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CTRI Number  CTRI/2024/09/073313 [Registered on: 04/09/2024] Trial Registered Prospectively
Last Modified On: 25/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A comparative evaluation of new implant placement technique by conventional way and computerized method: A randomized clinical trial 
Scientific Title of Study   A comparative evaluation of immediate implant placement by Vestibular socket therapy between Dynamic navigation system and conventional placement in defective labial wall cases: A Randomized Clinical 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  Mohamed Thaha A 
Designation  Post Graduate Student 
Affiliation  Saveetha Institute of Medical and Technical sciences 
Address  Department of Periodontics and Implantology, Clinic-25, 4th floor, Saveetha Dental College and Hospitals,162, Poonamalle High Road, Velappanchavadi, Chennai, Tamil Nadu- 600077.

Thiruvallur
TAMIL NADU
600077
India 
Phone  8220694720  
Fax    
Email  mohamedthaha9991@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Kaarthikeyan G 
Designation  Professor And Head of Department 
Affiliation  Saveetha Institute of Medical and Technical sciences 
Address  Department of Periodontics and Implantology, Clinic-25, 4th floor, Saveetha Dental College and Hospitals 162, Poonamalle High Road, Velappanchavadi, Chennai, Tamil Nadu- 600077.

Thiruvallur
TAMIL NADU
600077
India 
Phone  9841222027  
Fax    
Email  kaarthikeyan@saveetha.com  
 
Details of Contact Person
Public Query
 
Name  Dr Kaarthikeyan G 
Designation  Professor And Head of Department 
Affiliation  Saveetha Dental College and Hospitals 
Address  Department of Periodontics and Implantology, clinic 25, 4th floor, Saveetha Dental College and Hospitals, 162, Poonamalle High Road, Velappanchavadi,Chennai, Tamil Nadu, India- 600077.
162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu, India- 600077
Thiruvallur
TAMIL NADU
600077
India 
Phone  9841222027  
Fax    
Email  kaarthikeyan@saveetha.com  
 
Source of Monetary or Material Support  
Department of Periodontics and Implantology, Clinic 25, Saveetha Dental College and Hospitals, Chennai, Tamil Nadu, India - 600077 
 
Primary Sponsor  
Name  Dr Ashish Jain Indian Society of Periodontology 
Address  Secretary ISP, 721, Phase 3B-1, Mohali, SAS Nagar. 160060.  
Type of Sponsor  Other [Speciality society in Dentistry] 
 
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 Mohamed Thaha A  Saveetha Dental college and Hospitals  Department Of Periodontics and Implantology, clinic 25, 4th floor,162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu, India-600077
Thiruvallur
TAMIL NADU 
8220694720

mohamedthaha9991@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Saveetha Dental College - Institutional Human Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K069||Disorder of gingiva and edentulousalveolar ridge, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional free hand Implant placement.  Immediate placement of dental implant following vestibular socket protocol by conventional free hand placement for period of 6 months 
Intervention  Dynamic navigation system  Immediate placement of dental implant following vestibular socket protocol using Dynamic navigation system for 6 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  The tooth in the Maxillary anterior region which had undergone trauma, has root fracture or non-vital teeth with thin labial plate /dehiscence which is indicated for extraction and immediate implant placement 
 
ExclusionCriteria 
Details  Periapical lesions, smokers, pregnant and lactating women, and patients with systemic conditions. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Buccal wall Thickness and marginal bone loss.  6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Pink and white esthetic score  6 months post-operatively. 
 
Target Sample Size   Total Sample Size="26"
Sample Size from India="26" 
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   Phase 1/ Phase 2 
Date of First Enrollment (India)   25/09/2024 
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="2"
Months="0"
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  

 Immediate implants placed conventionally have a high chance of encroaching the safe zone which results in both soft and hard tissue complications in the long run. By using this VST method, we can augment both hard and soft tissue at the extraction site. By using a Dynamic navigation system precise implant placement at 360° in esthetic areas, offering real-time adjustments during osteotomy for enhanced accuracy compared to static guides. The study is a randomized controlled clinical trial proposed to be done in the Department of Periodontics, Saveetha Dental College and Hospitals, Chennai. After patient recruitment, the patients are allotted using lot sampling and patient will be made to pick up the concealed envelop are divided into subsequent groups-
a)The control group is going to be the participants who will be receiving conventional immediate implants via VST.
b)The test group will be receiving implants through DNS via VST.

Technique: Perform vestibular socket therapy by incising 1 cm apical to the tooth. Dissect vestibular pouch towards root apex for access. Use bur for osteotomy at the apex and release the ligament. Elevate root fragments and excavate apex. Place the implant with 360-degree contact using the DNS system. Use xenograft in bone defects with GBR membrane. Suture with 4-0 polypropylene and provide permanent prosthesis after period of temporization. The data from results are compared using Student’s T-test and One-way  ANOVA.  The primary objective is to assess buccal wall thickness and marginal bone loss between the two groups. The pink esthetic score and white esthetic score are also assessed secondarily.

 
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