| CTRI Number |
CTRI/2024/06/068754 [Registered on: 12/06/2024] Trial Registered Prospectively |
| Last Modified On: |
31/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Treatment of Chronic Periodontitis with Open Flap surgery along with Platelet- rich Fibrin (PRF) to see its effect on agents causing inflammation (MIP-1α). |
|
Scientific Title of Study
|
Evaluation and Co-relation of Macrophage Inflammation Protein (MIP-1α) in Gingival Crevicular Fluid (GCF) of patients suffering from Chronic Periodontitis, treated with Open Flap debridement with and without Platelet rich Fibrin- A Split-Mouth Randomized Controlled Clinical Trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Arunima Bansal |
| Designation |
Post Graduate Student |
| Affiliation |
ITS Dental College Hospital and Research Centre, Greater Noida |
| Address |
Room number 8 Department of Periodontics and Oral Implantology ITS Dental College Hospital and Research Centre 47 Knowledge Park 3 Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
7017189639 |
| Fax |
|
| Email |
arunima15aug@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sachit Anand Arora |
| Designation |
Principal Head department of Periodontics and Oral Implantology & Senior Professor |
| Affiliation |
ITS Dental College Hospital and Research Centre, Greater Noida |
| Address |
Room number 8 Department of Periodontics and Oral Implantology ITS Dental College Hospital and Research Centre 47 Knowledge Park 3 Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9910222799 |
| Fax |
|
| Email |
prin.dntl.gn@its.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arunima Bansal |
| Designation |
Post Graduate Student |
| Affiliation |
ITS Dental College Hospital and Research Centre, Greater Noida |
| Address |
Room number 8 Department of Periodontics and Oral Implantology ITS Dental College Hospital and Research Centre 47 Knowledge Park 3 Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
7017189639 |
| Fax |
|
| Email |
arunima15aug@gmail.com |
|
|
Source of Monetary or Material Support
|
| ITS Dental College Hospital and Research Centre Greater Noida Uttar Pradesh India 201310 |
|
|
Primary Sponsor
|
| Name |
ITS Dental College Hospital and Research Centre Greater Noida |
| Address |
47 Knowledge Park 3 Greater Noida Uttar Pradesh India 201310 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Arunima Bansal |
ITS Dental College Hospital and Research Centre |
Room number 8 Department of Periodontics and Oral Implantology 47 Knowledge Park 3 Greater Noida Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH |
7017189639
arunima15aug@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ITS Dental College Hospital and Research Centre Greater Noida |
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 |
Open flap surgery with Platelet- rich fibrin |
Biomaterial is prepared by following the protocol developed by Choukroun et al in 2001.
10ml of blood is centrifuged at 1500 rpm for 12 mins. |
| Comparator Agent |
Open flap surgery without Platelet- rich fibrin |
Only open flap surgery is done |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Chronic periodontitis patients with Probing depth- ≥ to 4mm and ≤ 7mm (AAP Classification 2017).
2. Presence of at least ≥ to 20 natural teeth in both upper and lower arches.
|
|
| ExclusionCriteria |
| Details |
1. Subjects using smoked and smokeless tobacco.
2. Pregnant and lactating females.
3. Subjects with history of uncontrolled systemic diseases affecting the periodontium.
4. Subjects allergic to medications prescribed during treatment.
5. Subjects who have received surgical or non- surgical periodontal therapy 6 months prior.
6. Those undergoing antibiotic and anti- inflammatory therapy or have had in last 6 months.
7. Post-menopausal women.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Plaque Index (PI)- Silness and Loe(1964)
2. Gingival Index (GI)- Loe and Silness (1963)
3. Bleeding Index (BI)- Ainamo and Bay (1975)
4. Relative Pocket Probing Depth (PPD)
5. Wound healing Index (WHI)- (Landry et. al. 1988)
6. Relative Attachment Level (RAL)
7. ELISA for biomarker |
Measured at 0, 3 and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Phenotype for gingiva |
Measured at 0, 3 and 6 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/07/2024 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This
study holds significance in the field of periodontics due to its potential to
address critical gaps in understanding the inflammatory response in chronic
periodontitis treatment. Chronic periodontitis is a prevalent inflammatory
condition affecting the supporting structures of teeth, where the role of
inflammatory mediators like Macrophage Inflammation Protein-1α (MIP-1α) remains
pivotal. The tenet for the study is to
assess and estimate the levels of MIP-1α, an inflammatory marker in patients
treated with Open flap debridement (OFD) with and without Platelet- rich Fibrin
(PRF). MIP-1α is a known biomarker which increases in cases of inflammatory
reaction. OFD is a classical and effective treatment modality for reducing
pocket probing depth and when combined with an autologous biomimetic material
such as PRF; which is rich in various growth factors and is known to accelerate
wound healing and reduces inflammation. Therefore this study is undertaken for
better understanding of the role of PRF along with OFD by evaluating and
assessing the levels of MIP-1α of a potent biomarker such as Macrophage
Inflammatory Protein- 1 Alpha (MIP-1α).
|