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CTRI Number  CTRI/2017/09/009714 [Registered on: 11/09/2017] Trial Registered Retrospectively
Last Modified On: 07/09/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To check the amount of bone growth by using two different artificial bone materials in patients with severe gum disease.  
Scientific Title of Study   Clinical and Radiographic Evaluation of Zinc Incorporated Nano Hydroxyapatite Graft in Regeneration of Intrabony Defects- A Randomized Controlled Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Bhardwaj Vasundhra Ajay 
Designation  Post graduate student 
Affiliation  JSS Dental College 
Address  Room no 9, Department of Periodontology, JSS Dental College and Hospital, Bannimantap,

Mysore
KARNATAKA
570015
India 
Phone  8128983937  
Fax    
Email  vasu31@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Deepika PC 
Designation  Professor 
Affiliation  JSS Dental College 
Address  Room no 9, Department of Periodontology, JSS Dental College and Hospital, Bannimantap,

Mysore
KARNATAKA
570015
India 
Phone  9902066073  
Fax    
Email  deepikamysore@yahoo.co.uk  
 
Details of Contact Person
Public Query  
Name  Bhardwaj Vasundhra Ajay 
Designation  Post graduate student 
Affiliation  JSS Dental College 
Address  Room no 9, Department of Periodontology, JSS Dental College and Hospital, Bannimantap,

Mysore
KARNATAKA
570015
India 
Phone  8128983937  
Fax    
Email  vasu31@hotmail.com  
 
Source of Monetary or Material Support  
Bhardwaj Vasundhra Ajay Room no 9, Department of Periodontology, JSS Dental College and Hospital, Bannimantap Mysuru-570015 
 
Primary Sponsor  
Name  Bhardwaj Vasundhra Ajay 
Address  JSS Dental College, Mysuru 
Type of Sponsor  Other [self sponserd] 
 
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 
Bhardwaj Vasundhra Ajay  JSS DENTAL COLLEGE AND HOSPITAL  Room no 9,dept of Periodontology
Mysore
KARNATAKA 		 812898393
8128983937
vasu31@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee JSS Dental College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Chronic Periodontitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Synthetic Nano Hydroxyapatite bone graft  Commercially available  
Intervention  zinc incorporated nano hydroxyapatite graft   A zinc incorporated nano hydroxyapatite graft which will be formulated in Polymer Science department, SJCE College, Mysuru. 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1. Systemically healthy patients, both males and females in the age range of 35-55 years having Chronic Generalized Periodontitis.
2. Patients with contralateral intra bony pockets measuring more or equal to 6 mm.
3. Patients with radiographic evidence of vertical/angular bone loss
4. Consenting patients who are co-operative and able to come for regular follow up
5. more than 20 remaining teeth
 
 
ExclusionCriteria 
Details  1.Pregnant /lactating women.
2.Patients allergic to zinc.
3.Patients on antibiotic therapy in the previous six months.
4. Patients who have undergone any periodontal therapy in past 6 months.
5. Smokers
6. Patients who are medically compromised or under therapeutic regimen that may alter the probability of soft tissue and bone healing.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
efficacy of Zinc Incorporated Nano hydroxyapatite graft regarding the following parameters as compared to Nano hydroxyapatite bone graft alone   12-month period, (3,6,9,12 month) 
 
Secondary Outcome  
Outcome  TimePoints 
to evaluate Clinical parameters and Bone fill  3,6,9,12 months 
 
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 1 
Date of First Enrollment (India)   13/08/2016 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   none yet  
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Periodontitis is a disease of the periodontium characterized by the irreversible loss of connective tissue attachment and supporting alveolar bone. 1

 The ultimate goal of periodontal therapy has been the regeneration of the new connective tissue attachment, i.e., new cementum with inserting collagen fibers, at diseased (denuded) root surfaces and also, the regrowth of alveolar bone. 2

 Filling of the intrabony defects with various bone grafts is one of the most widely employed techniques aimed at restoring the lost attachment. 3

 Synthetic Hydroxyapatite (HA-Ca10(PO4)6(OH)2), due of its chemical similarity with natural bone mineral, is frequently used as bone grafting material. HA which is known for its ability to bond with bone4, is not osteoinductive. Nevertheless, the crystal structure of HA can accommodate substitutions by various beneficial ions easily, amongst which zinc is a potential candidate.10

 Zinc, has a stimulatory effect on bone formation and mineralization in vivo and vitro 5,6. Zinc acts to increase bone formation and mineralization, decreases bone resorption, stimulates alkaline phosphatase (ALP) activity, in both calvaral organ cultures and osteoblast cell cultures. 5,7

 Though Zinc-hydroxyapatite has been shown to stimulate bone formation through the actions of zinc ions accelerating the proliferation and differentiation of osteogenic cells, no work has actually been directed towards the use of ZnHA for potential applications in dental fields. 8,10 

 Hence, the aim of this study will be to investigate the bone regenerative properties of a Zinc-nano hydroxyapatite graft in comparison to nano-hydroxyapatite alone in the surgical management of intrabony defects.

 
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