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CTRI Number  CTRI/2017/10/009979 [Registered on: 03/10/2017] Trial Registered Retrospectively
Last Modified On: 25/09/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Dentistry 
Study Design  Other 
Public Title of Study   To check the bone changes after immediate dental implant placement 
Scientific Title of Study   A radiographic evaluation of peri-implant bone following immediate implant placement with immediate temporization. 
Trial Acronym   
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-411041

Pune
MAHARASHTRA
411041
India 
Phone  9420481441  
Fax    
Email  drdevkar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Divya Agarwal 
Designation  PG Student 
Affiliation  Sinhgad Dental College and Hospital Pune 
Address  Sinhgad Dental College and Hospital Vadgaon Budruk Off Sinhgad Road Pune-411041

Pune
MAHARASHTRA
411041
India 
Phone  9011504817  
Fax    
Email  divagarwal11@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-411041

Pune
MAHARASHTRA
411041
India 
Phone  9420481441  
Fax    
Email  drdevkar@gmail.com  
 
Source of Monetary or Material Support  
Sinhgad Dental College and Hospital Vadgaon Budruk 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-411041 Maharashtra  
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   Dept. of Periodontology,Room no:4,vadgaon(Bk), Off Sinhgad road
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  15 patients who need extraction for trauma, endodontic treatment failure, or non-restorable carious teeth, teeth.,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Platelet Rich Fibrin  Platelet rich fibrin autologous, obtained from a dose of 10 ml intravenous blood, Route- direct delivery to the extraction site. Assessment duration- 6 months  
Intervention  Titanium Dental Implant , beta-tricalcium phosphate alloplast  Immediate Titanium Dental Implant with immediate restoration placed in maxillary and mandibular anterior and premolar zone. Beta-tricalcium phosphate alloplast 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  65.00 Year(s)
Gender  Both 
Details  1.Systemically healthy patients between the age group of 20-65 years with teeth indicated for extraction and future prosthesis.
2.Good oral hygiene defined as a full mouth plaque score <25%(O’Leary et al, 1972)
3.Indications for extraction include trauma, endodontic treatment failure, or non-restorable carious teeth, teeth with healthy periodontium, alveolar sockets with 4 wall architecture and intact labial plate.
4.Ideal soft tissue level and contour at the facial aspect of the failing tooth and thick gingival biotype as determined by De Rouck et al(2009)
5.Teeth should have adequate residual apical bone below the tooth ≥ 4 mm.
6.Patients willing to participate and sign an informed consent.
7.Patients who are compliant.
 
 
ExclusionCriteria 
Details  1.Systemic conditions contraindicating surgical intervention
2.Immediately placed implants that have failed before the prosthetic loading.
3.Patients having history of severe bruxism and/or clenching habits.
4.Smokers.
5.Patient having history of bone disorder.
6.Teeth having acute periapical or periodontal pathology before the extraction.
7.Pregnant and lactating females.

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Horizontal measurement:
1. distance from the external surface of the buccal and Palatal/lingual alveolar plates to the implant surfaces
2.distance from external surface of the buccal alveolar plate to the external surface of the palatal/lingual alveolar plate (buccolingual width)

Vertical facial bone level will be measured on facial surface of the implant as the perpendicular distance from the implant platform to the most coronal point of the facial bone.
 
The sites will be evaluated radiographically at baseline (day of immediate loading) and 6 months after loading. 
 
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)   31/10/2016 
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  

Patients receiving implants today are often unaware of the original loading protocols of 3 to 6 months of load-free healing prior to restorative therapy.

 Often, when patients require extraction of an anterior tooth, they do not accept even the shortest period of partial edentulism.

 Thus, the loss of a single tooth, mainly in the aesthetic zone, and its replacement by implants has been a challenge in recent decades.

There have been two main hurdles to overcome:

1.     -The final aesthetic result

2.     -The long waiting periods required by conventional implant protocols

In the early days of implant dentistry, encapsulation by fibrous connective tissue was reported when implants were immediately loaded, while a period of stress-free healing would allow for direct bone-to-implant contact i.e.

Osseointegration .

 

Therefore the recommended waiting time, according to the original Brånemark protocol, was at least three months in the mandible and six months in the maxilla.

 

However, during the past three decades, technological developments and continuous clinical research have provided us with improved protocols in an attempt to meet the expectations of a shorter treatment period, improved

aesthetics and more convenience for the patient.

 

The terms “non-functional immediate loading”, “immediate restoration” or “immediate provisionalization” or “immediate temporization” are used when the prosthesis is placed on implants at some point within the first 72 hours without

full occlusal contact with the teeth of the opposite jaw.

 

Keeping the provisional restoration out of occlusion has to do with the idea of controlling the load on a single tooth. Several studies have reported a high success rate on single-tooth implants placed post-extraction which received an immediate non-functional provisional crown.

 

The most important reason of immediate implant placement with immediate temporization is that positioning an implant into a post-extractive socket can considerably reduce crestal bone resorption and at the same time provide aesthetic rehabilitation immediately after extraction of the tooth especially in the aesthetic zone.

 

Some commonly seen advantages include better implant survival rates, improved esthetics, maintenance of the hard and soft tissues at the extraction site, and higher patient satisfaction compared with delayed implant placement.

 

It is critical to monitor the peri-implant bone changes after immediate implant placement especially after prosthetic loading.  This can be accomplished by a device that provides a three-dimensional view of the hard tissue.  The recently developed cone beam computed tomography (CBCT) scan meets these requirements, with the added benefit of decreased x-ray exposure as compared to conventional CT imaging.

 

Aim:

To evaluate Peri-implant bone following immediate implant placement with immediate temporization using Cone Beam Computed Tomography (CBCT).

Objectives:

1. To evaluate and compare the horizontal alveolar ridge changes on facial and palatal cortical plates following immediate implant placement with immediate temporization.

2. To evaluate and compare total bucco-lingual dimensional changes following immediate implant placement with immediate temporization.

 3. To evaluate and compare the vertical buccal alveolar ridge changes following immediate implant placement with immediate temporization.

 
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