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CTRI Number  CTRI/2022/09/045318 [Registered on: 07/09/2022] Trial Registered Prospectively
Last Modified On: 04/10/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   To Compare the effectiveness of platelet concentrate with two different bone graft material for the periodontal defect in human 
Scientific Title of Study   A clinical and radiographic study to evaluate and compare the effectiveness of Nanocrystalline hydroxyapatite with Advanced Platelet Rich Fibrin(A-PRF)and Hydroxyapatite reinforced Beta tri-calcium phosphate(HA+β-TCP) with A-PRF in the treatment of human infrabony defects-A cross sectional study.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Aishwarya Rathod 
Designation  Postgraduate Student  
Affiliation  Sharad Pawar Dental College, Sawangi, Wardha. 
Address  Sharad Pawar Dental College,Sawangi(Meghe), Wardha. Department Of Periodontics Room Number - 003 wardha, Maharashtra 442001 India

Wardha
MAHARASHTRA
442001
India 
Phone  09834240701  
Fax    
Email  aishwaryarathod55@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Priyanka Jaiswal 
Designation  Professor 
Affiliation  Sharad Pawar Dental College, Sawangi.Wardha. 
Address  Sharad Pawar Dental College,Sawangi(Meghe), Wardha. Department Of Periodontics Room Number - 003 wardha, Maharashtra 442001 India

Wardha
MAHARASHTRA
442001
India 
Phone  09960713010  
Fax    
Email  priyanka.banode@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Aishwarya Rathod 
Designation  PG student  
Affiliation  Sharad Pawar Dental College, Sawangi.Wardha. 
Address  Sharad Pawar Dental College,Sawangi(Meghe), Wardha. Department Of Periodontics Room Number - 003 wardha, Maharashtra 442001 India
Department Of Periodontics
Wardha
MAHARASHTRA
442001
India 
Phone  09834240701  
Fax    
Email  aishwaryarathod55@gmail.com  
 
Source of Monetary or Material Support  
Sharad Pawar Dental College, Sawangi(Meghe), Wardha . Department of Periodontics . Room number- 003  
 
Primary Sponsor  
Name  Dr Aishwarya Rathod 
Address  Sharad Pawar Dental College , Sawangi ( Meghe) , Wardha. 
Type of Sponsor  Other [Self] 
 
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 Aishwarya Rathod  Sharad Pawar Dental College , Wardha .  Sharad Pawar Dental College,Sawangi(Meghe), Wardha. Department Of Periodontics Room Number - 003 wardha, Maharashtra 442001 India
Wardha
MAHARASHTRA 		 09834240701

aishwaryarathod55@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K053||Chronic periodontitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Hydroxyapatite reinforced Beta tri-calcium phosphate with A-PRF   Hydroxyapatite reinforced Beta tri-calcium phosphate(β-TCP)with Advanced platelet rich fibrin(A-PRF) will be placed in 14 subjects having Infrabony Defects. 
Intervention  Nanocrystalline hydroxyapatite with Advanced platelet rich fibrin (A- PRF).  Nanocrystalline hydroxyapatite with A-PRF placed in 14 subjects having Infrabony defects . 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1.Systematically healthy patient.
2.Following initial therapy, presence of minimum 1 or 2 interproximal infrabony osseous defect PPD ≥ 5mm and CAL ≥ 5 and which are radiographically noticeable.
3.Clinically and radiographically there should be ≥ 3mm defect depth which is affirmed on intrasurgical measurement.
4.A radiographically determined defect base should be minimum of 3 mm above the apex of the tooth
5.Presence of minimum ≥2mm zone of keratinized gingiva to permit total soft tissue coverage of the defect area.

 
 
ExclusionCriteria 
Details  1.Patient diagnosed with aggressive periodontitis.
2.Patients with poor oral hygiene care (Plaque Index >1)
3.Patients using tobacco in any form .
4.Involved tooth with inadequate root canal therapy and subsequent restoration
5.Involved tooth having mobility greater than grade II ,or defect extending in to furcation and third molars .
6.Prior history of periodontal surgery of the selected segment.
7.Females who are pregnant or lactating.
8.There is clinical and radiographic sign of untreated acute infection at the selected site, root fracture,apical pathology ,severe root irregularities, cemental pearls, cementoenamel projections, untreated carious lesion on root surface.

 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Radiographic Bone Fill In Infrabony Defects at 6 Month Post Surgery.  Radiographic Bone Fill In Infrabony Defects at 6 Month Post Surgery. 
 
Secondary Outcome  
Outcome  TimePoints 
Gain in Clinical Attachment Level( CAL)
Reduction In Probing Pocket Depth (PPD) 		 6 Months 
 
Target Sample Size   Total Sample Size="28"
Sample Size from India="28" 
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 3/ Phase 4 
Date of First Enrollment (India)   15/09/2022 
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)  Not Yet Recruiting 
Publication Details
Modification(s)  		 NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  		    Aim of my study is to evaluate and compare the effectiveness of Nanocrystalline hydroxyapatite with Advanced platelet rich fibrin(A-PRF) and Hydroxyapatite reinforced Beta tri-calcium phosphate in Human infrabony defects.

Objectives

1)      To evaluate the effectiveness of Nanocrystalline hydroxyapatite in combination with A-PRF  in terms of gain in clinical attachment level(CAL), reduction in probing pocket depth (PPD) and radiographic bone fill in infrabony defects at 6 months post surgery.

2)      To evaluate  the effectiveness of Hydroxyapatite reinforced Beta-tricalcuim phosphate in combination with A- PRF in terms of gain in clinical attachment level , reduction in probing depth , and radiographic bone fill at 6 month post surgery.

3)      To compare the effectiveness of Nanocrystalline hydroxyapatite with A-PRF and Hydroxyapatite reinforced Beta–tricalcuim phosphate with A- PRF at 6 month post surgery clinically and radiographically.

          In the study  total of 28  healthy patients, with moderate to advanced chronic periodontitis based on clinical and radiographic confirmation of angular bony defects will be chosen from the outpatient Department of Periodontics. Clinical measurements recorded will be plaque index , Papillary bleeding index ,Probing Pocket depth, Relative attachment level , and Relative gingival marginal level . All the clinical measurements will be recorded on the day of surgery and 6 month post surgery .

     Test group will consist of  Nanocrystalline hydroxyapatite with Advanced platelet rich fibrin (A-PRF) and control group will consist of Hydroxyapatite reinforced Beta tricalcuim phosphate with A-PRF .The mean and standard deviation values will be calculated for plaque index  and papillary bleeding index and also for all clinical parameters including RGML ,RAL,PPD,WKG and GR. Student’s paired t- test will be used to correlate the data from baseline up to 6 months for each treatment group . Student’s unpaired t test will be used for comparisions between treatment groups at baseline level and 6 months.

       

Summary :


1.      At six month post-surgery both treatment modalities demonstrated statistically significant improvements with regards to CAL gains, PPD reduction and reduction in radiographic defect depth.                             

2.      Greater PPD reduction, CAL gain and reduction in radiographic defect depth was found in Nanocrystalline hydroxyapatite with A-PRF group than HA+β-TCP in combination with A-PRF group at six months after surgery but the difference was statistically non-significant when compared between both the groups.

3.      Grafting with Nanocrystalline hydroxyapatite along with A-PRF group resulted in higher radiographic defect fill compared to HA+β-TCP in combination with A-PRF group and the difference was statistically significant.

 
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