| CTRI Number |
CTRI/2023/10/059043 [Registered on: 23/10/2023] Trial Registered Prospectively |
| Last Modified On: |
17/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of bone grafts in treatment of bony defects |
|
Scientific Title of Study
|
Comparative evaluation of bioactive calcium phosphosilicate graft
with enamel matrix derivative in the treatment of three wall
intrabony defects: A Randomized Controlled Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ANJALI BATRA |
| Designation |
PG Student |
| Affiliation |
Manav Rachna Dental College |
| Address |
A-4, Mianwali Colony, Sector-12, Gurgaon-122001, Haryana
Manav Rachna Dental College, SDS, MRIIRS, Faridabad, Haryana-121004
Faridabad
HARYANA
122001
India |
| Phone |
9821130340 |
| Fax |
|
| Email |
anjalibatra04@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ruchi Pandey |
| Designation |
Professor |
| Affiliation |
MANAV RACHNA DENTAL COLLEGE |
| Address |
Department of periodontology,
Manav Rachna Dental College, SDS, MRIIRS
Department of Periodontology
MRDC,FDS,MRIIRS
Faridabad
HARYANA
121004
India |
| Phone |
7799690877 |
| Fax |
|
| Email |
ruchi.sds@mrei.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
ANJALI BATRA |
| Designation |
Post graduate |
| Affiliation |
MANAV RACHNA DENTAL COLLEGE |
| Address |
Department of Periodontology,
MRDC, SDS, MRIIRS
Surajkund-Bhadkal road, Sector 43,
Faridabad, 121004
Faridabad
HARYANA
121004
India |
| Phone |
9821130340 |
| Fax |
|
| Email |
anjalibatra04@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self Funded, Manav Rachna dental College, SDS, MRIIRS, Faridabad, Haryana-121004 (infrastructure) |
|
|
Primary Sponsor
|
| Name |
Dr Anjali Batra |
| Address |
Department of Periodontology, Surajkund Bhadkal Main road, Sector 43, Faidabad, Haryana |
| Type of Sponsor |
Other [Self Funded ] |
|
|
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 ANJALI BATRA |
Manav Rachna dental college |
QT-25,26, Department of Periodontology
Faridabad
HARYANA |
9821130340
anjalibatra04@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, MANAV RACHNA DENTAL COLLEGE, |
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 |
| Intervention |
Open Flap Debridement |
Clinical parameters like gingival index, plaque index, probing depth, clinical attachment level and radiographic assessment will be done at baseline and at 6 months |
| Comparator Agent |
Open Flap Debridement and bone graft Novabone putty |
Clinical parameters like gingival index, plaque index, probing depth, clinical attachment level and radiographic assessment will be done at baseline and at 6 months. |
| Comparator Agent |
Open Flap Debridement and bone graft Novabone putty along with Emdogain |
Clinical parameters like gingival index, plaque index, probing depth, clinical attachment level and radiographic assessment will be done at baseline and at 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria
1. Patients in the age group of 18-45 years.
2. Patients with probing pocket depth > 6 mm and clinical attachment level > 8
mm.
3. Patients with three wall intrabony defects in mandibular posterior teeth.
4. Patients willing to keep appointments.
Exclusion criteria
1. Patients on medication for systemic diseases.
2. Patients undergone regenerative periodontal therapy last 6 months.
3. Patients on antibiotics and non-steroidal anti-inflammatory analgesic
therapy in last 3 months.
4. Test and control sites involving caries and any kind of prosthesis.
5. Pregnant and lactating females.
6. Patients with history of allergy to synthetic grafts and EMD.
7. Patients on hormone replacement therapy.
8. Patients refusing to give consent for EMD.
9. Patients using any form of tobacco.
|
|
| ExclusionCriteria |
| Details |
Inclusion criteria
1. Patients in the age group of 18-45 years.
2. Patients with probing pocket depth > 6 mm and clinical attachment level > 8
mm.
3. Patients with three wall intrabony defects in mandibular posterior teeth.
4. Patients willing to keep appointments.
Exclusion criteria
1. Patients on medication for systemic diseases.
2. Patients undergone regenerative periodontal therapy last 6 months.
3. Patients on antibiotics and non-steroidal anti-inflammatory analgesic
therapy in last 3 months.
4. Test and control sites involving caries and any kind of prosthesis.
5. Pregnant and lactating females.
6. Patients with history of allergy to synthetic grafts and EMD.
7. Patients on hormone replacement therapy.
8. Patients refusing to give consent for EMD.
9. Patients using any form of tobacco.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary- There is no difference seen in clinical parameters and bone fill levels in patients with or without graft placement.
|
Baseline, 3 month, 6 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Clinical parameters like gingival index, plaque index, probing depth, clinical attachment level & radiographic assessment will be done at baseline & at 6 months
|
Baseline, 3 month, 6 month |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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
Modification(s)
|
N/A |
|
Date of First Enrollment (India)
|
31/10/2023 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Primary objective1. To evaluate the clinical parameters and bone fill of bioactive calcium phospho-silicate graft in the treatment of three wall intrabony defects at different time intervals. 2. To evaluate the clinical parameters and bone fill of bioactive calcium phospho-silicate graft with enamel matrix derivative in the treatment of three wall intrabony defects at different time intervals. Secondary objective To compare the clinical parameters and bone fill of bioactive calcium phospho-silicate graft and calcium phospho-silicate graft with enamel matrix derivative in the treatment of three wall intrabony defects at different time intervals. |