| CTRI Number |
CTRI/2020/11/028807 [Registered on: 02/11/2020] Trial Registered Prospectively |
| Last Modified On: |
21/10/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the new formation of lost bone supporting the teeth, by placing calcium phosphate bone graft. |
|
Scientific Title of Study
|
Clinical and radiographic evaluation of Calcium phosphate -Poly
(lactide co-glycolide) composite graft in the regeneration of
intrabony defects- A Randomized Controlled Trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MOITRI OJHA |
| Designation |
POSTGRADUATE STUDENT |
| Affiliation |
JSS DENTAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF PERIODONTOLOGY,
JSS DENTAL COLLEGE AND HOSPITAL,
BANNIMANTAP,
MYSORE
Mysore
KARNATAKA
570015
India |
| Phone |
9776308414 |
| Fax |
|
| Email |
moitriojha@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr DEEPIKA PC |
| Designation |
Professor |
| Affiliation |
JSS DENTAL COLLEGE AND HOSPITAL |
| Address |
Room-9,
DEPARTMENT OF PERIODONTOLOGY,
JSS DENTAL COLLEGE AND HOSPITAL,
BANNIMANTAP,
MYSORE
Mysore
KARNATAKA
570015
India |
| Phone |
9902066073 |
| Fax |
|
| Email |
deepikamysore@yahoo.co.uk |
|
Details of Contact Person
Public Query
|
| Name |
MOITRI OJHA |
| Designation |
POSTGRADUATE STUDENT |
| Affiliation |
JSS DENTAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF PERIODONTOLOGY,
JSS DENTAL COLLEGE AND HOSPITAL,
BANNIMANTAP,
MYSORE
KARNATAKA
570015
India |
| Phone |
9776308414 |
| Fax |
|
| Email |
moitriojha@yahoo.in |
|
|
Source of Monetary or Material Support
|
| JSS Dental College and Hospital |
|
|
Primary Sponsor
|
| Name |
JSSAHER |
| Address |
JSS UNIVERSITY,
BANNIMANTAP,
MYSORE- 570015 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| MOITRI OJHA |
JSS DENTAL COLLEGE AND HOSPITAL |
Room-9,
Department of periodontology,
JSS Dental college and hospital,
Bannimantap,
Mysore
Mysore
KARNATAKA |
9776308414
moitriojha@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JSS DENTAL COLLEGE AND HOSPITAL INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z408||Encounter for other prophylactic surgery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
caclium phosphate bone grafts |
bone regeneration of intrabony defects in patients with chronic periodontitis |
| Intervention |
Calcium phosphate -Poly (lactide co-glycolide) composite bone graft comprising of calcium phosphate cement with Poly (lactide co-glycolide)microspheres incorporated |
Bone regeneration of intrabony defects in patients with chronic periodontitis |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Systemically healthy patients, both males and females with age ranging from 35-55
years having chronic generalized periodontitis.
2. Patients having a minimum of two infrabony pockets measuring ≥ 6mm.
3. Patients with radiographic evidence of vertical/angular bone loss
4. Consenting patients who are co-operative and ready for regular follow up.
5. more than 20 remaining teeth |
|
| ExclusionCriteria |
| Details |
1.Patients on antibiotic therapy in the previous 6 months.
2. Patients who have undergone periodontal therapy in past six months.
3. Pregnant/lactating women
4. Smokers
5. Patients who are medically compromised and are under therapeutic medications that
may alter the probability of soft tissue and bone healing. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
comparison of bone regeneration between two groups. {test group:Calcium phosphate -Poly
(lactide co-glycolide)composite bone graft and control group:calcium phosphate bone graft |
At baseline, 3 months, 6 months, 9 months and 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison of clinical parameters |
At baseline, 3 months, 6 months, 9 months and 12 months |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
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)
|
30/11/2020 |
| 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="3"
Days="3" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
clinical and radiographic evaluation of Calcium phosphate -Poly(lactide co-glycolide) composite graft in the regenration of intrabony defects -A Randomized Controlled Trial. 2 groups will be taken
6 patients: control group where Calcium phosphate graft will be used 6 patients: test group where Calcium phosphate -Poly(lactide co-glycolide) graft will be used Cytotoxicity and biocompatibility tests will be conducted in JSS College of pharmacy
The grafts will be surgically placed into intrabony defects and clinical and radiographic parameters will be evaluated at baseline, 3 months, 6 months, 9 months and 12 months
|