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CTRI Number  CTRI/2018/02/011840 [Registered on: 12/02/2018] Trial Registered Retrospectively
Last Modified On: 14/10/2016
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Dentistry 
Study Design  Other 
Public Title of Study   Evaluation of hard tissue dimensional changes following Immediate Implant. 
Scientific Title of Study   Radiographic evaluation of alteration of peri-implant bone following immediate implant placement associated with the use of a synthetic bone substitute 
Trial Acronym  REOAOP 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nihal Devkar  
Designation  Professor 
Affiliation  Sinhgad Dental College and Hospital Pune 
Address  Sinhgad Dental College and Hospital Vadgaon Budruk Off Sinhgad Road Pune
Sinhgad Dental College and Hospital Vadgaon Budruk Off Sinhgad Road Pune
Pune
MAHARASHTRA
411041
India 
Phone  9420481441  
Fax    
Email  drdevkar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anupama Kaulgud 
Designation  PG student 
Affiliation  Sinhgad Dental College and Hospital Pune 
Address  Sinhgad Dental College and Hospital, Vadgaon Budruk, Off Sinhgad Road, Pune
Sinhgad Dental College and Hospital, Vadgaon Budruk, Off Sinhgad Road, Pune
Pune
MAHARASHTRA
411041
India 
Phone  7774039929  
Fax    
Email  drakaulgud@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Nihal Devkar  
Designation  Professor 
Affiliation  Sinhgad Dental College and Hospital Pune 
Address  Sinhgad Dental College and Hospital Vadgaon Budruk Off Sinhgad Road Pune
Sinhgad Dental College and Hospital Vadgaon Budruk Off Sinhgad Road Pune
Pune
MAHARASHTRA
411041
India 
Phone  9420481441  
Fax    
Email  drdevkar@gmail.com  
 
Source of Monetary or Material Support  
Sinhgad Dental College and Hospital, Vadagaon (Bk)., Off Sinhgad road, Pune,411041, Maharashtra 
 
Primary Sponsor  
Name  Sinhgad Dental College and Hospital 
Address  Sinhgad Dental College and Hospital, Vadgaon Budruk, Off Sinhgad Road, Pune  
Type of Sponsor  Private medical 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 Nihal Devkar  Sinhgad Dental College and Hospital, Pune  Dept of Periodontology, Room No.4, Vadgoan (Bk)., Off Sinhgad road, Pune 411041
Pune
MAHARASHTRA 
9420481441

drdevkar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sinhgad Dental College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients who need extraction of teeth in premolar zone due to trauma, endodontic failure or non-restorable carious teeth,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
Intervention  Titanium Dental Implant, calcium phosphosilicate bone graft  Titanium dental implant placement in Maxillary and Mandibular anterior and premolar zone.Calcium phosphosilicate bone graft placed between the implant and buccal plate. Evaluation of the outcome after 6 months period. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1. Systemically healthy patients between the age group 20 – 45 years.
2. Patients who need extraction of teeth in the premolar zone (anteriors and premolars).
3. Indications for extraction include trauma, endodontic treatment failure, or non-restorable carious teeth.
4. Teeth with healthy periodontium.
5. Alveolar sockets with 4 wall architecture and intact labial plate.
6. Patients willing to participate and sign an informed consent.
7. Patients who are compliant.
 
 
ExclusionCriteria 
Details  1. Patients who are systemically compromised.
2. Patients having history of smoking.
3. Patient having history of bone disorder.
4. Teeth having acute periapical or periodontal pathology.
5. Pregnant and lactating females.
6. Parafunctional habits.
7. Compromised soft tissue conditions at the surgical site.
8. Extraction sockets with one or more bony walls damaged.
9.Teeth showing periapical radiolucency.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
a. Horizontal measurement: of buccal and palatal cortical plates
b. Horizontal measurement of total bucco-lingual width of alveolar bone
c. vertical facial bone level
 
After 6 months follow-up radiograph.
 
 
Secondary Outcome  
Outcome  TimePoints 
none  none 
 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   18/08/2015 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

After tooth extraction,resorption of the alveolar walls has been observed. Since the buccal bone wall is predominantly composed of bundle bone, resorption is greater in this area, whereas less resorption of the lingual walls has been found, since they are thicker and composed of substantial proportions of lamellar bone.1,2

    On average, a loss of about 50% of the buccal bone contour has to be expected within 3 months after extraction.2,3Various strategies like socket preservation techniques and immediate implants have been tested to minimize the resorption and maintain the ridge dimensions after extraction.2

The placement of the implant into the fresh extraction socket is called as   Immediate implant. The advantages of the immediate implant includes reduced number of visits and surgical procedures, diminishing patient morbidity, and in some cases, enable immediate restoration.4,5,6

Despite these advantages, however, immediate implant placement has always been a challenge for clinicians because of its unpredictable outcome associated with implant position and soft tissue stability.7

 

Studies have demonstrated that buccolingual hard tissue resorption occurs irrespective of implant insertion.8,9Several approaches have been suggested in order to minimize the resorption process and/or promote better healingwith immediate implants. This includes implants with different geometries, collagen membranes, use of various graft or filler materials between the implant and the buccal bone wall.10

 

Commercially, bioactive glasses are available in different morphologic forms. A putty form (Novabone Dental Putty)of premixed composite of bioactive calcium silicophosphate has been made available.11

 

It is composed of elements naturally occurring in the body, which signals genetic pathways to accelerate natural bone growth. This process is defined as Osteostimulation. Osteostimulation leads to a catalytic response that accelerates the natural healing process and bone regeneration.NovaBone Dental Putty is available in multiple delivery mechanisms: clamshells, syringes and ‘Cartridge Delivery System’.It is dispensed in a pre-mixed state and can be placed directly into the defect site from the package.

 

It has found its multiple clinical applications in dentistry in the treatment of bone defects, ridge and socket preservations, and periodontal osseous defects including furcation defects.11

Aim:

To evaluate radiographic (CBCT) outcomes of the alveolar ridge following palatal flapless Immediate implant placement associated with the use of a synthetic bone graft placed between the implant and inner surface of the buccal alveolar plate.

 

Objectives:

 

 1. To evaluate and compare the horizontal alveolar ridge changes on facial and palatal cortical plates after placement of immediate implant associated with synthetic bone graft.

 

2.  To evaluate and compare totalbucco-lingual dimensional changes after   placement of immediate implant associated with synthetic bone graft.

 

 3. To evaluate and compare the verticalbuccal alveolar ridge changes after the placement of immediate implant associated with synthetic bone graft.

 
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