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CTRI Number  CTRI/2017/08/009386 [Registered on: 17/08/2017] Trial Registered Retrospectively
Last Modified On: 16/10/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparative Evaluation of Beta-Tricalcium Phosphate versus Platelet Rich Fibrin in the treatment of Mandibular Furcation Defects 
Scientific Title of Study   A Comparative Evaluation of the Regenerative Potential of alloplastic material Beta-Tricalcium Phosphate (β-TCP) and Autologous Platelet Rich Fibrin (PRF) in the treatment of Mandibular Furcation Defects: A Clinico-Radiographic Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Zeba Rahman 
Designation  Postgraduate Student 
Affiliation  Saraswati Dental College, Lucknow 
Address  Department of Periodontology, Saraswati Dental College, 233, Tiwariganj, Faizabad Road, Chinhat, Lucknow

Lucknow
UTTAR PRADESH
226028
India 
Phone    
Fax    
Email  zeba.rahman1@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vivek Kumar Bains 
Designation  Professor 
Affiliation  Saraswati Dental College, Lucknow 
Address  Department of Periodontology, Saraswati Dental College, 233, Tiwariganj, Faizabad Road, Chinhat, Lucknow

Lucknow
UTTAR PRADESH
226028
India 
Phone  9935023439  
Fax    
Email  doc_vivek76@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Vivek Kumar Bains 
Designation  Professor 
Affiliation  Saraswati Dental College, Lucknow 
Address  Department of Periodontology, Saraswati Dental College, 233, Tiwariganj, Faizabad Road, Chinhat, Lucknow


UTTAR PRADESH
226028
India 
Phone  9935023439  
Fax    
Email  doc_vivek76@yahoo.co.in  
 
Source of Monetary or Material Support  
Self funded by the investigators 
 
Primary Sponsor  
Name  Saraswati Dental College Lucknow 
Address  Department of Periodontology, Saraswati Dental College, 233, Tiwariganj, Faizabad Road, Chinhat, Lucknow 
Type of Sponsor  Other [Infrastructural support by Institution] 
 
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 Vivek Kmuar Bains  Sraswati Dental College, Lucknow  PG Clinic, Department of Peridontology,Room No. 6, First Floor,
Lucknow
UTTAR PRADESH 		 9935023439

doc_vivek76@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Insitutional Human Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Chronic periodontitis patients with grade II furcation involvement in mandibular teeth,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Beta Tricalcium phosphate and Platelet rich fibrin  1) Beta tricalcium phosphate is a Bone graft 2) Platelet rich fibrin is autologous  
Intervention  Grade II Furcation treatment  Mandibular Grade II furcation were treated with regenerative surgical techqinues 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1) Systemically healthy patients within the age group 30-50 years suffering from moderate to severe generalized chronic periodontitis.
2) Patient having at least one Glickman’s buccal grade II furcation defects in mandibular 1st and 2nd molars with ≥3mm horizontal probing depth.
3) Involved tooth must have gingival margin coronal to or at the level of the roof of furcation (fornix).
4) Patients who had not taken antibiotics or any other drug within 6 months that may modify the result of periodontal therapy.
5) Non mobile tooth.
6) Adequate RCT must have been completed 3 months before the commencement of the study.76
7) Compliant patient with full mouth plaque score 0.1 to 0.9 (good oral hygiene during phase I therapy).
 
 
ExclusionCriteria 
Details  1) Smokers and tobacco chewers
2) Pregnant and lactating mothers
3) Individual allergic to medication
4) History of periodontal surgery within 6 months
5) Inadequate endodontic treatment and/or restoration, with trauma from occlusion (TFO) or occlusal disharmony.
6) Lingual Class II furcation defects
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
horizontal clinical attachment level (HCAL), gingival recession (GR), relative vertical height of furcation (r-VHF) and relative horizontal depth of furcation (r-HDF)] and radiogaraphic parameters [horizontal depth of furcation (H-DOF), vertical height of furcation (V-HOF)]   Horizontal clinical attachment level (HCAL), gingival recession (GR), relative vertical height of furcation (r-VHF) and relative horizontal depth of furcation (r-HDF)] and radiogaraphic parameters [horizontal depth of furcation (H-DOF), vertical height of furcation (V-HOF)] at 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Clinical parameters [probing pocket depth (PPD), vertical clinical attachment level (VCAL), Radiographic analysis, Data are compared at asilene and 6 Months on CBCT  Data are compared at asilene and 6 Months on CBCT 
 
Target Sample Size   Total Sample Size="31"
Sample Size from India="31" 
Final Enrollment numbers achieved (Total)= "31"
Final Enrollment numbers achieved (India)="31" 
Phase of Trial   N/A 
Date of First Enrollment (India)   14/02/2014 
Date of Study Completion (India) 24/12/2015 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   : Siddiqui ZR, Jhingran R, Bains VK, Srivastava R, Madan R, Rizvi I. Comparative evaluation of platelet-rich fibrin versus beta‑tri‑calcium phosphate in the treatment of Grade II mandibular furcation defects using cone‑beam computed tomography. Eur J Dent 2016;10:496‑506. DOI: 10.4103/1305‑7456.195160  
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Objective: The objective of the study was to evaluate clinically and radiographically the efficacy of platelet ’rich fibrin (PRF) versus β ’tri calcium phosphate (β ’TCP) in the treatment of Grade II mandibular furcation defects. Materials and Methods: Forty ’five Grade II furcation defect in mandibular molars which were assigned to open flap debridement (OFD) with PRF Group I (n = 15), to OFD with β TCP Group II (n = 15), and to OFD alone Group III (n = 15) were analyzed for clinical parameters (probing pocket depth [PPD], vertical in 31 patients clinical attachment level [VCAL], horizontal clinical attachment level [HCAL], gingival recession, relative vertical height of furcation [r ’VHF], and relative horizontal depth of furcation [r ’HDF]) and radiographical parameters (horizontal depth of furcation [H ’DOF], vertical height of furcation [V ’HOF]) using cone ’beam computed tomography (CBCT) at 6 months interval. Results: For clinical parameters, reduction in PPD and gain in VCAL and HCAL were higher in Group II as compared to Group I. Change in r ’VHF and r ’HDF was greater in Group II as compared to Group I. Mean percentage clinical vertical defect fill was higher in Group II as compared to Group I (58.52% ± 11.68% vs. 53.24% ± 13.22%, respectively). On CBCT, mean change at 6 months for all parameters showed nonsignificant difference between the two experimental groups. Mean change in V ’HOF was higher in Group I as compared to Group II, but mean change in H DOF and furcation width was more in Group II as compared to Group I. Conclusion: For both experimental and control groups, there was statistically significant improvement at 6 months follow ’up from baseline values.

 
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