Evaluation Of Nonsurgical Treatment Of Deep Periodontal Pockets (7-10mm) Using AIRFLOW® Prophylaxis Master Device With Erythritol Powder vs Conventional Instrumentation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-80
SponsorCairo University

About this trial

Periodontitis is a chronic condition associated with the inflammatory destruction of the periodontal tissues ultimately leading to tooth loss. Clinically, it is identified by key features such as clinical attachment loss (CAL), bleeding upon probing (BOP), and an increase in probing pocket depth (PPD), and/or gingival recession. Periodontitis is mediated by polymicrobial dysbiosis with keystone pathogens affecting the virulence of the entire biofilm community. The removal of this biofilm and its retention factors is the ultimate goal of clinical treatment and oral measures applied. The elimination of the biofilm has traditionally been achieved with the use of either hand instruments or power driven devices. Promoting periodontal health or diminishing bacterial presence and calculus buildup on teeth can be accomplished with the same efficacy whether using manual scalers and curettes or ultrasonic scaling instruments. Both hand and ultrasonic instruments are characterized by being time- consuming and requiring technical skill, often causing patient discomfort and post-treatment pain, including hypersensitivity resulting from the loss of hard tissue when scaling the tooth surface. Ultrasonic instruments tend to leave a rougher surface behind compared to hand instruments. While effective the current techniques all have their disadvantages. The aim of this study is to evaluate changes in probing depth clinically, Bleeding on probing, Clinical attachment level, Plaque index, Calculus index, Patient pain/discomfort, Patient satisfaction, Cost effectiveness, Treatment time and Number of pockets closed after using AIRFLOW® Prophylaxis Master device with erythritol powder.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Systemically healthy patients.

Patients with an age range between 16 to 80 years.

Patients have a minimum of 20 teeth.

Periodontitis patients with at least one residual pocket with a probing depth ranging from 7 to 10 mm.

Disqualifiers

Pregnant and lactation females.

Patients reporting systemic conditions (eg: diabetes).

Patients with severe or unstable upper respiratory tract infections, chronic bronchitis/asthma.

Patients with severe inflammation and/or osteonecrosis.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Hand and ultrasonic scalers and curettes

    Procedure/Surgery

    Combination of ultrasonic and hand instrumentation only. Pockets ≥7 mm will be subgingivally debrided using the piezo device according to manufacturer's instructions, and hand curettes will be used until the operator considers the surfaces to be sufficiently clean and free of deposits.

  • Electro Medical Systems AIRFLOW® Prophylaxis Master Device

    Device

    (a) Disclosure of biofilm with erythrosine, (b) Removal of supragingival and subgingival (up to 10 mm) biofilm and stains with the use of AIRFLOW® Master Piezon® with AIRFLOW® PLUS powder (EMS-Dental, Nyon Switzerland). (c) Supra- and sub-gingival debridement by using the AIRFLOW® Master Piezon® device with Piezon NO PAIN® (EMS-Dental) technology.

Treatment groups

46 Participants
are divided into 2 treatment groups
Group A: Hand and ultrasonic scalers and curettesExperimental treatment 1 intervention
Group B: Electro Medical Systems AIRFLOW® Prophylaxis Master Device With Erythritol PowderActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in probing pocket depth

The PPD will be clinically measured by using UNC 15 periodontal probe from the gingival margin to the depth of the pocket.

Time frame
PPD will be taken at baseline, 1 month, 3 months and 6months after the intervention during the follow-up period and will be done by a single calibrated examiner.

Secondary outcomes

1

Bleeding On Probing

The BoP will be clinically measured by using UNC 15 periodontal probe from the CEJ to the gingival margin.

Time frame
BoP will be taken at baseline, 1 month, 3 months and 6months after the intervention during the follow-up period and will be done by a single calibrated examiner.
2

Clinical Attachment Level

The CAL will be clinically measured using UNC 15 periodontal probe from the cemento-enamel junction (CEJ) to the depth of defect.

Time frame
CAL gain will be taken at baseline, 3 months and 6 months after the intervention during the follow-up period and will be done by a single calibrated examiner.
3

Plaque index

The PI will be evaluated by using modified O'Leary index teeth are stained with a disclosing solution, presence of plaque is scored on a dichotomous variable and the final score per individual is the sum of the plaque scores divided by the number of surfaces examined.

Time frame
PI will be measured baseline, 1 month, 3 months and 6 months after the intervention during the follow-up period and will be done by a single calibrated examiner
4

Calculus index

0 =absence of calculus 1. =supragingival calculus extending only slightly below the free gingival margin (not more than 1 mm.) 2. = moderate amount of supra and subgingival calculus or subgingival calculus alone 3. = an abundance of supra and subgingival calculus

Time frame
CI will be taken at baseline, 1 month, 3 months and 6months after the intervention during the follow-up period and will be done by a single calibrated examiner.

Other outcomes

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