Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06490679

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Periodontal Pocket Gingival Bleeding Gingival Diseases Gingival Hemorrhage Hemorrhage Mouth Diseases Oral Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

16 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Cairo University

Cairo, Egypt

Location status: Recruiting

About this study

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:

  • Disclosure of biofilm with erythrosine,
  • 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).
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 7 to 10 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.

Treatment and study plan

Hand and ultrasonic scalers and curettes

Procedure

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.

Primary outcomes

  1. Change in probing pocket depth

    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.

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

Secondary outcomes

  1. Bleeding On Probing

    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.

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

  2. Clinical Attachment Level

    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.

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

  3. Plaque index

    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

    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.

  4. Calculus index

    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.

    0 =absence of calculus

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

  5. Patient pain/discomfort

    Time frame: Postoperative Pain will be measured after the surgical procedure and 1 month, 3 months and 6 months after the intervention

    Postoperative Pain will be measured by using Visual Analogue Score (VAS Score), Minimum 0 = No pain, Maximum 10 = Worst Pain possible

  6. Patient satisfaction

    Time frame: Patient satisfaction will be measured after the surgical procedure and 1 month, 3 months and 6 months after the intervention

    Patient satisfaction will be measured using a survey.

  7. Cost effectiveness

    Time frame: At Baseline and 6 months post-op

    Ratio of cost of treatment and time of procedure against the gained clinical benefit

  8. Treatment time

    Time frame: Up to 6 months

    Time from picking-up the handpiece from the instrument holder to put the handpiece back.

  9. Number of healed pockets

    Time frame: 6 months post-op

    Pocket depth of <3.5 mm clinically measured by using UNC 15 periodontal probe from the gingival margin to the depth of the pocket.

Study contacts

Contact information is provided by the study sponsor or research team.

Mohammad Aldawod, Bachelor

CONTACT

[email protected]

00201065747906

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jul 8, 2024
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.