| CTRI Number |
CTRI/2020/01/022883 [Registered on: 20/01/2020] Trial Registered Prospectively |
| Last Modified On: |
16/01/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluation of efficacy membrane with bone allograft in the treatment of Chronic Generalised Periodontitis Patients. |
|
Scientific Title of Study
|
Comparative evaluation of efficacy of amniotic membrane with demineralized freeze dried bone allograft versus collagen membrane with demineralized freeze dried bone allograft in the treatment of intrabony defects – 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 |
EITI AGRAWAL |
| Designation |
POST GRADUATE |
| Affiliation |
ITS CENTRE FOR DENTAL STUDIES AND RESEARCH |
| Address |
Agrawal Pharma
Jawahar Lal road, Choti Saraiyaganj
Muzaffarpur
ITS Centre For Dental Studies And Research,Delhi -Meerut Road,Muradnagar, Ghaziabad
Muzaffarpur
BIHAR
842001
India |
| Phone |
8909691625 |
| Fax |
|
| Email |
eiti4321@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rahul Chopra |
| Designation |
Professor |
| Affiliation |
ITS CENTRE FOR DENTAL STUDIES AND RESEARCH |
| Address |
ITS Centre for Dental Studies And Research,Delhi -Meerut Road,Muradnagar
ITS Centre for Dental Studies And Research,Delhi -Meerut Road,Muradnagar, Ghaziabad
Ghaziabad
UTTAR PRADESH
201206
India |
| Phone |
9953865327 |
| Fax |
|
| Email |
dr.rahulchopra@its.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
EITI AGRAWAL |
| Designation |
POST GRADUATE |
| Affiliation |
ITS CENTRE FOR DENTAL STUDIES AND RESEARCH |
| Address |
Agrawal Pharma
Jawahar Lal Road, Choti Saraiyaganj
Muzaffarpur
ITS Centre for Dental Studies And Research,Delhi -Meerut Road,Muradnagar, Ghaziabad
Muzaffarpur
BIHAR
842001
India |
| Phone |
8909691625 |
| Fax |
|
| Email |
eiti4321@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
EITI AGRAWAL |
| Address |
PG Girls Hostel 204 A ,ITS Centre for Dental Studies And Research,Delhi -Meerut Road,Muradnagar,201206, Ghaziabad,Uttar Pradesh |
| 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 |
| EITI AGRAWAL |
ITS CENTRE FOR DENTAL STUDIES AND RESEARCH |
ITS CENTRE FOR DENTAL STUDIES AND RESEARCH,DELHI -MEERUT ROAD,MURADNAGAR 201206
Ghaziabad
UTTAR PRADESH |
8909691625
eiti4321@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITEE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Chronic Periodontitis with intra bony defect |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Amniotic Membrane with Demineralized Freeze Dried Bone Allograft |
The flap was reflected, the osseous defect was exposed. DFDBA was delivered in small increments into the defect. Amniotic membrane was trimmed and was adapted over the defect which was filled with DFDBA. Sutures were removed after 14 days and patinet was recalled at 1 month ant at 3 months and 6 months for re-evaluation. |
| Comparator Agent |
Collagen Membrane with Demineralized Freeze Dried Bone Allograft |
The flap was reflected, the osseous defect was exposed. DFDBA was delivered in small increments into the defect. Collagen membrane was trimmed and was adapted over the defect which was filled with DFDBA. Sutures were removed after 14 days and patinet was recalled at 1 month ant at 3 months and 6 months for re-evaluation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Systemically healthy subjects.
2. Subjects with age between 18-60 years.
3. Patients having periodontal pockets with probing depth more than or equal to 5 mm
4. Patients suffering with chronic periodontitis requiring surgical intervention to treat an Intra bony defect adjacent to a natural tooth.
5. Patients showing radiographic evidence of infrabony osseous defect.
6. Patients who were willing to comply with all the study related procedures and who signed the informed consent form. |
|
| ExclusionCriteria |
| Details |
1. Patients who were medically compromised
2. Patients with inadequate plaque control.
3. Women who were pregnant or who intended to become pregnant during the study period.
4. Oral cancer or head and neck radiation within 6 months
5. Smoking >10 cigarettes per day; daily use of smokeless tobacco, pipe, or cigar smoking
6. Untreated infection at the study site other than periodontitis.
7. Patients with any history of allergy to the material used in this study.
8. Patients who were on antibiotics or antimicrobial therapy for last 6 months
9. Patients on any drug therapy which is known to influence the periodontium.
10. Patients who have undergone any type of periodontal flap surgical procedure or regenerative therapy 6 months prior to the initial examination.
11. Patients unable to provide informed consent. |
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| relative intrabony defect component level [rIBD] |
At Baseline and 6 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. GINGIVAL INDEX (Loe and Silness in 1963)
2. PLAQUE INDEX (Turesky- Gilmore- Glickman modification of Queigly- Hein Plaque index in 1970)
3. POCKET PROBING DEPTH
4. RELATIVE CLINICAL ATTACHMENT LEVEL (rCAL) |
at baseline, 3 months, 6 months |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
22/01/2020 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
COMPARATIVE EVALUATION OF EFFICACY OF AMNIOTIC MEMBRANE WITH DEMINERALIZED FREEZE DRIED BONE ALLOGRAFT VERSUS COLLAGEN MEMBRANE WITH DEMINERALIZED FREEZE DRIED BONE ALLOGRAFT IN THE TREATMENT OF INTRABONY DEFECTS – A CLINICO-RADIOGRAPHIC STUDY.
clinical standardized parameters measured are :
1. GINGIVAL INDEX (Loe and Silness in 1963) 2. PLAQUE INDEX (Turesky- Gilmore- Glickman modification of Queigly- Hein Plaque index in 1970) 3. POCKET PROBING DEPTH in mm (from gingival margin to the base of the sulcus). 4. RELATIVE CLINICAL ATTACHMENT LEVEL in mm (from the fixed reference point to the base of the sulcus). 5. The relative intrabony defect component level [rIBD] was measured between the cementoenamel junction (CEJ) and the most apical extension of the defect by counting the number of squares of 1 mm in a grid.
|