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CTRI Number  CTRI/2019/08/020775 [Registered on: 19/08/2019] Trial Registered Prospectively
Last Modified On: 16/08/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect Of Photothermal Therapy along With Surgical gum Treatment In Patients With severe gum diseases. 
Scientific Title of Study   Effect Of Photodynamic Therapy Combined With Surgical Periodontal Treatment In Patients With Chronic Periodontitis: A clinical and microbiological study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  patri krishna chaitanya 
Designation  post graduate student 
Affiliation  vishnu dental college 
Address  16-10-31/l raghurama colony anakapalli
department of periodontics, vishnu dental college, vishnupur,bhimavaram
Visakhapatnam
ANDHRA PRADESH
531001
India 
Phone  7731021396  
Fax    
Email  krishnachaitanya648@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Gautami S Penmetsa  
Designation  professor and head 
Affiliation  vishnu dental college 
Address  room no 7 department of periodontics and implantology, vishnu dental college

West Godavari
ANDHRA PRADESH
534202
India 
Phone  9951011618  
Fax    
Email  gautamipenmetsa@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Gautami S Penmetsa  
Designation  professor and head 
Affiliation  vishnu dental college 
Address  room no 7 department of periodontics and implantology, vishnu dental college

Krishna
ANDHRA PRADESH
534202
India 
Phone  9951011618  
Fax    
Email  gautamipenmetsa@gmail.com  
 
Source of Monetary or Material Support  
vishnu dental college, bhimavram, 534202  
 
Primary Sponsor  
Name  P Krishna chaitanya 
Address  vishnu dental college bhimavaram, west godavari, 534202. 
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 
vishnu college  patri krishna chaitanya   vishnu pur, bhimavaram.
West Godavari
ANDHRA PRADESH 
7731021396

krishnachaitanya648@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institution of ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 8||Other Procedures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  conventional flap surgery along with phototdynamic therapy   using indocyanine green dye( aurogreen) and activatng with 3watts power and continuous pulse laser with 400 micrometers of laser tip. 
Intervention  conventional periodontal flap surgery  flap debridement will be done and suturing will be placed. 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Presence of minimum of 2 teeth with chronic periodontitis.
Presence of probing pocket depths ≥ 5mm
 
 
ExclusionCriteria 
Details  Patients with uncontrolled systemic diseases.
Smokers.
Patients on long term steroidal and antibiotic therapy.
History of previous periodontal surgery in past 6 months.
Pregnant and lactating woman.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Plaque index PI (Sillness and Loe 1964).
Gingival index GI (Loe and Sillness 1963).
Clinical Attachment Level CAL.
Probing pocket depth (PPD).
Microbial assessment of Porphyromons ginigvalis, Tannerella forsythia and Treponema denticola will be measured by conventional multiplex PCR at base line and 3 months after the therapy. 
baseline and 6months after surgery  
 
Secondary Outcome  
Outcome  TimePoints 
Plaque index PI (Sillness and Loe 1964).
Gingival index GI (Loe and Sillness 1963).
 
baseline and 6months after surgery  
 
Target Sample Size   Total Sample Size="15"
Sample Size from India="15" 
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)   25/08/2019 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Chronic periodontitis is an infectious disease resulting in inflammation within supporting tissues of teeth, progressive attachment and bone loss. Periodontal pockets form a unique environment which harbours almost 400 species of microorganisms. These bacterial biofilms interact with host cells resulting in tissue destruction. Periodontal therapy aims to achieve complete periodontal health, Which can only be accomplished by complete debridement of microbiota and endotoxins present on the root surface (1).

Non-surgical and Surgical periodontal therapy (SPT) have been used successfully for many years to treat periodontitis. However, there is transient reduction in quality of periodontal pathogens when mechanical therapy alone is used. Mechanical therapy was not successful in eliminating or preventing recolonization of bacterial pathogens. As a result there has been a search for adjunctive therapy for periodontal treatment approaches (2).

Photodynamic therapy (PDT) also known as phototherapy, involves the use of photoactive dye (photosensitizer) that is activated by exposure to light of a specific wavelength in the presence of oxygen. It could provide an alternative for targeting microbes directly at the site of infection, thus overcoming the problems associated with antimicrobials (3). The use of PDT presents a divergent results in treating chronic periodontitis. (4).

Based on the previous literature, PDT may be effective as an adjunctive therapy to periodontal mechanical debridement, especially in cases of advanced periodontal disease and sites which are difficult to access. 
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