| CTRI Number |
CTRI/2024/04/066213 [Registered on: 24/04/2024] Trial Registered Prospectively |
| Last Modified On: |
15/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To assess the efficacy of Metronidazole+Amoxicillin VS Doxycycline VS Azithromycin VS Amoxicillin as an adjunct to Scaling and Root planing (SRP) in the treatment of chronic periodontitis.
|
|
Scientific Title of Study
|
EFFECTIVENESS OF SYSTEMIC ADMINISTRATION OF 4 diffrent antibiotics IN CHRONIC PERIODONTITIS - A RANDOMISED CONTROLLED CLINICAL TRIAL
|
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
vazeeha afrin syed |
| Designation |
post graduate |
| Affiliation |
saveetha dental college and hospital,SIMATS UNIVERSITY |
| Address |
department of periodontology, clinic 25, 4 th floor,no.162, ponamallee high road, vellapanchavadi, chennai 600077
kancheepuram
Chennai
TAMIL NADU
600077
India |
| Phone |
09618696972 |
| Fax |
|
| Email |
152205001.sdc@saveetha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
vazeeha afrin syed |
| Designation |
post graduate |
| Affiliation |
saveetha dental college and hospital,SIMATS UNIVERSITY |
| Address |
Department of periodontology, clinic 25, 4th floor, no.162, poonamallee high road, vellapanchavadi,
Chennai
TAMIL NADU
600077
India |
| Phone |
09618696972 |
| Fax |
|
| Email |
152205001.sdc@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
vazeeha afrin syed |
| Designation |
post graduate |
| Affiliation |
saveetha dental college and hospital,SIMATS UNIVERSITY |
| Address |
Department of periodontology, clinic 25, 4th floor, no.162, poonamallee high road, vellapanchavadi,
Chennai
TAMIL NADU
600077
India |
| Phone |
09618696972 |
| Fax |
|
| Email |
152205001.sdc@saveetha.com |
|
|
Source of Monetary or Material Support
|
| Saveetha dental college and hospital , SIMATS university clinic 25, 4 th floor, no 162, poonamalle high road, vellapanchavadi, chennai 600077 |
|
|
Primary Sponsor
|
| Name |
saveetha dental college and hospital |
| Address |
saveetha dental college and hospital Department of periodontology , clinic 25, 4th floor, 162, ponamallee high road,vellapanchavadi, chennai 600077 |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| vazeeha afrin syed |
Department of periodontology clinic 25, 4th floor, No 162, Ponamallee high road, vellapanchavadi Chennai 600077 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr syed vazeeha afrin |
saveetha dental college and hospital |
Department of periodontology, clinic 25, 4th floor, no.162, poonamallee high road, vellapanchavadi,600077
Chennai
TAMIL NADU |
09618696972
152205001.sdc@saveetha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| saveetha dental college-institutional human ethical committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patients with chronic periodontitis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
amoxicillin and metronidazole vs Doxycycline vs Azithromycin vs Amoxicillin as adjunct to scaling and root planing |
Amoxicillin and Metronidazole 500 mg and 400 mg once daily respectively for
7days in 10 induviuals vs Doxycycline 200 mg once daily as loading dose and 100 mg once daily for 7 days in 10 induviuals vs Azithromycin 500 mg once daily for 1 day and 250 mg for 5 days vs Amoxicillin 500 mg twice daily for 7 days after scaling and root planing.
|
| Comparator Agent |
scaling and root planing |
scaling and root planing in 10 patients . |
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
50.00 Day(s) |
| Gender |
Both |
| Details |
Adults aged from 18 years to 50 years.
- Stage ∣ and Stage ∥ periodontitis based on criteria established by the American Academy of Periodontology.
- Presence of at least 6 teeth with probing depth ≥ [4 mm] and clinical attachment loss ≥ [2 mm].
|
|
| ExclusionCriteria |
| Details |
History of systemic antibiotic use within the past [3 months].
- Pregnant or lactating individuals.
- Known allergies to the study antibiotics.
- Severe systemic diseases affecting periodontal health.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
bleeding on probing
pocket depth
clinical attachment levels |
baseline, 2 weeks and 1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
plaque index
gingival index |
baseline
2 weeks
1 month |
|
|
Target Sample Size
|
Total Sample Size="55"
Sample Size from India="55"
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)
|
30/04/2024 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Chronic periodontitis, a prevalent inflammatory condition affecting periodontal tissues, necessitates multifaceted therapeutic approaches. While mechanical debridement remains fundamental, the adjunctive use of systemic antibiotics has garnered attention for its potential to enhance treatment outcomes. This randomized controlled clinical trial addresses a critical knowledge gap by systematically evaluating the effectiveness of four antibiotic regimens: amoxicillin and metronidazole, doxycycline, azithromycin, and amoxicillin alone in the management of chronic periodontitis.
|