Moderate to severe chronic periodontitis. k05.3
Conditions
Interventions
Intervention 1: Intervention group (1): scaling and root planning (SRP) plus systemic prescription of antibiotic Azithromycin
Azithromycin capsule: 250 mg (as Dihydrate), at mouth (Po), two times a day (bid) for three days
brand name: Zimexir (Exir Pharmaceutical Co.)
how to use: one hour before meals or two hours after a meal, one month after SRP. Intervention 2: Intervention group (2): SRP plus placement of the in-situ gel 1% Azithromycin (based on Carbopol) into
twice with an interval of 20 minutes, one month after SRP. Intervention 3: Control group (1): SRP plus systemic prescription of placebo capsule
placebo capsule: 250 mg, at mouth (Po), two times a day (bid) for three days
drug name: Zimexir (Exir Pharmaceutical Co.)
how to use: one hour before meals or two hours after a meal, one month after SRP. Intervention 4: Control group (2):SRP plus placement of the in-situ placebo gel (Carbopol) into the periodontal pocket
twice with an interval of 20 minutes, one month after SRP.
Treatment - Drugs
Placebo
Intervention group (1): scaling and root planning (SRP) plus systemic prescription of antibiotic Azithromycin
how to use: one hour before meals or two hours after a meal, one month after SRP
Intervention group (2): SRP plus placement of the in-situ gel 1% Azithromycin (based on Carbopol) into the periodontal pockets in single rooted teeth
twice with an interval of 20 minutes, one month after SRP
Control group (1): SRP plus systemic prescription of placebo capsule
Sponsors
Vice chancellor for research, Isfahan University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1) Patient's age over 18 years 2) At least 20 native teeth 3) With moderate to severe periodontitis. Exclusion criteria: 1) With Systemic diseases that affect periodontal conditions such as: diabetes, blood disorders and diseases of immune system 2) History of antibiotic therapy within the 4 months prior to study 3) History of Allergy to the macrolide group of antibiotics 4) Smoking 5) The lack of patient cooperation 6) History of periodontal treatment during the 4 months prior to the trial 7) Pregnancy 8) Lactating females 9) Patients treated with drugs such as: Anti-acid, Warfarin and Cyclisporine 10) Alcohol use.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Periodontal Pocket Depth. Timepoint: Before the intervention, one, two, three and four months after intervention. Method of measurement: color coded periodontal probe (Nordent).;Clinical Attachment Level. Timepoint: Before the intervention, one, two, three and four months after the intervention. Method of measurement: color coded periodontal probe (Nordent).;Periodontal disease index. Timepoint: Before the intervention, one, two, three and four months after the intervention. Method of measurement: color coded periodontal probe (Nordent), radiographic assessment, six Ramfjord selected teeth.;Papillary Bleeding Index. Timepoint: Before the intervention, one, two, three and four months after the intervention. Method of measurement: color coded periodontal probe (Nordent), (Muhlemann and Saxer) classification.;Porphyromonas gingivalis count. Timepoint: Before the intervention and three months after the intervention. Method of measurement: Real Time PCR - Primer Design kits.;Actinobacillus actinomycetemcomitans count. Timepoint: Before the intervention and three months after the intervention. Method of measurement: Real Time PCR - Primer Design kits. | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient Compliance. Timepoint: Before and four months after the intervention. Method of measurement: Visual Analogue Scale, AlignMap.;Plaque Index. Timepoint: Before the intervention, one, two, three and four months after the intervention. Method of measurement: Quigley-Hein, Turesky Modification.;Oral Hygiene Status. Timepoint: Before the intervention, one, two, three and four months after the intervention. Method of measurement: Simplified Oral Hygiene Index (Greene and Vermillion). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Mohammad Tavakoli
School of Dentistry, Isfahan University of Medical sciences
Outcome results
None listed