Clinical trial NCT03863093: 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
Overall status: COMPLETED
Phase: NA
Conditions: Gingivitis
Lead sponsor: Syrian Private University
Sponsor class: OTHER
First posted: 2019-03-05
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Patients are in generally good health
2. Patients are from both gender and their age is between 18 to 60 years.
3. Patients have a minimum of 20 teeth
4. The patient is a non-smoker (less than 5 cigarettes per day) and non-alcoholic.
5. Female participants must not be pregnant or breastfeeding (lactation).
6. the absence of severe oral habits
7. 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.
8. A sign informed consent from participation and permission to use obtained data for research purposes.

Exclusion Criteria:

1. Bruxism
2. Allergy to glycine or chlorhexidine;
3. systemic medical conditions requiring antibiotic prophylaxis (for endocarditis prophylaxis) and anti-inflammatory drugs before dental procedures;
4. active systemic infectious disease;
5. 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.
6. chronic high dose steroid therapy
7. Patients are undergone to radiotherapy or chemotherapy before or during the study period.
8. actively smoking more than five cigarettes per day;
9. signs of generalized severe periodontitis;
10. having received periodontal maintenance within 3 months before baseline
11. patients treated with antibiotics 6 months prior to the study
12. chronic bronchitis and asthma
13. compromised immune system
14. hypersensitivity to sugar alcohols.
15. any physical limitations or restrictions that might preclude normal oral hygiene procedures.

Primary outcomes:
measure: change in the papillary bleeding index
timeFrame: baseline, 2-weeks, 4-weeks, 6-weeks after the treatment
measure: change in the percentage of study sites positive for bleeding on probing
timeFrame: baseline, 6-weeks after the treatment
Secondary outcomes:
measure: change in the full mouth Plaque Index
timeFrame: baseline, 2-weeks, 4-weeks, 6-weeks after the treatment
measure: change in the Calculus index
timeFrame: baseline, 2-weeks, 4-weeks, 6-weeks after the treatment
measure: change in the Modified Gingival Index
timeFrame: baseline, 2-weeks, 4-weeks, 6-weeks after the treatment
measure: change in the Probing pocket depth
timeFrame: baseline, 6- weeks after the treatment
measure: The change of the root sensitivity
timeFrame: baseline, 24- hours, 48- hours, 72-hours, 1- week, 2-weeks, 4-weeks, 6-weeks after the treatment
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Syrian Private University
Study officials:
affiliation: Syrian Private University
name: Hala Albonni, DDS MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Syrian Private University
name: Hazem Sawaf, DDS MSc PhD
role: STUDY_CHAIR
References:
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.
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.
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.
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.
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.
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.