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PeriodontitisNCT04178291

Air Polishing as an Adjunct in Non-surgical Periodontal Therapy

A study testing Ultrasonic scaler and Gracey currettes and Air polishing with erythritol powder in people with Periodontitis, run by University of Malaya at 1 site in Malaysia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Periodontal disease is an infection that causes inflammation and destruction of the tooth supporting structures, and if untreated, will eventually lead to tooth loss. Periodontal disease has been identified as a significant contributor to the global burden of oral disease. Read more about this study

Who is it for?
Ages 30 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Periodontitis
What is being tested?
Ultrasonic scaler and Gracey currettes and Air polishing with erythritol powder
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteMalaysia
Study dates
31 Jan 2020to Jun 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age: 30-65 years old
  • Healthy or well controlled systemic diseases, including diabetes (HbA1c<7%) and hypertension (BP<140/90 mm Hg)
  • Diagnosed with moderate to severe periodontitis (Stage II and III) regardless of grade (Caton et al. 2017)
  • >20 remaining teeth

Who cannot join

  • Systemic conditions requiring antibiotic prophylaxis
  • Pregnant or breast feeding women
  • Immunosuppressive therapy
  • Immunocompromised such as HIV/AIDS patients
  • Periodontal therapy in the last 6 months
  • Antibiotic or anti-inflammatory therapy in the last 4 months
Show all 11Show fewer
  • Known hypersensitivity to sugar alcohol (polyol)
  • Physical limitations or restrictions that prevent normal oral hygiene procedures
  • Heavy smoker who smokes ≥ 1 pack of cigarettes per day
  • Plaque score > 30%
  • Probing pocket depth > 6mm

Trial locations and contacts

1 site in 1 country.

Nor Shafina Mohamed Nazari, MScClinSDent contact

0379674806

shafina.mnazari@um.edu.my

Nor Adinar A Baharuddin, DClinDent contact

0196935088

noradinar@um.edu.my

Malaysia1 site, 1 recruiting
  • Nor Adinar Baharuddin

    Kuala Lumpur, Selangor, 50603

    Nor Adinar Baharuddin, DClinDent, 0196935088, noradinar@um.edu.my

    Recruiting

Other trials in Malaysia

About this study

Official title: Erythritol Powder Air Polishing as an Adjunct in Non-surgical Periodontal Therapy in the Management of Periodontitis: a Randomised Clinical Trial

Periodontal disease is an infection that causes inflammation and destruction of the tooth supporting structures, and if untreated, will eventually lead to tooth loss. Periodontal disease has been identified as a significant contributor to the global burden of oral disease. This disease is reported to be the sixth most prevalent disease globally. Periodontal disease has an association with diabetes, cardiovascular diseases and preterm low birth weight babies. Therefore, treatment of this disease is necessary. Treatment of periodontal disease involves mechanical removal of oral biofilm. Biofilm removal is initially carried out via non-surgical periodontal therapy, with subgingival debridement being one of the most important steps. According to the first European Workshop on Periodontology, subgingival debridement comprises subgingival instrumentation to disrupt and remove the oral biofilm. Subgingival debridement involves various techniques including hand instrumentation and ultrasonic instrumentation. Recently, treatment modality such as air polishing is also gaining momentum. Air polishing was reported to be more comfortable than conventional periodontal therapy. Besides, a number of studies had portrayed similar clinical outcomes with the use of air polishing in comparison to conventional periodontal therapy. However, there is no study evaluating the health economic aspect of these treatment modalities. Health economic evaluation is a valuable evaluation in intervention studies. Such evaluations provide information on the best way of using available resources in health care settings. For instance, advances in health care technology have resulted in an array of alternative treatment options. Unfortunately, such options tend to cost more than the existing therapeutic approaches. Therefore, economic evaluations will identify the worth of the new treatment options in comparison to the gold standard, in this case, comparing the adjunctive use of air polishing with conventional periodontal therapy. Besides focusing at patient reported outcomes and cost effectiveness of air polishing, this prospective, parallel, single-blinded, randomised controlled clinical trial is also planned to investigate the clinical and biological responses after the adjunct use of Erythritol Powder Air Polishing (EPAP) in addition to root surface debridement (RSD).

Read the detailed description

Periodontal disease is an infection that causes inflammation of the tooth supporting structures, which results in the destruction of the periodontal ligament and alveolar bone, and eventually, tooth loss. The aetiology of the disease is oral biofilm. Therefore, the regular mechanical removal of biofilm, among others, is necessary to prevent and stop the disease progression. Biofilm and biofilm retentive calculus are removed via periodontal debridement. Subgingival debridement is an important procedure that is initially performed in the non-surgical periodontal therapy phase. According to the first European Workshop on Periodontology, subgingival debridement involves gently instrumenting subgingivally to disrupt and/or remove the biofilm. Various techniques are involved in subgingival debridement, with hand instruments and ultrasonic or sonic instruments being the most common, while modalities like air polishing are gaining momentum.

Mechanical periodontal debridement using hand instruments like curettes, sickles, hoes or files, and power driven instruments such as sonic or ultrasonic scalers, is generally known as root surface debridement (RSD). This modality is considered to be the gold standard of periodontal therapy. The usage of hand instruments has been advocated for their efficiency and the fact that it allows tactile sensation and operator control. However, various drawbacks from these instruments have been noted. Hand instruments and scalers are both technique sensitive, time consuming, and may cause irreversible hard tissue damage when used regularly. Besides, anatomical variations such as grooves, concavities and enamel pearls as well as deep pockets and furcation involvement, can influence debridement quality. Since periodontal therapy is performed regularly, being time efficient, acceptable to patient, and causing minimal tissue damage are important determinants. As such, treatment that causes minimal abrasion to root surface while being highly effective in biofilm removal would be a preferable choice.

One such treatment is air polishing. Air polishing was introduced in 1945 for the purpose of cavity preparation. Over time, its use expanded to periodontal debridement. Stain and biofilm are removed by the abrasive "slurry" which is formed by mixing together pressurised air, a jet of water and a stream of small particles. Sodium bicarbonate was the only abrasive powder available from the late 1970s until 2004. It is non-toxic and water soluble, with a mean size of up to 250μm. It has been shown to be safe and efficient to be

used on intact enamel surfaces. However, due to its abrasiveness, it could not be used on demineralised enamel surfaces. A study showed that regardless of parameters such as working time, powder and water setting, working distance, and angulation of the handpiece, substantial damage to the root occurs from sodium bicarbonate, concluding that it is contraindicated for use in exposed root surfaces. In order to overcome this problem, glycine based powders were then produced. In the in vitro study showed that glycine powder proved to have low abrasiveness towards cementum and dentine, while being efficient at plaque removal. The powder had a mean particle size of 45μm - 60μm, and was 80% less abrasive compared to sodium bicarbonate. More recently, erythritol powders have been used in air polishing. Erythritol is a sugar alcohol that is non-toxic, chemically neutral, and water soluble, and has been widely used as an artificial sweetener and food additive. Due to comparable physical properties to glycine and chemical characteristics allowing binding of antiseptic substances, it has been suggested for subgingival biofilm removal. Moreover, a recent study has shown erythritol to have an inhibitory effect on some periodontal bacteria, including P. gingivalis.

Advancements in air polishing devices have also occurred, mainly involving a disposable nozzle design to access the periodontal pocket directly, thus allowing the abrasive slurry to be delivered into moderate-to-deep periodontal pockets. The nozzle has a thickness of 0.7mm, which is within the diameter range of most periodontal probes, thereby allowing it to be inserted to the base of the pocket with minimal force. Besides, the new design resulted in a drop of pressure of the jet spray by 1 bar, thus reducing the risk of emphysema and allowing the nozzle to be used subgingivally.

The usage of air polishing in supportive periodontal therapy (SPT) has been extensively studied. However, minimal studies on the adjunctive use of air polishing in the management of active periodontitis have been conducted. One such study studied demonstrated that the effect of adjunctive subgingival glycerine powder air polishing (GPAP) in chronic periodontitis. It was a single blinded, 6 month study using the split mouth design with one of the outcomes being the reduction in the volume of gingival crevicular fluid (GCF). RSD followed by flushing of pockets with water was carried out in the control group, while RSD was followed by GPAP in the test group. Both groups showed significant reduction in periodontal parameters, and no significant differences between the two groups were seen. The test group showed significant reduction in GCF volume compared to control at 3 months, although at 6 months, no difference between the two groups was noted. Since GCF volume is an objective measure of subclinical inflammation, this study suggested that GPAP as an adjunct to RSD may improve periodontal inflammation in the short term.

Another study by Park et al. aimed to identify the clinical and microbiological effects of adjunctive subgingival erythritol powder air polishing (EPAP) in initial therapy. It was a 3 month study using a split mouth design in which treatment for the test group involved RSD and subgingival EPAP, whereas only RSD was done in the control group. Both groups showed significant changes in clinical parameters, and no difference was seen between the groups. Total bacterial count between baseline and 1 month after treatment decreased in both groups, but the decrease was significant in the test group. Between 1 month and 3 months after treatment, total bacterial count increased in both groups, but the increase was more significant in the control group. It appears that supplementing RSD with EPAP may have an effect on the total bacterial count. EPAP was also noted to have an anti-microbial effect, since the P. gingivalis count after 1 month treatment was significantly lower in the test group. This study concluded that both modes of treatment were clinically and microbiologically effective for initial therapy.

However, both studies were conducted using a split mouth design. Such a design has a risk of crossover effects, thus limiting intra-individual comparisons as local therapy can have systemic effects that are able to influence outcomes in different sites in the same individual. Therefore, there is a need to conduct a study using the parallel mouth design to identify the effects of adjunctive use of air polishing in periodontitis patient. Nevertheless, with new and more expensive technology, the question of cost effectiveness is not uncommon. Resources in health care such as time, money, and materials are often limited. This necessitates health economic evaluations to be carried out. One such evaluation is a cost effectiveness analysis that identifies the relationship between incremental resource consumption and outcome gain for various interventions. No such study has been conducted with regards to the cost effectiveness of air polishing. Therefore, the aim of this study is to investigate the adjunctive use of EPAP in NSPT and determine its cost effectiveness in the management of periodontitis.

Conditions
Periodontitis
Being tested
Ultrasonic scaler and Gracey currettes, Air polishing with erythritol powder
Keywords
Periodontitis, air polishing, randomised clinical trial, adjunct, debridement
Medical subject headings
Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ultrasonic scaler and Gracey currettesDevice

    Full mouth subgingival debridement using ultrasonic scaler and Gracey currettes

  • Air polishing with erythritol powderDevice

    Air flow PLUS

Study groups in NCT04178291
Study groupRoleWhat they receive
Conventional debridement and air polishingExperimentalAll participants will receive full mouth EPAP as an adjunct to RSD using ultrasonic scalers and Gracey currettes. The EPAP procedure will be performed using the Air-Flow Master R (EMS) equipment. For supragingival biofilm removal, the Air-Flow handpiece will be used, while the Perio-Flow handpiece with a disposable nozzle will be used for subgingival debridement at sites with PPD ≥ 5mm. No time limit is applicable for supragingival air polishing. However, for subgingival debridement, the nozzle will be inserted for 5 seconds into each pocket, and moved vertically up and down. Gracey currettes will be used at sites with PPD ≥ 5mm.
Receives: Device: Ultrasonic scaler and Gracey currettes; Device: Air polishing with erythritol powder
Conventional debridementActive comparatorAll participants will receive full mouth RSD using ultrasonic scalers and Gracey currettes. Gracey currettes will be used at sites with PPD ≥ 5mm.
Receives: Device: Ultrasonic scaler and Gracey currettes

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in probing pocket depth (PPD).

    Probing Pocket Depth (PPD) at 6 sites: Distance of margin of free gingiva to base of the pocket measured in millimetre using UNC-15 periodontal probe.

    Measured: 6 months

Secondary outcomes (6)
  1. Changes in clinical attachment level

    To determine change in clinical attachment level, measured in millimetre, from cementoenamel junction to base of pocket (sum of periodontal pocket and recession).

    Measured: 6 month

  2. Changes in recession

    Gingival recession (REC): Distance from CEJ to margin of free gingiva measured in millimetre using UNC-15 periodontal probe.

    Measured: 6 month

  3. Changes in Periodontal inflamed surface area

    To determine change in periodontal inflamed surface area i.e. the sum of the periodontal pocket depth of bleeding on probing - positive sites for the total dentition and can be easily calculated using routine periodontal charting

    Measured: 6 months

  4. Changes in full mouth bleeding score

    Full mouth bleeding score (FMBS): Using Gingival Bleeding Index (Ainamo and Bay, 1975), bleeding will be assessed at 6 sites each tooth using a dichotomous scoring method. It will be considered as present (1) if there is bleeding within 10 seconds after probing of the gingiva, and absent (0) if there is no bleeding.

    Measured: 6 months

  5. Changes in full mouth plaque score

    Full mouth plaque score (FMPS): Using the Visible Plaque Index (Ainamo and Bay, 1975) visible plaque on the mesiobuccal, midbuccal, distobuccal, and lingual/palatal, surfaces will be recorded using a dichotomous scoring method. It will be considered as present (1) if there is visible plaque on the respective surfaces, and absent (0) if there is no visible plaque. Plaque disclosing solution will be used to aid in the scoring.

    Measured: 6 months

  6. The ratio value of incremental Cost Effectiveness

    Using Incremental Cost Effectiveness ratio to identify if the adjunctive use of air polishing during conventional periodontal treatment in periodontal pockets up to 6mm deep is cost effective compared to conventional periodontal therapy alone. The analytic horizon will be for six months.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Nov 2019
  2. Study start31 Jan 2020
  3. Primary completionJan 2021 (estimated)
  4. Study completionJun 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04178291
Sponsor's protocol ID
101269-4
Status last verified
Feb 2020
First submitted
20 Nov 2019
Last updated
7 Feb 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Savage A, Eaton KA, Moles DR, Needleman I. A systematic review of definitions of periodontitis and methods that have been used to identify this disease. J Clin Periodontol. 2009 Jun;36(6):458-67. doi: 10.1111/j.1600-051X.2009.01408.x.

    PubMed 19508246
  • 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.

    PubMed 20059420
  • Laleman I, Cortellini S, De Winter S, Rodriguez Herrero E, Dekeyser C, Quirynen M, Teughels W. Subgingival debridement: end point, methods and how often? Periodontol 2000. 2017 Oct;75(1):189-204. doi: 10.1111/prd.12204.

    PubMed 28758304
  • Ng E, Byun R, Spahr A, Divnic-Resnik T. The efficacy of air polishing devices in supportive periodontal therapy: A systematic review and meta-analysis. Quintessence Int. 2018;49(6):453-467. doi: 10.3290/j.qi.a40341.

    PubMed 29700503
  • Lindhe J, Westfelt E, Nyman S, Socransky SS, Haffajee AD. Long-term effect of surgical/non-surgical treatment of periodontal disease. J Clin Periodontol. 1984 Aug;11(7):448-58. doi: 10.1111/j.1600-051x.1984.tb01344.x.

    PubMed 6378986
  • Kocher T, Fanghanel J, Sawaf H, Litz R. Substance loss caused by scaling with different sonic scaler inserts--an in vitro study. J Clin Periodontol. 2001 Jan;28(1):9-15. doi: 10.1034/j.1600-051x.2001.280102.x.

    PubMed 11142673
  • Flemmig TF, Petersilka GJ, Mehl A, Hickel R, Klaiber B. The effect of working parameters on root substance removal using a piezoelectric ultrasonic scaler in vitro. J Clin Periodontol. 1998 Feb;25(2):158-63. doi: 10.1111/j.1600-051x.1998.tb02422.x.

    PubMed 9495615
  • Ritz L, Hefti AF, Rateitschak KH. An in vitro investigation on the loss of root substance in scaling with various instruments. J Clin Periodontol. 1991 Oct;18(9):643-7. doi: 10.1111/j.1600-051x.1991.tb00104.x.

    PubMed 1960232
  • Zappa U, Smith B, Simona C, Graf H, Case D, Kim W. Root substance removal by scaling and root planing. J Periodontol. 1991 Dec;62(12):750-4. doi: 10.1902/jop.1991.62.12.750.

    PubMed 1765938
  • Leknes KN. The influence of anatomic and iatrogenic root surface characteristics on bacterial colonization and periodontal destruction: a review. J Periodontol. 1997 Jun;68(6):507-16. doi: 10.1902/jop.1997.68.6.507.

    PubMed 9203093
  • Petersilka GJ. Subgingival air-polishing in the treatment of periodontal biofilm infections. Periodontol 2000. 2011 Feb;55(1):124-42. doi: 10.1111/j.1600-0757.2010.00342.x. No abstract available.

    PubMed 21134232
  • Kontturi-Narhi V, Markkanen S, Markkanen H. Effects of airpolishing on dental plaque removal and hard tissues as evaluated by scanning electron microscopy. J Periodontol. 1990 Jun;61(6):334-8. doi: 10.1902/jop.1990.61.6.334.

    PubMed 2366141
  • Petersilka GJ, Bell M, Mehl A, Hickel R, Flemmig TF. Root defects following air polishing. J Clin Periodontol. 2003 Feb;30(2):165-70. doi: 10.1034/j.1600-051x.2003.300204.x.

    PubMed 12622860
  • Petersilka GJ, Bell M, Haberlein I, Mehl A, Hickel R, Flemmig TF. In vitro evaluation of novel low abrasive air polishing powders. J Clin Periodontol. 2003 Jan;30(1):9-13. doi: 10.1034/j.1600-051x.2003.300102.x.

    PubMed 12702105
  • Munro IC, Berndt WO, Borzelleca JF, Flamm G, Lynch BS, Kennepohl E, Bar EA, Modderman J. Erythritol: an interpretive summary of biochemical, metabolic, toxicological and clinical data. Food Chem Toxicol. 1998 Dec;36(12):1139-74. doi: 10.1016/s0278-6915(98)00091-x.

    PubMed 9862657

Questions about this trial

What is this clinical trial studying?

A study testing Ultrasonic scaler and Gracey currettes and Air polishing with erythritol powder in people with Periodontitis, run by University of Malaya at 1 site in Malaysia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Nor Shafina Mohamed Nazari, MScClinSDent (0379674806, shafina.mnazari@um.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in probing pocket depth (PPD). (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04178291, which also lists 25 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2020.

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