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CTRI Number  CTRI/2024/07/071152 [Registered on: 23/07/2024] Trial Registered Prospectively
Last Modified On: 22/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Single Arm Study 
Public Title of Study   Estimation of success of Socket shielding technique in patients requiring immediate implant placement in anterior aesthetic region as a replacement of bone graft  
Scientific Title of Study   Assessment of effectiveness of socket shielding in the placement of immediate implants in anterior aesthetic region 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ashwin Shravan Kumar 
Designation  Post graduate resident 
Affiliation  Sree Balaji dental college and hospital 
Address  Room no-3, Department of Oral and maxillofacial surgery, Sree balaji dental college and hospital, Velachery main road, Narayanapuram, Pallikaranai, Chennai-600100

Chennai
TAMIL NADU
600100
India 
Phone  8220372540  
Fax    
Email  drashwinomfs@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Balakrishnan 
Designation  Professor 
Affiliation  Sree Balaji dental college and hospital 
Address  Room no-3, Department of Oral and maxillofacial surgery, Sree balaji dental college and hospital, Velachery main road, Narayanapuram, Pallikaranai, Chennai-600100

Chennai
TAMIL NADU
600100
India 
Phone  9884630045  
Fax    
Email  drbalakrishnanomfs@gmail.com  
 
Details of Contact Person
Public Query  
Name  Ashwin Shravan Kumar 
Designation  Post graduate resident 
Affiliation  Sree Balaji dental college and hospital 
Address  Room no-3, Department of Oral and maxillofacial surgery, Sree balaji dental college and hospital, Velachery main road, Narayanapuram, Pallikaranai, Chennai-600100

Chennai
TAMIL NADU
600100
India 
Phone  8220372540  
Fax    
Email  drashwinomfs@gmail.com  
 
Source of Monetary or Material Support  
Sree Balaji Dental college and hospital, Velachery main road, Narayanapuram, Pallikaranai, Chennai-600100 
 
Primary Sponsor  
Name  Ashwin Shravan Kumar 
Address  Room no-3, Department of Oral and Maxillofacial surgery, Sree balaji dental college and hospital, Velachery main road, Narayanapuram, Pallikaranai, Chennai-600100 
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 Ashwin Shravan Kumar  Sree Balaji Dental College and Hospital  Room no-3, Department of Oral and maxillofacial surgery,Sree balaji dental college and hospital, Velachery main road, Narayanapuram, Pallikaranai, Chennai-600100
Chennai
TAMIL NADU 		 8220372540

drashwinomfs@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE ETHICS COMMITTEE (CLINICAL TRIAL) SREE BALAJI DENTAL COLLEGE AND HOSPITAL  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 8||Other Procedures, (2) ICD-10 Condition: K083||Retained dental root,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Effectiveness of socket shielding in immediate implant placement in anterior aesthetic region  post operative osseointegration to be checked for 1 week, 4 week and 12 week period 
Comparator Agent  Not applicable  Not applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  patients requiring extraction of anterior teeth due to trauma 
 
ExclusionCriteria 
Details  patients requiring extraction of anterior teeth due to periodontitis
patients requiring extraction of anterior teeth due to periapical pathologies
medically compromised patients 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Replacement of graft
Better stability of implant 		 At baseline, 1 week, 4 week and 12 week 
 
Secondary Outcome  
Outcome  TimePoints 
Bone growth & bone loss
Osse integration of implant 		 at baseline, 1 week,4 week & 12 week 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
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 3 
Date of First Enrollment (India)   30/08/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Other (Terminated) 
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  

Aims and objectives: The aim of the study is to provide an alternative treatment modality in immediate implant placement in the anterior aesthetic region by assessing the effectiveness of socket shielding technique for immediate implant placement with respect to specific clinical and radiographic parameters.

The main objectives of study will be: 

  1. Reducing need of bone graft there by reducing the cost of treatment

  2. Reducing the post operative complications of grafting

  3. Making a convenient and easy surgical technique thereby reducing operating time

  4. Promoting faster osseointegration of implants

  5. Providing a minimally invasive procedure benefitting the general population

  6. Providing more aesthetic value to the therapy 


Materials and methods: 

 Type Of Study : prospective study

Site of study : Sree Balaji Dental College and Hospital

Samplesize : 10 

   Sampling method: Purposive sampling

Study Design : clinical study

 Funding : self

 Expenditure : 90000

INITIALLY THE STUDY WILL BE PERFOMED BY SKILLED PROFESSIONAL AND THE INVESTIGATOR WILL BE PERFORMING UNDER GUIDANCE AFTER PROPER OBSERVATION OF INITIAL CASES 


Inclusion criteria:

 Cases requiring extraction of teeth in the anterior region of maxilla and mandible 

Patients above 18 years of age 


Exclusion criteria: 

Anterior teeth requiring extraction with periapical pathology.

 Completely edentulous patients.

Immunocompromised patients. 

 Patients with other systemic conditions contraindicated for surgery.


Procedure: 

1. Patient consent both written and informed will be obtained

 2. Pre-operative assessment and examination 

2a. History of the patient: The pre-operative data will be collected and recorded including name, age, gender, occupation, address, onset and aetiology of the fracture 

2b. Clinical examination

  Extraoral examination

 Inspection: To record swelling, or sinus discharge in the teeth to be extracted. 

 Intraoral examination

  Inspection: To find out mobility, presence of any cystic lesion or sinus tract opening

Palpation: To detect areas of tenderness and alteration of bony contour, each tooth was examined for mobility and fracture. 


2c. Radiographic examination:

Standard orthopantomograms (OPG) and intraoral periapaical radiographs (IOPA)  will be performed for all the cases.


3. Operative Procedure 

Patient will be prepared under sterile aseptic protocol

Preparation of surgical site will be done with 5% betadiene solution

Local anaesthesia (lignocaine) with adrenaline (1:80000) will be administered in buccal and palatal aspects as infiltration anaesthesia

Vertical release incision will be placed

Full thickness mucoperiosteal flap will be raised

Tooth will be sectioned using periotome and palatal fragment will be removed leaving behind the intact buccal fragment

Pulp tissue if present will be extripated

Initial pilot drill will be placed followed by sequential drilling

Implant will be placed in the socket and cover screw placement to be done

Check Xray will be taken for analysing the position of implant

Closure of socket will be done using simple interrupted or mattress suture

 
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