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CTRI Number  CTRI/2018/02/011699 [Registered on: 05/02/2018] Trial Registered Retrospectively
Last Modified On: 06/09/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Dentistry 
Study Design  Other 
Public Title of Study   To check increase in height of bone after sinus lift procedure 
Scientific Title of Study   Radiographic evaluation of maxillary sinus floor height after direct maxillary sinus augmentation using β-tricalcium phosphate and platelet rich fibrin. 
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 maharashtra

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

Pune
MAHARASHTRA
411041
India 
Phone  9028273960  
Fax    
Email  digantathube@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 maharashtra

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 Hospial 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
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  12 sites presenting with moderately or severely atrophic posterior maxilla with vertical residual ridge height ≤ 5mm.,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  beta tricalcium phosphate alloplast  Mucoperiosteal flap will be elevated and a bony window will be created on the lateral wall of the maxillary sinus using a round diamond bur under sufficient cooling.The Schneiderian membrane will be carefully elevated using sinus elevators and the bony wall gently pushed inside the sinus cavity. β-TCP will be used for the sinus elevation. Evaluation of the outcome after 5 months period. 
Comparator Agent  platelet rich fibrin  platelet rich fibrin autologous, obtained from a dose of 20 ml intravenous blood, Route- direct delivery to the extraction site. assessment duration- 5 month 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Systemically healthy patients between the age group 18 – 65 years.
2.Maxillary partial (unilateral or bilateral) edentulism involving the premolar/molar areas.
3.Patients willing for placement of implant in maxillary edentulous posterior region.
4.Patients presenting with moderately or severely atrophic posterior maxilla with vertical residual ridge height ≤ 5mm.
5.Patients willing to participate and sign an informed consent.
6.Patients who are compliant.
 
 
ExclusionCriteria 
Details  1.Patients who are systemically compromised.
2.Smoking > 5 cigarettes per day during the 3 months preceding the study.
3.Maxillary sinus pathology.
4.Pregnant and lactating females.
5.No untreated periodontal or periapical pathology especially with teeth adjacent to sinus floor.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
a.Vertical distance from alveolar ridge crest to the inferior most point on the sinus floor pre-operatively
b.Distance from alveolar ridge crest to the raised sinus floor post-operatively after 5 months.
 
a.Vertical distance from alveolar ridge crest to the inferior most point on the sinus floor pre-operatively
b.Distance from alveolar ridge crest to the raised sinus floor post-operatively after 5 months.
 
 
Secondary Outcome  
Outcome  TimePoints 
none  none 
 
Target Sample Size   Total Sample Size="12"
Sample Size from India="12" 
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)   12/05/2016 
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   Not yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

The rehabilitation of patients affected by posterior maxillary atrophy by the aid of implant-supported fixed prosthesis presents a challenge in many cases.  Frequently, the available residual alveolar ridge is insufficient for the placement of dental implants because of alveolar bone resorption, pneumatization of the maxillary sinus, or their combination. 

    Maxillary sinus floor augmentation is the treatment of choice when insufficient alveolar bone height prevents placement of dental implants in the posterior edentulous maxilla.  Maxillary sinus augmentation was first presented by Tatum in 1976.  Long term results showed that this technique can be an effective treatment option.

    Grafting materials used in sinus floor augmentation procedure can be in the form of bone blocks (cancellous or corticocancellous) or bone particles.   Although autogenous bone is considered the gold standard because of its high biocompatibility and osteoinductive potential, its disadvantages include  extra surgical site, donor site morbidity, increased cost and total operation time.

    To reduce the problems associated with autografts, many authors have advocated the use of bone substitutes such as demineralized freeze-dried bone allograft(DFDBA), mineralized freeze-dried bone allograft(FDBA), xenografts, hydroxyapatite preparations, calcium sulfate preparations, as well as growth factors embedded in different carrier materials to augment the floor of the maxillary sinus.

       Amongst alloplasts, β-tricalcium phosphate (β-TCP) is a biocompatible       alloplast and is of the highest purity. β- TCP has a crystalline structure and its porosity provides optimal biologic properties, i.e., osteoconductivity and total resorbability. It has calcium to phosphate ratio of 1:1.5, with particle size ranging from 0.5 to 1.0 mm and resorbs progressively, releasing calcium and phosphate ions, which promote new bone formation within 3-6 months. 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.

 

Platelet rich fibrin (PRF) is an autologous preparation of concentrated platelets created by centrifugation of a patient’s blood.  The use of PRF during surgical procedure is a current treatment concept used to accelerate wound healing and tissue maturation.  It can be used directly as a clot or after compression as a strong membrane.

Aim:


   To radiographically evaluate the newly formed bone after direct maxillary sinus floor augmentation using β-TCP and platelet rich fibrin (PRF).

Objectives:


1.     To evaluate distance from alveolar ridge crest to the inferior most point on the sinus floor pre-operatively.

2.    To evaluate distance from alveolar ridge crest to the raised sinus floor post-operatively after 5 months.

3.    To evaluate increase in height of alveolar ridge crest post-operatively after 5 months.

Sample size: 12

 

 

 
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