| 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
|
|
|
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
|
|
|
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. |