| CTRI Number |
CTRI/2020/04/024565 [Registered on: 13/04/2020] Trial Registered Prospectively |
| Last Modified On: |
09/04/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry
Other (Specify) [Local Drug delivery using ultrasound] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Sonophoresis in the treatment of periodontitis. |
|
Scientific Title of Study
|
A Comparative study to evaluate the effectiveness of sonophoresis as an adjunct to non-surgical periodontal therapy. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dipika Inbasekaran |
| Designation |
Post Graduate student |
| Affiliation |
Saveetha Instiyute of medical and technical sciences |
| Address |
Saveetha Dental college,
162, Poonamalle High Road,
Chennai 600077,
Tamilnad, India
Department of periodontics,
Saveetha Instiyute of medical and technical sciences,
162, Poonamalle High Road,
Chennai 600077,
Tamilnad, India
Chennai
TAMIL NADU
600077
India |
| Phone |
8828486379 |
| Fax |
|
| Email |
dipikagopalnambi@gamil.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jayakumar |
| Designation |
Professor |
| Affiliation |
Saveetha Instiyute of medical and technical sciences, |
| Address |
Saveetha Dental college,
162, Poonamalle High Road,
Chennai 600077,
Tamilnad, India
Department of periodontics,
Saveetha Instiyute of medical and technical sciences,
162, Poonamalle High Road,
Chennai 600077,
Tamilnad, India
Chennai
TAMIL NADU
600077
India |
| Phone |
8828486379 |
| Fax |
|
| Email |
profndj@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dipika Inbasekaran |
| Designation |
Post Graduate student |
| Affiliation |
Saveetha Instiyute of medical and technical sciences, |
| Address |
Saveetha Dental college,
162, Poonamalle High Road,
Chennai 600077,
Tamilnad, India
Department of periodontics,
Saveetha Instiyute of medical and technical sciences,
162, Poonamalle High Road,
Chennai 600077,
Tamilnad, India
Chennai
TAMIL NADU
600077
India |
| Phone |
8828486379 |
| Fax |
|
| Email |
dipikagopalnambi@gamil.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dipika Inbasekaran |
| Address |
4D, Block 3,
VGN La Parisienne,
Noolambur,Mogappair West,
Chennai |
| Type of Sponsor |
Other [Dipika Inbasekaran ] |
|
|
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 |
| Dipika Inbasekaran |
Saveetha Dental college |
Department of Periodontics,
4th floor, clinic 25,
Saveetha Dental College,
Chennai
Chennai
TAMIL NADU |
8828486379
dipikagopalnambi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Dental College Scientific Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, (2) ICD-10 Condition: R898||Other abnormal findings in specimens from other organs, systems and tissues, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Non-surgical periodontal therapy |
Scale and root planing, sham sonophoresis |
| Intervention |
Sonophoresis |
2% Metronidazole gel sonophoresis, scaling and root planing |
| Comparator Agent |
Topical metronidazole |
2% topical metronidazole, scaling and root planing, sham sonophoresis |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Chronic periodontitis (AAP 1999 classification)
Probing depth of 5mm or more in more than 30% sites
Systemically healthy
No antibiotic useage in the last 6 months
Did not undergo periodontal therapy in the last 6 months
Non-pregnant, not lactating women
|
|
| ExclusionCriteria |
| Details |
Patients with systemic diseases
Patients allergic to metronidazole |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Periodontal probing depth in mm, MMP-8 levels in saliva using ELISA, bacterial colony forming units (CFU) |
baseline, 1 month post treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Clinical attachment level |
Baseline, 1 month post treatment |
| Plaque index |
Baseline and 1 month post treatment |
| Bleeding index |
Baseline, 1 month post treatment |
|
|
Target Sample Size
|
Total Sample Size="21"
Sample Size from India="21"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
20/04/2020 |
| 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="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
|
Periodontitis is a chronic inflammatory disease of multi factorial origin. 50 to 90% of adult population is affected by it, if untreated results in tooth loss. Non surgical periodontal therapy which involves scaling and root planing is considered as gold standard for the management of periodontal diseases. In the past many treatment modalities have been tried as an adjunct to non surgical periodontitis. Sonophoresis is the use of therapeutic ultra sound in trans dermal drug delivery. It is commonly used in physiotherapy for the management of chronic inflammatory conditions. However, its application in dentistry is limited to the management of tempero mandibular joint disorders. This study aims to asses the role of sonophoresis as an adjunct to non surgical periodontal therapy. |