| CTRI Number |
CTRI/2020/10/028692 [Registered on: 28/10/2020] Trial Registered Prospectively |
| Last Modified On: |
19/10/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Azithromycin with full mouth cleaning in pyorrhoea patients |
|
Scientific Title of Study
|
Azithromycin as an Adjunct to One- Stage Full-Mouth Disinfection in Stage III Grade B Unstable generalised periodontitis: A Randomized Controlled Clinical Trialâ€
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chitrika Subhadarsanee |
| Designation |
Postgraduate Student |
| Affiliation |
Sharad pawar dental college |
| Address |
Department of periodontology and implantology, ROOM no-003 sharad pawar dental college,DMIMS,sawangi (Meghe)
Sharad Pawar Dental College,sawangi(Meghe),wardha, MAHARASHTRA
442001
India
Wardha
MAHARASHTRA
442001
India |
| Phone |
08763072403 |
| Fax |
|
| Email |
chitrikasubhadarsanee403@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pavan Bajaj |
| Designation |
Reader |
| Affiliation |
Sharad pawar dental college |
| Address |
Department of periodontology and implantology, ROOM no-003 sharad pawar dental college,DMIMS,sawangi (Meghe)
Sharad Pawar Dental College,sawangi(Meghe),wardha,MAHARASHTRA
442001
India
Wardha
MAHARASHTRA
442001
India |
| Phone |
08412045019 |
| Fax |
|
| Email |
pavbajaj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pavan Bajaj |
| Designation |
Reader |
| Affiliation |
Sharad pawar dental college |
| Address |
Department of periodontology and implantology, ROOM no-003 sharad pawar dental college,DMIMS,sawangi (Meghe)
Sharad Pawar Dental College,sawangi(Meghe),wardha, MAHARASHTRA
442001
India
Wardha
MAHARASHTRA
442001
India |
| Phone |
08412045019 |
| Fax |
|
| Email |
pavbajaj@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sharad Pawar Dental College Hospital |
| Address |
Sawwangi(Meghe),Wardha |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Dr chitrika Subhadarsanee |
Sharad Pawar Dental College & Hospital |
Department of Periodontics,Room Number-003,sawangi
Wardha
MAHARASHTRA |
08763072403
chitrikasubhadarsanee403@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K052||Aggressive periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Full mouth disinfection (chlorhexidine gel and mouthwash) |
15 subjects will be treated with full mouth disinfection (chlorhexidine gel and mouthwash) |
| Intervention |
Full mouth disinfection (chlorhexidine gel and mouthwash) with azithromycin |
15 subjects will be treated with full mouth disinfection (chlorhexidine gel and mouthwash) with azithromycin 500mg once daily for 7 days |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1.Generalized interproximal attachment loss involving at least three teeth apart from molars and ï¬rst incisors.
2.Amount of microbial deposits inconsistent with the severity of periodontal tissue destruction.
3.Patients with a minimum number of 20 teeth.
4.Patients with clinical attachment loss and probing depths (PDs) ≥ 4 mm at 2 sites of a minimum of 12 teeth
5.The patients included in the study should be systemically healthy.
6.Patients with no history of periodontal therapy in the preceding 6 months or under any antibiotic therapy.
7.Patients motivated to have the therapy and willing to complete the follow-up.
|
|
| ExclusionCriteria |
| Details |
1.Patients with a known or suspected allergy
2.Patients who have undergone periodontal therapy in the last 6 months.
3.Patients with any systemic disorder affecting periodontal health.
4.Patients with infectious conditions other than periodontitis.
5.Chronic alcoholics
6.Patients consuming tobacco in any form and smokers.
7.Immuno-compromised and systemically-unhealthy patients.
8.Pregnant or lactating females.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in Probing Pocket depth (PPD) |
3 and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in Bleeding on Probing (BOP), Gain in Clinical attachment level (CAL) |
Reduction in Bleeding on Probing (BOP), Gain in Clinical attachment level (CAL) at 3 and 6 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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/ Phase 2 |
|
Date of First Enrollment (India)
|
02/11/2020 |
| 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="1"
Months="6"
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)?
Response - NO
|
|
Brief Summary
|
The aim of this randomized clinical trial was to evaluate whether the adjunctive use of systemic azithromycin improves clinical outcomes in the treatment of Stage III Grade B Unstable generalised periodontitis. Sample size calculation- Sample size was calculated using the data of the previous studies Gazal Jain et al 2018 by using OpenEpi, version 3,open source calculator—SSMean(calculation shown at the end).The result of the calculation is 28, so a around figure of 30 sample will be undertaken for the study. Inclusion criteria- 1.Generalized interproximal attachment loss involving at least three teeth apart from molars and ï¬rst incisors. 2.Amount of microbial deposits inconsistent with the severity of periodontal tissue destruction. 3.Patients with a minimum number of 20 teeth. 4.Patients with clinical attachment loss and probing depths (PDs) ≥ 4 mm at 2 sites of a minimum of 12 teeth 5.The patients included in the study should be systemically healthy. 6.Patients with no history of periodontal therapy in the preceding 6 months or under any antibiotic therapy. 7.Patients motivated to have the therapy and willing to complete the follow-up. Exclusion criteria- 1.Patients with a known or suspected allergy 2.Patients who have undergone periodontal therapy in the last 6 months. 3.Patients with any systemic disorder affecting periodontal health. 4.Patients with infectious conditions other than periodontitis. 5.Chronic alcoholics 6.Patients consuming tobacco in any form and smokers. 7.Immuno-compromised and systemically-unhealthy patients. 8.Pregnant or lactating females. Material and method- There will be two groups in this study i. Intervantion group ii. Comparator agent. In intervantion group, 15 subjects will be treated with full mouth disinfection (chlorhexidine gel and mouthwash). In comparator agent, 15 subjects will be treated with full mouth disinfection (chlorhexidine gel and mouthwash) with systemic azithromycin 500mg once daily for 7 days.
|