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CTRI Number  CTRI/2023/04/052030 [Registered on: 27/04/2023] Trial Registered Prospectively
Last Modified On: 27/04/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Dentistry
Other (Specify) [Bone graft Evaluation]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Socket preservation by Bone graft placement 
Scientific Title of Study   Comparison of Bone Mineral Density and Primary Implant Stability after Socket Preservation by Calcium Phospho-silicate Putty, Sticky Bone and Natural Bone Healing: A Randomized Controlled Clinical Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kshipra Kawadkar 
Designation  Post Graduate Student 
Affiliation  VYWS Dental College and Hospital 
Address  Kawadkar hospital, 6, 7 tantra nagar, nandura road , khamgaon-444303.
Kawadkar hospital
Amravati
MAHARASHTRA
444303
India 
Phone  09404693955  
Fax    
Email  kshipra.kawadkar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Simran Parwani 
Designation  HOD and Professor department of periodontology 
Affiliation  VYWS Dental College and Hospital 
Address  Tapovan wadali road, camp road, SRPF colony, amravati

Amravati
MAHARASHTRA
444602
India 
Phone  9977132697  
Fax    
Email  simpar74@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Kshipra Kawadkar 
Designation  Post Graduate Student 
Affiliation  VYWS Dental College and Hospital 
Address  Kawadkar hospital, 6, 7 tantra nagar, nandura road , khamgaon-444303.
Kawadkar hospital
Amravati
MAHARASHTRA
444303
India 
Phone  09404693955  
Fax    
Email  kshipra.kawadkar@gmail.com  
 
Source of Monetary or Material Support  
VYWS Dental College And Hospital, Amravati 
 
Primary Sponsor  
Name  Dr Kshipra P Kawadkar 
Address  VYWS Dental College and Hospital, amravati-444602 
Type of Sponsor  Research institution and hospital 
 
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 KSHIPRA  Department of Periodontology   Department no 16, PG section room,1st floor,VYWS, Dental College and Hospital, Amravati.
Amravati
MAHARASHTRA 
9404693955

kshipra.kawadkar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC-VYWSDCHA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NATURAL HEALING SOCKETS  to evaluate bone mineral density and primary implant stability at the time of implant placement in sockets preserved with natural healing without adding bone graft after 4 months of extraction 
Comparator Agent  NIL  NIL 
Intervention  NOVABONE PUTTY  to evaluate after 4 months efficay of using novabone putty in socket prerservation to evaluate bone mineral density and primary implant stability at the time of implant placement 
Intervention  STICKY BONE  To evaluate after 4 months of socket preservation after extraction by sticky bone with help of CBCT by Bone Mineral Density and primary implant stability at the time of implant placement . 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1)Participants in the age range of 18 to 50 years
2)Participants having good oral hygiene
3)Presence of tooth or root piece indicated for extraction
4)Participant’s willingness for implant placement
5)Loe and Silness Gingival index less than or equal to 1
 
 
ExclusionCriteria 
Details  1) Acute infection.
2) Medically compromised patients.
3) Uncooperative patients.
4) Non-compliant patients for oral hygiene maintenance
5) Subjects with abnormal bleeding/clotting time
6) Presence of periodontal pockets
7) History Of Irradiation in Head and Neck
8) Uncontrolled diabetic patients (reported levels of glycemia over the normal threshold)
9) Current pregnancy or lactation
10) Current Smokers
 
 
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   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. To evaluate and compare the differences in bone mineral density by Lekholm and Zarb (1985) classification on CBCT.
2. Primary stability of implants after four months of socket preservation by nova-bone putty and sticky bone compared to spontaneous/ natural healing.
 
4 months after graft placement in socket the implant placement and bone density will be evaluated
 
 
Secondary Outcome  
Outcome  TimePoints 
NONE  NONE 
 
Target Sample Size   Total Sample Size="27"
Sample Size from India="27" 
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)   29/04/2023 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   not yet as trial is in initial stages 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Socket preservation is a procedure which preserves the hard as well as soft tissues of the alveolar ridge after tooth extraction. 40% bone height reduction and 60% bone width reduction occur after 6 months of extraction. Bone loss occurs more on labial surface rather than lingual or palatal surface.This alveolar ridge resorption makes it difficult or next to impossible for fabrication of implant supported prosthesis. Thakkar et al. conducted a clinical study to evaluate bone healing and soft tissue alterations after removal of teeth. The authors found that after 12 months 50% of buccolingual width of edentulous site was lost. They concluded that preservation of bone in that area is mandatory specifically if osseo-integrated implants are to be planned. Various studies have shown positive impact of using different grafts, membranes and growth factors to preserve the sockets compared to spontaneous healing. Primary implant stability is a prerequisite for a predictable, long term secondary stability (Osseo-integration), the success of secondary stability depends upon the bone quality and quantity at the receptor site. The term ‘‘bone quality’’ is not clearly defined in the literature. This includes physiological and structural aspects and the degree of bone tissue mineralization.

The present study is aimed to investigate bone mineral density (by Lekholm and Zarb classification, 1985), on Cone Beam Computed Tomography [CBCT] and primary implant stability (by Insertion Torque Value [ITV]) after three months of socket preservation with:  Nova bone putty (Group A); Sticky bone (Group B) as compared to spontaneous healing (Group C).

 
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