| CTRI Number |
CTRI/2023/04/051411 [Registered on: 10/04/2023] Trial Registered Prospectively |
| Last Modified On: |
06/04/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Benefits of systemically administered omega 3 fatty acids on nuclear factor kappa b levels in patients with rheumatoid arthritis and periodontitis . |
|
Scientific Title of Study
|
Efficacy of systemic administration of Omega 3 fatty acids when used as adjuvants to scaling and root planing on serum Nuclear Factor Kappa B levels in patients with Rheumatoid Arthritis and Periodontitis. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr k Rekha Rani |
| Designation |
Prof and HOD |
| Affiliation |
Panineeya Institute of Dental Sciences and Research centre. |
| Address |
Panineeya Institute of Dental Sciences and Research centre
Department of periodontics Room no 101 road no 5 kamalanagar
Dilsuknagar Hyderabad
Hyderabad.
Hyderabad
TELANGANA
500060
India |
| Phone |
04024141177 |
| Fax |
04024045037 |
| Email |
rekhasarat2304@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr k Rekha Rani |
| Designation |
Prof and HOD |
| Affiliation |
Panineeya Institute of Dental Sciences and Research centre. |
| Address |
Panineeya Institute of Dental Sciences and Research centre
Department of periodontics Room no 101 road no 5 kamalanagar
Dilsuknagar Hyderabad
Hyderabad.
TELANGANA
500060
India |
| Phone |
04024141177 |
| Fax |
04024045037 |
| Email |
rekhasarat2304@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr GUNDELLY MRUNALINI |
| Designation |
POST GRADUATE |
| Affiliation |
Panineeya Institute of Dental Sciences and Research centre. |
| Address |
Panineeya Institute of Dental Sciences and Research centre
Department of periodontics Room no 101 road no 5 kamalanagar
Dilsuknagar Hyderabad
Hyderabad.
Hyderabad
TELANGANA
500060
India |
| Phone |
8790588955 |
| Fax |
|
| Email |
gundellymrunalini@gmail.com |
|
|
Source of Monetary or Material Support
|
| Panineeya Institute of dental sciences and research centre room no 101 road no 5 kamalanagar
Dilshuknagar Hyderabad Telangana 500060 |
|
|
Primary Sponsor
|
| Name |
Panineeya Institute of Dental Sciences and Research centre |
| Address |
Road no 5 kamalanagar Dilsuknagar Hyderabad |
| 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 Rekha rani |
Panineeya Institute Of Dental Sciences and Research Centre |
Department of
Periodontics Room no
101 Road no 5
Kamalanagar
Dilsukhnagar 500060
Hyderabad
TELANGANA
Hyderabad
TELANGANA |
9885160094
04024045037
rekhasarat2304@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, (2) ICD-10 Condition: M057||Rheumatoid arthritis with rheumatoid factor without organ or systems involvement, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group I 12 Patients with Chronic Periodontitis |
6 patients will take omega 3 fatty acids(500 mg twice daily for 3 months ) and 6 patients will take placebo after scaling and root planing. |
| Intervention |
Group II(A) 6 patients who will be subdivided into 3 patients recently diagnosed with RA and 3 patients who are known arthritis patients under medication. |
These patients will receive Omega 3 fatty acids(500 mg twice daily for 3months ) after scaling and root planing. |
| Intervention |
Group II(B) 6 patients who will be subdivided into 3 patients recently diagnosed with RA and 3 patients who are known arthritis patients under medication. |
These patients will receive placebo after scaling and root planing. |
| Comparator Agent |
N/A |
N/A |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Rheumatoid arthritis.
Patients with Chronic periodontitis.
For Periodontitis: 20 teeth should be present with probing pocket depths ≥ 5mm in one or more sites.
Rheumatoid arthritis patients with Anti-CCP levels Positive for antibodies – (>20u/ml)
|
|
| ExclusionCriteria |
| Details |
Pregnant and lactating women, Smokers, Patients with any auto immune or systemic disorder other than Rheumatoid arthritis.
Use of Medicines (other than RA medicines) or antibiotics 3 months before the commencement of the study.
History of periodontal treatment within 6 months.
|
|
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Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate if omega-3 fatty acids have beneficial effects in patients with rheumatoid arthritis and periodontitis when used as adjuvant to non surgical periodontal therapy |
Baseline and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Plaque Index(PI),
Gingival Index (GI)
Probing pocket depths (PPD) |
base line and 12 weeks after non surgical periodontal therapy |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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)
|
15/04/2023 |
| 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="3"
Days="0" |
|
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)?
Response - NO
|
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Brief Summary
|
|
•
PERIODONTITIS: is a multifactorial chronic inflammatory infectious disease resulting
in inflammation within the supporting tissues of the teeth, progressive
attachment and bone loss
characterized by pocket formation and/or recession of the gingiva.
•
RHEUMATOID ARTHRITIS: is a chronic systemic, auto immune, inflammatory
disease affecting 0.5 - 1% of world population. It is characterized by
synovial hyperplasia, inflammatory cell recruitment and intra articular
fibrin deposition that leads to destruction of joint architecture and
consequent disability. Continuous low-grade infections, autoimmune and
genetic traits are considered to be involved in the pathogenesis of RA
•
PERIODONTITIS AND RHEUMATOID ARTHRITIS: The possible association
between RA and periodontitis has been investigated because of numerous
similarities in pathological and immunological characteristics. In spite of,
the differences in etiologies of RA, and periodontitis, there are similar
biological processes involved which may represent direct links between these
two conditions.
•
NONSURGICALPERIODONTAL THERAPY:
Scaling and rootplaning
(SRP) is the cornerstone of periodontal therapy. It has been observed that
the severity of RA in patients improved after SRP.
•
OMEGA 3 FATTY ACIDS. Have well documented anti-inflammatory properties,
and consequently therapeutic potential in chronic inflammatory diseases.
•
NUCLEAR FACTOR KAPPA B : is a
pro inflammatory marker which is elevated in chronic inflammatory conditions
and shows association with microbial load and,cytokine release.
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