| CTRI Number |
CTRI/2024/12/077589 [Registered on: 03/12/2024] Trial Registered Prospectively |
| Last Modified On: |
02/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A study to compare the efficacy of antimicrobial photodynamic therapy vs low level laser therapy in combination with scaling and root planing in the treatment of chronic periodontitis in type II diabetics: A RCT |
|
Scientific Title of Study
|
A comparative evaluation of antimicrobial photodynamic therapy vs low level laser therapy as an adjunct to non-surgical periodontal treatment on periodontal parameters in type II diabetics: A RCT |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mahima |
| Designation |
Post Graduate Student |
| Affiliation |
Goa Dental College and Hospital |
| Address |
Goa Dental College And Hospital, Department Number 2, Department of Periodontics, Bambolim, Goa
North Goa
GOA
403202
India |
| Phone |
8527918012 |
| Fax |
|
| Email |
mm.doc.2013@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr James Samuel |
| Designation |
Professor and Head Of Department (PG Guide) |
| Affiliation |
Goa Dental College And Hospital |
| Address |
Goa Dental College and Hospital, Department no 2, Department of Periodontics, Bambolim, Goa
North Goa
GOA
403202
India |
| Phone |
8527918012 |
| Fax |
|
| Email |
jamessamueldental@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr James Samuel |
| Designation |
Professor and Head Of Department (PG Guide) |
| Affiliation |
Goa Dental College And Hospital |
| Address |
Goa Dental College and Hospital, Department no 2, Department of Periodontics, Bambolim, Goa
North Goa
GOA
403202
India |
| Phone |
8527918012 |
| Fax |
|
| Email |
jamessamueldental@gmail.com |
|
|
Source of Monetary or Material Support
|
| Goa Dental College And Hospital, Bambolim, Goa
North Goa
GOA
403202
INDIA |
|
|
Primary Sponsor
|
| Name |
Dr. Mahima |
| Address |
Goa Dental College And Hospital, Department Number 2, Department Of Periodontics, Bambolim, Goa |
| 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 Mahima |
Goa Dental College And Hospital |
Department Number 2, Department of Periodontics, Bambolim, Goa
North Goa
GOA |
8527918012
mm.doc.2013@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Goa Dental College And Hospital Institutional Ethics Committee |
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: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group (Group C): Controlled Diabetics (Hba1c:6-8.4%)
Scaling and Root Planing alone |
Patients in this group will receive thorough scaling and root planing (SRP) and oral hyeine instructions. The periodontal clinical parameters including Gingival Index(GI), Plaque Index(PI), Pocket Probing Depth(PPD), Clinical Attachment Level(CAL) and Modified Sulcular Bleeding Index(mSBI) would be evaluated at baseline and reassessed at 3 months and 6 months follow up.
|
| Intervention |
Test Group (Group A): Controlled Diabetics (Hba1C: 6-8.4%)
Scaling and Root Planing (SRP) in combination with Antimicrobial Photodynamic Therapy(apdt) |
Patients in this group will receive a four weekly session of Antimicrobial photodynamic therapy(apdt) using photosensitizer Indocyanine green (ICG) irradiation by an 810 nm diode laser within the periodontal pocket on day 0 following SRP.
Method: For the preparation of the photosensitizer, the indocyanine green powder (ICG) will be mixed with sterile water, with a ratio of 5 mL water to 25 g bottle of powder, to obtain a concentration of 5 mg/mL. Since the aqueous solution of indocyanine green is unstable and must be used within 24 hours, the fresh solution will be prepared whenever necessary and the excess will be discarded. A diode laser with a wavelength of 810 nm will be used for ICG irradiation at a power of 0.2 watts. 1 mL of indocyanine green solution will inserted with a blunt needle in the periodontal pocket in apico-coronal
direction assuring that the needle tip reaches the depth of the pocket. The photosensitizer solution will be allowed to stay in the pocket for 60 seconds and excess solution will be washed out from the pocket before laser irradiation. Afterwards, a 400-μm optical fibre of the 810 nm diode laser set
at 0.2 watts in continuous wave mode will be inserted along the pocket and will be moved circumferentially around the tooth for 60 seconds. The procedure will be repeated at 7, 14 and 21 days. Oral hygiene instructions would be reinforced at each visit.
The periodontal clinical parameters including Gingival Index(GI), Plaque Index(PI), Pocket Probing Depth(PPD), Clinical Attachment Level(CAL) and Modified Sulcular Bleeding Index(mSBI) would be evaluated at baseline prior to intervention and reassessed at 3 months and 6 months follow up.
|
| Intervention |
Test Group (Group B): Controlled Diabetics (Hba1c:6-8.4%)
Scaling and Root Planing in combination with Low Level Laser Therapy (LLLT)
|
Patients in this group will receive a four weekly session of Low Level Laser Therapy (LLLT) using irradiation by an 810 nm diode laser within the periodontal pocket on day 0 following SRP.
Method: The inner and outer pocket mucosa will be laser-irradiated in a continuous wave mode using a 400-μm optical fiber at 0.2 watts (200 mw) power of the 810 nm diode laser set.
The optical fiber will be gently introduced into the pocket and will be moved circularly from the deepest part of the pocket towards the cervical margin for 60 seconds and then moved smoothly over the outer gingiva for 60 seconds. The procedure will be repeated at 7, 14 and 21 days. Oral hygiene instructions would be reinforced at each visit.
The periodontal clinical parameters including Gingival Index(GI), Plaque Index(PI), Pocket Probing Depth(PPD), Clinical Attachment Level(CAL) and Modified Sulcular Bleeding Index(mSBI) would be evaluated at baseline prior to intervention and reassessed at 3 months and 6 months follow up.
|
|
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Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Male and female patients with chronic periodontitis
Age Group- 30-65 years
Patients with clinical diagnosis of Type II Diabetes mellitus
HbA1c levels ranging from 6.0-8.4%
A minimum of 20 teeth present
Presence of at least one/two sites with probing pocket depth (PPD) of 5-6mm
|
|
| ExclusionCriteria |
| Details |
Periodontal mechanical therapy in previous 6 months.
History of antibiotic intake at least 3 months prior
Diabetic complications
Pregnancy or lactation
Smokers or tobacco users
Patients with unknown allergy or hypersensitivity reactions
Systemic condition other than diabetes that could affect the outcome of treatment
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
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Method of Concealment
|
Other |
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Blinding/Masking
|
Participant and Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in probing depth |
Baseline, 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in Plaque Index (PI) |
Baseline, 3 months and 6 months |
| Reduction in Gingival Index (GI) |
Baseline, 3 months and 6 months |
| Gain in Clinical Attachment Level(CAL) |
Baseline, 3 months and 6 months |
| Reduction in Modified sulcular bleeding index (mSBI) |
Baseline, 3 months and 6 months |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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 4 |
|
Date of First Enrollment (India)
|
18/12/2024 |
| 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 Applicable |
| 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
|
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Brief Summary
|
Study aims to investigate and compare the effects of Antimicrobial photodynamic therapy with indocyanine green versus Low level laser therapy as an adjunct to scaling and root planing on periodontal clinical parameters in Type II Diabetics.
OBJECTIVES: ØTo evaluate the efficacy of antimicrobial photodynamic therapy with indocyanine green as an adjunct to scaling and root planing on periodontal clinical parameters. ØTo evaluate the efficacy of low level laser therapy as an adjunct to scaling and root planing on periodontal clinical parameters ØTo compare the outcomes and evaluate if antimicrobial photodynamic therapy or low level laser therapy has an added advantage to mechanical therapy based on clinical parameters at 3 and 6 months follow up. Group A: Scaling & root planing (SRP) (n=25) Group B: SRP+ aPDT (n=25) Group C: SRP+ LLLT (n=25) ØA total of 4 sessions of aPDT and LLLT procedure will be administered to individuals at 7-day intervals. ØThe clinical measurements of the patients will be taken at baseline, 3 months and 6 months after the procedures.
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