FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/06/068965 [Registered on: 14/06/2024] Trial Registered Prospectively
Last Modified On: 04/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study on the effect of egg shell derived material for treatment of jaw bone defects 
Scientific Title of Study   Evaluation of the efficacy of Egg Shell derived NanoHydroxyapatite graft in Intrabony defects: A Clinical and Radiographic Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrRavi Kumar Saka 
Designation  Post graduate Student 
Affiliation  Government dental college and hospital 
Address  Department of Periodontics, Room no.4, Floor -2, Government dental college and hospital, Vijayawada

Krishna
ANDHRA PRADESH
520008
India 
Phone  9010546592  
Fax    
Email  drravikumarsaka@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Lahari Buggapati 
Designation  Associate Professor 
Affiliation  Government dental college and hospital 
Address  Department of Periodontics, Room no.4, Floor -2, Government dental college and hospital, Vijayawada

Krishna
ANDHRA PRADESH
520008
India 
Phone  8142098984  
Fax    
Email  drlaharimds@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrRavi Kumar Saka 
Designation  Post graduate Student 
Affiliation  Government dental college and hospital 
Address  Department of Periodontics, Room no.4, Floor -2, Government dental college and hospital, Vijayawada

Krishna
ANDHRA PRADESH
520008
India 
Phone  9010546592  
Fax    
Email  drravikumarsaka@gmail.com  
 
Source of Monetary or Material Support  
Dr Vivekanand Kattimani, Head of the Department, Department of Clinical Research, Sibar Institute of Dental Sciences ,Guntur 522509, Andhra Pradesh, India 
Government Dental College and Hospital, Vijayawada - 520004, Krishna district, Andhra Pradesh, India 
 
Primary Sponsor  
Name  DrRavi Kumar Saka 
Address  Post graduate student, Department of Periodontics, Government Dental College and Hospital, Vijayawada - 520004, Krishna district, Andhra Pradesh, India  
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 Ravi Kumar Saka  Government Dental College and Hospital  Room no.-4, Floor -2,Department of Periodontics, Government Dental College and Hospital, Vijayawada
Krishna
ANDHRA PRADESH 
9010546592

drravikumarsaka@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K055||Other periodontal diseases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Peridontal Flap Surgery and Egg shell derived nanohydroxyapatite graft  During the periodontal flap surgery the Egg shell derived nanohydroxyapaptite graft material will be placed in the intrabony defect immediately 
Comparator Agent  Periodontal Flap Surgery  Periodontal flap surgery will be done with no graft material 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1. Patient with age between 25 to 55 years.
2. Patient with periodontitis having intrabony defects.
3. Probing pocket probing depth ≥6mm. Two and three wall bony defects.
4. Systemically healthy compliant patients who had not received any periodontal treatment in the past 6 months.
 
 
ExclusionCriteria 
Details  1. Patients who are systemically ill
2. Patients having immune system related problems
3. Patients having bone pathologies 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Alveolar bone regeneration in intrabony defect  1. Alveolar bone regeneration in intrabony defect - Baseline, 9 months 
 
Secondary Outcome  
Outcome  TimePoints 
Probing pocket depth & relative attachment level  Probing pocket depth & relative attachment level at 3months, 6month, 9 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   N/A 
Date of First Enrollment (India)   21/06/2024 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Hydroxyapatite [HA] is apatite calcium phosphate. HA shows highest level of bioactivity and forms a quick bond with bone. The eggshell is a ubiquitous source of HA, and nanotechnology has made it possible to elicit a veritable biomaterial1.EnHA meets the required criteria and properties of an ideal graft substitute with its inherent porosity and osteotransconductivity. Lack of disease transfer risks, biocompatibility, and ease of use makes EnHA a viable source as regenerative material. EnHA is hydrophilic in nature, absorbed by body fluids and blood, so that handling becomes easy for placing it in the surgical site.The clinical studies have demonstrated the significant role of conventional graft materials in bone regeneration in periodontal intrabony defects. But to the best of our knowledge, there are limited studies on eggshell derived nanohydroxyapatite (EnHA) as a graft material in an intrabony defect. Hence the present study is planned to evaluate the effectiveness of EnHA graft in regeneration of bone in periodontal intra bony defects using a precise technology such as Cone Beam Computed Tomography [CBCT].

 
Close