| CTRI Number |
CTRI/2020/11/029299 [Registered on: 23/11/2020] Trial Registered Prospectively |
| Last Modified On: |
23/11/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effects of scaling, root planing and laser on the levels of interleukin-12 |
|
Scientific Title of Study
|
EFFECT OF SCALING, ROOT PLANING AND SCALING, ROOT PLANING WITH LASER DEBRIDEMENT ON THE LEVELS OF INTERLEUKIN - 12 IN PATIENTS WITH CHRONIC PERIODONTITIS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
G Poojitha Reddy |
| Designation |
Postgraduate |
| Affiliation |
Rajarajeswari Dental College and Hospital |
| Address |
Rajarajeswari Dental Colleg and Hospital
No.14 Ramohalli Cross Mysore Road Kumbalgodu Bengaluru Karnataka 560074
RAJARAJESWARI DENTAL COLLEGE
MYSORE ROAD BANGALORE
Bangalore
KARNATAKA
560074
India |
| Phone |
7019329691 |
| Fax |
|
| Email |
gpr9508@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R S Senthil Rajan |
| Designation |
Professor |
| Affiliation |
Rajarajeswari Dental College and Hospital |
| Address |
Rajarajeswari Dental Colleg and Hospital
No14 Ramohalli Cross Mysore Road Kumbalgodu Bengaluru Karnataka 560074
RAJARAJESWARI DENTAL COLLEGE
MYSORE ROAD BANGALORE
Bangalore
KARNATAKA
560074
India |
| Phone |
9036943516 |
| Fax |
|
| Email |
senthilrajanrs21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
G Poojitha Reddy |
| Designation |
Postgraduate |
| Affiliation |
Rajarajeswari Dental College and Hospital |
| Address |
Rajarajeswari Dental Colleg and Hospital
No14 Ramohalli Cross Mysore Road Kumbalgodu Bengaluru Karnataka 560074
RAJARAJESWARI DENTAL COLLEGE
MYSORE ROAD BANGALORE
Bangalore
KARNATAKA
560074
India |
| Phone |
7019329691 |
| Fax |
|
| Email |
gpr9508@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajarajeswari Dental College and Hospital
No 14 Ramohalli Cross Mysore Road Kumbalgodu Bangalore Karnataka 560074 |
|
|
Primary Sponsor
|
| Name |
Rajarajeswari Dental College and Hospital |
| Address |
No 14 Ramohalli Cross Mysore Road Kumbalgodu Bengaluru Karnataka 560074 |
| Type of Sponsor |
Other [Private Dental College 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 |
| G Poojitha Reddy |
Rajarajeswari Dental College and Hospital |
No14 Ramohalli Cross Mysore Road Kumbalgodu Bengaluru Karnataka 560074
Bangalore
KARNATAKA |
7019329691
gpr9508@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee of Rajarajeswari Dental College and Hospital |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
laser |
2nd group scaling and root planing with sulcular debridement with diode laser of 970nm. The laser beam will be delivered into the periodontal pocket using a 320µm fiber optic tip in contact mode from apical to coronal direction using a sweeping motion for 1 minute using 1 watt as a continuous wave. |
| Comparator Agent |
randomised controlled trial |
comparing the levels of interleukin 12 |
| Intervention |
scaling and root planing |
1st group scaling, root planing
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
• Male and female subjects aged between 25 to 45 years.
Subjects with good general health.
Should have mild to moderate periodontitis with probing depth less than 4mm
Should have severe chronic periodontitis with probing depth more than 5mm
|
|
| ExclusionCriteria |
| Details |
Patients with systemic illness known to affect the outcomes of periodontal therapy
Patients on any medication taken within the last 6 months which may alter the periodontal status
Individuals allergic to medications
Pregnant or lactating women
|
|
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Method of Generating Random Sequence
|
Random Number Table |
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Method of Concealment
|
An Open list of random numbers |
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Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
Gingival index
Plaque index
Pocket probing depth
|
baseline one month three months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes in Gingival index scores
Plaque index score and
Pocket probing depth scores will be documented |
At baseline visit one month three months |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
24/11/2020 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet done |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Periodontal disease results from release of
inflammatory mediators and the consequence is a significant breakdown of tooth
supporting tissues, finally leading to tooth loss. The interplay between periodontal pathogens
and the inflammatory immune system leads to the development of chronic
inflammation. The intensity, duration and resolution of inflammation depend on
shifting balance between the activities of pro inflammatory cytokines and anti
inflammatory cytokines during the periodontal inflammation. Cytokines are
considered to play an important role in the initiation, progression and the
host modulation of periodontal disease. Interleukin (IL)-12 regulates the
balance between Th1 and Th2 cells by inducing naive T cells in a Th1-speciï¬c
manner and stimulating T cells and natural killer cells to synthesize multiple
pro inflammatory cytokines [Interferon (IFN)-γ, IL-1β, Tumour Necrosis Factor
(TNF)-α, IL-8]. Failure to resolve inflammatory periodontal disease may be the
result of an imbalance in both Th1/Th2 response and pro inflammatory and anti inflammatory
cytokines. In humans, the major effect of IL-12 is to stimulate IFN-γ production by Th1 cells and regulate the
transition from an early innate immune response to an adaptive immune response.
These T-helper type 1 (Th1), Th2 and monocyte which are derived from cytokines
in gingival tissues, the Gingival Crevicular
Fluid (GCF) is involved in periodontal
inflammation. IL - 12 is produced by monocytes,
macrophages and neutrophils.IL - 12 is comprised of two disulphide – linked
protein subunits designated p35 and p40, which are encoded by two different
genes. Both subunits have to be produced within the same cell to obtain the
biologically active dimmer designated p70 . The importance of IL-12 is not limited to
initiating an immune response, but may contribute to maintaining immunity
because Th1 responses rapidly fade in the absence of IL-12. The presence or
absence of IL-12 will then determine whether a Th1 or Th2 response predominates
with periodontal disease progression. IL-12 has
multiple biological activities. IL-12 might be potentially useful in
distinguishing health from disease and monitoring periodontal disease activity. Lasers have been suggested as a new alternative
for the treatment of periodontal therapy. They are used due to their
antibacterial potential by direct ablation, thermal denaturation and
destruction of bacterial cells. Diode lasers help to reduce subgingival
microbiota thus providing sites for new connective tissue attachment. It also
helps in the promotion of hemostasis, has detoxifying effects and enhances
healing. the need of this
study is to assess the levels of IL-12
before and after
Non- surgical periodontal
therapy and Sulcular Debridement with diode laser and to assess and compare
these levels.
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