| CTRI Number |
CTRI/2019/12/022223 [Registered on: 03/12/2019] Trial Registered Prospectively |
| Last Modified On: |
26/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Medical Device Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study comparing the effects of light therapy and an antibiotic-Minocycline gel on the levels of a certain microorganism present in patients with gum diseases |
|
Scientific Title of Study
|
A RANDOMIZED CONTROL TRIAL COMPARING THE EFFICACY OF MINOCYCLINE AS LOCAL DRUG DELIVERY AND DIODE LASER DEBRIDEMENT ON THE LEVELS OF PORPHYROMONAS GINGIVALIS IN CHRONIC PERIODONTITIS:A CLINICO MICROBIOLOGICAL STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrSneha Fal Dessai |
| Designation |
Post graduate student |
| Affiliation |
Coorg Institute Of Dental Sciences |
| Address |
Department Of Periodontics
Coorg Institute Of Dental Sciences
KK Campus
Coorg District Virajpet
Kodagu KARNATAKA 571218 India |
| Phone |
9483925940 |
| Fax |
|
| Email |
snehafaldessai9@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DrKrishnaraj GN |
| Designation |
Professor |
| Affiliation |
Coorg Institute Of Dental Sciences |
| Address |
Department Of Periodontics
Coorg Institute Of Dental Sciences
KK Campus
Coorg District Virajpet
Kodagu KARNATAKA 571218 India |
| Phone |
7259456314 |
| Fax |
|
| Email |
dentalsolutions@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DrKrishnaraj GN |
| Designation |
Professor |
| Affiliation |
Coorg Institute Of Dental Sciences |
| Address |
Department Of Periodontics
Coorg Institute Of Dental Sciences
KK Campus
Coorg District Virajpet
Kodagu KARNATAKA 571218 India |
| Phone |
7259456314 |
| Fax |
|
| Email |
dentalsolutions@gmail.com |
|
|
Source of Monetary or Material Support
|
| Coorg Institute Of Dental Sciences
Coorg Instituite of Dental Sciences,
K.K.Campus, Maggula Village,
Virajpet
Coorg District
Karnataka
Pin: 571218 |
|
|
Primary Sponsor
|
| Name |
Dr Sneha Fal Dessai |
| Address |
Department of Periodontics
Coorg Institute of Dental Sciences
KK Campus
Maggula village
Virajpet
Kodagu District
Karnataka 571218 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sneha Fal Dessai |
Coorg Institute of Dental Sciences |
Department Of Periodontics and Implantology,Department No-4
Kodagu KARNATAKA |
9483925940
snehafaldessai9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board Coorg Institute Of Dental Science |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Chronic Generalised Periodontitis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Diode LASER therapy |
One quadrant will receive the laser therapy using 980 nm Diode LASER on the 1st, 3rd and the 7th day after scaling and root planing. |
| Intervention |
Minocycline |
2% Minocycline Gel application after scaling and root planing in the other quadrant.The gel application will be repeated at two and four weeks after scaling and root planing in the test sites,according to the manufacturer’s instructions. |
| Comparator Agent |
Scaling and Root Planing |
Debridement of supragingival and subgingival calculus |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with probing depth of greater than 4mm
Patients suffering from chronic periodontitis without any medical history.
No history of smoking
No periodontal treatment within the previous 6 month
|
|
| ExclusionCriteria |
| Details |
Pregnant ladies, lactating mothers were excluded from the study.
Patients on anti-inflammatory and steroid therapy within the last three months.
History of any systemic diseases.
Use of hormonal contraceptives.
|
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
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Method of Concealment
|
|
|
Blinding/Masking
|
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Primary Outcome
|
| Outcome |
TimePoints |
| Expecting reduction in the number of levels of Porphyromonas Gingivalis along with reduction in Sulcus Bleeding Index,Plaque Index,Probing Pocket depth and Clinical Attachment Levels. |
Baseline and Three Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Gradual reduction in the number of levels of Porphyromonas Gingivalis along with reduction in Sulcus Bleeding Index,Plaque Index,Probing Pocket depth and Clinical Attachment Levels. |
Baseline and Three months |
|
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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 1 |
|
Date of First Enrollment (India)
|
07/12/2019 |
| 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="0" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
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 the supporting tissues of
the teeth, progressive attachment loss, and bone loss.The role of Porphyromonas
gingivalis is well established in the development and pathogenesis of
periodontitis.Minocycline acts by interfering with
protein synthesis in the bacterial cell wall along with its anti-collagenase
effect.Diode laser accelerates wound
healing, promotes angiogenesis and also augments growth factor release. This
Randomized Clinical Trial protocol is designed as a split mouth single masked
clinical trial of 12 weeks duration simulating the treatment flow of
conventional periodontal therapy. After qualifying for the study, 15 patients
age ranging from 30-65 years will be enrolled and 4 clinical variables along
with the microbiological samples will be evaluated at the baseline by one
examiner who will be recording all measurements in a single blind design. This will include Sulcus Bleeding Index (SBI)Plaque
Index (PI), Probing Pocket depth (PPD), Clinical Attachment Level (CAL)
along with subgingival plaque samples for Porphyromonas Gingivalis. Full mouth scaling and root planing will be
performed at baseline appointment following initial examination.One
quadrant will receive the diode laser therapy on the 1st, 3rd and
the 7th day after scaling and root planing. The other will receive
minocycline gel application after scaling and root planing and the gel
application will be repeated at two and four weeks in the test sites, according
to the manufacturer’s instructions.Subgingival plaque samples will be collected at
baseline, and at three month intervals. Sterile periodontal curette will be
used for collection of subgingival plaque samples.For
sample collection the teeth surfaces will be dried with sterile gauze to avoid
contamination by saliva. Sub gingival plaque samples will be collected from deepest
periodontal pockets using sterile periodontal curette and assessed for the
microbial load using Polymerase chain reaction This study is done to compare the
efficacy of minocycline as local drug delivery and diode laser debridement and
also to evaluate the levels of Porphromonasgingivalisin chronic periodontitis
patients.
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