| CTRI Number |
CTRI/2018/04/012987 [Registered on: 03/04/2018] Trial Registered Prospectively |
| Last Modified On: |
27/03/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of Clinical and Radiographic Evaluation of the Effect of Decalcified Freeze Dried Bone Allograft(DFDBA) with Amniotic Membrane and Decalcified Freeze Dried Bone Allograft
(DFDBA) with Platelet Rich Fibrin(PRF) Membrane in the Treatment of Intrabony Defects in Periodontitis Patients |
|
Scientific Title of Study
|
Comparative Clinical and Radiographic Evaluation of the Effect of Decalcified Freeze Dried Bone Allograft (DFDBA) with Amniotic Membrane and Decalcified Freeze Dried Bone Allograft (DFDBA) with Platelet Rich Fibrin (PRF) as Membrane in the Treatment of Intrabony Defects in Chronic Periodontitis Patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Geetika Prabhakar |
| Designation |
1st Yr Postgraduate Student |
| Affiliation |
Nair Hospital Dental College |
| Address |
Room nbr 202, 2nd floor, Department of Periodontology, Nair Hospital Dental College, opp Maratha Mandir, Dr. A.L.Nair road, Mumbai Central, mumbai-08
Mumbai
MAHARASHTRA
400012
India |
| Phone |
7827528727 |
| Fax |
|
| Email |
geetikaprabhakar20@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mala Dixit Baburaj |
| Designation |
Professor and Head of the Department |
| Affiliation |
Nair Hospital Dental College |
| Address |
Room nbr 202, 2nd floor, Department of Periodontology, Nair Hospital Dental College, opp Maratha Mandir, Dr. A.L.Nair road, Mumbai Central, mumbai-08
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02223082714 |
| Fax |
|
| Email |
maladixit25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Geetika Prabhakar |
| Designation |
1st Yr Postgraduate Student |
| Affiliation |
Nair Hospital Dental College |
| Address |
Room nbr 202, 2nd floor, Department of Periodontology, Nair Hospital Dental College, opp Maratha Mandir, Dr. A.L.Nair road, Mumbai Central, mumbai-08
Mumbai
MAHARASHTRA
400012
India |
| Phone |
7827528727 |
| Fax |
|
| Email |
geetikaprabhakar20@gmail.com |
|
|
Source of Monetary or Material Support
|
| 202, 2nd floor,Department of Periodontology, Nair Hospital Dental College.
opp Maratha Mandir, Dr.A.L.Nair road, Mumbai Central,Mumbai-08 |
|
|
Primary Sponsor
|
| Name |
Geetika Prabhakar |
| Address |
202, 2nd floor, Department of Periodontology, Nair Hospital Dental College, Mumbai-08 |
| Type of Sponsor |
Other [1st year postgraduate student] |
|
|
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 |
| Geetika Prabhakar |
Nair Hospital Dental College |
202, 2nd floor, Department of Periodontology, Nair Hospital Dental College,Mumbai central
Mumbai
MAHARASHTRA |
7827528727
geetikaprabhakar20@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee-Nair Hospital Dental College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Chronic Periodontitis patients with interproximal bone defects of 5mm or more, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Decalcified Freeze Dried Bone Allograft (DFDBA) with Amniotic Membrane |
Commercially available DFDBA and Amniotic Membrane |
| Comparator Agent |
Decalcified Freeze Dried Bone Allograft (DFDBA) with Platelet Rich Fibrin (PRF) as Membrane |
commercially available DFDBA and PRF obtained from patients own blood sample |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1).Age group between 20-60years
2).Diagnosis with chronic periodontitis
3).Patients in good systemic health with no contraindication to periodontal surgery
4).Patients having Intrabony defects with pocket depths of >5mm and with radiographic evidence of vertical / angular bone loss in the affected sites.
5).Involved teeth to be vital and asymptomatic.
|
|
| ExclusionCriteria |
| Details |
1).One — wall osseous defects.
2).Patients suffering from any systemic diseases or with compromised immune system.
3).Patients who had received any type of periodontal therapy for the past 6 months
4).Patients taking any immuno-suppressive drugs like corticosteroids
5).Patients with a known history of allergy to doxycycline or Chlorhexidine or any other medicine are used in the study.
6).Patients showing unacceptable oral hygiene compliance during / after the phase I therapy.
7).Patients taking any drug known to cause gingival enlargement.
8).Pregnant and/or lactating mothers.
9).Patients who were smokers or had tobacco in any other form.
10).Endodontically treated teeth.
11).Patient on anticoagulant therapy
12).Patient with bleeding disorders. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Plaque Index (P.I.) (SILNESS AND LOE, 1964)
2. Gingival Index (G.I.) (LOE &SILNESS, 1963).
3. Probing Pocket Depth (PPD).
4. Clinical Attachment Level (CAL).
5.Radiographic Bone fill will be evaluated using intra oral periapical radiograph of the surgical site. |
clinical evaluation at baseline, 1 month, 3 months and 6 months after surgery.
Radiographic evaluation at baseline, immediate post surgery and 6 months post surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Plaque Index (P.I.) (SILNESS AND LOE, 1964)
2. Gingival Index (G.I.) (LOE &SILNESS, 1963).
3. Probing Pocket Depth (PPD).
4. Clinical Attachment Level (CAL).
5.Radiographic Bone fill will be evaluated using intra oral periapical radiograph of the surgical site. |
clinical evaluation at baseline, 1 month, 3 months and 6 months after surgery.
Radiographic evaluation at baseline, immediate post surgery and 6 months post surgery. |
|
|
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)
|
15/05/2018 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/05/2018 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The aim of the study is to evaluate and compare clinically and radiographically the Effect Of Decalcified Freeze Dried Bone Allograft (DFDBA) with Amniotic Membrane and Decalcified Freeze Dried Bone Allograft (DFDBA) with Platelet Rich Fibrin (PRF) as Membrane in the Treatment of Intrabony Defects in Chronic Periodontitis Patients. A total of 40 patients with Chronic Periodontitis will be selected from out patient department of Periodontology, Nair Hospital Dental College, Mumbai and will be equally divided into two groups of 20 each. In group A, Decalcified Freeze Dried Bone Allograft (DFDBA) with Amniotic Membrane will be placed and in Group B, Decalcified Freeze Dried Bone Allograft (DFDBA) with Platelet Rich Fibrin (PRF) as Membrane will be placed in interproximal bone defects. The study is interventional prospective study. Computer generated randomization method will be used as sampling method. The duration of study is 20 months which includes a duration of 14 months for treatment procedure and 6 months for follow up. The primary efficacy parameters are plaque index, gingival index, probing pocket depth and clinical attachment level. Plaque and gingival index will be recorded at baseline, 1 month, 3 months and 6 months post surgery. Probing pocket depth and clinical attachment level will be recorded at baseline, 3 months and 6 months post surgery. Radiographic analysis of the surgical site will be done to measure bone fill at baseline, immediately post surgery and 6 months post surgery. The data will be analysed individually for all the patients. The values will be subjected to comparison within and between the groups using Paired and Unpaired Student T-Test. There is no conflict of interest. |