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CTRI Number  CTRI/2024/08/072596 [Registered on: 16/08/2024] Trial Registered Prospectively
Last Modified On: 14/08/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Biological
Dentistry 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Effectiveness of powdered tooth combined with amniotic membrane in healing of third molar socket in patients undergoing extraction of tooth 
Scientific Title of Study   Effectiveness of autogenous dentin graft along with amniotic membrane in post extraction wound healing  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nidhisha L K 
Designation  Undergraduate Student  
Affiliation  A.J. Institute of Dental Sciences  
Address  Department of Oral Surgery, Room NO 2, Ground Floor, A.J. Institute of Dental Sciences, Kuntikana, Mangalore

Dakshina Kannada
KARNATAKA
575004
India 
Phone  7619656032  
Fax    
Email  lknidhisha@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Karthik Kumar 
Designation  Assistant Professor  
Affiliation  A.J. Institute of Dental Sciences  
Address  Department of Oral Surgery, Room No 2, Ground Floor, A.J. Institute of Dental Sciences, Kuntikana, Mangalore

Dakshina Kannada
KARNATAKA
575004
India 
Phone  9901518944  
Fax    
Email  karthikkumar.kk69@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Karthik Kumar  
Designation  Assistant Professor  
Affiliation  A.J. Institute of Dental Sciences  
Address  Department of Oral Surgery, Room No 2, Ground Floor, A.J. Institute of Dental Sciences, Kuntikana, Mangalore

Dakshina Kannada
KARNATAKA
575004
India 
Phone  9901518944  
Fax    
Email  karthikkumar.kk69@gmail.com  
 
Source of Monetary or Material Support  
Rajiv Gandhi University of Health Sciences,4th T Block, Jayanagar, Bangalore 560041 Karnataka, India 
 
Primary Sponsor  
Name  Nidhisha L K 
Address  A.J. Institute of Dental Sciences, NH 66, Kuntikan, Mangaluru, Karnataka 575004 India 
Type of Sponsor  Other [] 
 
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 Karthik Kumar   A J Institute of Dental Sciences  Department of Oral and Maxillofacial surgery, Room No 2, ground floor ,NH66, Kuntikan, Mangalore Karnataka 575008
Dakshina Kannada
KARNATAKA 
9901518944

karthikkumar.kk69@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AJIDS Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z481||Encounter for planned postprocedural wound closure,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Autogenous dentin graft along with amniotic membrane   Autogenous dentin graft along with amniotic membrane with standard of care will be used to facilitate wound healing which will placed once immediately after extraction. Patient will be assessed for wound healing at 10 days, 1 month and 3 months. 
Comparator Agent  Standard of Care  Standard of Care will be provided immediately after extraction. Wound Healing will be assessed at 10 days, 1 month and 3 months. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  Indications for extractions of impacted lower third molar
Patients belonging to ASA I and II
Identical third molar impactions on either sides 
 
ExclusionCriteria 
Details  Pregnant or lactating women
Patients with periodontal diseases
Patients with carious impacted tooth
Periapical pathologies associated with impacted lower molar 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Wound Healing will be considered to be a success if more than 2/3rd of the socket is filled with bone, which will be assessed using radiograph at Ten days, one month and three months  Ten days, one month and three months 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="15"
Sample Size from India="15" 
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)   26/08/2024 
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="0"
Months="3"
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  
According to world health organization an impacted tooth, is the one that is unable to fully erupt in its normal functional occlusion/location by its expected age of eruption, because it is blocked by overlying soft tissue or bone or another tooth. Impacted third molars are classified by winters in 1926 according to the long axis of the second molar as mesioangular impaction, distoangular impaction, horizontal impaction, vertical impaction, transverse impaction and inverted impaction. In Impacted lower third molar extraction . Surgery, whether prophylactic or therapeutic, is a very common procedure in the field of oral and maxillofacial surgery. In case where the teeth are deeply impacted and covered by large quantity of bone. The frequency of impaction lies between 66% and 77% . In addition to its high prevalence, third molar extraction is a surgical procedure accompanied by complications that include periodontal problems characterized by bone loss on the distal aspect of the second molar. Post extraction socket healing is a coordinated, sequence of biochemical, physiological cellular response, aiming to restore tissue integrity and functional capacity. Over the years, surgical adjuvant, bone grafting have been used to improve periodontal status, regeneration, bone quality . Over the years, a lot of efforts have been made to improve the periodontal status of 2nd molar after surgical removal of third molar. Osborne et al showed only minimal reduction. of PD or induction of reattachment of gingival tissues achieved by root planning the distal aspect of second molar after extraction of an adjacent impacted third molar. Similarly, little or no benefit was found with different flap designs used in these situations. Guided tissue regeneration (GTR)-based procedures with or without bone grafting therapies provide some adjunctive clinical benefit compared to standard non-grafting procedures. Augmentation of the osseous defect with bone grafts has become one of the most common surgical techniques in recent years. Various bone-grafting materials have been used in post extraction site, include autogenous bone (harvested from the mandible during the rotatory osteotomy), allogenic bone, platelet rich plasma, plateletrich fibrin, synthetic bone graft substitutes (eg, Bio-oss, bioactive glass, and synthetic calcium hydroxyapatite) and a combination of these materials. Although different degrees of success were achieved, the autogenous bone. still proved to be the gold standard for bone regeneration, because of its osteoconductive and osteoinductive properties. The autotooth bone graft material is a system that treats patients by manufacturing bone graft material from their own extracted teeth. It has first been introduced by the Korea Tooth Bank R&D Center and has satisfied many clinicians and patients for its osteoconduction as well as osteoinduction capacity. Human dentin is composed of 70% organic content with four types of calcium phosphate (hydroxyapatite, tricalcium phosphate, octacalcium phosphate, and amorphous calcium phosphate), which provide dentin with its osteoconductive properties. However few studies are done where autogenous bone graft showed better results than other bone grafts, but relatively less studies have addressed combination of autogenous dentin graft with amniotic membrane in the extracted socket. Therefore, the purpose of the study is to evaluate effectiveness of autogenous dentin graft combined with amniotic membrane in wound healing after impacted third molar extraction. 
 
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