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GingivitisNCT03863093

Evaluation of Air Polishing With Ultrasonic Debridement in the Treatment of Initial Periodontal Pockets

A study testing Electro Medical Systems AIRFLOW® and Electro Medical Systems Piezo in people with Gingivitis, run by Syrian Private University at 1 site in Syria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Clinical evaluation of using erythritol powder as air polishing with ultrasonic scaling and root planing in the treatment of initial periodontal pockets. This trial will be split-mouth design, in which each patient will receive traditional treatment (ultrasonic mechanical therapy and polishing) in one side, while the… Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Gingivitis
What is being tested?
Electro Medical Systems AIRFLOW® and Electro Medical Systems Piezo
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
1 siteSyria
Study dates
9 Feb 2019to 30 Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Patients are in generally good health
  • Patients are from both gender and their age is between 18 to 60 years.
  • Patients have a minimum of 20 teeth
  • The patient is a non-smoker (less than 5 cigarettes per day) and non-alcoholic.
  • Female participants must not be pregnant or breastfeeding (lactation).
  • the absence of severe oral habits
  • the presence of at least one residual pocket with pocket depth >4 mm with interdental sites with a probing depth of 3 to 5 mm without furcation involvement or subgingival restorations.
  • A sign informed consent from participation and permission to use obtained data for research purposes.

Who cannot join

  • Bruxism
  • Allergy to glycine or chlorhexidine;
  • systemic medical conditions requiring antibiotic prophylaxis (for endocarditis prophylaxis) and anti-inflammatory drugs before dental procedures;
  • active systemic infectious disease;
  • major systemic illnesses (diabetes mellitus, cancer, immunodeficiency virus, bone metabolic diseases or disorders that compromise wound healing, radiation or immunosuppressive therapy, neutropenia, agranulocytosis, or bleeding disorders.
  • chronic high dose steroid therapy
Show all 15Show fewer
  • Patients are undergone to radiotherapy or chemotherapy before or during the study period.
  • actively smoking more than five cigarettes per day;
  • signs of generalized severe periodontitis;
  • having received periodontal maintenance within 3 months before baseline
  • patients treated with antibiotics 6 months prior to the study
  • chronic bronchitis and asthma
  • compromised immune system
  • hypersensitivity to sugar alcohols.
  • any physical limitations or restrictions that might preclude normal oral hygiene procedures.

Trial locations and contacts

1 site in 1 country.

Syria1 site

  • Syrian Private University

    Damascus

Other trials in Syria

About this study

Official title: Clinical Outcomes of Using Erythritol Powder by Means of Air Polishing With Ultrasonic Debridement in the Treatment of Initial Periodontal Pockets in Hand of Dental Students: A Split-mouth, Randomized, Comparative, Controlled Study

Clinical evaluation of using erythritol powder as air polishing with ultrasonic scaling and root planing in the treatment of initial periodontal pockets. This trial will be split-mouth design, in which each patient will receive traditional treatment (ultrasonic mechanical therapy and polishing) in one side, while the contralateral two quadrants of the jaws will be treated with erythritol powder by means of air polishing and ultrasonic scaling and root planing.

Read the detailed description

The aim of the study is to evaluate the usage of erythritol powder by means of air polishing in hand of undergraduate dental students as a single way to remove biofilm and the adjunctive application of ultrasonic piezo afterward for calculus removal and root planing only in the treatment of initial periodontal pockets.

The sample size will be 15 patients. Initially, oral hygiene instructions with scaling and root planing will consist of the treatment phase. Each subject will be informed comprehensively about oral hygiene instructions using disclosing solution (such as erythrosine) and hand mirror. The participant will be shown modified bass technique and the proper usage of dental floss and appropriate interdental brushes.

The control side will be treated with supra- and subgingival ultrasonic piezo scalers then supragingival polishing with rubber cup and a special fluoride containing paste as a traditional way of removal of plaque and calculus, while the test side, will be confined to erythritol powder by means of air polishing as the only way to remove ultrasonic piezo scalers.

At the end of treatment, hand instruments may be used to ensure the smoothness 0f the teeth surfaces.

Clinical measurements will be performed at baseline and at 2 weeks, 4 and 6 weeks for the plaque index and gingival indices, whereas probing will be performed only after 6 weeks.

Conditions
Gingivitis
Being tested
Electro Medical Systems AIRFLOW®, Electro Medical Systems Piezo
Medical subject headings
Gingivitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Electro Medical Systems AIRFLOW®Device

    An erythritol powder will be used by Electro Medical Systems AIRFLOW® and then Electro Medical Systems Piezo will be used for supra- and subgingival ultrasonic instrumentation

  • Electro Medical Systems PiezoDevice

    Electro Medical Systems Piezo will be used for supra- and subgingival ultrasonic instrumentation

Study groups in NCT03863093
Study groupRoleWhat they receive
An erythritol powderExperimentalAn erythritol powder will be used by Electro Medical Systems AIRFLOW® and then Electro Medical Systems Piezo will be used for supra- and subgingival ultrasonic instrumentation
Receives: Device: Electro Medical Systems AIRFLOW®; Device: Electro Medical Systems Piezo
ultrasonic instrumentationActive comparatorElectro Medical Systems Piezo will be used for supra- and subgingival ultrasonic instrumentation
Receives: Device: Electro Medical Systems Piezo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. change in the papillary bleeding index

    Probing is performed in all four quadrants. A quadrant 1 is probed only from the oral aspect, quadrant 2 from the facial, 3 again from oral, and from the facial in quadrant 4

    Grade 1-Point: 20-30 seconds after probing the mesial and distal sulci with a periodontal probe, a single bleeding point is observed.

    Grade 2-Line/Points: A fine line of blood or several bleeding points become visible at the gingival margin.

    Grade 3-Triangle: The interdental triangle becomes more or less filled with blood.

    Grade 4-Drops: Profuse bleeding. Immediately after probing, blood flows into the interdental area to cover portions of the tooth and/or gingiva.

    Calculation:

    Papillary bleeding index= Bleeding Number/ Number of sites measured

    Measured: baseline, 2-weeks, 4-weeks, 6-weeks after the treatment

  2. change in the percentage of study sites positive for bleeding on probing

    All four surfaces of all teeth are assessed with regard to whether probing elicits bleeding (+) or not (-). The severity of gingivitis is expressed as a percentage.

    • no bleeding upon probing (not recorded)

    + bleeding upon probing

    Calculation:

    Bleeding on probing= Number of bleeding sites x100 / Number of sites evaluated

    Measured: baseline, 6-weeks after the treatment

Secondary outcomes (5)

  1. change in the full mouth Plaque Index

    a score of 0 to 5 is assigned to each facial and lingual unrestored surface of all the teeth except third molars, as follows: The Plaque Index System

    Scores Criteria

    • 0 No plaque
    • 1 Separate flecks of plaque at the cervical margin of the tooth
    • 2 A thin continuous band of plaque (up to one mm) at the cervical margin of the tooth
    • 3 A band of plaque wider than one mm but covering less than one-third of the crown of the tooth
    • 4 Plaque covering at least one-third but less than two-thirds of the crown of the tooth
    • 5 Plaque covering two-thirds or more of the crown of the tooth

    Measured: baseline, 2-weeks, 4-weeks, 6-weeks after the treatment

  2. change in the Calculus index

    • 0, no calculus;
    • 1, mild supragingival calculus extending to marginal gingiva is present;
    • 2, moderate supra and subgingival calculus or only subgingival calculus is present; and
    • 3, excessive supra and subgingival calculus is present. it will be estimated visually

    Measured: baseline, 2-weeks, 4-weeks, 6-weeks after the treatment

  3. change in the Modified Gingival Index

    • 0 = Normal gingiva;
    • 1 = Mild inflammation - slight change in color and slight edema;
    • 2 = Moderate inflammation - redness, edema and glazing;
    • 3 = Severe inflammation - marked redness and edema, ulceration with tendency to spontaneous bleeding. it will be estimated visually

    Measured: baseline, 2-weeks, 4-weeks, 6-weeks after the treatment

  4. change in the Probing pocket depth

    measure as the change in distance from the gingival margin to the bottom of the gingival sulcus by using a periodontal probe (UNC 15 "University of North Carolina")

    Measured: baseline, 6- weeks after the treatment

  5. The change of the root sensitivity

    will be evaluated using a visual analogue scale (VAS). The VAS root sensitivity scores ranges between 0 to 10. (0: no root sensitivity, 5: moderate root sensitivity, 10: severe root sensitivity).

    Measured: baseline, 24- hours, 48- hours, 72-hours, 1- week, 2-weeks, 4-weeks, 6-weeks after the treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2019
  2. Study start9 Feb 2019
  3. Primary completion30 Sep 2019
  4. Study completion30 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03863093
Sponsor's protocol ID
SPU-DN-Perio-2
Status last verified
Nov 2023
First submitted
18 Feb 2019
Last updated
24 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Flemmig TF, Arushanov D, Daubert D, Rothen M, Mueller G, Leroux BG. Randomized controlled trial assessing efficacy and safety of glycine powder air polishing in moderate-to-deep periodontal pockets. J Periodontol. 2012 Apr;83(4):444-52. doi: 10.1902/jop.2011.110367. Epub 2011 Aug 23.

    PubMed 21861637

  • Hagi TT, Hofmanner P, Salvi GE, Ramseier CA, Sculean A. Clinical outcomes following subgingival application of a novel erythritol powder by means of air polishing in supportive periodontal therapy: a randomized, controlled clinical study. Quintessence Int. 2013 Nov-Dec;44(10):753-61. doi: 10.3290/j.qi.a30606.

    PubMed 24078975

  • Muller N, Moene R, Cancela JA, Mombelli A. Subgingival air-polishing with erythritol during periodontal maintenance: randomized clinical trial of twelve months. J Clin Periodontol. 2014 Sep;41(9):883-9. doi: 10.1111/jcpe.12289. Epub 2014 Aug 7.

    PubMed 25041441

  • Moene R, Decaillet F, Andersen E, Mombelli A. Subgingival plaque removal using a new air-polishing device. J Periodontol. 2010 Jan;81(1):79-88. doi: 10.1902/jop.2009.090394.

    PubMed 20059420

  • Park EJ, Kwon EY, Kim HJ, Lee JY, Choi J, Joo JY. Clinical and microbiological effects of the supplementary use of an erythritol powder air-polishing device in non-surgical periodontal therapy: a randomized clinical trial. J Periodontal Implant Sci. 2018 Oct 24;48(5):295-304. doi: 10.5051/jpis.2018.48.5.295. eCollection 2018 Oct.

    PubMed 30405937

  • Wennstrom JL, Dahlen G, Ramberg P. Subgingival debridement of periodontal pockets by air polishing in comparison with ultrasonic instrumentation during maintenance therapy. J Clin Periodontol. 2011 Sep;38(9):820-7. doi: 10.1111/j.1600-051X.2011.01751.x. Epub 2011 Jul 7.

    PubMed 21736599

Questions about this trial

What is this clinical trial studying?

A study testing Electro Medical Systems AIRFLOW® and Electro Medical Systems Piezo in people with Gingivitis, run by Syrian Private University at 1 site in Syria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change in the papillary bleeding index (time frame: baseline, 2-weeks, 4-weeks, 6-weeks after the treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03863093, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2023.

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