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CTRI Number  CTRI/2022/06/043216 [Registered on: 13/06/2022] Trial Registered Prospectively
Last Modified On: 02/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Use of Photodynamic therapy in surgical management of Chronic Periodontitis. 
Scientific Title of Study   Effect of Photodynamic therapy as an adjunct to surgical management of Chronic Periodontitis 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mohammad Habib Shahir Chisty 
Designation  PG Student 
Affiliation  Sibar Institute of Dental Sciences 
Address  Room no 8,Second Floor, Department of Periodontics, Sibar Institute of Dental Sciences, Takkellapadu, Guntur, Andhrapradesh-522509

Guntur
ANDHRA PRADESH
522509
India 
Phone  9247279897  
Fax    
Email  shahirchst73@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr K Lakshmi Kanth 
Designation  Professor  
Affiliation  Sibar Institute of Dental Sciences 
Address  Room no 8,Second Floor, Department of Periodontics, Sibar Institute of Dental Sciences, Takkellapadu, Guntur, Andhrapradesh-522509

Guntur
ANDHRA PRADESH
522509
India 
Phone  9441081047  
Fax    
Email  drkanth99@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Mohammad Habib Shahir Chisty 
Designation  PG Student 
Affiliation  Sibar Institute of Dental Sciences 
Address  Room no 8,Second Floor, Department of Periodontics, Sibar Institute of Dental Sciences, Takkellapadu, Guntur, Andhrapradesh-522509

Guntur
ANDHRA PRADESH
522509
India 
Phone  9247279897  
Fax    
Email  shahirchst73@gmail.com  
 
Source of Monetary or Material Support  
Sibar Institute of Dental Sciences-Guntur 
 
Primary Sponsor  
Name  Dr Mohammad Habib Shahir Chisty 
Address  Room no 8,Second Floor, Department of Periodontics, Sibar Institute of Dental Sciences, Takkellapadu, Guntur, Andhrapradesh-522509 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mohammad Habib Shahir Chisty  Department of Periodontics and Implantology  Room no 8,Second Floor, Department of Periodontics, Sibar Institute of Dental Sciences, Takkellapadu, guntur, Andhrapradesh-522509
Guntur
ANDHRA PRADESH 
9247279897

shahirchst73@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K053||Chronic periodontitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  periodontal flap surgery  Periodontal Flap Surgery will be done without Photodynamic therapy in control group patients 
Intervention  Photodynamic therapy  Photodynamic therapy with Indocyanine green dye will be used in Periodontal flap surgery, test site will be rinsed with ICG dye and light source with 810nm wavelength diode laser will be carried out for 40sec in test group patients 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1. Age group 30-55 years.
2. Subjects who are apparently healthy.
3. Generalised chronic periodontitis with Probing pocket depth of ≥5mm and clinical
attachment loss of ≥3mm.
5. Radiographic evidence of horizontal bone loss.
 
 
ExclusionCriteria 
Details  1. Pregnancy or lactating females.
2. Tobacco consumption.
3. History of previous periodontal surgery.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Centralized 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1.To evaluate the probing pocket depth and clinical attachment level with and without photodynamic therapy
 
Baseline and 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
1)To evaluate the microbial changes of open flap debridement with and without photodynamic therapy.
2)To evaluate and compare the clinical and microbial aspect of open flap debridement with and without photodynamic therapy. 
Baseline and 3 months 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
Final Enrollment numbers achieved (Total)= "10"
Final Enrollment numbers achieved (India)="10" 
Phase of Trial   N/A 
Date of First Enrollment (India)   17/06/2022 
Date of Study Completion (India) 22/12/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 22/12/2023 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Chronic periodontitis is an infectious disease resulting in inflammation within the supporting tissues of the teeth, loss of progressive attachment and bone loss and is characterized by pocket formation and/or gingival recession. Scaling and root planning (SRP) is the most common periodontal treatment which has proven clinical effectiveness in terms of decreasing the probing pocket depth, reducing inflammation and improving the clinical attachment level (CAL).SRP has some limitations, such as difficulties in accessing deeper pockets, root concavities and furcation areas. Hence to facilitate SRP, flap surgery is recommended  to gain better access, Periodontal flap surgery is an open  flap debridement procedure, which eliminates the periodontal pocket depth with a potential to remove the bacterial biofilm and endotoxins from root surfaces of the teeth and to prevent further clinical attachment loss. Although elimination of granulation tissue reduces bacterial pathogen, it still remains a fact that it fails to eradicate the periopathogens. The success of such treatment depends on complete removal of  granulation tissue, adequate oral hygiene maintenance and success to comply with supportive periodontal therapy. Hence development of alternative antibacterial therapeutic strategies has become important in evolution of modalities to control microbial growth in oral cavity.

Recently an application of light energy with laser, also known as phototherapy to decontaminate the pockets environment, has been explored. Anti-microbial photodynamic therapy also known as photoactivated disinfection (PAD), involves the use of selective photosensitizer which is activated by a light source of a wavelength corresponding to the absorption maximum of the photosensitizer. The activated photosensitizer reaches the deeper tissues to bind to the bacterial cell wall and in some instances, penetrates into the cytoplasm.

Indocyanine green (ICG), a water soluble tricarbocyanine dye, has proven to be a photosensitizer which has an optimal peak absorption at 800-810nm range of wavelengths. This range has a penetration depth of 6-6.5mm, which exceeds the thickness of the mucous membrane, both in normal and pathological state, ICG has been effective in eradicating the organisms such as: Staphylococcus Aureus, Pseudomonas Aeruginosa, Porphyromonas gingivalis and Aggregatibacter Actinomycetemcomitans, thereby reducing their concentrations and ultimately improving periodontal status.

The present study aimed to evaluate the clinical and microbial effect of open flap debridement with and without photodynamic therapy.

STUDY PROCEDURE

The present study is a split mouth design. A total of 10 patients with chronic periodontitis will be selected into the study. The contralateral quadrants will be randomly divided into two groups according to the inclusion and exclusion criteria.

Group A-Open flap debridement in combination with photodynamic therapy(OFD+PDT) (n=10 sites).

Group B-Open flap debridement alone(OFD) (n=10 sites).

At the initial visit, clinical examination will be performed on each patient and clinical parameters will be recorded such as Plaque index(PI),Gingival index(GI),Probing pocket depth(PPD) and Clinical attachment level(CAL).

All patients will receive phase I therapy which includes scaling and thorough oral hygiene instructions. One week after scaling, baseline subgingival plaque samples will be collected using sterile curette placed into the deepest periodontal pocket for 45sec, the collected sample will be transferred to a transport medium (Tris EDTA Buffer medium) and will be sent to laboratory for microbiological analysis of Porphyromonas gingivalis(Pg),Aggregatibacter actinomycetomcomitans(Aa), Prevotella intermedia(Pi).

 

 SURGICAL PROCEDURE

All patients will be treated using the following surgical protocol. Pre-operative rinse with 0.2% chlorhexidine for 60sec and local administration of 2% lignocaine with adrenaline at a concentration of 1:80000.

After local anesthesia, a crevicular incision will be given using a No.15 surgical blade.

A full thickness mucoperiosteal flap is raised, using a periosteal elevator.

Following this, a thorough debridement of the root surfaces will be performed.

In Group A-After complete debridement, each test site will be rinsed with ICG dye using a blunt side release cannula. Sterile saline will be used to remove the excess dye from the site. After thorough rinsing the light source with 810nm wavelength diode laser will be carried out for 40sec, then flap will be closed with interrupted sutures using 3-0 braided silk suture material.

In Group B-After thorough debridement of root surfaces, flap will be closed with interrupted sutures using 3-0 braided silk suture material.

 Post-operative care

The patient will be instructed not to disturb the surgical site until the sutures are removed. Antibiotics and analgesics will be prescribed.  After two weeks, the sutures will be removed and the oral hygiene instructions will be emphasized. Clinical parameters will be recorded 3 months after treatment, post operative subgingival plaque samples will be collected from both groups using sterile curette and then transferred into vial with transporting medium (Tris EDTA Buffer medium), which is then labelled with an appropriate code in correspondence with the operator. The labelled vials will be transported for Real Time polymerized chain reaction for microbiological analysis.

 
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