| CTRI Number |
CTRI/2019/09/021017 [Registered on: 02/09/2019] Trial Registered Prospectively |
| Last Modified On: |
20/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Comparing egg shell derived calcium phosphate cement with bone graft (synthetic hydroxyapatite) in bone defects |
|
Scientific Title of Study
|
A Clinical and Radiographic evaluation of Egg Shell derived Calcium Phosphate Cement over Synthetic Hydroxyapatite in Periodontal Osseous Defects: A Randomized Controlled Split Mouth Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
GODASI SRIPOOJA |
| Designation |
POST GRADUATE |
| Affiliation |
Kamineni Institute of dental scienes |
| Address |
KAMINENI INSTITUTE OF DENTAL SCIENCES SREEPURAM NARKETPALLY NALGONDA DISTRICT
Nalgonda
TELANGANA
508254
India |
| Phone |
8985576801 |
| Fax |
|
| Email |
spgodasi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S VIDYA SAGAR |
| Designation |
PROFESSOR |
| Affiliation |
Kamineni Institute of dental scienes |
| Address |
KAMINENI INSTITUTE OF DENTAL SCIENCES SREEPURAM NARKETPALLY NALGONDA DISTRICT
Nalgonda
TELANGANA
508254
India |
| Phone |
9989117747 |
| Fax |
|
| Email |
drsagarperio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S VIDYA SAGAR |
| Designation |
PROFESSOR |
| Affiliation |
Kamineni Institute of dental scienes |
| Address |
KAMINENI INSTITUTE OF DENTAL SCIENCES SREEPURAM NARKETPALLY NALGONDA DISTRICT
TELANGANA
508254
India |
| Phone |
9989117747 |
| Fax |
|
| Email |
drsagarperio@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
GODASI SRIPOOJA |
| Address |
KAMINENI INSTITUTE OF DENTAL SCIENCES SREEPURAM NARKETPALLY NALGONDA DISTRICT |
| 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 |
| GODASI SRIPOOJA |
kamineni institute of dental sciences |
DEPARTMENT OF PERIODONTOLOGY AND IMPLANTOLOGY, ROOM NO 211
Nalgonda
TELANGANA |
8985576801
spgodasi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| instituitional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
EGG SHELL DERIVED CALCIUM PHOSPHATE CEMENT |
EGG SHELL DERIVED TETRA CALCIUM PHOSPHATE will be prepared by heating a mixture consisting equimolar concentration of dicalcium phosphate anhydrous and calcium carbonate |
| Intervention |
SYNTHETIC HYDROXYAPATITE |
It is synthetically derived hydroxyapatite which fills bone defect |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Systemically healthy patients.
Patients having maxillary & mandibular osseous defects with probing depth ≥ 5 mm and clinical attachment loss of ≥5 mm from the cementoenamel junction.
Patients with radiographic osseous defects.
|
|
| ExclusionCriteria |
| Details |
Systemically compromised patients and those on medications.
Pregnant women and lactating mother.
Patients allergic to drugs.
Smokers.
Bruxism.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| INCREASE IN BONE LEVEL AFTER PLACEMENT OF EGG SHELL DERIVED CALCIUM PHOSPHATE CEMENT |
BASE LINE, 1 MONTH, 3 MONTHS AND 6 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| DECREASE IN THE POCKET PROBING DEPTH |
BASE LINE, 1 MONTH, 3 MONTHS AND 6 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 |
|
Date of First Enrollment (India)
|
08/09/2019 |
| 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="2"
Months="3"
Days="10" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
COMPARES CLINICALLY AND RADIOGRAFICALLY EGG SHELL DERIVED CALCIUM PHOSPHATE CEMENT OVER SYNTHETIC HYDROXYAPATITE IN BONE DEFECTS |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
|
Calcium
phosphate cements act as both graft material
and
barrier membrane to promote guided bone regeneration in defect site which
makes it
a
unique material for grafting by acting significantly better than hydroxyapatite
ceramic granules
and thus it could be considered as a “barrier-graftâ€.
|
|