| CTRI Number |
CTRI/2024/10/075837 [Registered on: 24/10/2024] Trial Registered Prospectively |
| Last Modified On: |
22/05/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Photodynamic therapy in Endo-Perio Lesions |
|
Scientific Title of Study
|
Evaluation of Photodynamic therapy using Indocyanine green and Methylene Blue in reducing Enterococcus Faecalis and Porphyromonas Gingivalis in Endo-perio lesions. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Katuri Kishore Kumar |
| Designation |
professor |
| Affiliation |
sibar institute of dental sciences |
| Address |
Department of Periodontology,
Sibar Institute of Dental Sciences,
Takellapadu, Guntur.
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
09000534590 |
| Fax |
|
| Email |
kishoreuga@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Katuri Kishore Kumar |
| Designation |
professor |
| Affiliation |
sibar institute of dental sciences |
| Address |
Department of Periodontology,
Sibar Institute of Dental Sciences,
Takellapadu, Guntur.
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
09000534590 |
| Fax |
|
| Email |
kishoreuga@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Katuri Kishore Kumar |
| Designation |
professor |
| Affiliation |
sibar institute of dental sciences |
| Address |
Department of Periodontology,
Sibar Institute of Dental Sciences,
Takellapadu, Guntur.
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
09000534590 |
| Fax |
|
| Email |
kishoreuga@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| katuri kishore kumar,
Department of Periodontology,
Sibar Institute of Dental Sciences,
Takellapadu, Guntur.
India.
PIN: 522509 |
|
|
Primary Sponsor
|
| Name |
SIBAR Institute of dental sciences |
| Address |
Department of Periodontology,
Sibar Institute of Dental Sciences,
Takellapadu, Guntur.
Andhra Pradesh, India.
PIN: 522509 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| department of endodontics |
department of endodontics,
sibar institute of dental sciences
takellapadu
Guntur, Andhra Pradesh. India. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr katuri kishore kumar |
sibar institute of dental sciences |
Department of Periodontology,Room no:8, and Department of Endodontics, Room no:5,
Sibar Institute of Dental Sciences
Takellapadu
Guntur, Andhra Pradesh. India.
Guntur
ANDHRA PRADESH |
09000534590
kishoreuga@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| sibar institute of dental sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
combined endo-perio lesions |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
photodynamic therapy using Diode Laser |
comparison between methylene blue and indocyanine green dye |
| Intervention |
photodynamic therapy using diode laser |
photodynamic therapy using Diode Laser with the application of sensitization dye in Endo-Perio Lesions |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1 Age between 21-55 yrs.
2 presence of at least 20 permanent teeth.
3 Presence of pocket depth ≥ 5mm.
4 Non-vital tooth (pulp necrosis)
5 Presence of radiolucency at peri-apical area with evidence of bone loss from marginal bone to root apex.
6 Radiolucency without root damage.
7 Adult patient who did not received any active periodontal or endodontic treatment in the teeth undergoing treatment.
|
|
| ExclusionCriteria |
| Details |
1•Tooth with mobility.
2•Individuals with tobacco use,
4•pregnancy or lactation.
5•Use of NSAIDS and antibiotics within the previous 3 months.
6•Suffering with CVD, renal disease, diabetes and hypertension
7•Syndromes or developmental disorders with periodontal disease
8•Horizontal and vertical fractures.
9•Iatrogenic root perforations.
10•Open apices.
11•Tooth that could not be isolated with rubber dam.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| ATP RLU values and microbiological analysis of Porphyromonas gingivalis and Enterococcus faecalis from the rootcanal and periodontal pocket |
at baseline and 3 months post-operative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Plaque Index, Probing Depth, and Clinical attachment Level |
at baseline and 3 months post-operative |
|
|
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 4 |
|
Date of First Enrollment (India)
|
05/11/2024 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
Antimicrobial photodynamic therapy has been introduced as a promising and non invasive local and adjuvant treatment in several oral infectious diseases. It is a strategy that involves the chemical interaction of a topical nontoxic photosensitizer and a light source with a specific wavelength. The excited photosensitizer reacts with the molecular oxygen from the environment to generate highly reactive oxygen species, causing, among other factors, bacterial cell wall rupture and bacteria death. Its efficacy for elimination of bacterial, fungal, and viral infections and key pathogens such as Streptococcus mutans, Porphyromonas gingivalis, Candida albicans and Enterococcus faecalis.Methylene blue, Curcumin, and Indocyanine green are the most common commercially available PS. They are chemical compounds, disinfectants, and antiseptics used as dyes or indicators in oxirreduction reactions. Methylene Blue has photosensitizing characteristics and an absorption range of 500 nm to 700 nm, being activated by red light. Methylene Blue was chosen as the photosensitizer since its activity against oral bacteria is known and has reported clinical application.Indocyanine Green has gained special attention as a new PS due to its low toxicity and activation near the infrared spectrum. Its absorption peak at 810 nm coincides with commercially available laser diodes for dental use, which penetrate deeper than a red laser, thus favoring the elimination of bacteria during endodontic treatment. The AIM of the study is to Evaluate the effect of Photodynamic therapy using Indocyanine green and Methylene Blue in reducing Enterococcus Faecalis and Porphyromonas Gingivalis in Endo-perio lesions. Total of 40 Maxillary and mandibular Premolar and Molar teeth with endo-perio lesions (pulp necrosis) in systemically healthy subjects will be taken into the study. They will be assigned into 2 groups consisting of 20 in each with one site in each patient.
Group I (n= 20): Indocyanine green irrigation (ICG) placement in canal and periodontal pocket followed by laser irradiation.
Group II (n=20): Methylene Blue (MB) placement in canal and periodontal pocket followed by laser irradiation. analysis of plaque index, probing pocket depth, clinical attachment level and microbiological analysis of Porphyromonas gingivalis and Enterococcus faecalis from periodontal pocket at baseline and 3 months post operative
|