None listed
Conditions
Brief summary
Test null hypothesis: there is no difference in pocket depth reduction, between one stage full mouth disinfection with and without the use of adjuvant systemic antimicrobial therapy (Azithromycin) against the alternative hypothesis of a difference. AIM :The purpose of this study will be to evaluate the use of systemically administered azithromycin as an adjuvant to OSFD (one stage full mouth disinfection) in the treatment of chronic periodontitis through clinical and microbiological periodontal parameters at baseline, 90 post therapy. SIGNIFICANCE OF THE RESEARCH - Although general consensus favours the use of systemic antibiotics in conjunction with conventional staged debridement therapy in treatment of advanced periodontal diseases, there are limited studies where systemic antimicrobials were used in conjunction with one stage full mouth disinfection. To the best of our knowledge, there are no studies that evaluated clinically or microbiologically the use of azithromycin as an adjuvant to the OSFMD. This trial could help provide evidence based guidelines for the use of azithromycin in conjunction with OSFMD in treatment of patients with chronic periodontitis.
Interventions
Dentist will be delivering the treatment (nonsurgical instrumention of teeth) which is the conventional form o therapy for chronic periodontitis
study will be conducted in 7 sessions, ( treatment will be in 2 sessions) over 6 months followup at the Oral health centre of WA
Arm 1: One Stage Full Mouth Disinfection protocol (Nonsurgical periodontal scaling and root planing+ use of mouthwash) + placebo x 3 days orally
Arm2; One Stage Full Mouth Disinfection protocol(Non Surgical periodontal scal
Dentist will be delivering the treatment (nonsurgical instrumention of teeth) which is the conventional form o therapy for chronic periodontitis study will be conducted in 7 sessions, ( treatment will be in 2 sessions) over 6 months followup at the Oral health centre of WA Arm 1: One Stage Full Mouth Disinfection protocol (Nonsurgical periodontal scaling and root planing+ use of mouthwash) + placebo x 3 days orally Arm2; One Stage Full Mouth Disinfection protocol(Non Surgical periodontal scaling and root planing + use of mouthwashes ) +systemic antimicrobial (Azithromycin, 5oomg x 3 days orally) Treatment session 1) Clinical charting ( microbiological , saliva sampling using paper points) completed by Specialist periodontist at least 5 years ( 90 min session ) 2) Oral hygiene instructions and plaque score ( 30 minutes session ) completed by experienced hygienist ( 5years) 3) Treatment session ( 90 - 120 minute session ) nonsurgical debridement of upper and lower left side of the mouth , use of mouthwash during session and to be used daily( 2 times, morning and night) for following 2 weeks . Antimicrobial is provided to for start of use following session & for following 3 days( 1 tablet a day for 3 days) - compliance sheet will be provided to the patient to tick each use of mouthwash and medication..Compliance sheet needs to be returned in 2 weeks review., empty medication bottles and empty mouthwash containers to be returned as well Session 4( 90 -120 minutes) - Nonsurgical debridement of the upper and lower right side of mouth .In chair use of mouthwash during session as well. Session 3 and Session 4 will be completed by a periodontics registrar( General dentist with 5 years experience in training for specialization) they will be both scheduled within 24 hours, as in 2 consecutive days Session 5( Review in 2 weeks post therapy) , return medication pack , compliance sheet , and questionnaires to be filled by patient ( 20 minutes by Periodontics registrar ) Session 6 ( 3 months post therapy ) (90 minutes) Clinical charting and microbiological sampling of saliva using paper points( performed by same specialist who previously did the charting ) Mouth wash used is 0.2 % Chlorhexidine mouthwash which is commonly used in periodontal therapy. Its available for non prescription used and has very effective antimicrobial qualities , to be used rinsing twice/ day morning and night 30 ml for 1 minute
Sponsors
University of Western Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
25 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1) Healthy patients (ASA I and II classification) 2) Presence of 12 scorable teeth (not including third molars and teeth with orthodontic appliances, bridges, crowns, or implants) 3) Diagnosis of chronic periodontitis with the presence of at least four teeth with a probing depth (PPD) 5 mm, periodontal attachment loss (AL) 3 mm, and radiographic evidence of bone loss
Exclusion criteria
Uncontrolled systemic illnesses (i.e. diabetes mellitus, cancer, human Immunodeficiency syndrome, bone metabolic diseases or disorders that compromise wound healing, radiation, or immunosuppressive therapy) - Pregnancy or lactation - Confirmed or suspected intolerance to azithromycin, macrolides or Chlorhexidine mouthwash - Regular use of antibiotics or anti-inflammatory drugs within 3 months preceding the start of the study - Regular use (twice a day) of chlorhexdine mouthwash or regular use within 3 months before study entry - Periodontal therapy including dental scaling and root planing procedures in the 12 months preceding the start of the study - Antibiotic prophylaxis required for periodontal clinical examination
Outcome results
None listed