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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Gingivitis

Intervention / Treatment
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* Device: Electro Medical Systems AIRFLOW®
* Device: Electro Medical Systems Piezo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: An erythritol powder<br>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 | Device: Electro Medical Systems AIRFLOW®<br>* 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<br>Device: Electro Medical Systems Piezo<br>* Electro Medical Systems Piezo will be used for supra- and subgingival ultrasonic instrumentation<br>|
| Active Comparator: ultrasonic instrumentation<br>Electro Medical Systems Piezo will be used for supra- and subgingival ultrasonic instrumentation | Device: Electro Medical Systems Piezo<br>* Electro Medical Systems Piezo will be used for supra- and subgingival ultrasonic instrumentation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | baseline, 2-weeks, 4-weeks, 6-weeks after the treatment | 
| 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 | baseline, 6-weeks after the treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | baseline, 2-weeks, 4-weeks, 6-weeks after the treatment | 
| 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 | baseline, 2-weeks, 4-weeks, 6-weeks after the treatment | 
| 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 | baseline, 2-weeks, 4-weeks, 6-weeks after the treatment | 
| 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) | baseline, 6- weeks after the treatment | 
| 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). | baseline, 24- hours, 48- hours, 72-hours, 1- week, 2-weeks, 4-weeks, 6-weeks after the treatment |