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CTRI Number  CTRI/2023/02/049420 [Registered on: 02/02/2023] Trial Registered Prospectively
Last Modified On: 03/06/2023
Post Graduate Thesis   
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparision between healing extraction socket with and without use of Autogenous Sticky dentin for Socket Preservation Following Tooth Extraction 
Scientific Title of Study   A Clinical and Radiographic Comparative Evaluation of healing extraction socket with and without use of Autogenous Sticky dentin for Socket Preservation Following Tooth Extraction 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ashutosh Agarwal 
Designation  POST GRADUATE STUDENT 
Affiliation  Government College of Dentistry Indore 452001 
Address  Government College of Dentistry Indore , Department of Periodontology ,Room No 10

Indore
MADHYA PRADESH
452001
India 
Phone  09399039680  
Fax    
Email  masterashutoshagarwal@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shaleen Khetarpal 
Designation  Reader  
Affiliation  GOVERNMENT COLLEGE OF DENTISTRY INDORE 452001 
Address  Government College of Dentistry Indore ,Department of Periodontology, Room no10

Indore
MADHYA PRADESH
452001
India 
Phone  9827529603  
Fax    
Email  drshaleenk@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr ASHUTOSH AGARWAL 
Designation  POST GRADUATE STUDENT 
Affiliation  GOVERNMENT COLLEGE OF DENTISTRY INDORE 452001 
Address  Government College of Dentistry Indore ,Department of Periodontology, Room no 10

Indore
MADHYA PRADESH
452001
India 
Phone  09399039680  
Fax    
Email  masterashutoshagarwal@gmail.com  
 
Source of Monetary or Material Support  
Government College of Dentistry Indore  
 
Primary Sponsor  
Name  DR ASHUTOSH AGARWAL 
Address  GOVERNMENT COLLEGE OF DNTISTRY INDORE 
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 ASHUTOS AGARWAL  Government College of Dentistry Indore  Government College of Dentistry Indore, Department of Periodontology, Room No 10
Indore
MADHYA PRADESH 
9399039680

masterashutoshagarwal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTION ETHICS COMMITTE GOVERNMENT COLLEGE OF DENTISTRY INDORE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K029||Dental caries, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  AUTOGENOUS TOOTH  AUTOGENOUS GRAFT PREPARE FROM TOOTH AND GRAFTED IN EXTRACTED SOCKET at T0 (Base line) and evaluate after 4 months (T1) 
Comparator Agent  AUTOGENOUS TOOTH  INTER GROUP COMPARISION OF HEALING SOCKET WITHOUT USE OF AUTOGENOUS STICKY DENTIN AT T0(base line) to after four months (T4) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Adult patients, free of any known systemic illness (such as diabetes mellitus, hypertension, or on drugs like steroids) who agreed to participate.
Periodontal sound toot that indicated for extraction due to trauma, root caries, iatrogenic errors.
18 to 60 years of age and able to sign an informed consent form.
Maintainable oral hygiene.
Who will be ready to have their progress followed for at least 4-months.
 
 
ExclusionCriteria 
Details  Patients with systemic illness/systemic drugs that would affect postoperative healing.
Patients with poor oral hygiene
Periodontal compromised patients with severe bone loss
Pregnancy or lactation
Psychiatric illness,
Unwillingness to return for the follow-up examination
 
 
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   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To Measure the Vertical Bone Fill In Healed Socket   TO Measure immediately After Extraction of Tooth and T4 Measure extraction Socket After 4 months 
 
Secondary Outcome  
Outcome  TimePoints 
TO EVALUATE CHANGES IN SOFT TISSUE   4 WEEKS AND 16 WEEKS 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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 2/ Phase 3 
Date of First Enrollment (India)   10/02/2023 
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="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response (Others) -  -

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response (Others) -  -
  3. Who will be able to view these files?
    Response (Others) -  -

  4. For what types of analyses will this data be available?
    Response (Others) -  -

  5. By what mechanism will data be made available?
    Response (Others) -  -

  6. For how long will this data be available start date provided 20-11-2022 and end date provided 20-11-2024?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NO
Brief Summary  

·        After tooth extraction, the remaining socket heals from the apex toward the crest.

·        When no additives are placed into the socket at the time of the extraction, the soft-tissue infiltration at the crest often results in facial and crestal bone loss.

·        Most of the bone loss occurs during the first six months after the procedure. Afterward, the resorption rate progresses at a pace of 0.5–1% on average annually. Moreover, an estimated 50% of the alveolar bone width is lost within 12 months after the extraction, 30% of which occurs within the first 12 weeks. 

·        Dimensional changes after tooth extraction often result in bone resorption that complicates placement of implants or traditional prosthesis.

·        Socket preservation is a surgical procedure, in which graft material or a scaffold is placed in a fresh extraction socket to preserve the alveolar ridge dimensions for a future prosthesis.

·        There are many techniques, like using autogenous, allogeneic, xenograft, and alloplast graft materials, to guide and assist specialized cellular components of the periodontium to participate in the regenerative process to preserve bone width and height of the alveolus.

·        At present, all extracted teeth are generally considered clinical waste and, therefore, are simply discarded.

·        Recently, several studies have reported that extracted teeth from patients, which undergo a process of cleaning, grinding, demineralization, and disinfection, can be a very effective graft to fill alveolar bone defects in the same patient.

·        Injectable platelet-rich fibrin (iPRF ) forms a dynamic fibrin gel embedding platelets, leukocytes, type 1 collagen (COL1), osteocalcin (OC), and growth factors and providing slow release of growth factors it also stimulate intrinsic tissue regeneration capacity by stimulating the proliferation of human mesenchymal stem cells (MSCs) by inducing osteogenic differentiation of MSCs

The dentin graft preparation done according to protocol given by Dwivedi A, Kour M. A neoteric procedure for alveolar ridge preservation using autogenous fresh mineralized tooth graft prepared at chair side. Journal of Oral Biology and Craniofacial Research. 2020 Oct 1;10(4):535-41.

·        After adequate local anaesthesia atraumatic extraction of tooth is done. Then tooth is cleaned with carbide bur removing all soft tissue debris if any.

·        Enamel is sectioned off from tooth by carbide bur and pulpal tissue is extirpated by endo hand files and root canal is cleaned and made pulp free.

·        Autogenous dentin graft is prepared by conventional grinder of 1500w

·        Graft is then demineralised and sterilised by 30%basic alcohol (combination of NAOH +ethyl alcohol ) for 10 mins

·        Graft is then washed twice in phosphate buffer saline and now Graft is ready.

·        5ml blood is withdrawn from patient for preparation of injectable PRF (iPRF) and dentin graft is placed into i-PRF forming sticky dentin

This sticky dentin is placed into extraction socket site and extraction socket is approximated by applying abgel sponge followed by suturing

thtThe purpose of study  is to evaluate and compare the radiographical vertical bone fill in self healing socket vs sticky dentin grafted socket.

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