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PeriodontitisNCT04493398

Air-polishing or Conventional Treatment

A study testing Gracey curette., Ultrasonic scaler. and Erythritol air-polishing. in people with Periodontitis and Adult Periodontitis, run by University of Bergen.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Background: To effectively disrupt microbial biofilm and remove dental calculus with minimal damage to the root surface and soft tissues with limited patient discomfort constitute a significant tenet of periodontal therapy. Read more about this study

Who is it for?
Ages 30 to 80 years
Conditions the study is for
Periodontitis, Adult Periodontitis
What is being tested?
Gracey curette., Ultrasonic scaler. and Erythritol air-polishing.
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
No sites listed yet
Study dates
1 Jun 2015to 1 Dec 2018
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Received supportive periodontal therapy (SPT) every 3-6 months for 2-3 years following periodontal therapy.
  • Having bilateral non-mobile, fully erupted mandibular first, second or third molars with degree II furcation defects.
  • PD≥4 mm with bleeding or pus on probing. -

Who cannot join

  • Mobile mandibular molars, molars with clinical or radiographic evidence of supra-/subgingival calculus or apical pathology.
  • Use of systemic antibiotics within 6 months or SPT within 3 months of study.
  • Any current medical condition affecting periodontal treatment or use of the abrasive air-polishing device.
  • Subjects with diabetes, cancer, HIV/aids, acute infections, disorders that may compromise wound healing, or pregnant women.
  • -

About this study

Official title: Erythritol Air-polishing Versus Curette/Ultrasonic Debridement of Mandibular Furcation Lesions in Supportive Periodontal Therapy A 12-Month Randomized Controlled Trial

Background: To effectively disrupt microbial biofilm and remove dental calculus with minimal damage to the root surface and soft tissues with limited patient discomfort constitute a significant tenet of periodontal therapy. The aim of the present prospective 12-month study was to compare clinical and microbiological effects following an erythritol air-polishing vs. conventional mechanical debridement of furcation defects in a cohort of periodontal maintenance patients.

Methods: Twenty patients with grade II mandibular molar furcation defects volunteered to enroll in this study. In a split-mouth design, two furcation sites in each patient were randomly assigned to either receive subgingival debridement using erythritol air-polishing (test) or conventional ultrasonic/curette debridement (control) at baseline, and at 3, 6, 9 and 12 months. Probing depth, clinical attachment level and bleeding on probing were recorded at 3-month intervals. Subgingival microbiological samples obtained at baseline, 6 and 12 months were analyzed using checkerboard DNA-DNA hybridization. Discomfort from treatment was scored at 12 months using a visual analogue scale.

Read the detailed description

INTRODUCTION.Traditionally, periodontal debridement is accomplished using curettes, sonic or ultrasonic scalers, all presenting comparable outcomes.1,2 However, periodic root instrumentation may lead to dental hard tissue3-6 and soft tissue damage,7 and sensitivity due to exposure of dentinal tubules.8-10 Air-polishing using low abrasive glycine or trehalose powder has been shown to reach similar clinical outcomes as hand and ultrasonic instrumentation, but with less hard tissue loss.11-16 Moreover, air-polishing provides superior outcomes relative to patient comfort and time efficiency.7,11,12,14 Recently, a low abrasive erythritol powder with comparable physical properties to glycine air-polishing powder was introduced for subgingival air-polishing.17 Erythritol, a non-toxic, chemically neutral and completely water-soluble polyol is widely used in food industry as an artificial sweetener. Two studies comparing conventional mechanical debridement with erythritol air-polishing, reported similar results in supportive periodontal therapy (SPT) relative to clinical and microbiological outcomes.18,19 Such observations are also reflected in a systematic review concluding that air-polishing systems as a monotherapy are comparable to conventional therapy in patients undergoing SPT in single- and multi-rooted teeth without furcations.20 Moreover, inhibitory effects on pathogenic bacteria including Porphyromonas gingivalis have also been observed.21 To the investigator's knowledge, no prospective studies investigating the efficacy of a low abrasive erythritol air-polishing system in molar furcation defects during SPT have been reported. The objective of this 12-month prospective study was to compare clinical and microbiological effects following an erythritol air-polishing system vs. conventional mechanical debridement of furcation defects in a cohort of periodontal maintenance patients.

METHOD AND MATERIALS. The study protocol and informed consent following the Helsinki Declaration of 1975 (version 2008) was approved by the Medical Research Ethics Committee (2016/793), University of Bergen, Norway. Participating subjects read and signed the informed consent prior to enrolling in the study.

Prestudy calibration and training. Two operators performed the clinical aspects of this study. Author TS, masked to treatment assignments, performed all clinical recordings and sampling, author IU performed all treatments.

Sample size. The sample size estimation was based on change in PD. A difference of 0.5 mm was considered clinically relevant.22 Standard deviation of the difference between repeated PD measurements from the intra-calibration exercise was 0.5 mm. A power analysis based on 20 subjects and with the level of significance (α) set to 0.05, resulted in 98.9% power to detect a true difference of 0.5 mm.

Treatments. Following baseline examination, mandibular jaw quadrants were randomized (coin toss) to either receive debridement using the erythritol powder/air-polishing system (test) or conventional ultrasonic/curette instrumentation (control) using a split-mouth study design. Sequence of treatments was randomized in a similar fashion. Treatments were delivered at baseline, and repeated at 3, 6, 9 and 12 months. Test sites thus received root debridement using the low abrasive erythritol powder (Air-flow powder plus®, EMS, Nyon, Switzerland ) applied through a Perio-Flow hand piece connected to an airflow unit (Air-Flow Master®, EMS, Nyon, Switzerland). The hand piece was fitted with a nozzle for subgingival delivery directing the power/air jet perpendicular to the root surface at the water exit at the tip of the nozzle. The nozzle was inserted to the apical aspect of furcation sites with PD≥ 4 mm using striking movements over the furcation area for 5 sec.12 Sites adjoining the test site with PD≥ 4 mm were similarly treated.

Control sites were debrided using an ultrasonic scaler (Piezon Master 400 Perio Slim Tip®; Electro Medical System, Nyon, Switzerland) with power set at 75% and water as coolant, and root planed with sharp curettes (Gracey SAS, Hu-Friedy, Chicago, IL, USA).

Patients were returned to their regular SPT upon completion of study. Gingival crevicular fluid assessments. Gingival crevicular fluid (GCF) was recorded at baseline, and at 6 and 12 months. Briefly, furcation sites were isolated with cottons rolls, cleaned for supragingival plaque, and air-dried. A perio paper strip was then placed 1-2 mm into the orifice of the site and left in place for 30 sec. Next, the perio strip was inserted into the Periotron 8000® (Oraflow, Smithtown, NY, USA) calibrated to estimate the volume of GCF collected.

Microbiological assessments. At baseline, and at 6 and 12 months the supragingival area above the furcation site was wiped clean using sterile cotton pellets. Three sterile paper points were then inserted into the pocket of the furcation site. The paper points were kept in place 20 sec27 removed and immersed into pre-reduced, anaerobic transport medium (PRAS; Dental Transport Medium, Morgan Hill, CA, USA).

Pain experience assessments. Visual analogue scale (VAS) scores were used to estimate patient discomfort experienced during test and control treatment.31 Scoring was performed at 12 months following completion of the debridement with 0="no pain" and 100="worst pain I can imagine".

Statistical analysis Data were entered into MS-Excel (Microsoft, Redmond, WA, USA ) proofed for errors and then imported into Stata, version 15 (StataCorp, College Station, TX, USA).

Summary statistics (means ± SEM) for the clinical variables were calculated for the test and control at baseline, and at 6 and 12 months. Due to the repeated nature of data, a mixed effect model taking into consideration incomplete data at 12 months was applied to analyze the data at patient and tooth level. Time and treatment were considered fixed factors. Mixed models were applied for both primary and secondary outcome variables.

For testing differences in microbial composition at test and control sites harboring different proportions of bacteria >105 at baseline, and at 6 and 12 months, logistic regression models with robust standard error were applied. VAS scores were analyzed using ordinary linear regression models with robust standard error. The level of significance was set at 0.05.

Being tested
Gracey curette., Ultrasonic scaler., Erythritol air-polishing.
Keywords
Furcation involvement, Periodontal maintenance
Medical subject headings
Periodontitis, Chronic Periodontitis

What participants receive

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

  • Gracey curette.Procedure or surgery

    Root planed was performed with curettes (Gracey SAS, Hu-Friedy, Chicago, IL, USA).

  • Ultrasonic scaler.Procedure or surgery

    Debridement was performed with an ultrasonic scaler (Piezon Master 400 Perio Slim Tip®; Electro Medical System, Nyon, Switzerland).

  • Erythritol air-polishing.Procedure or surgery

    Treatment was performed with a low abrasive erythritol powder (Air-flow powder plus®, EMS, Nyon, Switzerland ) applied through a Perio-Flow hand piece connected to an airflow unit (Air-Flow Master®, EMS, Nyon, Switzerland).

Study groups in NCT04493398
Study groupRoleWhat they receive
Titanium curette and ultrasonic.Active comparatorDebridement of mandibular furcations with conventional ultrasonic/curette (control).
Receives: Procedure: Gracey curette.; Procedure: Ultrasonic scaler.
Erythritol air-polishing.ExperimentalTreatment of mandibular furcations with erythritol powder/air-polishing system (test)
Receives: Procedure: Erythritol air-polishing.

What is being measured

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

  1. In 20 patients with grade II mandibular molar furcation defects, probing depth (PD) will be measured.

    PD: The vertical distance from the gingival margin to the probable base of the pocket in mm.

    Measured: 12 months.

  2. In 20 patients with grade II mandibular molar furcation defects clinical attachment level (CAL) will be measured.

    CAL: The vertical distance in mm from the cemento-enamel junction or the margin of a dental restoration to the probable base of the pocket.

    Measured: 12 months.

Secondary outcomes (3)
  1. Bleeding on probing (BoP).

    At site level, BoP was recorded as present upon gentle probing to the base of the vertical furcation pocket.

    Measured: 12 months.

  2. Gingival crevicular fluid (GCF).

    Twenty test and control sites were isolated with cottons rolls, cleaned for supragingival plaque, and air-dried. A perio paper strip was then placed 1-2 mm into the orifice of the site and left in place for 30 sec. The perio strip was inserted into the Periotron 8000® (Oraflow, Smithtown, NY, USA) calibrated to estimate the volume of GCF collected.

    Measured: 12 months.

  3. Visual analogue scale (VAS).

    VAS scores were used to estimate patient discomfort experienced during test and control treatment by drawing a vertical line on a 100-millimeter standardized horizontal line (0="no pain" and 100="worst pain I can imagine").

    Measured: 12 months.

Timeline

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

  1. First posted30 Jul 2020
  2. Study start1 Jun 2015
  3. Primary completion30 Jun 2016
  4. Study completion1 Dec 2018

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
Crossover
Model description
Randomized, single-masked controlled trial (RCT). A split-mouth study design where each of the furcation in the lower jaw molars was randomized to the two specific treatments. Hence, each patient received both interventions randomly allocated to each side of the lower jaw.
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04493398
Sponsor's protocol ID
2016/793
Status last verified
Jul 2020
First submitted
23 Jul 2020
Last updated
30 Jul 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wilson TG Jr. Supportive periodontal treatment introduction--definition, extent of need, therapeutic objectives, frequency and efficacy. Periodontol 2000. 1996 Oct;12:11-5. doi: 10.1111/j.1600-0757.1996.tb00074.x. No abstract available.

    PubMed 9567987
  • Badersten A, Nilveus R, Egelberg J. Effect of nonsurgical periodontal therapy. II. Severely advanced periodontitis. J Clin Periodontol. 1984 Jan;11(1):63-76. doi: 10.1111/j.1600-051x.1984.tb01309.x.

    PubMed 6363463
  • 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
  • Flemmig TF, Petersilka GJ, Mehl A, Hickel R, Klaiber B. Working parameters of a magnetostrictive ultrasonic scaler influencing root substance removal in vitro. J Periodontol. 1998 May;69(5):547-53. doi: 10.1902/jop.1998.69.5.547.

    PubMed 9623897
  • Lie T, Leknes KN. Evaluation of the effect on root surfaces of air turbine scalers and ultrasonic instrumentation. J Periodontol. 1985 Sep;56(9):522-31. doi: 10.1902/jop.1985.56.9.522.

    PubMed 3897504
  • Schmidlin PR, Beuchat M, Busslinger A, Lehmann B, Lutz F. Tooth substance loss resulting from mechanical, sonic and ultrasonic root instrumentation assessed by liquid scintillation. J Clin Periodontol. 2001 Nov;28(11):1058-66. doi: 10.1034/j.1600-051x.2001.281111.x.

    PubMed 11686828
  • 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
  • Fischer C, Wennberg A, Fischer RG, Attstrom R. Clinical evaluation of pulp and dentine sensitivity after supragingival and subgingival scaling. Endod Dent Traumatol. 1991 Dec;7(6):259-65. doi: 10.1111/j.1600-9657.1991.tb00214.x.

    PubMed 1820859
  • Latheef P, Sirajuddin S, Gundapaneni V, Mn K, Apine A. Iatrogenic Damage to the Periodontium Caused by Periodontal Treatment Procedures. Open Dent J. 2015 Jun 26;9:203-7. doi: 10.2174/1874210601509010203. eCollection 2015.

    PubMed 26312087
  • Lin YH, Gillam DG. The Prevalence of Root Sensitivity following Periodontal Therapy: A Systematic Review. Int J Dent. 2012;2012:407023. doi: 10.1155/2012/407023. Epub 2012 Oct 31.

    PubMed 23193405
  • Petersilka GJ, Steinmann D, Haberlein I, Heinecke A, Flemmig TF. Subgingival plaque removal in buccal and lingual sites using a novel low abrasive air-polishing powder. J Clin Periodontol. 2003 Apr;30(4):328-33. doi: 10.1034/j.1600-051x.2003.00290.x.

    PubMed 12694431
  • Petersilka G. Re: "Subgingival plaque removal using a new air-polishing device". Moene R, Decaillet F, Andersen E, Mombelli A. (J Periodontol 2010;81:79-88.). J Periodontol. 2010 Jul;81(7):962-3. doi: 10.1902/jop.2010.100118. No abstract available.

    PubMed 20553116
  • 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.

    PubMed 21861637
  • 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.

    PubMed 21736599
  • Caygur A, Albaba MR, Berberoglu A, Yilmaz HG. Efficacy of glycine powder air-polishing combined with scaling and root planing in the treatment of periodontitis and halitosis: A randomised clinical study. J Int Med Res. 2017 Jun;45(3):1168-1174. doi: 10.1177/0300060517705540. Epub 2017 Apr 20.

    PubMed 28425827

Questions about this trial

What is this clinical trial studying?

A study testing Gracey curette., Ultrasonic scaler. and Erythritol air-polishing. in people with Periodontitis and Adult Periodontitis, run by University of Bergen.

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 3 inclusion and 5 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: finished, as of the sponsor's last update on 30 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

In 20 patients with grade II mandibular molar furcation defects, probing depth (PD) will be measured. (time frame: 12 months.). The study lists 2 primary outcomes in all. 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 NCT04493398, which also lists 45 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 30 Jul 2020.

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