| CTRI Number |
CTRI/2018/05/014239 [Registered on: 30/05/2018] Trial Registered Retrospectively |
| Last Modified On: |
29/05/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Efficacy of Artificial Bone in Angular Bone Loss |
|
Scientific Title of Study
|
Evaluation of efficacy of Xenograft in intrabony defect: A Clinico-Radiographic study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sheetal Surjeet |
| Designation |
post graduate student |
| Affiliation |
Sri Rajiv Gandhi college of Dental sciences and Hospital |
| Address |
Room no 12
Department of periodontics
Sri Rajiv Gandhi college of dental Sciences and Hospital
Bangalore
Bangalore
KARNATAKA
560032
India |
| Phone |
8151893103 |
| Fax |
|
| Email |
god.surman@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sarita Joshi Narayan |
| Designation |
Head of the Department |
| Affiliation |
Sri Rajiv Gandhi college of Dental sciences and Hospital |
| Address |
Room no 12
Department of Periodontics
Sri Rajiv Gandhi College of Dental Sciences and Hospital
Bangalore
Bangalore
KARNATAKA
560032
India |
| Phone |
9845112838 |
| Fax |
|
| Email |
drsaritanarayan@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Sheetal Surjeet |
| Designation |
post graduate student |
| Affiliation |
Sri Rajiv Gandhi college of Dental sciences and Hospital |
| Address |
Room no 12
Department of Periodontics
Sri Rajiv Gandhi college of Dental sciences and Hospital
Bangalore
Bangalore
KARNATAKA
560032
India |
| Phone |
8151893103 |
| Fax |
|
| Email |
god.surman@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Rajiv Gandhi College of Dental Sciences and Hospital |
|
|
Primary Sponsor
|
| Name |
Sheetal S |
| Address |
24 Chindananda Reddy Layout
RT Nagar
Bangalore |
| 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 |
| Sheetal S |
Sri Rajiv Gandhi College of Dental Sciences and Hospital |
Room no 12
Department of Peridontics
Bangalore
KARNATAKA |
8151893103
god.surman@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Rajiv Gandhi College of Dental Sciences and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
angular bone loss in jaw, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
not applicable |
not applicable |
| Intervention |
Xenograft in intrabony defect |
Bovine bone graft placed in angular bone defect of more than 3 mm
Total duration of therapy was 6 months |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1 Subjects should be non smoker
2 Subjects should have no systemic disease
3 Sites with infrabony pocket depth of greater than or equal to 6 mm (at least at one site)
4 Sites with clinical attachment loss of greater than or equal 4 mm
|
|
| ExclusionCriteria |
| Details |
1 Patient who cannot maintain good oral hygiene
2 Patient who are known allergic to bone graft material
3 Pregnant women or lactating mothers
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
pocket depth
clinical attachment level
bone fill |
baseline
3 months
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
gingival index
plaque index |
base line
3 months
6 months |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
Final Enrollment numbers achieved (Total)= "10"
Final Enrollment numbers achieved (India)="10" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
06/01/2016 |
| Date of Study Completion (India) |
13/02/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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
|
The aim of the study was to clinically and radiographically evaluate the
efficacy of xenograft in the treatment of
infrabony defect. the results showed that there was gain in clinical attachment level and reduction in pocket probing depth and other secondary clinical outcome which was clinically significant when compared to that of baseline and in follow-ups. |