Actively Recruiting
Evaluation of Nonsurgical Treatment of Deep Periodontal Pockets (7-10mm) Using AIRFLOW4 Prophylaxis Master Device with Erythritol Powder versus Conventional Instrumentation: A Randomized Controlled Clinical Trial
Led by Cairo University · Updated on 2024-08-09
46
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Periodontitis is a chronic inflammatory condition that damages the tissues supporting the teeth, often leading to tooth loss. This trial is evaluating the effects of two nonsurgical treatments for deep periodontal pockets measuring 7 to 10 mm. The study compares the use of the AIRFLOW4 Prophylaxis Master device with erythritol powder against conventional hand and ultrasonic instruments, assessing various clinical and patient-centered outcomes. Participants will receive either treatment with the AIRFLOW device that removes biofilm and stains both above and below the gum line using a special erythritol powder and advanced piezo technology, or conventional treatment using a combination of ultrasonic and hand scaling tools. The AIRFLOW treatment includes biofilm disclosure and no-pain technology. Conventional treatment involves subgingival debridement with piezo devices and hand curettes until the teeth surfaces are clean. All patients receive oral hygiene instructions after treatment. During the study, participants will undergo clinical examinations including pocket depth, attachment level, plaque and calculus indexes, bleeding on probing, and pain and satisfaction assessments at baseline and multiple follow-up visits up to 6 months. Radiographs and photographs will be taken at specific time points. The primary outcome is change in probing pocket depth, and other outcomes include patient comfort, treatment time, cost-effectiveness, and number of healed pockets. The total study duration per participant is 6 months with regular follow-ups.
CONDITIONS
Brief Title
Evaluation Of Nonsurgical Treatment Of Deep Periodontal Pockets (7-10mm) Using AIRFLOW® Prophylaxis Master Device With Erythritol Powder vs Conventional Instrumentation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Systemically healthy patients
- Age between 16 and 80 years
- Have at least 20 teeth
- Diagnosed with periodontitis with at least one pocket measuring 7 to 10 mm
- Able and willing to attend follow-up visits
You will not qualify if you...
- Pregnant or breastfeeding females
- Patients with systemic diseases such as diabetes
- Patients with severe or unstable respiratory infections, chronic bronchitis, or asthma
- Patients with severe inflammation or osteonecrosis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single treatment session
Participants receive nonsurgical treatment for deep periodontal pockets using either the AIRFLOW® Prophylaxis Master Device with erythritol powder or conventional hand and ultrasonic instrumentation.
1 treatment visit (in-person)
Duration - 6 months
Participants attend follow-up visits to assess periodontal health and treatment outcomes including pocket depth, bleeding on probing, attachment level, plaque and calculus indices, pain, satisfaction, and healing.
Visits at 1 month, 3 months, and 6 months post-treatment (in-person)
Trial Site Locations
Total: 1 location
1
Faculty of Dentistry, Cairo University
Cairo, Egypt
Actively Recruiting
Research Team
M
Mohammad Aldawod, Bachelor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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