Compare Air Polishing With Ultrasonic During Maintenance

February 5, 2020 updated by: Nor Adinar Baharuddin, University of Malaya

Subgingival Debridement by Erythritol Powder Air-Polishing (EPAP) in Comparison With Ultrasonic Instrumentation During Periodontal Maintenance. A Randomised Clinical Trial

Periodontal disease is a chronic multifactorial inflammatory disease that affects the soft and hard supporting tissues of the teeth. It is one of the most common oral health problems which 90% of the global adult population has been reported to have some form of the disease. Microorganisms in dental biofilm play a critical etiological factor in the development of this progressive destruction disease, and if left untreated, will eventually lead to tooth loss. Recurrent periodontal disease did occur in treated and well-maintained patients at different time intervals and is a site-specific disorder. Therefore, subgingival biofilm removal during supportive periodontal therapy has become a fundamental part in achieving a stable oral health after completion of active treatment. Subgingival debridement involves various techniques. In recent years, many studies have reported on the effectiveness of air polishing device using different powders versus conventional hand instruments and/or oscillating scalers. However, there is no study evaluating the health economic aspect of these treatment modalities. As development leads to advancement of treatment options, they often involve higher cost than the existing measures. Therefore, besides clinical efficacy, economic evaluation enables health decision makers to allocate limited health resources in a more efficient manner, to ensure best possible outcomes, without neglecting any segment of care.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

As a result of ongoing microbiological challenge from accumulated dental plaque, it is paramount to ensure thorough removal of such deposits from the root surface to maintain periodontal health. Mechanical instrumentation using conventional hand instrument and/or oscillating scalers is the gold standard of periodontal therapy. Patient is commonly recalled every 3-4 months interval for supportive periodontal therapy (SPT) to decrease disease recurrence and prevent further tooth loss. This repeated mechanical instrumentation, however, may cause irreversible damage to dental hard tissue. As such, the use of treatment modalities effective in removing biofilm, being time efficient, causing minimal discomfort, tissue damage, and less abrasion of root surface would be preferable during SPT.

With the advancement of technology in dentistry, air polishing (AP) was introduced to dentistry for cavity reparation in 1945. The usage then extended into periodontal debridement in SPT, by means of slurry pressurized air with a novel low abrasive powder and water. A study done by Petersilka et al. 2003 in 27 SPT patients of pockets 3-5mm depth revealed an approximately 90% reduction in all viable bacterial counts and offered greater patient comfort when compared to conventional hand instrument. It was also time saving as only 5 seconds is needed per tooth surface. Since 1980s, sodium bicarbonate has been used in AP devices and was the only powder available until 2004. It is non-toxic, water-soluble, safe for intra-oral use and is efficient in removing biofilm and staining on intact enamel surfaces. However, this conventional powder can cause substantial damage to the root cementum and dentine at area of receded gingiva, severe epithelial erosion and unpleasant perception by patients.

In order to deal with this issue, several types of AP abrasive powders with improved clinical performance and patient comfort have been produced. As early as in 2003, glycine based (amino acid) powders were produced with smaller mean particle size 45-60 µm and less chiseled shape, compared to sharp edged and up to 250 µm mean particle size of sodium bicarbonate. Due to its ≈80% less abrasiveness, studies had shown that glycine powder air-polishing (GPAP) was more efficient in plaque removal in root debridement, caused non-critical substance loss and lower the rate of increase in root surface roughness when compared to sodium bicarbonate. On the other hand, in a publication by Flemmig et al. in 2007, efficacy of GPAP was assessed in periodontal pockets of various depths. The results revealed the average debridement depth of 2mm was obtained at pockets depth of 4mm, and 60% of subgingival root surface was cleaned. In deeper pockets, the efficacy reduced to about 40% and the use of hand instruments or ultrasonic scalers may be superior.

Thus, Moёne et al. had described a newly designed nozzle in 2010 in order to extend the use of air polishing in deeper pockets. This nozzle allowed access to subgingival root surfaces and the jet spray has a lower flow and pressure compared to supragingivally applied air polishing. This new device appeared to be safe, perceived to be more acceptable by patients and was more time efficient than scaling and root planing. However, Petersilka (2010) pointed out two cases of air emphysema developed after using this jet system but fortunately the cases resolved within 4 days without additional intervention. Therefore, he remarked that emphysema cannot be completely ruled out in all other types of air-polishing systems. Since then, more studies have been carried out using this newly designed nozzle with GPAP. A 2-months trial by Wennstrӧm et al. in 20 recall patients showed no significant differences in clinical or microbiological outcomes between subgingivally applied GPAP (SubGPAP) and ultrasonic debridement of moderate deep pockets (5-8mm). They also noted there was only a short-term reduction of subgingival microflora in both modalities.

Recently, a natural sugar erythritol powder has gained its popularity as it has slightly lower abrasiveness and smaller particle size 14-31 µm compared to glycine. In 2013, Hashino et al. found that erythritol has inhibitory effect on the biofilm produced by Streptococcus gordonii and Porphyromonas gingivalis. A year after, Drago and team tested on a new formulation consisting of erythritol and chlorhexidine with the standard glycine powder. This in vitro study demonstrated that the combination of erythritol/chlorhexidine displayed a stronger antimicrobial and antibiofilm activity on titanium discs. While in a 12 months clinical trial by Müller and co-workers, repeated subgingival air polishing with erythritol containing 0.3% chlorhexidine appeared to be safe, reduced the number of pockets >4mm and induced less pain than ultrasonic instrumentation. As subgingival biofilm may not mineralise between two SPT visits, less aggressive approach with better microbiological outcome may be appropriate for residual pockets.

Based on the available literature, requirements like time efficiency, minimal hard and soft tissue damage, along with high patient acceptance and safety, are important for repeated treatments especially in SPT. Whether a new air-polishing powder, used with a specially designed nozzle may be a valid alternative to conventional debridement, cost efficiency is another essential aspect to be defined. As periodontitis patients need long-term professional care and in the light of rising healthcare costs, a cost- and clinically effective treatment modality is required.

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
      • Kuala Lumpur, Malaysia, 50603
        • Recruiting
        • Faculty of Dentistry
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients aged 30 to 65 years old.
  • Patients with at least 20 teeth available.
  • Patients already in SPT at least 3 months after completion of comprehensive periodontal therapy.
  • Presence of at least 4 teeth with residual pockets of ≥5mm and positive bleeding on probing.
  • Patients with controlled systemic diseases.

Exclusion Criteria:

  • Patients with a plaque control record >30%.
  • Patients who had undergone radiation or immunosuppressive therapy.
  • Patients with cardiac pacemaker, defibrillators and any implantable electronic device.
  • Patients who are on antibiotics, anti-inflammatory drugs or other medication taken within the previous 3 months.
  • Patients who are confirmed or suspected intolerance to the test products.
  • Patients with history or known case of root hypersensitivity.
  • Patients with physical limitation that might hinder proper home care or oral hygiene procedures.
  • Patients who are pregnant.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ultrasonic instrumentation and Air Polishing
All participants will receive full mouth conventional ultrasonic subgingival debridement, followed by air-polishing with erythritol powder which include activating device for 5 seconds of each surface (Petersilka 2003). Subsequently, Perio-Flow handpiece with a special disposable nozzle will be used for pocket depth >4mm. Perio-Flow handpiece with a special disposable nozzle will be used for pocket depth >4mm
Other: Ultrasonic instrumentation
Full mouth root surface debridement
Other: Air polishing with erythritol powder
Air flow PLUS
Active Comparator: Ultrasonic instrumentation
All participants will receive full mouth conventional ultrasonic subgingival debridement only. No time limit (Flemmig 2012), until dental surfaces feel smooth.
Other: Ultrasonic instrumentation
Full mouth root surface debridement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of pocket depth >4mm
Time Frame: 6 months
To determine presence of pocket depth > 4 mm after 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical attachment level gain (CAL)
Time Frame: 6 months
To determine presence of CAL after 6 months
6 months
Patient reported outcome measures (PROM)
Time Frame: 6 months
Patient reported outcome measures using visual analogue scales score where 0 is no pain and 10 is the worst pain
6 months
Incremental Cost Effectiveness Ratio (ICER)
Time Frame: 6 months
Incremental Cost Effectiveness Ratio
6 months
Patient reported outcome measures (PROM)
Time Frame: 6 months
Patient reported outcome measures using oral health impact profile (OHIP-14) score, based on the likert scale responses; which were coded as (1) very often, (2) quite often, (3) sometimes, (4) seldom, (5) never and (6) don't know.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Malaya

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2020

Primary Completion (Anticipated)

January 1, 2021

Study Completion (Anticipated)

June 1, 2021

Study Registration Dates

First Submitted

November 14, 2019

First Submitted That Met QC Criteria

November 18, 2019

First Posted (Actual)

November 20, 2019

Study Record Updates

Last Update Posted (Actual)

February 7, 2020

Last Update Submitted That Met QC Criteria

February 5, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 101269-3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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