| CTRI Number |
CTRI/2019/04/018354 [Registered on: 01/04/2019] Trial Registered Prospectively |
| Last Modified On: |
18/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry
Other (Specify) [IRRADIATED ALLOGENIC BONE GRAFT (RMTBTM) ] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinicaly and Radiographically Evaluating The regenerative potential Of Bone Grafts (RMTB-TM) In The Treatment Of Angular Bone Defects In Patients With Chronic Periodontitis. |
|
Scientific Title of Study
|
Clinical and Radiographic Evaluation of Irradiated Allogenic Bone Graft (RMTB-TM) In The Treatment Of Intrabony Defects In Patients With Chronic Periodontitis. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aysha Jebin A |
| Designation |
MDS Student |
| Affiliation |
Vydehi Institute Of Dental Sciences And Research Center, Bangalore |
| Address |
1410 SYEDS, 4th cross 6th main,E-block, AECS Layout, Kundalahalli
A M Mahal, Kumarlane, Thottakkara, Ottapalam, Palakkad, Kerala 679102
Bangalore
KARNATAKA
560037
India |
| Phone |
9895205190 |
| Fax |
|
| Email |
ayshpathu3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjeela Guru |
| Designation |
Reader, Department Of Periodontics |
| Affiliation |
Vydehi Institute Of Dental Sciences And Research Center, Bangalore |
| Address |
Room Number:6,
Department Of Periodontics,Vydehi Institute Of Dental Sciences And Research Center, Bangalore, BANGALORE,#82, EPIP AREA, NALLURAHALLI, WHITEFIELD, BANGALORE-560066.
Bangalore
KARNATAKA
560066
India |
| Phone |
7259665551 |
| Fax |
|
| Email |
sanjeelaguru@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aysha Jebin A |
| Designation |
MDS Student |
| Affiliation |
Vydehi Institute Of Dental Sciences And Research Center, Bangalore |
| Address |
1410 SYEDS
4th Cross 6th Main, E-Block
AECS Layout Kundalahalli
A M MAHAL, KUMARLANE, THOTTAKKARA, OTTAPALAM, PALAKKAD, KERALA 679102
Bangalore
KARNATAKA
560037
India |
| Phone |
9895205190 |
| Fax |
|
| Email |
ayshpathu3@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vydehi Institute Of Dental Sciences And Research Center, Bangalore |
|
|
Primary Sponsor
|
| Name |
Dr Aysha Jebin A |
| Address |
1410 SYEDS, 4TH CROSS 6TH MAIN
E BLOCK, AECS LAYOUT, KUNDALAHALLI, BANGALORE, KARNATAKA 560037
|
| Type of Sponsor |
Other [MDS Student (Individual)] |
|
|
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 Aysha Jebin A |
Vydehi Institute Of Dental Sciences And Research Center, Bangalore |
Room Number:6,
Department Of Periodontics,Vydehi Institute Of Dental Sciences And Research Center, Bangalore, BANGALORE,#82, EPIP AREA, NALLURAHALLI, WHITEFIELD, BANGALORE-560066.
Bangalore
KARNATAKA |
9895205190
ayshpathu3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| VIDS/ACM/039/2019 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
1. Moderate to severe chronic periodontitis as defined by the AAP classification 1999 •Probing Pocket Depth more than or equal to 5mm, Radiographic defects of 2 wall, 3 wall or combination defects Delete
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
IRRADIATED ALLOGENIC BONE GRAFT (RMTBTM) |
IRRADIATED ALLOGENIC BONE GRAFT (RMTBTM) IN THE TREATMENT OF INTRABONY DEFECTS IN PATIENTS WITH CHRONIC PERIODONTITIS |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE
SINGLE ARM TRIAL |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Systemically healthy patients
2.Moderate to severe chronic periodontitis as defined by the AAP classification 1999.
3.Probing Pocket Depth > 5mm, Radiographic defects > 3mm of 2 wall, 3 wall or combination defects
|
|
| ExclusionCriteria |
| Details |
1.Known drug allergies or Infectious diseases
2.1 wall defects
3.Periodontal treatment or antibiotic therapy in the preceding six months prior to initial examination.
4.History of Smoking/Alcohol consumption.
5.Pregnant and/or Lactating
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Probing pocket depth
2.Radiographic bone fill
|
1.Probing pocket depth at baseline, 3, 6, 9 months after periodontal surgery
Radiographic examination at baseline and 9 months after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.Clinical Attachment Level |
At baseline, 3, 6, 9 months after periodontal surgery
|
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
Final Enrollment numbers achieved (Total)= "6"
Final Enrollment numbers achieved (India)="6" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/04/2019 |
| Date of Study Completion (India) |
04/11/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="1"
Days="10" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
1.The ultimate goal of regenerative therapy is to restore the lost tissues with a functional attachment apparatus. Although bone tissues exhibit a large regenerative potential and may restore its original structure and function completely, bone defects often fail to heal with bone tissue. In order to facilitate or promote healing, bone grafting materials have been placed into bony defects. 2. Mineralized bone allografts have been studied as an augmentation material for maxillary sinus graft, ridge augmentation and extraction sites but limited information is available as to how these grafts materials perform in periodontal Intrabony defects. 3.The present study is designed to evaluate clinically and radiographically the efficacy of irradiated allogenic bone graft (RMTB TM) in the treatment of Intrabony defects post surgically over a 9 months period.
|