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CTRI Number  CTRI/2021/04/033061 [Registered on: 23/04/2021] Trial Registered Prospectively
Last Modified On: 10/01/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Biological
Medical Device
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Assessment of Use of eggshell derived bone graft material with patients own blood for repair of bone defects in back tooth region of mouth 
Scientific Title of Study   Effectiveness of nano hydroxyapatite graft with or without platelet rich fibrin membrane in the treatment of periodontal intrabony defects.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Karlapudi Keerthi Mekhala 
Designation  Post Graduate Trainee, Department of periodontics and implantology 
Affiliation  Sibar institute of Dental Sciences, Takkellapadu, Guntur. Andhra Pradesh, India 
Address  Department of periodontics and implantology, 2nd floor, Room No.8 SIBAR institute of Dental Sciences, Takkellapadu, Guntur. Andhra Pradesh, India 522509.

Guntur
ANDHRA PRADESH
522509
India 
Phone  7975322230  
Fax    
Email  keerthik161@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ravindranath 
Designation  Head of department, Department of periodontics and implantology 
Affiliation  Sibar institute of Dental Sciences, Takkellapadu, Guntur. Andhra Pradesh, India 
Address  Department of periodontics and implantology, 2nd floor, Room No.8 SIBAR institute of Dental Sciences, Takkellapadu, Guntur. Andhra Pradesh, India 522509.

Guntur
ANDHRA PRADESH
522509
India 
Phone  9849222259  
Fax    
Email  ravident69@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vivekanand Kattimani 
Designation  Professor 
Affiliation  Sibar institute of Dental Sciences, Takkellapadu, Guntur. Andhra Pradesh, India. 
Address  Department of oral and maxillofacial surgery, Room no.3 SIBAR institute of Dental Sciences, Takkellapadu, Guntur. Andhra Pradesh, India 522509.

Guntur
ANDHRA PRADESH
522509
India 
Phone  9912400988  
Fax    
Email  drvivekanandsk@gmail.com  
 
Source of Monetary or Material Support  
Dr E K Girija, Department of Physics Periyar University Salem 
 
Primary Sponsor  
Name  Dr L Krishna Prasad 
Address  Dean, SIBAR Institute of Dental Sciences, Takkellapadu, Guntur. Andhra Pradesh, India 522509.  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Dr Girija E K   Biomedical and Material laboratory Department of Physics. Periyar University Salem, Tamilnadu  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Karlapudi Keerthi Mekhala  Department of periodontics and implantology  2nd floor, Room No.8 Sibar institute of Dental Sciences, Takkellapadu, Guntur. Andhra Pradesh, India 522509.
Guntur
ANDHRA PRADESH 		 7975322230

keerthik161@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC Sibar Institute of Dental Sciences Guntur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K053||Chronic periodontitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Graft material  Egg shell derived hydroxyapatite and platelet rich fibrin membrane, one time application, will remain until tooth exfoliation, it will act as barrier and osteoconductive material for regenerative dentin formation like any other pulp capping agents  
Intervention  Graft material   Egg shell derived hydroxyapatite, One time application like any other pulp capping agents, will remain until tooth exfoliation, it will act as barrier and osteoconductive material for regenerative dentin formation like any other pulp capping agents  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1)Patients of age 20 – 60 years.
2)Intrabony defects in the posterior teeth.
3)Patients with a probing depth of greater than or equal to 5mm.
4)Patients with radiographic evidence of greater than or equal to 3mm distance between alveolar crest and base of defect.
 
 
ExclusionCriteria 
Details  1)Presence of any systemic disease.
2)Pregnant and lactating women.
3)Smokers.
4)Patients who underwent periodontal therapy from the past 6 months 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Centralized 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1) Improvement in clinical attachment level,
2)Reduction of probing depth
3)Bone regeneration 		 Base line and 3 and 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Increased Stability of tooth and function  Base line and 3 and 6 months 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   02/05/2021 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   NOT YET 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [keerthik161@gmail.com].

  6. For how long will this data be available start date provided 08-08-0023 and end date provided 08-07-0026?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Periodontitis is a progressive inflammatory disease which causes destruction of the periodontal ligament and alveolar bone with pocket formation. The ultimate goal of periodontal therapy is the regeneration of periodontal tissues that have been destroyed due to periodontal disease. Periodontal regeneration is the reconstruction of the lost tissues as evidenced histologically in the formation of new cementum, new alveolar bone, and functionally oriented periodontal ligament.2 Loss of alveolar bone support is one of the characteristic signs of destructive periodontal disease and is generally considered to represent the anatomical sequelae to the apical spread of periodontitis. The intrabony defects are associated with the loss of tooth support, relates to the site specificity of the periodontal destruction and to the possibility that ecological niches may represent site specific risk factors or indicators for disease progression. Treatment of bony defects is intended to meet two objectives. Elimination of microbial plaque from exposed surfaces of the root and establishing the anatomy of effected surfaces that facilitates proper self-performed plaque control. Different types of bone grafts are used to fill the periodontal defects and restore the lost periodontal attachment apparatus such as autografts, allografts and alloplastic materials. Alloplasts are synthetic, inorganic, biocompatible and non-antigenic graft substitutes. Eggshell derived hydroxyapatite is hydrophilic in nature, absorbed by body fluids and blood, so that handling becomes easy for placing it in the surgical site. Lack of disease transfer risks, biocompatibility, and ease of use makes it a viable choice as regenerative material. Hydroxyapatite is a naturally occurring mineral component of bone and is osteoconductive in nature. PRF membrane is a second-generation autologous platelet concentrate and is a fibrin mesh consisting of leukocytes and cytokines. It activates the vascular system and angiogenesis and releases growth factors like PDGF, insulin like growth factor, vascular endothelial growth factor, and TGF, which are involved in soft and hard tissue healing. PRF has been utilized for a variety of clinical procedures acting as an autologous barrier membrane for the treatment of intrabony periodontal defects.  PRF has a proliferative effect on different types of cells such as osteoblasts, gingival fibroblasts, and PDL cells. Thus, this homogenous fibrin network is considered as healing biomaterial and is used to enhance bone regeneration. Two dimensional radiographic methods such as IOPA, bitewing radiographs, periapical radiographs and OPG are severely limited by the inherent overlay of anatomic structures and the difficulty to reproduce angles over time. Cone beam computed tomography (CBCT) enables cross-sectional and 3D analysis without distortion and evaluating osseous defects with high resolution. To evaluate the effectiveness of nano hydroxyapatite graft which may help in achieving favorable bone regeneration by promoting healing and platelet rich fibrin membrane when used in combination provides graft stabilization and improves clinical parameters in the intra bony defects. 
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