Clinical trial NCT06351982: Treatment Of Shallow Periodontal Pockets 4-6mm Using AIRFLOW Prophylaxis Master Device With Erythritol vs Manual Scalers
Official title: Evaluation Of Nonsurgical Treatment Of Shallow Periodontal Pockets (4-6mm) Using AIRFLOW® Prophylaxis Master Device With Erythritol Powder vs Conventional Instrumentation: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Periodontal Pocket
Periodontitis
Gingival Diseases
Gingival Bleeding
Keywords: Air Abrasive
Erythritol
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-04-08
Enrollment: 46
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Patients will be selected from the outpatient clinic of the Oral Medicine and Periodontology Department, Faculty of Dentistry-Cairo University

* Screening of patients will continue until the target sample is achieved. (Consecutive sampling)
* Identifying and recruiting potential subjects will be achieved through patient database.

Preoperative evaluation:

- Clinical examination

Each patient will be examined to confirm that he/she met the eligibility criteria.

Age, gender and smoking status will be collected at baseline, along with a complete periodontal charting including 6-point pocket probing depth (PPD), clinical attachment level (CAL), plaque index (PI) according to a modified O'Leary index (O'Leary et al. 1972) measured on 6 surfaces per tooth (distobuccal, buccal, mesiobuccal, distolingual, lingual and mesiolingual), Calculus index according to (Ramfjord SP. 1967).

Periapical x-rays will be taken to confirm the diagnosis of periodontitis.

* Clinical photographs Clinical photographs will be taken at baseline, immediately after treatment and 6 months after treatment.
* Radiographic examination Periapicals radiographs will be taken at the site of interest at baseline and after 3 and 6 months.
* Surgical procedure

Test sites:

1. Disclosure of biofilm with erythrosine,
2. Removal of supragingival and subgingival (up to 4 mm) biofilm and stains with the use of AIRFLOW® Master Piezon® with AIRFLOW® PLUS powder (EMS- Dental, Nyon Switzerland).
3. Supra- and sub- gingival debridement by using the AIRFLOW® Master Piezon® device with Piezon NO PAIN® (EMS-Dental) technology.

Controls will receive conventional treatment with the combination of ultrasonic and hand instrumentation only. Pockets ≥4 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.

- Postoperative: At the end of the session, the patients will receive oral hygiene instructions on manual toothbrushing and the use of interdental cleaning devices.

Eligibility criteria: Inclusion Criteria:

* 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 4 to 6 mm.
* Cooperative patients able and willing to come for follow up appointments.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in probing pocket depth
timeFrame: 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:
measure: Bleeding On Probing
timeFrame: 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.
measure: Clinical Attachment Level
timeFrame: 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.
measure: Plaque index
timeFrame: 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
measure: Calculus index
timeFrame: 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.
measure: Patient pain/discomfort
timeFrame: Postoperative Pain will be measured after the surgical procedure and 1 month, 3 months and 6 months after the intervention
measure: Patient satisfaction
timeFrame: Patient satisfaction will be measured after the surgical procedure and 1 month, 3 months and 6 months after the intervention
measure: Cost effectiveness
timeFrame: At Baseline and 6 months post-op
measure: Treatment time
timeFrame: Up to 6 months
measure: Number of healed pockets
timeFrame: 6 months post-op
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry, Cairo University
Study officials:
affiliation: Cairo University
name: Hani El-Nahas, Professor
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Omnia Tawfik, Lecturer
role: STUDY_CHAIR
affiliation: Cairo University
name: Asim Al Ammour, Bachelor
role: PRINCIPAL_INVESTIGATOR
References: