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

NCT03863093 | Completed DMC

• 1 other identifier: SPU-DN-Perio-2
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingivitis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• change in the full mouth Plaque Index

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

• change in the Calculus index

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

• change in the Modified Gingival Index

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

• change in the Probing pocket depth

  baseline, 6- weeks after the treatment

• The change of the root sensitivity

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

Study Arms (2)

An erythritol powder

EXPERIMENTAL

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®; Device: Electro Medical Systems Piezo

ultrasonic instrumentation

ACTIVE COMPARATOR

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

Device: Electro Medical Systems Piezo

Interventions

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

An erythritol powder

Electro Medical Systems Piezo DEVICE

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

An erythritol powder; ultrasonic instrumentation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Syrian Private University: lead

Study Sites (1)

Syrian Private University

Damascus, Syria

Location

Related Publications (6)

• 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.

  PMID: 21861637 BACKGROUND

• 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.

  PMID: 24078975 BACKGROUND

• 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.

  PMID: 25041441 BACKGROUND

• 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.

  PMID: 20059420 BACKGROUND

• 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.

  PMID: 30405937 BACKGROUND

• 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.

  PMID: 21736599 BACKGROUND

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Hala Albonni, DDS MSc

  Syrian Private University

  PRINCIPAL INVESTIGATOR

• Hazem Sawaf, DDS MSc PhD

  Syrian Private University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: February 18, 2019
• First Posted: March 5, 2019
• Study Start: February 9, 2019
• Primary Completion: September 30, 2019
• Study Completion: December 30, 2019
• Last Updated: November 24, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)