FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/07/044401 [Registered on: 27/07/2022] Trial Registered Prospectively
Last Modified On: 11/07/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Clinical Trial to study the healing of extraction socket and implant stability on using a naturally sourced bone graft 
Scientific Title of Study   Evaluation of healing of extraction socket, bone morphologic changes, primary implant stability and patient reported outcome measures with the use of E-Bone (naturally sourced nano-hydroxyapatite graft): A Randomized Control Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pragati Kaurani 
Designation  Professor, Department of Prosthodontics, Crown and Bridge 
Affiliation  Mahatma Gandhi Dental College and Hospital 
Address  Mahatma Gandhi Dental College and Hospital, Department of Prosthododntics, Crown and Brisge, MGUMST, RIICO Industrial Area, Sitapura, Jaipur

Jaipur
RAJASTHAN
302022
India 
Phone  9829663314  
Fax    
Email  drpragati@mgumst.org  
 
Details of Contact Person
Scientific Query  
Name  Dr Vivekanand Kattimani 
Designation  Head of Department, Dept of Clinical Research, Professor, Dept of Oral and Maxillofacial Surgery 
Affiliation  Sibar Institute of Dental Sciences 
Address  Department of Clinical Research, Sibar Institute of Dental Sciences, Guntur- 522509 NSS- Program Coordinator, Dr. N.T.R. University of Health Science, Andhra Pradesh, India

Guntur
ANDHRA PRADESH
522509
India 
Phone  9492473628  
Fax    
Email  drvivekanandsk@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Pragati Kaurani 
Designation  Professor, Department of Prosthodontics, Crown and Bridge 
Affiliation  Mahatma Gandhi Dental College and Hospital 
Address  Mahatma Gandhi Dental College and Hospital, Department of Prosthodontics, Crown and Bridge, MGUMST, RIICO Industrial Area, Sitapura, Jaipur

Jaipur
RAJASTHAN
302022
India 
Phone  9829663314  
Fax    
Email  drpragati@mgumst.org  
 
Source of Monetary or Material Support  
Mahatma Gandhi Dental College and Hospital, Sitapura Jaipur 
 
Primary Sponsor  
Name  Mahatma Gandhi Dental College and Hospital 
Address  MGUMST, RIICO Industrial Area, Sitapura, Jaipur- 302022 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Dr Girija EK  Periyar University, Salem 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Pragati Kaurani  Mahatma Gandhi Dental College and Hopsital  Department of Prosthodontics, Crown and Bridge, MGUMST, RIICO Industrial Area, Sitapura, Jaipur
Jaipur
RAJASTHAN 		 9929663314
0141-2770326
drpragati@mgumst.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K080||Exfoliation of teeth due to systemic causes, (2) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, (3) ICD-10 Condition: K083||Retained dental root, (4) ICD-10 Condition: K085||Unsatisfactory restoration of tooth,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Egg shell derived nano hydoxyapatite biomaterial  Dose-as needed to fill the defect approximately 1gm for socket to fill in molar and 0.5gm for other teeth Duration- One time implantation 
Comparator Agent  No treatment provided to the extraction socket.  No treatment shall be provided to the extraction socket and shall heal normally. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1. Patients who had teeth with indication for extraction, with extensive cavities, root fracture or vertical periodontal defects of maxillary or mandibular first and second molars.2. Patients in whom single or multiple teeth were indicated for extraction for reasons other than chronic periodontitis.3. Patients with age 18-45 years with good oral hygiene and teeth in need of extraction in regions where the use of a temporary prosthesis or mucosal support was not necessary shall be recruited. 
 
ExclusionCriteria 
Details  1. Smokers, ASA III and IV, pregnant women, patients with Stage III or IV periodontal disease will be excluded from the study.
2. Patients with gross tooth mobility due to complete bone loss (more than 3/4 of root length).
3. Patients with any abnormal findings during clinical or radiological examination. Example: Patients with ankylosed roots or other root morphological alterations that may complicate the procedure.
4. Patients undergoing Immunosuppressive conditions such as AIDS, Cancer or Radiation therapies.
5. Subjects with positive COVID results.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Assessment of the bone quality and bone dimensions and assessment of primary stability of implant  4 months after tooth extraction surgery 
 
Secondary Outcome  
Outcome  TimePoints 
Pain  At time of implant placement (4 months after tooth extraction surgery) 
Number of consultation  At time of implant placement (4 months after tooth extraction surgery) 
Recommendation of patient  At time of implant placement (4 months after tooth extraction surgery) 
Treatment difficulty  At time of implant placement (4 months after tooth extraction surgery) 
Histomorphic Evaluation  At time of implant placement (4 months after tooth extraction surgery) 
 
Target Sample Size   Total Sample Size="26"
Sample Size from India="26" 
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)   01/08/2022 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This Study is a single centered, randomized control trial.
Aim:The aim of this study is to evaluate the bone changes, primary stability and patient reported outcome measures on placing egg shell derived nanohydroxyapatite bone grafting material into an extraction socket followed by implant placement.
Objectives:
1. To evaluate the bone changes (radiographic and histomorphic) on placement of the nano-hydroxyapatite egg shell derived biomaterial in the extraction socket followed by implant placement.
2. To evaluate the primary stability of the implants placed in the implant site formed on placement of the nano-hydroxyapatite egg shell derived biomaterial using a Osstell ISQ RFA device.
3. To evaluate the patient reported outcome measures for the surgical procedures involving socket preservation and implant placement using the nano-hydroxyapatite egg shell derived biomaterial.
Material and Method:
Patients shall be selected from the OPD of Department of Prosthodontics and Oral and Maxillofacial Surgery. After the extraction of the indicated tooth, the patients shall be randomly assigned into two groups:  to the Test group 1 (Control group) the Test group 2 (Interventional Group). For the TG2, the sockets shall be filled with the egg shell derived nano-hydroxyapatite biomaterial up to the original level of the alveolar ridge; For the TG1, pressure pack is applied and allowed to be  filled by clotting that will be allowed to form naturally. Nano-hydroxyapatite Graft Material used for grafting are synthesized from natural calcium precursors obtained from chicken eggshell waste and produced using a rapid microwave processing technique. Extraction of the tooth or tooth root will be performed atraumatically under local anesthesia. If necessary, curettage shall be performed and irrigation will be done with Betadine and saline. After hemostasis, nHA grafting will be performed to the crestal level in the TG2 group and buccal advancement flap will be used for primary closure of the site using 4.0 non absorbable polyamide sutures.
Postoperative care for both the groups shall include continued 500 mg amoxicillin+ 125mg Clavulenic Acid every 12 hr for 5 days and Aceclofenac 100mg +Serratiopeptidase 15mg + Paracetamol 325 mg twice daily for 5 days, as well as use of the mouthwash with 0.12% chlorhexidine two times a day for 14 days. After sevendays, the sutures shall be removed. Patients shall be instructed to use ice bags on the surgical region within 48 h after surgeries and to eat only soft and cold food during this period. Four months after tooth extraction surgery, implant planning shall be done. The following shall be evaluated for each patient in both the groups: radiographic bone density, bone height and width. The data from the CBCT shall be further be used for implant planning and assessment. Assessment of the bone quality and bone dimensions shall be done by a single blinded assessor who shall not be involved in the graft placement. Surgical placement of the implant shall be done by one trained operator who shall be blinded for the groups. Primary stability of the implant placed shall be recorded for each patient by the same blinded operator by using Osstell ISQ RFA device. 
Referance articles
1. SureshKumar G, Thamizhavel A, Girija EK. Microwave conversion of eggshells into flower-like hydroxyapatite nanostructure for biomedical applications. Mater Lett 2012;76:198-200.
2. Kattimani VS, Lingamaneni KP, Kreedapathi GE, Kattappagari KK. Socket preservation using eggshellderived nanohydroxyapatite with platelet-rich fibrin as a barrier membrane: a new technique. J Korean Assoc Oral Maxillofac Surg 2019;45:332-342. https://doi.org/10.5125/jkaoms.2019.45.6.332
3. Kattimani VS, Prathigudupu RS, et al. Role of Synthetic  Hydroxyapatite—In Socket Preservation: A Systematic Review and Meta-analysis. J Contemp Dent Pract 2019;20(8):987–993.
 
Close