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CTRI Number  CTRI/2022/03/041386 [Registered on: 25/03/2022] Trial Registered Prospectively
Last Modified On: 26/03/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Evaluation of various bone forming material for bone preservation after tooth removal.  
Scientific Title of Study   comparison of clinical and radiographic assessment of efficacy of eggshell-derived nanohydroxyapatite (EnHA) and demineralized freeze dried bone allograft(DFDBA), both covered with platelet-rich fibrin (PRF) in socket preservation - a randomized controlled clinical study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
U1111-1275-3240  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Neha V Nainoor 
Designation  Post graduate student 
Affiliation  Dayananda Sagar College Of Dental Sciences 
Address  Department of Oral And Maxillofacial Surgery, Dayananda Sagar College Of Dental Sciences, Bangalore-560078. Karnataka

Bangalore
KARNATAKA
560078
India 
Phone  8147201542  
Fax    
Email  drnehanomfs@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shobha E S 
Designation  Guide And Head Of The Department, Department Of Oral And Maxillofacial Surgery 
Affiliation  Dayananda Sagar College Of Dental Sciences 
Address  Department of Oral And Maxillofacial Surgery, Dayananda Sagar College Of Dental Sciences, Bangalore-560078. Karnataka

Bangalore
KARNATAKA
560078
India 
Phone  9880821614  
Fax    
Email  shobha_es@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shobha E S 
Designation  Guide And Head Of The Department, Department Of Oral And Maxillofacial Surgery 
Affiliation  Dayananda Sagar College Of Dental Sciences 
Address  Department of Oral And Maxillofacial Surgery, Dayananda Sagar College Of Dental Sciences, Bangalore-560078. Karnataka

Bangalore
KARNATAKA
560078
India 
Phone  9880821614  
Fax    
Email  shobha_es@yahoo.com  
 
Source of Monetary or Material Support  
Dayananda Sagar College Of Dental Sciences 
 
Primary Sponsor  
Name  Dr Neha V Nainoor 
Address  Post graduate student, Department of Oral And Maxillofacial Surgery, Dayananda Sagar College Of Dental Sciences, Bangalore-560078. Karnataka  
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 Neha V Nainoor  Dayananda Sagar College of Dental Sciences  No:3 Department Of Oral And Maxillo facial Surgery 1st floor
Bangalore
KARNATAKA 
8147201542

drnehanomfs@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC, Dayananda Sagar College of Dental Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K039||Disease of hard tissues of teeth,unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Demineralized Freeze Dried Bone Allograft  demineralized freeze-dried bone allograft(DFDBA) covered with platelet-rich fibrin (PRF) for socket preservation and observed over a period of 4 months. 
Intervention  Egg shell derived hydroxyapatite  eggshell-derived nanohydroxyapatite (EnHA) covered with platelet-rich fibrin (PRF) for socket preservation and observed over a period of 4 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Patients consenting to be a part of the study and have agreed for periodic recall.
2. Systemically healthy patients (ASA-I) between the age group of 18-50 years of either gender requiring bilaterally symmetrical mandibular molar extractions.
3. Patients consenting to standard sterile phlebotomy technique for PRF preparation.
4. Presence of teeth adjacent to the extraction socket.
 
 
ExclusionCriteria 
Details  1. Patients with a known history of diabetes mellitus, endocrine and bone disorders.
2. Patients with immunosuppressive conditions.
3. Pregnant patients.
4. Patients with poor oral hygiene
5. Patients with acute infections.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. To clinically assess pain, wound healing, in bilaterally symmetrical mandibular molar extraction sockets filled with eggshell-derived nanohydroxyapatite (EnHA) covered with PRF as barrier membrane.
2. To clinically assess pain, wound healing in bilaterally symmetrical mandibular molar extraction sockets filled with DFDBA covered with PRF as a barrier membrane.
3. To radiologically assess bone density, changes in lamina dura and crestal bone level in bilaterally symmetrical mandibular molar extraction sockets filled with eggshell-derived nanohydroxyapatite (EnHA) covered with PRF as barrier membrane.
4. To radiologically assess bone density, changes in lamina dura and crestal bone level in bilaterally symmetrical mandibular molar extraction sockets filled with DFDBA covered with PRF as a barrier membrane.
5. To compare the effect of EnHA covered with PRF and DFDBA covered with PRF in bilaterally symmetrical mandibular molar extraction sockets.
 
1st month, 4th month 
 
Secondary Outcome  
Outcome  TimePoints 
Adequate bone width and height
Better periodontal health
 
1st month, 4th month 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   15/04/2022 
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)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Need for the study:

Socket preservation is a procedure to preserve hard and soft tissue of the alveolar ridge after extraction. The alveolar process is a tooth dependent structure. extraction of teeth leads to an edentulous space and loss of alveolar bone, function and aesthetics. studies have shown mean reduction of 3.8mm in width and 1.24 mm of height of the alveolar bone in the first six months following extraction. Bone regeneration is a major challenge in reconstructive surgery. Bone substitutes are frequently used in the surgical procedure to augment and regenerate hard tissues. The gold standard for alveolar reconstruction is the autologous bone enhancing osteogenesis, osteoinduction, and osteoconduction. The problem lies in its scarcity, depending on the donor site, and association with several risks like nerve damage, infection, bleeding, scarring and loss of function. Other disadvantages include possible donor site injury, host morbidity, prolonged operation times and cost. Since the first successful bone transplantation carried out in 1668 by van meek’ren, a dutch surgeon, more than 50 bone substitutes have been described in the literature. Unfortunately, none has fulfilled all the requirements to gain wide acceptance in clinical practice. the ideal bone substitute should be biocompatible, osteoinductive or at least osteoconductive, and have satisfactory mechanical properties. This bone should be available in unlimited quantity and at a low cost. Among inorganic materials, calcium salts were the first implants to be successfully used in clinical practice. They present the advantage of mimicking the human mineral bone phase and they do not elicit any immune response as they do not contain living cells or organic matrix. Hydroxyapatite (ha) is the main inorganic constituent of bones and teeth. It is a key material of skeletal tissue; many types of bone graft materials have ha as a basic component. In many disciplines of surgery ha is being used as graft material successfully. In particular, ha shows highest level of bioactivity and forms quick bond with bone. The eggshell formulations are being used since beginning as trace element and mineral supplying agents. The eggshell powder has been examined in rats for bone healing. Few studies show surface modified eggshell powder as osteoconductive bone filling material with variable benefit in bone regeneration.the literature showed material properties of eggshell-derived hydroxyapatite (enha) are superior when compared with the commercially available graft materials. So, the enha has been introduced as bone graft substitute recently. Histomorphometric evaluation showed that the enha has excellent new bone formation ability. This has led to the curiosity to prepare the enha from eggshell waste in a very economical way. Many current socket preservation techniques use barrier membrane for primary closure, but there are often difficulties in adoption of the membrane, and a second surgical procedure is required to remove the membrane. In general, membrane use is time-consuming and expensive.   prf is an autologous source, and it contains various growth factors such as platelet-derived growth factors and insulin-like growth factors.  prf is mostly preferred over other concentrates because it releases the growth factors at a sustained rate over a longer period, thereby optimizing wound healing. The prf membrane acts as a cover for graft material and as a barrier membrane for guided bone regeneration. Therefore, according to the characteristics of eggshell-derived nanohydroxyapatite such as bone healing, bone remodelling and bone regeneration with increased density, as suggested in the literature, in this study we utilize eggshell-derived nanohydroxyapatite along with prf as a barrier membrane to assess pain, wound healing, changes in lamina dura, crestal bone level and bone density in mandibular extraction sockets and compare it with commonly used demineralised freeze dried bone allograft (DFDBA) covered with prf membrane. This study is taken up considering the limitations of allografts and the fact that no study has been undertaken to compare the efficacy of eggshell-derived nanohydroxyapatite with the commonly used demineralised freeze dried bone allograft (DFDBA) in human extraction sockets 

 
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