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CTRI Number  CTRI/2018/06/014580 [Registered on: 20/06/2018] Trial Registered Retrospectively
Last Modified On: 15/06/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Biological
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study comparing the effectiveness between PRF and hydroxyapatite graft material placement after removal of periapical cyst 
Scientific Title of Study   A comparative clinical evaluation of efficacy of PRF and hydroxyapatite granules in surgical management of periapical pathological defects 
Trial Acronym  EOPAHGPAD 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  B Shravya Kalavant 
Designation  Final year post graduate student 
Affiliation  Sri hasanamba dental college and hospital 
Address  Room no 2, Department of Oral and Maxillofacial Department Sri hasanamba dental college and hospital, vidyanagar Hassan
Room no 2, Department of Oral and Maxillofacial Department Sri hasanamba dental college and hospital, vidyanagar Hassan
Hassan
KARNATAKA
573202
India 
Phone  9743702388  
Fax    
Email  kavyakalavant@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  MANJUNATH K S 
Designation  PROFESSOR AND HOD 
Affiliation  Sri hasanamba dental college and hospital 
Address  Room no 2, ground floor Department of Oral and Maxillofacial Surgery Sri hasanamba dental college and hospital, vidya nagar Hassan
Room no 2, ground floor Department of Oral and Maxillofacial Surgery Sri hasanamba dental college and hospital, vidya nagar Hassan
Hassan
KARNATAKA
573202
India 
Phone  9743779536  
Fax    
Email  manjunath_kurki@yahoo.in  
 
Details of Contact Person
Public Query
 
Name  Manjunath K S 
Designation  Professor and HOD 
Affiliation  Sri hasanamba dental college and hospital 
Address  Room no 2, Department of Oral and Maxillofacial Surgery Sri hasanamba dental college and hospital, vidya nagar Hassan

Hassan
KARNATAKA
573202
India 
Phone  9743779536  
Fax    
Email  manjunath_kurki@yahoo.in  
 
Source of Monetary or Material Support  
Room no 2, Department of Oral and Maxillofacial Surgery Sri hasanamba dental college and hospital, vidya nagar Hassan 
 
Primary Sponsor  
Name  Sri hasanamba dental college and hospital 
Address  Room no 2, Department of Oral and Maxillofacial Surgery Sri hasanamba dental college and hospital, vidya nagar Hassan 
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 
B SHRAVYA KALAVANT  Sri hasanamba dental college and hospital  Room no 2 Department of Oral and maxillofacial department Sri hasanamba dental college and hospital vidyanagar hassan 573202
Hassan
KARNATAKA 
9743702388

kavyakalavant@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  patients with periapical cyst in jaws 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  hydroxyapatite graft  placement of hydroxyapatite graft after removal of periapical cyst in the jaws and regular follow up for 6 months. 
Intervention  platelet rich fibrin graft  placement of prf graft after removal periapical cyst in the jaws and regular follow up for 6 months. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Age: - 18 years and above of both sexes
The tooth to be treated should have a periradicular lesion and for which nonsurgical treatment alone is considered insufficient or retreatment is considered unfeasible or had previously failed.
Periapical pathology in anterior region of maxillary and mandibular region.
The diameter of the bone defect, as will be determined from the intraoral periapical radiographs, should be up to 2 cm x 2cm in diameter.
 
 
ExclusionCriteria 
Details  Patients in whom surgery is medically contraindicated.
Age less than 18 years.
Immuno-compromised and patients with metabolic disorders.
An active infection or a history of persistent infections.
The diameter of bony defect more than 2 cm× 2 cm as determined from the intra oral periapical radiograph.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
it was concluded that both the graft materials prf and hydroxyapatite were efficient in improving clinical parameters as well as regenerative effects when used in the treatment of periapical defect  it was concluded that both the graft materials prf and hydroxyapatite were efficient in improving clinical parameters as well as regenerative effects when used in the treatment of periapical defect 
 
Secondary Outcome  
Outcome  TimePoints 
nil


 
nil 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" 
Phase of Trial   N/A 
Date of First Enrollment (India)   05/01/2016 
Date of Study Completion (India) 20/08/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="7"
Days="21" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   not yet  
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

For complete regeneration, delivery of growth factors in the local environment holds a great deal of adjunct to bone grafts. Platelet rich fibrin (PRF) is considered as second generation platelet concentrate, consisting of viable platelets, releasing various growth factors.  Hence, this study aims to investigate the clinical and radiological (bone fill) effectiveness of autologous PRF and synthetic Hydroxyapatite granules in the treatment of periapical defect bony defects.

Aim and Objective: Comparison of the efficacy of PRF and HA bone grafts in periradicular surgery by clinical and radiographic evaluation.

Study Design/Methodology: A randomised clinical trial was conducted in patients who were assigned for periradicular surgery. 20 patients were included in this study and were divided into 2 groups. The patients were randomly assigned for the surgery, received synthetic HA graft and PRF obtained from the patient in the respective assigned groups. A clinical and radiographic evaluation was performed postoperatively at the period of 1 month, 3 months and 6 months.

Results: There was no statistical difference in clinical healing as well as reduction in defect size radiographically in both the groups. Although both the biomaterials were seen to enhance the rate of bone deposition and can be used as an adjuvant in the treatment of periapical defects.

Conclusion: It was concluded from the study that a good quality apical seal can be obtained using root‑end filling materials contributing to the success of the treatment. To further enhance the success rate, grafts, and various host modulating agents can be used. HA crystals used as grafts are bioactive materials that promote the formation of new bone. However, PRF is preferred over grafts as it is autologous and promotes faster healing by release of growth factors needed for the formation of bone

 
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