| CTRI Number |
CTRI/2024/09/073715 [Registered on: 10/09/2024] Trial Registered Prospectively |
| Last Modified On: |
09/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Difference in artificial bone material and naturally obtained bone material in terms of new bone formation following removal of infection |
|
Scientific Title of Study
|
Comparative Evaluation of the Efficacy of Eggshell Derived Hydroxyapatite (EHA) with Commercial Available Synthetic Hydroxyapatite (SHA) In Bone Regeneration following Periapical Cyst Enucleation.
|
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrNeha Agarwal |
| Designation |
Post graduate student |
| Affiliation |
Dr.DY Patil dental college and hospital,Dr.DYPatil vidyapeeth,Pune |
| Address |
Department of Oral and Maxillofacial surgeryOPD 9,Dr.DY Patil dental college and hospital,Dr.DYPatil vidyapeeth,Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
7585952765 |
| Fax |
|
| Email |
nehu.agarwal1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrBMRudagi |
| Designation |
HOD and professor |
| Affiliation |
Dr.DY Patil dental college and hospital,Dr.DYPatil vidyapeeth,Pune |
| Address |
Department of Oral and Maxillofacial surgery OPD 9,Dr.DY Patil dental college and hospital,Dr.DYPatil vidyapeeth,Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9673494111 |
| Fax |
|
| Email |
drbmr17@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrBMRudagi |
| Designation |
HOD and professor |
| Affiliation |
Dr.DY Patil dental college and hospital,Dr.DYPatil vidyapeeth,Pune |
| Address |
Department of Oral and Maxillofacial surgery OPD 9,Dr.DY Patil dental college and hospital,Dr.DYPatil vidyapeeth,Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9673494111 |
| Fax |
|
| Email |
drbmr17@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.DY Patil dental college and hospital,Dr.DYPatil vidyapeeth, Pimpri Pune 411018 India |
|
|
Primary Sponsor
|
| Name |
Dr.DY Patil dental college and hospital,Dr.DYPatil vidyapeeth,Pune |
| Address |
Department of Oral and Maxillofacial surgery OPD 9,Dr.DY Patil dental college and hospital,Dr.DYPatil vidyapeeth,Pune |
| 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 |
| DrNeha Agarwal |
Dr.DY Patil dental college and hospital,Dr.DYPatil vidyapeeth,Pune |
Department of Oral and Maxillofacial surgery OPD 9,Dr.DY Patil dental college and hospital,Dr.DYPatil vidyapeeth,Pune
Pune
MAHARASHTRA |
7585952765
nehu.agarwal1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Sub Committee Dr.DY Patil Dental college and hospital ,Dr.DY Patil Vidyapeeth ,Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Egg shell derived hydroxyapatite bone graft |
To evaluate the efficacy of Egg shell derived hydroxyapatite bone graft in bone regeneration following periodical cyst enucleation at 3,6,9 months |
| Comparator Agent |
Commercially Available Synthetic Hydroxyapatite (SHA) bone graft |
Efficacy of Commercially Available Synthetic Hydroxyapatite (SHA) In Bone Regeneration following Periapical Cyst Enucleation at 3,6,9 months
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with periapical cystic lesions (1.5-2 cm in diameter) of the maxilla and mandible involving up to three teeth, as confirmed by clinical and radiological evaluations, will be included in the study.
2. Patients in the age group of 18-40 years.
3. Patients who will give written informed consents.
|
|
| ExclusionCriteria |
| Details |
1. Immunocompromised individuals including those with severe debilitating diseases,
2. Pregnant and lactating female participants.
3. Individuals with endocrine disorders.
4. Patients in which satisfactory endodontic treatment cannot be done.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The effect of grafting will be evaluated using digital radiographic imaging technique and computer densitometry in bone regeneration at time intervals of 3,6 and 9 months following periapical cyst enucleation. |
The effect of grafting will be evaluated using digital radiographic imaging technique and computer densitometry in bone regeneration at time intervals of 3,6 and 9 months following periapical cyst enucleation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The effect of grafting will be evaluated using digital radiographic imaging technique and computer densitometry in bone regeneration at time intervals of 3,6 and 9 months following periapical cyst enucleation. |
4,7,10 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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
10/11/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
To promote healing of large bone defects using graft material is well known. Missing bone is replaced traditionally with material either from patient or donor. Clinicians and scientists are in search of alternative bone graft substitutes because of factors like donor site morbidity, time, and skill required for second surgery to harvest graft, inadequate quantity available with respect to auto grafts, and so. Multiple sources and different forms of bone grafts have been used for bone augmentation and reconstruction in oral maxillofacial and orthopedic surgery to stimulate bone healing since long time. In recent years, use of synthetic or processed bone graft substitute has gained popularity over traditional grafting methods.  Hydroxyapatite (HA) is apatite calcium phosphate Ca10(PO4)6(OH)2. In many disciplines of  surgery HA is being used as graft material successfully. In particular, HA shows highest level  of bioactivity and forms a quick bond with bone.  The eggshell formulations are being used since beginning as trace element and mineral  supplying agents. Few studies show surface modified eggshell powder as osteoconductive bone Objective of the study: To assess the efficacy of eggshell derived hydroxyapatite in terms of bone regeneration by densitometer after 3,6 and 9 months following periapical cyst enucleation in maxilla and mandible To assess the efficacy of synthetic hydroxyapatite in terms of bone regeneration by densitometer after 3,6 and 9 months following periapical cyst enucleation in maxilla and mandible To compare the efficacy of eggshell derived hydroxyapatite (EHA) with commercially available synthetic hydroxyapatite (SHA)in terms of bone regeneration by densitometer after 3,6 and 9 months following periapical cyst enucleation in maxilla and mandible
 |