by fully guided, pilot guided and freehand surgical implant protocols in partially edentulous mandibular posterior region. The implants will be planned with CBCT and after intraoral scanning, the DICOM and STL files obtained will be merged and fabrication of guides will be done. The accuracy of implant position will be evaluated and compared for all three groups. 
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