| CTRI Number |
CTRI/2024/09/073681 [Registered on: 10/09/2024] Trial Registered Prospectively |
| Last Modified On: |
10/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparing the use of methylene blue and indocyanine green dyes in photodynamic therapy for the treatment of moderate periodontitis patients. |
|
Scientific Title of Study
|
Comparative evaluation of antimicrobial effect of indocyanine green and methylene blue dye as photosensitizers for photodynamic therapy as an adjunct to scaling and root planing in patients with moderate periodontitis - A randomized controlled 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 Jasleen Thakker |
| Designation |
Post-graduate |
| Affiliation |
KAHERs KLE V.K Institute of Dental Sciences |
| Address |
Room no.9, Department of Periodontics, KAHERs KLE V.K Institute of Dental Sciences, Nehru Nagar, Belagavi, Karnataka, India 590010
Belgaum KARNATAKA 590010 India |
| Phone |
7506367111 |
| Fax |
|
| Email |
jasangle11@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Vilas Pattar |
| Designation |
Reader |
| Affiliation |
KAHERs KLE V.K Institute of Dental Sciences |
| Address |
Room no.9, Department of Periodontics, KAHERs KLE V.K Institute of Dental Sciences, Nehru Nagar, Belagavi, Karnataka, India 590010 Belgaum KARNATAKA 590010 India |
| Phone |
9886597561 |
| Fax |
|
| Email |
vilspat83@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Jasleen Thakker |
| Designation |
Post-graduate |
| Affiliation |
KAHERs KLE V.K Institute of Dental Sciences |
| Address |
Room no.9, Department of Periodontics, KAHERs KLE V.K Institute of Dental Sciences, Nehru Nagar, Belagavi, Karnataka, India 590010
KARNATAKA 590010 India |
| Phone |
7506367111 |
| Fax |
|
| Email |
jasangle11@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHERs KLE V.K Institute of Dental Sciences, Nehru Nagar, Belagavi, Karnataka, India 590010 |
|
|
Primary Sponsor
|
| Name |
Dr Jasleen Thakker |
| Address |
KAHERs KLE V.K Institute of Dental Sciences, Nehru Nagar, Belagavi, Karnataka, India 590010 |
| Type of Sponsor |
Other [Self sponsored] |
|
|
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 Jasleen |
KAHERs KLE V.K Institute of Dental Sciences |
Room no.9, Department of Periodontics, KAHERs KLE V.K Institute of Dental Sciences, Nehru Nagar, Belagavi, Karnataka, India 590010 Belgaum KARNATAKA |
7506367111
jasangle11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Research and Ethics Committee KLE VKIDS |
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 |
0.5% Indocyanine green dye |
Assessing the antimicrobial efficacy of photodynamic therapy with 0.5% Indocyanine green dye as an adjunct to scaling and root planing. |
| Intervention |
1% Methylene blue dye |
Assessing the antimicrobial efficacy of photodynamic therapy with 1% Methylene blue dye as an adjunct to scaling and root planing |
| Comparator Agent |
Scaling and root planing |
Patients will receive full mouth scaling and root planing under local anesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Non smoking adults more than 18 years of age
Patients with minimum 20 teeth present
Untreated moderate periodontitis with probing depth more than or equal to 5mm & less than 7mm, presence of bleeding on probing and clinical attachment loss of 3mm to 4mm.
Signed informed consent
|
|
| ExclusionCriteria |
| Details |
Pregnant or lactating women.
Periodontal treatment in the past 6 months.
Patients allergic to the use of dyes.
Patients presenting with a history of ocular problems.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Gingival index, Pocket probing depth, Clinical attachment loss |
Baseline, 1 week, 1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Colony forming units/ml |
Baseline, 1 week, 1 month |
|
|
Target Sample Size
|
Total Sample Size="63" Sample Size from India="63"
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)
|
26/09/2024 |
| 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="1" Months="0" 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
|
|
Brief Summary
|
Ø The primary goal of periodontal therapy is to eliminate bacterial bioï¬lm and endotoxins from root surfaces of the teeth. However, owing to anatomical variations in root surfaces, complex furcation areas, concavities on root surfaces, and bacterial invasion of the surrounding soft tissues, nonsurgical periodontal therapy (NSPT) alone cannot eliminate periodontal pathogens.1 Ø Although systemic and local administration of antibiotics into periodontal pockets may be effective for disinfection, the frequent usage of antibiotics bears the potential risk of producing resistant microorganisms.1 Ø In recent years, photodynamic therapy (PDT) with the help of lasers has been used to decontaminate the pocket environment as it is a minimally invasive treatment that activates the immune system, has low systemic toxicity, and possesses high bactericidal properties. The eradication of tissue invasive microorganisms associated with periodontitis and peri-implantitis by lasers has been amply demonstrated.2 Ø Combining lasers and photosensitizing agents can result in photo destruction of target cells due to cytotoxic effect in the presence of oxygen. This light-induced effect is due to the conversion of the excited photosensitizer from the ground state to the triplet state resulting in production of singlet oxygen and other reactive agents, which are very toxic to certain cells or bacteria.3 Ø A recent in vitro study had shown the efficacy of a new photosensitizer dye, indocyanine green (ICG), against Aggregatibacter actinomycetemcomitans and Porphyromonas gingivalis, when activated at a wavelength of 810 nm by a diode laser. It has high absorption in the infrared spectrum, low toxicity, and rapid elimination.4 Ø Methylene blue has a strong absorption band in the 550-700 nm region and has been extensively used for photooxidation of natural and synthetic molecules. Fontana et al, in 2009, demonstrated aPDT with 25 μg/mL methylene blue and red light resulted in 63% reduction of planktonic bacteria and 32% decrease in bacteria forming biofilms.5 Ø The photokilling rate in antimicrobial photodynamic therapy is highly related to interaction of reactive oxygen species (ROS) produced, ability of photosensitizers (PS) in incorporating into microorganisms and light devices/microorganism type.6 Ø While methylene blue and indocyanine green are present in the dental practice as PS there is an acute paucity of literature comparing their efficacy in terms of improvement of clinical parameters and suppression of periodontal pathogens. Therefore, the present study aims at comparative evaluation of antimicrobial effect of indocyanine green and methylene blue dye as photosensitizers for photodynamic therapy as an adjunct to scaling and root planing in patients with moderate periodontitis. |