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CTRI Number  CTRI/2017/11/010591 [Registered on: 22/11/2017] Trial Registered Retrospectively
Last Modified On: 26/10/2018
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 artificial bone material with and without Hyaluronic acid gel in patients with severe gum disease. 
Scientific Title of Study   Clinical and Radiographic Evaluation of Hyaluronan-Nano Hydroxyapatite Composite Graft in the Regeneration of Infrabony 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  Eeshita Bhowmik 
Designation  Post graduate student 
Affiliation  JSS Dental College and Hospital 
Address  Room No-9, Dept. of Periodontology, JSS Dental College and Hospital Bannimantap

Mysore
KARNATAKA
570015
India 
Phone  7829916764  
Fax    
Email  dr.eeshita@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Deepika PC 
Designation  Professor 
Affiliation  JSS Dental College and Hospital 
Address  Room No-9, Dept. 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  Eeshita Bhowmik 
Designation  Post graduate student 
Affiliation  JSS Dental College and Hospital 
Address  Room No-9, Dept. of Periodontology, JSS Dental College and Hospital Bannimantap

Mysore
KARNATAKA
570015
India 
Phone  7829916764  
Fax    
Email  dr.eeshita@gmail.com  
 
Source of Monetary or Material Support  
Eeshita Bhowmik Room no 9 Dept of Periodontology JSS Dental College and Hospital Mysuru-570015 
 
Primary Sponsor  
Name  Eeshita Bhowmik 
Address  Room no 9 Department of Periodontology JSS Dental College and Hospital Bannimantap Mysuru - 570015 
Type of Sponsor  Other [Self sponsored] 
 
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 
Eeshita Bhowmik  JSS Dental College and Hospital  Room No-9, Dept. of Periodontology, JSS Dental College and Hospital Bannimantap
Mysore
KARNATAKA 
7829916764

dr.eeshita@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Commitee 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 
Intervention  Hyaluronic acid combined with Nano-hydroxyapatite bone graft  commercially available Hyaluronic acid gel combined with commercially available Nano-hydroxyapatite bone graft 
Comparator Agent  Nano-Hydroxyapatite bone graft  commercially available 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1. Systemically healthy male and female patients in the age range of 30-55 years having chronic generalised periodontitis.
2. Patients with contralateral intrabony pockets measuring more than or equal to 6mm.
3. Patients with radiographic evidence of bilateral vertical/angular defects.
4. Consenting patients who are cooperative and ready for regular follow up.
 
 
ExclusionCriteria 
Details  1. Patients on antibiotic therapy in the previous six months.
2. Patients who have undergone any periodontal therapy in past 6 months.
3. Smokers
4. Pregnant /lactating women.
5. 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 Blinded 
Primary Outcome  
Outcome  TimePoints 
efficacy of Hyaluronan-Nano hydroxyapatite composite graft in comparison with Nano hydroxyapatite graft alone, in the treatment of infrabony defects.  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="10"
Sample Size from India="10" 
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)   27/07/2017 
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)
Modification(s)  
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 an inflammatory disease of the supporting tissues of the teeth caused by specific microorganisms or groups of specific microorganisms, resulting in progressive destruction of the periodontal ligament and alveolar bone with pocket formation, recession or both. 1

Periodontal therapy aims primarily at the arrest of progression of disease, along with formation of new bone, cementum and periodontal ligament (PDL). 2

Various types of bone grafts have been used along with conventional surgical procedures for regeneration of bone and PDL.3 Hydroxyapatite, having a biomimetic property of replicating the native mineral content of bone tissue, is most commonly used. It is osteophilic and osteoconductive. Osteoconductive materials neither inhibit nor induce bone formation. They only act as a scaffold for bone formation.4

Hyaluronan or Hyaluronic acid, an important component of extra cellular matrix, on the other hand, has a stimulatory effect on osteoblasts.  Thus it imparts osteogenic and osteoconductive properties to bone graft, when added to it. It also acts as a connective tissue scaffold allowing cell growth and regeneration of bone.5

Hence an attempt is being made in this study to combine the properties of both the above materials for regeneration of bone.

As per our knowledge there are very sparse studies evaluating the efficacy of hyaluronan and bone graft together. Thus, in this study, an attempt is made to evaluate the regenerative property of hyaluronan in combination with Nano-hydroxyapatite bone graft in comparison with Nano-hydroxyapatite bone graft alone, in the surgical management of infrabony defects, in patients with chronic periodontitis.

 
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