| CTRI Number |
CTRI/2022/04/041859 [Registered on: 13/04/2022] Trial Registered Prospectively |
| Last Modified On: |
11/04/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing organic bone replacement material from egg shell with man-made materials in rate of bone healing after lower wisdom tooth removal |
|
Scientific Title of Study
|
Comparative evaluation of egg shell derived Nano hydroxyapatite and synthetic hydroxyapatite both combined with concentrated growth factor in bone regeneration after mandibular 3rd molar surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jayaindhraeswaran J |
| Designation |
Postgraduate |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Saveetha Dental College and Hospitals
162, Poonamallee High Rd,
Velappanchavadi,
Chennai, Tamil Nadu 600077
Chennai
TAMIL NADU
600077
India |
| Phone |
7200500633 |
| Fax |
|
| Email |
Eshwaran.jjjj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Senthilnathan |
| Designation |
Professor and Head of Department of OMFS |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Saveetha Dental College and Hospitals
162, Poonamallee High Rd,
Velappanchavadi,
Chennai, Tamil Nadu 600077
Chennai
TAMIL NADU
600077
India |
| Phone |
|
| Fax |
|
| Email |
dr.nathankps@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Senthilnathan |
| Designation |
Professor and Head of Department of OMFS |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Saveetha Dental College and Hospitals
162, Poonamallee High Rd,
Velappanchavadi,
Chennai, Tamil Nadu 600077
Chennai
TAMIL NADU
600077
India |
| Phone |
|
| Fax |
|
| Email |
dr.nathankps@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Dental College and Hospitals |
|
|
Primary Sponsor
|
| Name |
Saveetha Dental College |
| Address |
Saveetha Dental College and Hospitals
162, Poonamallee High Rd,
Velappanchavadi,
Chennai, Tamil Nadu 600077 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| J JAYINDHRAESWARAN |
Saveetha Dental College and Hospitals |
Clinic 20,
Department of Oral & Maxillofacial Surgery
Saveetha Dental College and Hospitals
162, Poonamallee High Rd,
Velappanchavadi,
Chennai, Tamil Nadu 600077
Chennai
TAMIL NADU |
7200500633
Eshwaran.jjjj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patients undergoing surgical removal of Impacted lower third molar teeth under local anaesthesia |
| Patients |
(1) ICD-10 Condition: K011||Impacted teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Egg shell derived hydroxyapatite |
Chicken egg shell, sterilised and ground into powder. Concentrated growth factors
Mix will be packed into extraction at socket at time of surgery (single sitting). Procedure time is approximately 15-20 minutes. |
| Comparator Agent |
Synthetic hydroxyapatite |
Commercially available synthetic bone graft material will be compared.
Mix will be packed into extraction at socket at time of surgery (single sitting). Procedure time is approximately 15-20 minutes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients undergoing bilateral mandibular 3rd molar extraction
2. Patients with no associated pathologies and medical conditions or any medications that might alter the healing potential - ASA 1 and ASA 2 |
|
| ExclusionCriteria |
| Details |
1. Medically compromised patients
2. Patients with unilateral impacted lower third molars
3. Patients on preoperative anti-inflammatory medication
4. History of systemic diseases
5. Pregnant patients |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Bone regeneration: Verified using CBCT
|
1. 1 month, 3 months, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Wound healing - clinical examination |
1 month |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
Phase 3 |
|
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="6"
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
|
Use of various bone graft substitutes are advised to prevent bone loss, periodontal problems and enhance bone formation. Choice of the graft substitute depend on the biological properties and the cost of the material. Hence, a preliminary study was planned to evaluate the effectiveness of eggshell derived nano hydroxyapatite as an emerging graft substitute for the enhancement of bone regeneration.Hydroxyapatite (HA) is apatite calcium phosphate. In many disciplines of surgery HA is being used as graft material successfullyIn particular, HA shows highest level of bioactivity and forms a quick bond with bone.A recent study showed bioactive effect of the HA ceramic is because of the ability to concentrate active fibronectin on its surface.Hydroxyapatite is available in porous/dense block or granular form for clinical use. It is an inorganic ceramic substance which does not cause any foreign body reaction; in porous grafts the hard tissue grows into it and mingles with natural tissues. The eggshell formulations have been used since the 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 egg- shell-derived hydroxyapatite (EHA) are superior when compared with the commercially available graft materials.So, the EHA has been introduced as bone graft substitute recently. Histomorphometric evaluation showed that the EHA has excellent new bone formation ability.This has led to the curiosity to prepare the EHA from eggshell waste in a very economical way. |