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CTRI Number  CTRI/2018/01/011245 [Registered on: 10/01/2018] Trial Registered Prospectively
Last Modified On: 15/12/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   comparative evaluation of the effects of Bovine derived xenograft (osseograft TM) and combination of bovine derived xenograft and calcium sulphate hemihydrate (osseograftTM) , used for the treatment of bone defects due to diseases of gums, clinically and using radiograph 
Scientific Title of Study   Comparative Clinical and Radiographic Evaluation of the Effect of Bovine Derived Xenograft (OsseograftTM) Alone Vs A Combination of Bovine Derived Xenograft and Calcium sulphate hemihydrate (OsseomoldTM) in the Treatment of Intrabony Defects in Chronic Periodontitis Patients 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nikita Dilip Patil 
Designation  1st Year Post Graduate Student 
Affiliation  Nair Hospital Dental College 
Address  K. H. Patil house, Vashi Village, Near R.C.F. Gate no-2, Opp. Mysore Colony, Chembur, Mumbai
202, second floor,Nair Hospital Dental College, Opposite Maratha mandir, Mumbai Central -08
Mumbai (Suburban)
MAHARASHTRA
400074
India 
Phone  9699696160  
Fax    
Email  patilnikii19@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mala Dixit Baburaj 
Designation  Professor and Head of the Department 
Affiliation  Nair Hospital Dental College 
Address  202, second floor,Nair Hospital Dental College, Opposite Maratha mandir, Mumbai Central -08
202, second floor,Nair Hospital Dental College, Opposite Maratha mandir, Mumbai Central -08
Mumbai
MAHARASHTRA
400008
India 
Phone  9699696160  
Fax    
Email  maladixit25@gmail.com  
 
Details of Contact Person
Public Query  
Name  Nikita Dilip Patil 
Designation  1st Year Post Graduate Student 
Affiliation  Nair Hospital Dental College 
Address  K. H. Patil house, Vashi Village, Near R.C.F. Gate no-2, Opp. Mysore Colony, Chembur, Mumbai
202, second floor,Nair Hospital Dental College, Opposite Maratha mandir, Mumbai Central -08

MAHARASHTRA
400074
India 
Phone  9699696160  
Fax    
Email  patilnikii19@gmail.com  
 
Source of Monetary or Material Support  
primary investigator. dr. nikita patil 202, second floor, Nair Hospital Dental College, Mumbai Central . Mumbai -08 
 
Primary Sponsor  
Name  Nikita Dilip Patil  
Address  K. H. Patil house, Vashi Village, Near R.C.F. Gate no-2, Opp. Mysore Colony, Chembur, Mumbai - 400074 
Type of Sponsor  Other [First Year Post Graduate Student] 
 
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 
Nikita Dilp Patil  Nair Hospital Dental College  202, Dept. Of Periodontlogy, Second floor, Nair Hospital Dental College
Mumbai
MAHARASHTRA 		 9699696160

patilnikii19@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Nair Hospital Dental College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Chronic Periodontitis patients with interproximal bone defects of 5mm or more, (1) ICD-10 Condition: R688||Other general symptoms and signs,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Bovine derived Xenograft   commercially available as Osseograft TM 
Intervention  bovine derived xenograft plus calcuim sulphate hemi hydrate  commercially available as Osseomold TM 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1) Age group between 20-60
2) Diagnosis with chronic periodontitis
3) Patients in good systemic health with no contraindication to periodontal surgery
4) Patients having Intrabony defects with pocket depths of >5mm and with radiographic evidence of vertical / angular bone loss in the affected sites.
5) Involved teeth to be vital and asymptomatic
 
 
ExclusionCriteria 
Details  1) One — wall osseous defects.
2) Patients suffering from any systemic diseases or with compromised immune system.
3) Patients who had received any type of periodontal therapy for the past 6 months
4) Patients taking any immuno-suppressive drugs like corticosteroids
5) Patients with a known history of allergy to doxycycline or Chlorhexidine or any other medicine are used in the study.
6) Patients showing unacceptable oral hygiene compliance during / after the phase I therapy.
7) Patients taking any drug known to cause gingival enlargement.
8) Pregnant and/or lactating mothers.
9) Patients who were smokers or had tobacco in any other form.
10) Endodontically treated teeth.
11) Patient on anticoagulant therapy
12) Patient with bleeding disorders.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1 Probing Pocket Depth
2 Clinical Attachment Level
3 Plaque Index (Turskey Gilmore-Glickman Modification of Quigley Hein)
4 Gingival Index (Loe & Silness, 1963) 		 the outcomes will be assessed pre-operatively, immediate post operatively, 3 months post operatively and 6 month post operatively  
 
Secondary Outcome  
Outcome  TimePoints 
Radiographic bone fill will be evaluated using intra oral periapical radiographs of the surgical site   radiographs will be taken at baseline post surgery and 6 months post surgery 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/01/2018 
Date of Study Completion (India) 01/02/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 none yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  
The aim of the study is to evaluate and compare clinically and radiographically the effect of Bovine Derived Xenograft  (OsseograftTM) Alone Vs A Combination of Bovine Derived Xenograft and Calcium sulphate hemihydrate (OsseomoldTM) in the Treatment of Intrabony Defects in Chronic Periodontitis Patients. A total of 40 patients will be selected from the outpatient department of Periodontics, Nair Hospital Dental College, Mumbai and will be equally divided into two groups of 20 each. In Group  A Bovine Derived Xenograft  (OsseograftTM) and in Group B A Combination of Bovine Derived Xenograft and Calcium sulphate hemihydrate (OsseomoldTM) will be placed as a graft in interproximal bone defects. The study is clinical interventional prospective study. Computer generated randomization method will be used as sampling method. The durtion of the study is 20 months which includes a duration of 14 months for treatment procedures and 6 months follow up. The primary efficacy parameters are plaque index, gingival index, pocket probing depth and clinical attachment level. plaque and gingival index will be recored at baseline, 1 month, 3 months and 6 months post operatively. Radiographic analysis of the surgical site will be done to measure bone fill at baseline, immediately post surgery and 6 months post surgery. The data will be analysed  individually for all the patients. The values will be subjected to comparison within and between groups using student t test and ANOVA analysis. There is no conflict of interest
 
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