| CTRI Number |
CTRI/2021/03/032251 [Registered on: 23/03/2021] Trial Registered Prospectively |
| Last Modified On: |
15/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
TO CHECK THE VALUE OF"ADVANCED GLYCATION END PRODUCTS" IN THE GUMS OF TYPE 2 DIABETIC PEOPLE BEFORE AND AFTER PROFESSIONAL TOOTH CLEANING WITH LOW LEVEL LIGHT THERAPY DONE ON ONE SIDE OF THE MOUTH. |
|
Scientific Title of Study
|
COMPARATIVE EVALUATION OF ADVANCED GLYCATION END PRODUCTS IN GINGIVAL CREVICULAR FLUID OF CHRONIC PERIODONTITIS PATIENTS WITH TYPE-II DIABETES MELLITUS BEFORE AND AFTER SCALING AND ROOT PLANING AND WITH LOW LEVEL LASER THERAPY AS AN ADJUNCT. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ananya Elchuri |
| Designation |
Postgraduate student |
| Affiliation |
Coorg Institute Of Dental Sciences |
| Address |
Coorg Institute Of Dental Sciences Department Of Periodontics and Implantology Room Number 4
KK Campus Maggula village kodagu District
Virajpet
Kodagu
KARNATAKA
571218
India |
| Phone |
9986055106 |
| Fax |
|
| Email |
ananyaelchuri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ananya Elchuri |
| Designation |
Postgraduate student |
| Affiliation |
Coorg Institute Of Dental Sciences |
| Address |
Coorg Institute Of Dental Sciences Department Of Periodontics and Implantology Room Number 4
KK Campus Maggula village kodagu District
Virajpet
Kodagu
KARNATAKA
571218
India |
| Phone |
9986055106 |
| Fax |
|
| Email |
ananyaelchuri@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Radhika B |
| Designation |
Professor |
| Affiliation |
Coorg Institute Of Dental Sciences |
| Address |
Coorg Institute Of Dental Sciences Department Of Periodontics and Implantology Room Number 4
KK Campus Maggula village kodagu District
Virajpet
Kodagu
KARNATAKA
571218
India |
| Phone |
9742096982 |
| Fax |
|
| Email |
radika_b24@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Coorg Institute Of Dental Sciences, KK Campus, Maggula village, Virajpet, Kodagu District, Karnataka-571218 |
|
|
Primary Sponsor
|
| Name |
Dr Ananya Elchuri |
| Address |
Coorg Institute Of Dental Sciences Department Of Periodontics and Implantology Room Number 4
KK Campus Maggula village kodagu District
Virajpet |
| Type of Sponsor |
Other [SELF] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ananya Elchuri |
Coorg Institute Of Dental Sciences |
Coorg Institute Of Dental Sciences Department Of Periodontics and Implantology Room Number 4
KK Campus Maggula village kodagu District
Virajpet
Kodagu
KARNATAKA |
9986055106
ananyaelchuri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL REVIEW BOARD |
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: E119||Type 2 diabetes mellitus without complications, (2) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Low Level Laser Therapy |
Low Level Laser Therapy will be done on the same side where it was previously done in the second appointment |
| Comparator Agent |
Not Applicable |
Clinical Parameters and Advanced Glycation End Product levels are compared on both the sides at third appointment |
| Intervention |
Scaling And Root Planing
Low Level Laser Therapy |
Scaling and root planing on one side and scaling and root planing along with low level laser therapy on the opposite side is done in first appointment
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with confirmed diagnosis of Type 2 Diabetes Mellitus with HbA1c levels ≥6.5% and on medication for the same.
Currently under the care of a physician for Diabetes management.
No change in diabetes related medications during 3 months duration prior to enrolment.
Subjects with minimum complement of 20 teeth.
Subjects who possesses at least two non adjacent sites with probing pocket depths(PPD) of ≥5 mm.
|
|
| ExclusionCriteria |
| Details |
• Patients with any other systemic diseases or condition(other than type2 Diabetes Mellitus) which would influence the course of periodontal disease or treatment.
• Patients with medical conditions that would require antibiotic prophylaxis for routine dental procedure.
• Patients who have taken antibiotics in previous 3 months.
• Pregnant or lactating women.
• Patients using any form of tobacco products.
• Patients who change the medications and or the dose during the course of the study.
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in the clinical parameters and Advanced Glycation End Product Levels |
Reduction in the clinical parameters and Advanced Glycation End Product Levels at 4 weeks and at 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in the clinical parameters and Advanced Glycation End Product Levels in group with low level laser therapy |
Reduction in the clinical parameters and Advanced Glycation End Product Levels in group with low level laser therapy at 12 weeks. |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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)
|
30/03/2021 |
| 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 |
|
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 inflammation of the supporting tissues of teeth resulting in gingival detachment and disintegration of alveolar bone.1 It results from interactions between periodontal microflora and the multifaceted response of the host.2 Diabetes is a major risk factor for periodontal disease.3 Longitudinal studies have demonstrated a two-way relationship between Diabetes and Periodontitis, with more severe periodontal tissue destruction in Diabetic patients and poorer glycemic control.4 In the chronic hyperglycemic state, several proteins undergo glycosylation that subsequently leads to the accumulation of Advanced Glycation End Products (AGEs)5. The formation of AGEs cross-link collagen which makes it less soluble. Cellular migration and tissue integrity is impaired as a result of damaged collagen.6 Poor glycemic control with the associated increase in AGEs, renders the periodontal tissues more susceptible to destruction.7 Hence AGEs can be used as a marker of tissue destruction in Diabetics. Several meta analyses have confirmed that effective periodontal therapy can result in reduced glycated haemoglobin levels in Diabetics.3 Conventional scaling and root planing(SRP) is the gold standard of Non Surgical Periodontal Therapy.8 However its efficacy gets compromised in situations like deep pockets, furcations etc which results in recolonization of treated areas with periodontal pathogens. Laser therapy is used in periodontics to overcome these drawbacks. Studies have shown that Low Level Laser Therapy has anti-inflammatory and wound healing effects on diseased tissues.9 The purpose of this study is to compare the efficacy of SRP alone and SRP with Low Level Laser Therapy on the levels of Advanced Glycation End Products in GCF of Chronic Periodontitis patients with Type 2 Diabetes Mellitus. |