| CTRI Number |
CTRI/2026/02/103196 [Registered on: 06/02/2026] Trial Registered Prospectively |
| Last Modified On: |
06/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic
Preventive
Screening
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical Study to Evaluate Gum Health Around Dental Implants After Fixing the Crown. |
|
Scientific Title of Study
|
EFFECT OF INDOCYANINE GREEN MEDIATED PHOTODYNAMIC THERAPY ON PERIODONTAL INFLAMMATORY MARKERS TUMOR NECROSIS FACTOR- ALPHA AND MATRIX METALLOPROTEINASE 8 AROUND PERI-IMPLANT SULCUS AFTER PLACEMENT OF CROWN- A RANDOMIZED CLINICAL 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 |
Priyanka Gupta |
| Designation |
Post graduate student in periodontology |
| Affiliation |
The Oxford Dental College |
| Address |
The Oxford Dental College, Bommanahalli, NH 44, Hosur road, cluster b, Hongasandra Metro Station
Bommanahalli,NH44, Hongasandra Metro Station
Bangalore
KARNATAKA
560068
India |
| Phone |
9279068445 |
| Fax |
|
| Email |
guptadrpriyanka22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amita Coutinho |
| Designation |
Reader , Department of Periodontics |
| Affiliation |
The Oxford dental college |
| Address |
The Oxford dental college , Bomanahalli, NH 44, Hosur road, cluster b, Hongasandra , near metro station
Bommanahalli
Bangalore
KARNATAKA
560068
India |
| Phone |
09886789080 |
| Fax |
|
| Email |
amitacou@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Priyanka Gupta |
| Designation |
Post graduate student in periodontology |
| Affiliation |
The Oxford dental college |
| Address |
The Oxford dental college, Bommanahalli, NH 44 , Hosur road, cluster b , Hongasandra, near metro station
Bangalore
KARNATAKA
560068
India |
| Phone |
9279068445 |
| Fax |
|
| Email |
guptadrpriyanka22@gmail.com |
|
|
Source of Monetary or Material Support
|
| The Oxford Dental College And hospital, Bommanahalli, NH 44 ,hosur road,near hongasandra metro station, bengaluru, karnataka |
|
|
Primary Sponsor
|
| Name |
Priyanka Gupta |
| Address |
The Oxford Dental college,Hosur road , cluster b ,Bommanahalli ,NH44 ,Hongasandra , near metro station, bengaluru |
| Type of Sponsor |
Research institution 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 |
| Dr Priyanka Gupta |
The Oxford dental college |
Department of periodontology , room no 3, Hosur road, cluster b , NH 44, Bommanahalli, near Hongasandra metro station
Bangalore
KARNATAKA |
9279068455
guptadrpriyanka22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K036||Deposits [accretions] on teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Subjects with 10 endosseous dental implants with crown who will undergo scaling and root planing with Indocyanine green mediated Photodynamic therapy. |
Scaling and root planing will be done using hand and ultrasonic instrumentation with Implacare and U/S Implant tip , Photodynamic therapy will be done using indocyanine green dye. The needle of the syringe will be replaced with a blunt cannula to fill the Peri-implant sulcus with the dye. Peri-implant sulcus will be rinsed with sterile water ICG dye( for group II) starting from the bottom of sulcus to achieve complete filling of the sulcus and coating of the root surface and also between the within the sulcus and within cavities between abutments and implants. After incubating for 1 minute, buccal, lingual/palatal, mesial, distal site was exposed to the laser light for 30 seconds, respectively. For abutment screw cavities, the dye was applied in the cavity and exposed to the laser light for 30 seconds. Cotton rolls and a high vacuum suction will be used to prevent ingestion of the dye solution. After 3 min, the subject will be asked to rinse with water to remove excess photosensitizer. An 810 nm diode laser will be used to activate the photosensitizer. Laser will be applied in a continuous mode with a power of 0.8 Watts and irradiation time of 60s.
Total energy produced will be 5.4J/cm2. |
| Intervention |
Subjects with 10 endosseous dental implants with crown who will undergo scaling and root planing with sterile water irrigation with laser photobiomodulation therapy. |
Scaling and root planing will be done using hand and ultrasonic instrumentation with Implacare and U/S Implant tip , Photodynamic therapy will be done using indocyanine green dye. The needle of the syringe will be replaced with a blunt cannula to fill the Peri-implant sulcus with the dye. Peri-implant sulcus will be rinsed with sterile water(for group I) starting from the bottom of sulcus to achieve complete filling of the sulcus and coating of the root surface and also between the within the sulcus and within cavities between abutments and implants. After incubating for 1 minute, buccal, lingual/palatal, mesial, distal site was exposed to the laser light for 30 seconds, respectively. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Systematically healthy individuals, Presence of at least one screw type titanium endosseous dental implants at different sites, No implant mobility, No evidence of occlusal overload, Dental implant which has not elicited signs and symptoms of peri-implant mucositis or peri-implantitis |
|
| ExclusionCriteria |
| Details |
Individuals who have history is antimicrobial and anti-inflammatory therapy in last 3 months, Subjects with diabetes mellitus, hypertension,heart disease,rheumatoid arthritis,tumors, Pregnant/lactating women, Smokers |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Gingival index, Bleeding and probing, Probing pocket depth, Mucosal recession,Clinical attachment loss, MMP-8 and TNF-alpha biomarkers in the peri-implant sulcular fluid at baseline and 4 months |
At baseline and 4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
20/03/2026 |
| 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="4"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [guptadrpriyanka22@gmail.com].
- For how long will this data be available start date provided 30-01-2026 and end date provided 30-01-2028?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Dental implants are considered to be one of the most commonly used treatment options in the replacement of missing teeth. Bacterial colonization occurs rapidly on oral implant surfaces, after installation in oral cavity. More bacterial penetration was detected through screw hole of suprastructures than marginal gaps, and bacteria from the internal cavities are associated with peri-implant bone loss. So, it seems reasonable to timely disinfect the inner surface of suprastructures and reduce the bacteria flow outside into the sulcus, therefore reducing the incidence of peri-implantitis.
Novel approaches are still necessary to solve this problem. One such modality is the photodynamic therapy. This therapy, introduced by von Tappeiner, uses red light, infrared light and diode lasers with a certain wavelength to reduce the number of microorganisms in the body. The transfer of energy leads to the release of free oxygen radicals, which destroy bacteria and their by-products.
Antibacterial indocyanine green is a potential new photosensitizer which has gained special attention in dentistry. It has the ability to absorb light around 805 nm wavelength which is closer to absorption peak of most diode lasers and has advantages like, free of side effects, simple handling for practitioner and patient, low toxicity and has ability to eliminating periodontal pathogens, including P. gingivalis.
Peri-implant sulcular fluid contain biomarkers to diagnose and predict future disease which aids in choosing a specific treatment protocol. Tumor necrosis factor-alpha and Matrix metalloproteinase-8 have been proven to increase in peri-implantitis by causing extracellular matrix degradation and bone resorption.
Hence, the aim of this study is to evaluate the effect of photodynamic therapy on periodontal inflammatory markers Tumor Necrosis Factor-alpha and Matrix Metalloproteinase-8 around peri-implant sulcus after placement of crown. |