- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03863093
Evaluation of Air Polishing With Ultrasonic Debridement in the Treatment of Initial Periodontal Pockets
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Damascus, Syrian Arab Republic
- Syrian Private University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: An erythritol powder
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
|
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 Piezo will be used for supra- and subgingival ultrasonic instrumentation
|
Active Comparator: ultrasonic instrumentation
Electro Medical Systems Piezo will be used for supra- and subgingival ultrasonic instrumentation
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Electro Medical Systems Piezo will be used for supra- and subgingival ultrasonic instrumentation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in the papillary bleeding index
Time Frame: baseline, 2-weeks, 4-weeks, 6-weeks after the treatment
|
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 |
baseline, 2-weeks, 4-weeks, 6-weeks after the treatment
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change in the percentage of study sites positive for bleeding on probing
Time Frame: baseline, 6-weeks after the treatment
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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 |
baseline, 6-weeks after the treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in the full mouth Plaque Index
Time Frame: baseline, 2-weeks, 4-weeks, 6-weeks after the treatment
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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
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baseline, 2-weeks, 4-weeks, 6-weeks after the treatment
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change in the Calculus index
Time Frame: baseline, 2-weeks, 4-weeks, 6-weeks after the treatment
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it will be estimated visually |
baseline, 2-weeks, 4-weeks, 6-weeks after the treatment
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change in the Modified Gingival Index
Time Frame: baseline, 2-weeks, 4-weeks, 6-weeks after the treatment
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it will be estimated visually |
baseline, 2-weeks, 4-weeks, 6-weeks after the treatment
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change in the Probing pocket depth
Time Frame: baseline, 6- weeks after the treatment
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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")
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baseline, 6- weeks after the treatment
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The change of the root sensitivity
Time Frame: baseline, 24- hours, 48- hours, 72-hours, 1- week, 2-weeks, 4-weeks, 6-weeks after the treatment
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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).
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baseline, 24- hours, 48- hours, 72-hours, 1- week, 2-weeks, 4-weeks, 6-weeks after the treatment
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hala Albonni, DDS MSc, Syrian Private University
- Study Chair: Hazem Sawaf, DDS MSc PhD, Syrian Private University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SPU-DN-Perio-2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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