| CTRI Number |
CTRI/2024/04/065478 [Registered on: 09/04/2024] Trial Registered Prospectively |
| Last Modified On: |
03/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Efficacy of rose Bengal dye in addition with mechanical cleaning using laser assisted therapy in implant defects. |
|
Scientific Title of Study
|
Rosebengal Assisted Antimicrobial Photodynamic Therapy as an Adjunct To Mechanical Debridement In Non Surgical Management Of Periimplantitis- A Randomised Control 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 |
Nivedha N |
| Designation |
PG student |
| Affiliation |
Saveetha dental college and hospital, SIMATS University |
| Address |
4th floor, clinic 25,
Department of peridontology,
Saveetha Dental college and hospital, SIMATS UNIVERSITY
No 162, Poonamallee High Road,
Vellapanchavadi,
Kancheepuram
TAMIL NADU
600077
India |
| Phone |
9600177122 |
| Fax |
|
| Email |
152205003.sdc@saveetha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arvina Rajasekar |
| Designation |
Professor |
| Affiliation |
Saveetha Dental College and Hopsital, SIMATS University |
| Address |
4th floor, clinic 25,
Department of peridontology,
Saveetha Dental college and hospital,
SIMSTS UNIVERSITY,
No 162, Poonamallee High Road,
Vellapanchavadi, chennai.
Kancheepuram
TAMIL NADU
600077
India |
| Phone |
9486442309 |
| Fax |
|
| Email |
arvinar.sdc@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arvina Rajasekar |
| Designation |
Professor |
| Affiliation |
Saveetha Dental College and Hopsital, SIMATS University |
| Address |
4th floor, clinic 25,
Department of peridontology,
Saveetha Dental college and hospital,
SIMSTS UNIVERSITY,
No 162, Poonamallee High Road,
Vellapanchavadi, chennai.
TAMIL NADU
600077
India |
| Phone |
9486442309 |
| Fax |
|
| Email |
arvinar.sdc@saveetha.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Dental College and Hospital, Saveetha Institute of Medical And Technical Sciences, No 162, Poonamallee High Road, Vellapanchavadi, Chennai, Tamil Nadu, India, 600077 |
|
|
Primary Sponsor
|
| Name |
Dr Nivedha N |
| Address |
Department of peridontology,
clinic 25, 4th floor,
Saveetha Dental College and Hospital,
Saveetha institute of Medical and Technical sciences,
No 162, Poonamallee High Road,
Vellapanchavadi, Chennai, Tamil Nadu,India, 600077. |
| 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 Nivedha N |
Saveetha Dental college and hospital |
Clinic 25, 4th floor,
Department of peridontology,
Saveetha Dental college and hospital,
Saveetha institute of Medical and Technical sciences,
No 162, Poonamallee High Road,
Vellapanchavadi, Chennai 600077.
Kancheepuram
TAMIL NADU |
9600177122
152205003.sdc@saveetha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethical Committee (SDC-IHEC) - Approval Certificate |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K055||Other periodontal diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mechanical debridement + methylene blue mediated aPDT |
Use of methylene blue mediated antimicrobial photodynamic therapy post non surgical therapy after baseline evaluation. Total duration of study 6months |
| Intervention |
mechanical debridement + Rose Bengal mediated aPDT |
Use of Rose Bengal mediated antimicrobial photodynamic therapy post non surgical therapy after baseline evaluation. Total duration 6months |
| Comparator Agent |
Mechanical debridement of pocket |
Only mechanical debridement of the peri implantitis site post evaluation of baseline values. Total duration of study 6 months |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 patients above or equal to 20years of age.
2 Absence of relevant medical conditions.
3 Initial peri-implantitis a pocket probing depth (PPD) of 4–6 mm with concomitant bleeding on probing (BoP) at 1 peri-implant site and radiographic marginal bone loss ranging from 0.5 to 2 mm between delivery of the suprastructure and pre-screening appointment.
4 Implant in function for at least 1 year.
5 Solid screw bone level titanium implants with sandblasted and acid etched surface (Straumann dental implant system)
|
|
| ExclusionCriteria |
| Details |
(1) Uncontrolled medical conditions.
(2) Pregnant or lactating females.
(3) Tobacco smoking.
(4) Untreated periodontal conditions.
(5) Use of antibiotics in the past 3 months.
(6) Subjects treated for more than 2 weeks with any
medication known to affect soft tissue conditions (e.g. phenytoin, calcium antag- onists, cyclosporin, coumadin and non- steroidal anti-inflammatory drugs) within 1 month of the baseline examination.
(7) Peri-implant mucositis defined as the absence of radiographic marginal bone loss between delivery of the suprastructure and pre-screening appointment.
(8) Failure to sign written informed consent. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Pocket Probing Depth (PPD).
(2) Clinical Attachment Level (CAL).
(3) Mucosal recession (REC).
(4) Bleeding on Probing (BoP)
(5) Modified Plaque Index (mPlI) |
Baseline
3 months
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Microbial colony count
Inflammatory bio marker levels |
Baseline
3 months
6 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
25/04/2024 |
| 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
|
Peri-implantitis refers to a localized infection that triggers inflammation in soft tissues and leads to bone deterioration around a surgically integrated implant in use. The causes of this implant-related infection are influenced by factors such as the condition of the tissue surrounding the implant, the design of the implant itself, its surface roughness, external shape, and excessive mechanical stress. The primary cause behind implant failure are typically spiral-shaped bacteria and mobile variants of Gram-negative anaerobic bacteria, unless the issue stems solely from mechanical strain. Over the years, lasers have been utilized in the field of periodontology to disinfect the periodontal pockets since they possess exceptionally good bactericidal capabilities. By causing heat denaturation, direct ablation, or destruction of bacterial cells, the lasers possess a bactericidal effect. An unintentional discovery made in the early 20th century, antimicrobial photodynamic therapy (a-PDT) is used in medicine to inactivate cells using light. The three main components of antimicrobial photodynamic treatment are oxygen, nontoxic photosensitizers, and a source of visible light. The principle behind its use is when a suitable light of a specific wavelength when irradiated can activate the photosensitizes by producing high reactive state of oxygen called as singlet oxygen which reacts with the surrounding cells. The reactive oxygen species damage the cell wall of the microorganisms. This happens in a limited space leading to localized response. There are various photosensitizing agents like toluidine blue, methylene blue, erythrosine, hematoporphyrin, chlorine and xanthene dyes. Rose bengal (RB) dye, a xanthene derivate is a potent photosensitizing agent, that once activated transfer this energy directly to oxygen, resulting in the formation of singlet oxygen. It has beendemonstrated as a potent photosensitizer used to eliminate Candida albicans, Streptococcus sanguis and Streptococcus mutans. It has also been proved in an in vitro study, to be effective against periodontopathogens like Porphyromonas gingivalis. However, there are no clinical studies assessing the efficiency of rose bengal mediated photodynamic therapy in treating peri implantitis . In this context, the present randomized controlled clinical trial has been carried out to ascertain the efficiency of rose bengal mediated photodynamic therapy as an adjunct to non-surgical management of peri implantitis. |