Efficacy of subgingival Air Polishing using Erythritol Powder in Periodontitis patients during Supportive Periodontal Therapy (spt)



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Efficacy of subgingival Air Polishing using Erythritol Powder in Periodontitis patients during Supportive Periodontal Therapy (SPT)

Introduction

Chronic Periodontitis is an infectious, inflammatory disease caused by a microflora consisting of mostly Gram-negative bacteria. Porphyromonas gingivalis (P.g.), Aggregatibacter actinomycetemcomitans (A.a.), Tanerella forsythensis (T.f.), Prevotella intermedia (P.i.) and Treponema denticola (T.d.), are considered to be the some of the most important periodontal pathogens. They are organised, together with less periopathogenic organisms, in a bacterial biofilm colonising the root surfaces. Minerals like calcium phosphate originating from saliva and blood causes mineralisation of the biolfilm resulting in calculus formation. The subsequent infection triggers host inflammatory responses resulting in the destruction of the periodontal or tooth supporting tissues.


Removal of both calculus and biofilm by supra and subgingival debridement is essential for the reduction of periodontal pathogens to avoid further disease progression. However, despite our best attempts, complete removal of all microbial deposits colonising root surfaces is virtually not attainable. Even the additional use of systemic and/or local antibiotics has not been able to completely eliminate all periodontal pathogens [Salvi et al. 2002, Hung and Douglass 2002]. Furthermore, recolonisation of the periodontal pockets can occur within 4-8 weeks if plaque control is not maintained [Magnusson et al 1984]. It is necessary to regularly monitor patient’s oral health and hygiene, diagnose the incipient signs of recurrent disease and intercept with appropriate supportive periodontal therapy (SPT) [Lang et al 2008]. The crucial role of regular SPT in maintaining successful results has been well documented by Baderston et al. [Baderston 1981, 1984], demonstrating that probing depths and clinical attachment levels were maintained as a result of a well-organised professional maintenance program that consisted of regular recalls between 3 to 6 months.
Conventionally these SPT sessions consisted of a review of the patients’ oral hygiene and re-instrumentation of the persisting and inflamed periodontal pockets to remove any newly formed biolfim. Overinstrumentation however, can lead to hypersensitivity and pulpitis due to excessive cementum and dentine removal [Fogel and Pashley 1993, Zappa 1991].

In recent times a novel approach has been developed for the removal of subgingival biolfim during SPT using a slurry of water, an abrasive powder and pressurized air (Air Polishing). Today, the indication for the use of air polishing devices has been expanded from supragingival, utilising sodium bicarbonate powders, to subgingival air polishing in recent years. With the development of new low abrasive and resorbable powders, such as glycine and recently erythritol and application devices with a subgingival nozzle, better access to deeper pockets and interdental areas can be achieved. [Petersilka 2003d]. Recent studies using glycine powder have indicated that the subgingival use of air polishing could be able to reduce the damage to the root surface from over-instrumentation, reduce clinical time and enhance patient comfort. This could ultimately help to reduce the use of local and/or systemic antibiotics as well as the need for periodontal surgery with all their negative side/adverse effects and costs [Petersilka et al 2003b].


At this time there are only a few randomized and controlled in vivo studies published which investigate the clinical and antimicrobial effects of erythritol, a naturally derived sugar alcohol, on the subgingival microbiota [Hägi et al 2013]
Therefore, the aim of this study is to investigate whether the use of an air polishing therapy with a specific low-abrasive erythritol powder is equal or more efficient than conventional reinstrumentation using ultrasonic scalers and hand currettes (SRP) in SPT patients with a mild or moderate type of chronic periodontitis who already received initial therapy (SRP) but are still showing probing pocket depths (PPD) of ≥5mm including bleeding on probing (BOP).
Hypotheses:

In pockets of SPT patients still showing a PPD of ≥5mm and BOP after completion of initial therapy (full mouth SRP) Air-polishing therapy (Ap) with the use of erythritol is equal or superior to a conventional recapitulation of SRP using ultrasonic scalers and hand currettes.


All abbreviations used in the following text are explained in detail on page 10.
Study Design:

The present study is a prospective randomized single-blinded controlled clinical pilot study.


Material and methods
Unit of observation

A single periodontal pocket of a single tooth is considered as unit of observation

The study will be performed using the split-mouth design. That means, one pocket at one tooth will be compared with a similar pocket (similar pocket depth ± 1mm, similar location) of the same or similar tooth in the contralateral quadrant of the same patient (i.e. 6mm pocket at tooth 14d with 6mm pocket at tooth 24d). Within one patient, the allocation of the single pockets to test group (Air polishing therapy. Ap) or control group (Debridement using conventional ultrasonic scalers. SRP) will be performed by randomization (coin toss).
Patient selection:
Inclusion criteria:


  • Patients with a mild or moderate chronic periodontitis and completed initial periodontal therapy (SRP)

  • Approximal Plaque Indes (API) ≤ 40 %

  • Sulcus Bleeding Index (SBI) ≤ 30 %

  • A minimum of two pockets at similar single-rooted teeth in contralateral quadrants with similar PPDs (± 1mm) ≥ 5 mm and BOP.


Exclusion criteria:

Pockets with PPDs < 5mm, API > 40%, SBI > 30%

Multi-rooted teeth

Patients below an age of 18

Patients with a risk of endocarditis

Patients on bisphosphonates

Use of local or systemic antibiotic within the last 6 months

Allergy against erythritol

Patients with a blood coagulation disorder

Patients using anticoagulants

Patients with liver disorders

Patients with gastro-intestinal disorders

Mentally disabled patients

Pregnancy

Lactation

Smoker
Patient recruitment:

All patients will be recruited of the Patients of the Department of Periodontics, Sydney Dental Hospital
Definition of Test- and Control Group

Test Group: Air Polishing using erythritol powder

Control Group: Replication of conventional SRP using ultrasonic scalers and hand curettes
Definition command variables:
Main variables:
Clinical variables:


  • Probing Pocket Depth (PPD)

  • Clinical Attachment Level (CAL)

  • Bleeding on Probing (BOP)

All clinical variables will be measured by a computerized probe (Florida Probe)
Microbiological variables:

Bacterial counts of Porphyromonas gingivalis (P.g.), Aggregatibacter actinomycetemcomitans (A.a.), Tanerella forsythensis (T.f.), Prevotella intermedia (P.i.) and Treponema denticola (T.d.)

All microbiological variables will be measured using Real-time PCR. They will only be measured if the clinical variables indicate an equal or superior efficacy of the air polishing therapy compared to conventional SRP.

The first periodontal pathogen will be P. gingivalis, representing the most common, important periodontal pathogen in pockets showing further inflammation and/or attachment loss in patients with a chronic periodontitis. All other periodontal pathogens will be only analysed if counts of P. gingivalis show a superior effect of air polishing using erythritol.



Secondary variables:

Full mouth assessment:

  • Approximal Plaque Index (API)
    0-100%

  • Sulcus Bleeding Index (SBI)
    0-100 %

    Only on selected teeth:



  • Plaque-Index (PlI)
    Grade 0-3

  • Gingival Index (GI)
    Grade 0-3

  • Suppuration of Pus(SUP)
    Yes - No


Total number of patients included in this pilot study

15 Patients => 15-30 tooth pairs



Materials:

Air Flow Therapy Equipment: Air-Flow Master

Powder: Air Flow Plus- Erythritol, Grain size ~14 µm

Ultrasonic Scaler EMS, Perio- tips

Gracey Currettes, Hu-Friedy
Manufacturer:

Electro Medical Systems EMS SA

Nyon, Switzerland
Distributor Australia:

HENRY SCHEIN HALAS

44 O''Dea Avenue

Waterloo 2017 NSW Australia


Timeline:

Recruitment phase

  • Reevaluation of patients 2-3 months after completion of SRP or during Supportive Periodontal Therapy (SPT) inclusive API/SBI

  • Assessment inclusion- and exclusion criteria, written information and consent of the patient

  • Professional prophylaxis (PPX) inclusive oral hygiene instructions (OHI)

  • Impression (Alginate) of the respective jaw, fabrication of a cast and a splint with references for measuring clinical attachment level


Randomization

The 2 selected pockets of each patient are randomly assigned to test- or control group by “coin toss”.


Baseline-measurements (2-3 weeks after PPX):

Assessment clinical variables, collection of subgingival plaque samples, OHI, clinical photographs


Periodontal Therapy:

Test Group: Air-Polishing therapy

Control Group: Conventional SRP using ultrasonic scalers and hand currettes

The periodontal therapy will be repeated again in the test and control group in an identical manner after 3 months. This will keep in line with the regular supportive periodontal therapy regimen that the patient’s would be receiving following their initial phase of treatment.


Control assessments:
Clinical investigations


Microbiological investigations:

  • Baseline

  • Immediately after therapy

  • 1 week after therapy

  • 1 month after therapy

  • 3 months after therapy

  • 6 months after therapy


Time required for treatment:

  • Record the time required for each round of the control therapy

  • Record the time required for each round of the test therapy



Bias:

The present study is a prospective randomized single-blinded controlled clinical pilot study.

That means that the assessment of the variables and the treatment of the patients are performed by two different dentists. The dentist who is assessing the variables and collecting the subgingival plaque samples doesn’t know which therapy was or will be performed at which tooth (test vs. control group).

Safety / circumstances under which the study will be terminated

All measures on patients will be continuously supervised by a periodontal specialist.

All clinical measures mentioned above are part of the normal maintenance therapy (SPT) of a patient with a mild or moderate chronic periodontitis. Additional measures, which are only performed for this study are impressions, stent and repeated collection of the subgingival plaque samples. All the additional measures are considered as non- or only minimal invasive measures.

Air Polishing using glycine powder is already used conventionally during maintenance therapy. The Air Polishing equipment, Airlfow Master and Powder Plus (erythritol powder), used in the present study is TGA-approved and is already marketed in Australia. There are no studies/reports describing any significant side-/adverse effects with this system.

The application of different low abrasive powders used in air polishing therapy has already been published in various studies. There are no side-/adverse effects reported. Petersilka et al. for example observed no adverse effects of Glycine powder air polishing on the periodontal structures. According to patients’ perception, air polishing was significantly more comfortable than the use of curettes during SPT. These results were recently confirmed by Wennstrom et al 2011 who reported no adverse effects with the use of erythritol powder. Moreover, patients reported a statistically significant increase in comfort with the use of the air polishing compared to debridement using ultrasonic instruments.

Therefore, based on the current state of knowledge and the current literature, there are no circumstances expected under which the study has to be terminated.

Complications associated with the conventional periodontal therapy will be treated as appropriate and addressed/reported according to the protocol/policy of the Sydney Dental Hospital / The Sydney Local Health District (IMS).

Nevertheless, in the unlikely case of any serious side-/adverse effects, the study would be stopped and further investigation to evaluate these problems would be undertaken.


Withdrawal

Every patient can withdraw from the study at any time without any negative impact on his current or further therapy.


Explanatory power of this study

The present study could provide valuable data regarding the efficacy of air polishing therapy with erythritol in SPT patients with persisting pockets ≥ 5 mm, BOP and ongoing attachment loss.

This could reduce the damage from over-instrumentation, reduce clinical time and enhance patient comfort. This could also help to reduce the use of local and/or systemic antibiotics as well as the need for periodontal surgery with all their negative side/adverse effects and costs.
Data Analysis / Power calculation

The present study is considered as a pilot study to evaluate possible beneficial effects of the EMS AirFlow Master System with the use of Powder Plus as erythritol based powder for supra and subgingival use.

After completion of the 15 patients or 15-30 tooth pairs enrolled in this study, the received data will be evaluated to verify whether there is any evidence/hint of a beneficial effect of the use of the AirFlow System with AirFlow Powder Plus (erythritol), compared to the conventional supportive periodontal therapy.

To describe the clinical and microbiological results, box and whisker plots (of the main variables) including median, upper and lower quartiles, minimum and maximum data values will be generated. For the statistical analyses of the clinical and microbiological parameters, a Generalized-Estimation-Equation-Modell with the influencing quantities treatment group, observation time, gender and age will be adjusted.

In case of an evidence/hint of a beneficial effect of the use of the Airflow System with Eythritol, the recruitment of additional patients will be discussed with the ethical committee to further validate the efficacy of AirFlow with an erythritol powder in supportive periodontal therapy.

Investigator obligations

Storage of data

All clinical variables will be measured by a computerized probe (Florida Probe). The received data will be stored on the associated computer. A back-up of the clinical data as well as the microbiological data will be stored on the PC of A/Prof. Spahr.


Adverse event reporting

Adverse events will be addressed/reported according to the protocol/policy of the The Sydney Local Health District (Incident Information Management System IIMS).

Incident Management NSW Health: Document Number PD2007_061
Handling of adverse events

Adverse events/complications will be clinically treated as appropriate and addressed/reported according to the protocol/policy of The Sydney Local Health District (IIMS).



List of References:

Badersten A, Nilveus R, Egelberg J. Effect of non- surgical periodontal therapy. I. Moderately advanced periodontitis. J Clin Periodontol 1981;8:57-72.

Badersten A, Nilveus R, Egelberg J. Effect of non- surgical periodontal therapy. III. Single versus repeated instrumentation. J Clin Periodontol 1984;11: 114-124.

Badersten A, Nilveus R, Egelberg J. Effect of non- surgical periodontal therapy. II. Severely advanced periodontitis. J Clin Periodontol 1984;11:63-76.

Fogel HM, Pashley DH (1993) Effect of periodontal root planning on dentine permeability. Journal of Clinincal Periodontology 20: 673-677

Hägi T, Hofmänner P, Salvi G, Ramseier C, Sculean A (2013). Clinical outcomes following subgingival application of a novel erythritol powder by means of air polishing in supportive periodontal therapy: a randomised, controlled clinical study. Quintessence International 44(10):753-61

Hung HC and Douglass CW. (2002). Meta-analysis of the effect of scaling and root planing, surgical treatment and antibiotic therapies on periodontal probing depth and attachment loss. J. Clin. Periodontol. 29(11):975-986.

Lang NP, Bragger U, Salvi GE. & Tonetti MS. (2008) Supportive periodontal therapy (SPT). In Lang, N. P. & Lindhe, J (eds). Clinical Periodontology and Implant Dentistry, 5th edition, pp. 1297–1317. Oxford: Blackwell Publishing Ltd.

Magnusson I, Lindhe J, Yoneyama T, Liljenberg B. Recolonization of a subgingival microbiota following scaling in deep pockets. J Clin Periodontol 1984;11: 193-207. 

Moenne, R., Décaillet, F., Andersen, E. & Mombelli, A. (2010) Subgingival plaque removal using a new air- polishing device. Journal of Periodontology 81, 79– 88.

Petersilka, GJ., Bell, M., Haberlein, I., Mehl, A., Hickel, R. & Flemmig, T. F. (2003a) In vitro evaluation of novel low abrasive air polishing powders. Journal of Clinical Periodontology 30, 9–13.

Petersilka, GJ., Steinmann, D., Haberlein, I., Heinecke, A. & Flemmig, T. F. (2003c) Subgingival plaque removal in buccal and lingual sites using a novel low abrasive air-polishing powder. Journal of Clinical Periodontology 30, 328–333.

Petersilka, GJ., Tunkel, J., Barakos, K., Heinecke, A., Haberlein, I. & Flemmig, T. F. (2003d) Subgingival plaque removal at interdental sites using a low- abrasive air polishing powder. Journal of Perio- dontology 74, 307–311.

Petersilka, GJ. (2011) Subgingival air-polishing in the treatment of periodontal biofilm infections. Periodontology 2000 55, 124–142.

Salvi GE., Mombelli A., Rutar. A. Suvan J., Garrett S. Lang N. P. (2002). Local antimicrobial therapy after initial periodontal treatment. A randomized clinical trial comparing three biodegradable sustained release polymers. J. Clin. Periodontol. 29(6):540-550.

van der Weijden, GA. & Timmerman, MF. (2002) A systematic review on the clinical efficacy of subgingival debridement in the treatment of chronic periodontitis. Journal of Clinical Periodontology 29 (Suppl. 3), 55–71.

Wennström JL, Dahlén G, Ramberg P. Subgingival debridement of periodontal pockets by air polishing in comparison with ultrasonic instrumentation during maintenance therapy. J Clin Periodontol 2011;38:820–827. 

Zappa U, Smith B, Simona C, Graf H, Case D. & Kim W. (1991) Root substance removal by scaling and root planing. Journal of Periodontology 62, 750–754. 



Abbreviations (in alphabetical order)

Ap Air Polishing Therapy

A.a. Aggregatibacter actinomycetemcomitans

API approximal plaque index

BOP bleeding on probing

CAL clinical attachment level

GI gingival index

P.g. Porphyromonas gingivalis

P.i. Prevotella intermedia

PlI plaque index

PPD probing pocket depth

PPX professional prophylaxis

SBI sulcus bleeding index

SRP scaling and root planning

SPT supportive periodontal therapy

SUP suppuration

T.d. Treponema denticola

T.f. Tanerella forsythensis

Devices:

AirFlow Master



* TGA approval for device and powder attached



Study Protocol Version 2 08/10/2014





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