| CTRI Number |
CTRI/2020/03/024075 [Registered on: 19/03/2020] Trial Registered Prospectively |
| Last Modified On: |
17/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative evaluation of Amniotic membrane/Collagen membrane for the management of periodontal intra-bony defects |
|
Scientific Title of Study
|
Comparative evaluation of clinical and radiological parameters following the use of biphasic alloplastic material with Amniotic membrane / Collagen membrane
for the management of
periodontal intra-bony defects - A prospective double blind randomized controlled clinical trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NivedhaV |
| Designation |
Postgraduate |
| Affiliation |
Sri Ramachandra institute of higher education and research |
| Address |
3C-4 DABC Mithilam flats, Sriram nagar mainroad, Nolambur
Sri Ramachandra institute of higher education and research, Porur, Chennai 116
Chennai
TAMIL NADU
600095
India |
| Phone |
9445513282 |
| Fax |
|
| Email |
nive16roro@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SKBalaji |
| Designation |
Dr |
| Affiliation |
Sri Ramachandra institute of higher education and research |
| Address |
Sri Ramachandra institute of higher education and research, Porur.
Sri Ramachandra institute of higher education and research, Porur, Chennai 116
Chennai
TAMIL NADU
600116
India |
| Phone |
9445513282 |
| Fax |
|
| Email |
venarun7@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
NivedhaV |
| Designation |
Postgraduate |
| Affiliation |
Sri Ramachandra institute of higher education and research |
| Address |
3C-4 DABC Mithilam flats, Sriram nagar mainroad, Nolambur
Sri Ramachandra institute of higher education and research, Porur, Chennai 116
Chennai
TAMIL NADU
600095
India |
| Phone |
9445513282 |
| Fax |
|
| Email |
nive16roro@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
nivedhav |
| Address |
3C4 DABC Mithilam flats
Sriram nagar mainroad
Chennai |
| Type of Sponsor |
Other [self sponsor ] |
|
|
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 |
| NivedhaV |
sri ramachandra institute of higher education and research |
sri ramachandra institute of higher education and research
porur
Chennai
TAMIL NADU |
9445513282
nive16roro@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Sriramachandra Institute of Higher education and research |
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 |
amniotic membrane |
use of amniotic membrane with biphasic calcium phosphate in the management of intrabony defects |
| Comparator Agent |
collagen membrane |
use of collagen membrane with biphasic calcium phosphate in the management of intrabony defects |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1 Age 21-50 years
2 Patients with moderate to severe localized periodontitis with a Probing Depth (PD) ≥6 mm and an intrabony component of more than 3 mm as detected on Intra oral periapical radiographs (IOPAR) and bone sounding (Sali 2016).
3 Intrabony defect angle of less than 40 degree (Sali 2016).
4 Circumferential defect with interdental intrabony defect depth of more than 3mm will be included.
5 Nonsmoker (Never smoker) or former smoker (Does not smoke now and has not smoked at all for a minimum of the last 12 consecutive months)
|
|
| ExclusionCriteria |
| Details |
1 Current Smokers (smokers who have smoked more than 100 cigarettes in their lifetime and currently smoke)
2 Systemic chronic conditions known to be associated with periodontitis or with changes in systemic inflammation: Diabetes, Cardiovascular diseases, Rheumatoid Arthritis, Rheumatic Fever, SLE, Malignancy, Respiratory diseases, Renal diseases, Other (e.g., autoimmune diseases, fungal infections, immunological deficiencies, etc.)
3 Pregnant / Lactating mothers
4 Previous History of periodontal treatment at the selected site
5 Teeth with intrabony defect component and furcation involvement were also excluded from the study.
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Probing Pocket Depth or Clinical Attachment Level and Radiographic bone gain |
baseline, 1 month, 3 month and 6 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Wound Healing index, Visual Analogue Scale |
at 3, 10 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
22/03/2020 |
| 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="1"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a prospective double blind, randomised, parallel group clinical trial comparing the clinical and radiological parameters following the use of biphasic alloplastic material with amniotic membrane/ collagen membrane for the management of periodontal intrabony defects. The primary outcomes will be to assess the change in probing pocket depth/ clinical attachment level and radiographic bone gain at 1, 3 and 6 months, secondary outcomes will be assess the wound healing index, visual analogue scale at 3 and 10 days post operatively. |