| 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
|
|
|
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
|
|
|
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. |