Back to resultsEvaluation of Air Polishing With Ultrasonic Debridement in the Treatment of Initial Periodontal Pockets
Primary Purpose
Gingivitis
Status
Completed
Phase
Not Applicable
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
Electro Medical Systems AIRFLOW®
Electro Medical Systems Piezo
Sponsored by
About this trial
This is an interventional treatment trial for Gingivitis
Eligibility Criteria
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.
Sites / Locations
- Syrian Private University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
An erythritol powder
ultrasonic instrumentation
Arm Description
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
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
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
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
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
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")
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).
Full Information
NCT ID
NCT03863093
First Posted
February 18, 2019
Last Updated
May 12, 2020
Sponsor
Syrian Private University
1. Study Identification
Unique Protocol Identification Number
NCT03863093
Brief Title
Evaluation of Air Polishing With Ultrasonic Debridement in the Treatment of Initial Periodontal Pockets
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
February 9, 2019 (Actual)
Primary Completion Date
September 30, 2019 (Actual)
Study Completion Date
December 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Syrian Private University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
An erythritol powder
Arm Type
Experimental
Arm Description
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
Arm Title
ultrasonic instrumentation
Arm Type
Active Comparator
Arm Description
Electro Medical Systems Piezo will be used for supra- and subgingival ultrasonic instrumentation
Intervention Type
Device
Intervention Name(s)
Electro Medical Systems AIRFLOW®
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Electro Medical Systems Piezo
Intervention Description
Electro Medical Systems Piezo will be used for supra- and subgingival ultrasonic instrumentation
Primary Outcome Measure Information:
Title
change in the papillary bleeding index
Description
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
Time Frame
baseline, 2-weeks, 4-weeks, 6-weeks after the treatment
Title
change in the percentage of study sites positive for bleeding on probing
Description
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
Time Frame
baseline, 6-weeks after the treatment
Secondary Outcome Measure Information:
Title
change in the full mouth Plaque Index
Description
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
Time Frame
baseline, 2-weeks, 4-weeks, 6-weeks after the treatment
Title
change in the Calculus index
Description
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
Time Frame
baseline, 2-weeks, 4-weeks, 6-weeks after the treatment
Title
change in the Modified Gingival Index
Description
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
Time Frame
baseline, 2-weeks, 4-weeks, 6-weeks after the treatment
Title
change in the Probing pocket depth
Description
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")
Time Frame
baseline, 6- weeks after the treatment
Title
The change of the root sensitivity
Description
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).
Time Frame
baseline, 24- hours, 48- hours, 72-hours, 1- week, 2-weeks, 4-weeks, 6-weeks after the treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hala Albonni, DDS MSc
Organizational Affiliation
Syrian Private University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hazem Sawaf, DDS MSc PhD
Organizational Affiliation
Syrian Private University
Official's Role
Study Chair
Facility Information:
Facility Name
Syrian Private University
City
Damascus
Country
Syrian Arab Republic
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
21861637
Citation
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.
Results Reference
background
PubMed Identifier
24078975
Citation
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.
Results Reference
background
PubMed Identifier
25041441
Citation
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.
Results Reference
background
PubMed Identifier
20059420
Citation
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.
Results Reference
background
PubMed Identifier
30405937
Citation
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.
Results Reference
background
PubMed Identifier
21736599
Citation
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.
Results Reference
background
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Evaluation of Air Polishing With Ultrasonic Debridement in the Treatment of Initial Periodontal Pockets
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