| 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
|
|
|
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
|
|
|
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.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Centralized |
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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 |