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Air-polishing or Conventional Treatment

Primary Purpose

Periodontitis, Adult Periodontitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Gracey curette.
Ultrasonic scaler.
Erythritol air-polishing.
Sponsored by
University of Bergen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis focused on measuring Furcation involvement, Periodontal maintenance

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

    -

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Titanium curette and ultrasonic.

    Erythritol air-polishing.

    Arm Description

    Debridement of mandibular furcations with conventional ultrasonic/curette (control).

    Treatment of mandibular furcations with erythritol powder/air-polishing system (test)

    Outcomes

    Primary Outcome Measures

    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.
    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.

    Secondary Outcome Measures

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

    Full Information

    First Posted
    July 23, 2020
    Last Updated
    July 28, 2020
    Sponsor
    University of Bergen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04493398
    Brief Title
    Air-polishing or Conventional Treatment
    Official Title
    Erythritol Air-polishing Versus Curette/Ultrasonic Debridement of Mandibular Furcation Lesions in Supportive Periodontal Therapy A 12-Month Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    June 1, 2015 (Actual)
    Primary Completion Date
    June 30, 2016 (Actual)
    Study Completion Date
    December 1, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Bergen

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Periodontitis, Adult Periodontitis
    Keywords
    Furcation involvement, Periodontal maintenance

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    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
    InvestigatorOutcomes Assessor
    Masking Description
    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. All analyses were performed by a statistician (SAL) who had not taken part in data collection or treatments.
    Allocation
    Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Titanium curette and ultrasonic.
    Arm Type
    Active Comparator
    Arm Description
    Debridement of mandibular furcations with conventional ultrasonic/curette (control).
    Arm Title
    Erythritol air-polishing.
    Arm Type
    Experimental
    Arm Description
    Treatment of mandibular furcations with erythritol powder/air-polishing system (test)
    Intervention Type
    Procedure
    Intervention Name(s)
    Gracey curette.
    Intervention Description
    Root planed was performed with curettes (Gracey SAS, Hu-Friedy, Chicago, IL, USA).
    Intervention Type
    Procedure
    Intervention Name(s)
    Ultrasonic scaler.
    Intervention Description
    Debridement was performed with an ultrasonic scaler (Piezon Master 400 Perio Slim Tip®; Electro Medical System, Nyon, Switzerland).
    Intervention Type
    Procedure
    Intervention Name(s)
    Erythritol air-polishing.
    Intervention Description
    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).
    Primary Outcome Measure Information:
    Title
    In 20 patients with grade II mandibular molar furcation defects, probing depth (PD) will be measured.
    Description
    PD: The vertical distance from the gingival margin to the probable base of the pocket in mm.
    Time Frame
    12 months.
    Title
    In 20 patients with grade II mandibular molar furcation defects clinical attachment level (CAL) will be measured.
    Description
    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.
    Time Frame
    12 months.
    Secondary Outcome Measure Information:
    Title
    Bleeding on probing (BoP).
    Description
    At site level, BoP was recorded as present upon gentle probing to the base of the vertical furcation pocket.
    Time Frame
    12 months.
    Title
    Gingival crevicular fluid (GCF).
    Description
    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.
    Time Frame
    12 months.
    Title
    Visual analogue scale (VAS).
    Description
    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").
    Time Frame
    12 months.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. - Exclusion Criteria: 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. -
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Knut N. Leknes, Professor
    Organizational Affiliation
    Department of Clinical Dentistry - Periodontics, University of Bergen, NORWAY.
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
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