| CTRI Number |
CTRI/2020/03/024163 [Registered on: 23/03/2020] Trial Registered Prospectively |
| Last Modified On: |
10/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Antibiotics in Treatment of Chronic periodontitis |
|
Scientific Title of Study
|
Evaluation of Cefixime and Ofloxacin as an adjunct to scaling and root planing in the treatment of generalized chronic periodontitis - A clinicomicrobiological study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shreedevi Pashupatimath |
| Designation |
Post Graduate Student Department of periodontics |
| Affiliation |
Sri Hasanamba Dental college and hospital |
| Address |
Sri Hasanamba Dental college and hospital
Vidyanagar
Hasan
Sri Hasanamba Dental college and hospital
Vidyanagar
Hasan
Hassan
KARNATAKA
573202
India |
| Phone |
6364224430 |
| Fax |
|
| Email |
shreedentist6364@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Harsha MB |
| Designation |
Head of department |
| Affiliation |
Sri Hasanamba Dental college and hospital |
| Address |
Room number-5. Department of periodontics,Sri Hasanamba Dental college and hospital
Vidyanagar
Hasan
Room number-5. Department of periodontics,Sri Hasanamba Dental college and hospital
Vidyanagar
Hasan
Hassan
KARNATAKA
573202
India |
| Phone |
9845735007 |
| Fax |
|
| Email |
harshamb@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Harsha MB |
| Designation |
Head of department |
| Affiliation |
Sri Hasanamba Dental college and hospital |
| Address |
Room number-5. Department of periodontics,Sri Hasanamba Dental college and hospital
Vidyanagar
Hasan
Room number-5. Department of periodontics,Sri Hasanamba Dental college and hospital
Vidyanagar
Hasan
Hassan
KARNATAKA
573202
India |
| Phone |
9845735007 |
| Fax |
|
| Email |
harshamb@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Sri Hasanamba Dental College and Hospital
Vidyanagar
Hasan |
|
|
Primary Sponsor
|
| Name |
Sri Hasanamba Dental College |
| Address |
vidyanagar
Hassan
Karnataka 573202 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| SHREEDEVI |
Department of periodontics, sri hasanamba dental college and hospital. |
ROOM NO 5 SRI
HASANAMBA DENTAL
COLLEGE AND HOSPI
TALVIDYANAGAR,
HASSAN
Hassan
KARNATAKA
Hassan
KARNATAKA |
6364224430
shreedentist6364@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Periodontitis |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cefixime-Ofloxacin adjunct to Sclaing and root planing |
It is a combination drug of Cefixime(200mg) and ofloxacin(200mg). Both are antibiotics and will given twice daily for 5 days. |
| Comparator Agent |
Scaling and root planing alone |
Traditional therapy for this disease has involved elimination or suppression of sub-gingival microbial complexes by mechanical debridement such as scaling and root planning or surgical therapy. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.willingness to comply with the study protocol.
2.Systemically healthy individuals who are diagnosed with chronic periodontitis.
3.Subjects who are having more than 20 teeth. |
|
| ExclusionCriteria |
| Details |
1.Subjects who has undergone antibiotic therapy within 6 months prior the study.
2.Subjects who has allergy to any medications.
3.Pregnant and lactating females.
4.Subjects who were suffering from any systemic diseases and smokers.
Unable or not willing to comply with the study protocol.
Subjects who take any antibacterial drug within the study period. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction of clinical signs of periodontitis, reduction in bleeding on probing, clinical attachment level and periodontal pocket depth. |
0 and 90th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction of clinical signs of periodontitis, reduction in bleeding on probing, clinical attachment level and periodontal pocket depth. |
0 and 90th day |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
01/06/2020 |
| 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
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The Cefixime-Ofloxacin combination has no drug-drug interaction and is non-toxic as predicted through computational analysis. The administration of both these drugs in combination could be highly safe without cross reactions. This combination of Cefixime and Ofloxacin improves the efficiency of treatment by acting and inhibiting two different targets, with a short course of therapy. Cefixime-Ofloxacin combination showed synergy in the time kill assay and highest bactericidal activity at 24 hours compared to Cefixime or Ofloxacin alone. There are few studies regarding combination of Cefixime and Ofloxacin in treatment of periodontal diseases. Henceforth, the present study aims to evaluate the clinical and microbiological effect of Cefixime-Ofloxacin combination as an adjunct to scaling and root planing treatment in chronic periodontitis patients. |