| CTRI Number |
CTRI/2018/03/012803 [Registered on: 23/03/2018] Trial Registered Retrospectively |
| Last Modified On: |
14/03/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
EFFICACY OF TWO DIFFERENT LIGHT SOURCES ON CHRONIC PERIODONTITIS |
|
Scientific Title of Study
|
EFFICACY OF PHOTODYNAMIC THERAPY WITH TWO DIFFERENT WAVE LENGTH LIGHT SOURCES ON CHRONIC PERIODONTITIS – A CLINICO 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 |
Atheena Surendran |
| Designation |
Post graduate student |
| Affiliation |
Rajiv gandhi university of health science, Bangalore |
| Address |
Sri hasanamba dental college and hospital, Vidyanagar, Hassan
Same as above
Hassan
KARNATAKA
573201
India |
| Phone |
9449035181 |
| Fax |
|
| Email |
atheena10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vivekananda MR |
| Designation |
Assisstant proffessor |
| Affiliation |
Rajiv gandhi university of health science, Bangalore |
| Address |
Sri hasanamba dental college and hospital, Vidyanagar, Hassan
Same as above
Hassan
KARNATAKA
573201
India |
| Phone |
9980843531 |
| Fax |
|
| Email |
vivekcodsperio@ymail.com |
|
Details of Contact Person
Public Query
|
| Name |
Atheena Surendran |
| Designation |
Post graduate student |
| Affiliation |
Rajiv gandhi university of health science, Bangalore |
| Address |
Sri hasanamba dental college and hospital, Vidyanagar, Hassan
same as above
Hassan
KARNATAKA
573201
India |
| Phone |
9449035181 |
| Fax |
|
| Email |
atheena10@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri hasanamba dental college and hospital, Hassan |
|
|
Primary Sponsor
|
| Name |
Atheena Surendran |
| Address |
Post Graduate Student, Sri Hasanamba dental college and Hospital, Hassan, |
| 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 |
| Atheena Surendran |
Sri Hasanamba Dental college and Hospital |
sri hasanamba dental college and hospital
Hassan
KARNATAKA |
9449035181
9449035181
atheena10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri hasanamba dental college and hospital institutional ethical committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Chronic periodontitis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
diode laser and erythrosine.Frequency- only once.Subjects will be recalled for review after 3 months. |
In this randomized controlled clinical trial, 30 subjects were randomly assigned to three groups with 10 subjects in each groups they are, group A- SRP, group B- SRP+ Visible light +Erythrosine, group C- SRP+ Diode laser + Erythrosine. |
| Intervention |
LED and erythrosine. Frequency- only once.Subjects will be recalled for review after 3 months. |
In this randomized controlled clinical trial, 30 subjects were randomly assigned to three groups with 10 subjects in each groups they are, group A- SRP, group B- SRP+ Visible light +Erythrosine, group C- SRP+ Diode laser + Erythrosine |
| Comparator Agent |
SRP ALONE. Frequency- only once.Subjects will be recalled for review after 3 months. |
In this randomized controlled clinical trial, 30 subjects were randomly assigned to three groups with 10 subjects in each groups they are, group A- SRP, group B- SRP+ Visible light +Erythrosine, group C- SRP+ Diode laser + Erythrosine |
|
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Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Subjects with at least 10 natural teeth present.
2) Subjects who had undergone no dental treatment in the previous 6 months.
3) Age between 35 and 60 year old.
4) Diagnosed with untreated chronic periodontitis clinically and radiographically
5) Probing pocket depth ≥ 5mm
6) Subjects who are willing to comply with the study protocol.
|
|
| ExclusionCriteria |
| Details |
1) Pregnancy and lactation.
2) Subjects with systemic diseases.
3) Current smoking or smoking within last 10 years.
4) Administration of antibiotics or periodontal treatment in the previous 6 months.
5) Subjects who are known allergic to any type of light or dye.
6) Subjects who are not willing to comply with the study.
|
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Probing pocket depth, Relative attachment level, Number of Porphyromonas gingivalis |
Baseline, 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Gingival index, Papillary bleeding index, Plaque index |
Baseline,3 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
23/06/2017 |
| Date of Study Completion (India) |
23/09/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="12" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
EFFICACY OF PHOTODYNAMIC THERAPY WITH TWO DIFFERENT WAVE LENGTH LIGHT SOURCES ON CHRONIC PERIODONTITIS - A CLINICOMICROBIOLOGICAL STUDYBACKGROUND AND OBJECTIVES:
Periodontitis is a multifactorial chronic inflammatory disease primarily of microbial origin, characterized by the destruction of the supporting structure of teeth. Most individuals require antibiotic therapy as an adjunct to mechanical debridement of biofilm for the management of the periodontal disease. This increase the risk of developing resistance and makes it difficult to use in other complicated diseases. Therefore, antimicrobial photodynamic therapy has been suggested as an alternative to eliminate the microbes in the subgingival region. Hence the present study aimed to evaluate the efficacy of photodynamic therapy with two different wavelength light sources ( LED 440-480 nm/ diodde laser- 810nm ) using erythrosine as phtosensitizer on chronic periodontitis.
Materials and methods:
In this randomized controlled clinical trial, 30
subjects were randomly assigned to three groups with 10 subjects in each groups
they are, group A- SRP, group B- SRP+ Visible light +Erythrosine, group C- SRP+
Diode laser + Erythrosine. Clinical parameters like Plaque index (PI), Gingival
index (GI), Papillary bleeding index (PBI), Probing pocket depth (PPD), and
Relative attachment level (RAL) were assessed and quantification of Porphyromonas gingivalis had done using
PCR. Subjects followed up for a period of 3
months. Statistical analysis carried out
using SPSS software version 20.
Results:
There was a significant reduction in PI, GI, PBI, PPD and RAL in all three groups at the end of third month. Compared to other two groups, Group C showed enhanced reduction in all clinical parameters. Primary outcome measures PPD, RAL had sown a greater improvement in both LED/Diode laser group compared to scaling and root planing alone. Both intra group and inter group comparison did not show a statistically significant difference in Porphyromonas gingivalis counts in all the three groups and between the groups.But
both intra group and inter group comparison did not show a statistically
significant difference in all the three groups and between the groups.
Interpretation and conclusion: Use of antimicrobial photodynamic therapy using visible light/Diode laser as
light source and erythrosine as photosensitizer enhanced the clinical outcomes
up to three months. Hence it is a valuable adjunct to SRP in the treatment of
chronic periodontitis. There is a great need to develop an evidence based
approach of the use of photodynamic therapy for the treatment of periodontitis.
Key words:
Photodynamic therapy, SRP, LED, Diode laser, Erythrosine, Porphyromonas gingivalis
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