FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/05/087490 [Registered on: 23/05/2025] Trial Registered Prospectively
Last Modified On: 23/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Single Arm Study 
Public Title of Study   Preserving Jawbone After Wisdom Tooth Removal Using Your Own Bone: A New Study on a Special Bone-Cutting Tool 
Scientific Title of Study   Alveolar Socket Preservation Following Autogenous Bone Grafting Using Auto-Chip Maker In 3rd Molar Extraction Site: An Experimental Study 
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 Priyankur Omer 
Designation  Post Graduate Student 
Affiliation  Institute of Dental Sciences, Bareilly 
Address  Room no. 110 Department of Oral and Maxillofacial Surgery Institute of Dental Sciences, Pilibhit Bypass Road, Opposite Suresh Sharma Nagar, Bareilly- 243006

Bareilly
UTTAR PRADESH
243006
India 
Phone  7571094743  
Fax    
Email  priyankuromar005@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Niranjanaprasad Indra B 
Designation  Professor 
Affiliation  Institute of Dental Sciences, Bareilly 
Address  D-2 D-Block Professor quarters Dental Campus Institute of Dental Sciences, Pilibhit Bypass Road, Opposite Suresh Sharma Nagar, Bareilly- 243006

Bareilly
UTTAR PRADESH
243006
India 
Phone  7248124467  
Fax    
Email  niranjanbvnbt@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Niranjanaprasad Indra B 
Designation  Professor 
Affiliation  Institute of Dental Sciences, Bareilly 
Address  D-2 D-Block Professor quarters Dental Campus Institute of Dental Sciences, Pilibhit Bypass Road, Opposite Suresh Sharma Nagar, Bareilly- 243006

Bareilly
UTTAR PRADESH
243006
India 
Phone  7248124467  
Fax    
Email  niranjanbvnbt@gmail.com  
 
Source of Monetary or Material Support  
Institute of Dental Sciences, Pilibhit Bypass Road, Opposite Suresh Sharma Nagar, Bareilly- 243006 
 
Primary Sponsor  
Name  Institute of Dental Sciences 
Address  Institute of Dental Sciences, Pilibhit Bypass Road, Opposite Suresh Sharma Nagar, Bareilly- 243006 
Type of Sponsor  Other [Private Dental College] 
 
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 Priyankur Omer  Institute of Dental Sciences  Room no. 110 Department of Oral and Maxillofacial Surgery.
Bareilly
UTTAR PRADESH 
7571094743

priyankuromar005@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, IDS, Bareilly, U.P.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K011||Impacted teeth, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Auto-Chip Maker  ALVEOLAR SOCKET PRESERVATION FOLLOWING AUTOGENOUS BONE GRAFTING USING AUTO-CHIP MAKER IN 3RD MOLAR EXTRACTION SITE Clinical follow-up will occur at 24 hours, 72 hours, and 1 week, sutures will be removed, as well as at 1 month, 3 months, and 6 months after the operation. Radiographs will be taken immediately after the procedure, at 3 months, and at 6 months post-operation to evaluate and assess the extent of bone gain. 
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  - Healthy adult individuals between 18-35 years.
- Patient should have adequate bone availability in donor sites.
- Patient who is willing to give informed consent.
- Patient with impacted mandibular third molar. 
 
ExclusionCriteria 
Details  - Patient associated with local site infection or inflammation in donor site.
- Patient who are on medication for any systemic conditions like pregnancy.
- Patient with history of past surgery or trauma reducing the availability of bone at donor site.
- Patient with a history of smoking and tobacco consumption. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Autogenous Bone Grafts is the gold standard in bone regeneration.  24hrs, 72hrs, 1 week, 1 month, 3 month and 6 month. 
 
Secondary Outcome  
Outcome  TimePoints 
Autogenous Bone Grafts is the gold standard in bone regeneration.  Immediate, 3 months, 6 months 
 
Target Sample Size   Total Sample Size="22"
Sample Size from India="22" 
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)   03/06/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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   Autogenous bone graft being a bone graft harvested from the patient’s own body is considered the ‘Gold standard’ amongst other options, due to its superior osteoconductive, osteo-inductive and osteogenic properties.An Auto-Chip Maker serve as an essential tool for harvesting autogenous bone from the mandibular molars or incisors, for achieving guided bone augmentation in the defected site. The use of this device makes it possible to obtain uniform bone chips in minimally traumatic manner for use in bone grafting procedures. Its automation features significantly increase the process and accuracy of use in grafting, shortening the surgery time and improving the clinical outcome for patients.

Patients will be informed about the full procedure, potential benefits, and possible complications through the participant Information Sheet (Appendix I), while written informed consent of all the patients will be taken in their vernacular language (Appendix II). The data of all subjects will be recorded on a customized case history Performa (Appendix III).
Before the surgery, a radiograph will be performed to assess the quality and amount of remaining bone, a clinical evaluation of occlusion will be conducted to identify the available inter-arch space, and laboratory tests will be carried out to check for any underlying systemic conditions.

Surgical planning will be done based on the pre-operative radiograph. Gow Gates Mandibular nerve block will be administered for both pain control and local haemostasis in all patients using local anaesthesia of 2% lignocaine hydrochloride with 1:80000 adrenaline solution.
The tooth will be accessed using a ward’s incision starting at the cervical line of the second molar and extending posteriorly and laterally along the front edge of the ramus. After the tooth is exposed, Bone removal will be done buccal and distal to the impacted tooth by guttering, preserving the lingual aspect, tooth will be then extracted by application of elevator. After wound toileting, a stab incision will be made in the mucobuccal ford at the donor site to reveal the bone underneath.
Next, attach the mount stopper to the auto-chip maker and connect it to the dental implant motor. Position the drill at the donor site by applying gentle pressure while using ample saline irrigation13. The suggested drilling speed ranges from 50 to 300 rpm, with a maximum torque exceeding 50 N cm, while ensuring that the stopper does not exceed 4 mm.
Once the harvested bone is placed in the cavity, remove the bone chips from the Auto-chip Maker and transfer them to the stainless-steel bowl after taking off the stopper. Bone harvested from auto-chip maker will be compacted at the 3rd molar extraction site and sutured.
The patient will be instructed to maintain strict oral hygiene practices and to continue the necessary medications following the surgery. Povidone-iodine mouthwash will be used three times a day for one week, beginning 24 hours after the operation.
Clinical follow-up will occur at 24 hours, 72 hours, and 1 week, at which point sutures will be removed, as well as at 1 month, 3 months, and 6 months after the operation. Radiographs will be taken immediately after the procedure, at 3 months, and at 6 months post-operation to evaluate and assess the extent of bone gain.
 
Close