Actively Recruiting

Phase Not Applicable
Age: 16Years - 80Years
All Genders
Healthy Volunteers
ID06490679

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

Age: 16Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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)

Follow-up

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

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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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