Azithromycin with full mouth cleaning in pyorrhoea patients
- Conditions
- Aggressive periodontitis,
- Registration Number
- CTRI/2020/10/028692
- Lead Sponsor
- Sharad Pawar Dental College Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 30
- 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.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction in Probing Pocket depth (PPD) 3 and 6 months
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Sharad Pawar Dental College & Hospital
🇮🇳Wardha, MAHARASHTRA, India
Sharad Pawar Dental College & Hospital🇮🇳Wardha, MAHARASHTRA, IndiaDr chitrika SubhadarsaneePrincipal investigator08763072403chitrikasubhadarsanee403@gmail.com