| CTRI Number |
CTRI/2021/07/035196 [Registered on: 28/07/2021] Trial Registered Prospectively |
| Last Modified On: |
26/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
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Public Title of Study
|
comparison between two bone filling agents,one using patients blood and other without patients blood. |
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Scientific Title of Study
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“Comparative Clinical and Radiographic Evaluation of the Efficacy of Bovine Derived Xenograft and Calcium Sulfate Hemihydrate (OsseomoldTM) with Autologous Injectable Platelet Rich Fibrin (i-PRF) and Bovine Derived Xenograft and Calcium Sulfate Hemihydrate (OsseomoldTM) with Normal Saline used in the Treatment Of Intrabony Defects in Chronic Periodontitis Patients –A Randomized Clinical Trialâ€
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| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pradnya Dattatraya Kadam |
| Designation |
MDS first year student |
| Affiliation |
Nair Hospital Dental College |
| Address |
G-1302,Sukhkarta building,behind Avighna park,currey road, mumbai 12
201,Department of Periodontics, Nair Hospital Dental College, Mumbai Central 08.
Mumbai
MAHARASHTRA
4000012
India |
| Phone |
7721875665 |
| Fax |
|
| Email |
pradnyakadam024@gmail.com |
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Details of Contact Person
Scientific Query
|
| Name |
Dr Mala Dixit Baburaj |
| Designation |
Professor and H.O.D. of Department of Periodontics. |
| Affiliation |
Nair Hospital Dental College |
| Address |
201,Department of Periodontics, Nair Hospital Dental College, Mumbai Central,mumbai08.
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9223340938 |
| Fax |
|
| Email |
maladixit25@gmail.com |
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Details of Contact Person
Public Query
|
| Name |
Dr Mala Dixit Baburaj |
| Designation |
Professor and H.O.D. of Department of Periodontics. |
| Affiliation |
Nair Hospital Dental College |
| Address |
201,Department of Periodontics, Nair Hospital Dental College, Mumbai Central 08.
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9223340938 |
| Fax |
|
| Email |
maladixit25@gmail.com |
|
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Source of Monetary or Material Support
|
| Nair Hospital Dental College |
|
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Primary Sponsor
|
| Name |
Pradnya dattatraya kadam |
| Address |
201, Department of periodontics, Nair hospital dental college, mumbai central 08, mumbai |
| Type of Sponsor |
Other [first year postgraduate student] |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr pradnya kadam |
Nair hospital and Dental college |
202,department of periodontics ,Nair hospital and dental college
Mumbai
MAHARASHTRA |
7721875665
pradnyakadam024@gmail.com |
|
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Details of Ethics Committee
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| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics commitee-NHDC |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Intervention |
Bovine derived Xenograft plus calcium sulfate hemihydrate with normal saline |
commercially available as OsseomoldTM for 6 month in intrabony defect |
| Comparator Agent |
Osseomold with injectable platelet rich fibrin |
Bovine derived Xenograft with calcium sulfate hemihyadrate and injectable platelet rich fibrin for 6 month in intrabony defect |
|
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Inclusion Criteria
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| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients in the age group between 20-60 yrs.
2)patients diagnosed with Chronic Periodontitis.
3)Patients who are non smokers or do not consume tobacco in any other form.
4)Patients are in good systemic health with no contraindication to periodontal surgery.
5) Patients having pocket depths >5mm, intraosseous defects > 3mm and with radiographic evidence of vertical / angular bone loss in the affected sites.
6) Involved teeth to be vital and asymptomatic.
|
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| ExclusionCriteria |
| Details |
1) One-walled osseous defects.
2) Patients suffering from any systemic diseases or with a compromised immune system.
3) Patients who had received any type of periodontal therapy for the past 6 months.
4) Patients taking immunosuppressant drugs like corticosteroids.
5) Patients with a known history of allergy to Doxycycline or Chlorhexidine or any other medicine used in the study.
6) Patients showing unacceptable oral hygiene compliance during / after Phase I periodontal 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) Patients on anticoagulant therapy.
11) Patients with bleeding disorders.
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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On-site computer system |
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Blinding/Masking
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Open Label |
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Primary Outcome
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| Outcome |
TimePoints |
Plaque index(P.I.)(SILNESS&LOE,1964)
Gingival index(G.I.)(LOE&SILNESS,1963)
Probing pocket depth(PPD)
Clinical attachment Level(CAL)
|
Baseline
1 month
3 months.
6 months. |
|
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Secondary Outcome
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| Outcome |
TimePoints |
| Radiograph Bone fill will be evaluated using Intraoral radiographs of the surgical site |
Radiographs will be taken at baseline post surgery and 6 months post surgery. |
|
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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" |
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Phase of Trial
|
N/A |
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Date of First Enrollment (India)
|
03/08/2021 |
| 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 |
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Estimated Duration of Trial
|
Years="1"
Months="8"
Days="0" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
NIL |
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
Aims and Objective: 1.To
evaluate and compare clinically the
effect of Bovine
Derived Xenograft and Calcium Sulfate Hemihydrate (OsseomoldTM) with
Autologous Injectable Platelet Rich Fibrin (i-PRF) and Bovine Derived Xenograft and Calcium Sulfate
Hemihydrate (OsseomoldTM)
with Normal Saline and its effect on
clinical parameters like plaque index ,gingival index ,Probing pocket Depth and
Clinical Attachment Level.
2.
To evaluate and compare Radiographically the effect of Bovine Derived
Xenograft and Calcium Sulfate Hemihydrate (OsseomoldTM) with
Autologous Injectable Platelet Rich Fibrin (i-PRF) and Bovine Derived Xenograft and Calcium Sulfate
Hemihydrate (OsseomoldTM)
with Normal Saline in the bone fill
of Intrabony Periodontal Defects.
Methodology: This study
is an Interventional Prospective Randomized Clinical Trial. It is a
singleblinded, single-centre, Institution-based study.
The
patients selected as per the inclusion and exclusion criteria, will be randomly
allotted by a computerized automated randomization method into 2 groups, Group
A and Group B, and treated as follow.
Group
A: Open flap debridement, followed by placement of Bovine Derived
Xenograft and Calcium Sulfate Hemihydrate (OsseomoldTM) with
Autologous Injectable Platelet Rich Fibrin (i-PRF) .
Group B: Open flap debridement, followed by
placement of Bovine
Derived Xenograft and Calcium Sulfate Hemihydrate (OsseomoldTM) with Normal Saline.
Study population: A
total of 40 patients for this study will be selected from outpatient department
of Periodontics.
Sample size: The assumption for sample size was
obtained from parent article Standard deviation (S.D.) of group 1= 0.78 S.D. for group 2= 0.88 Considering the difference in group means to
be 20%, power of the study as 80%, at 95% confidence interval, a ratio of sample
size (group1/ group 2) as 1 and with the significance level set at 5%, a sample
size of 40 was derived (i.e. 20 in each group). Methods of measurement:
Clinical
parameters:
The
following clinical parameters are to be recorded at baseline (pre-surgery), 1
month post-surgery, 3 months post-surgery, and 6 months post-surgery.
1. Plaque Index (P.I.)
(Tureskey-Gilmore-Glickman Modification of Quigley Hein)
2. Gingival Index (G.I.) (Loe and Silness,
1963)
The
following clinical parameters to be recorded at baseline (pre-surgery), 3
months post- surgery, and 6 months post-surgery.
3. Probing Pocket Depth (PPD)
4. Clinical Attachment Level (CAL)
|