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Amount of Cementum After Scaling, Root Planing and Glycine Air Polishing

Primary Purpose

Dental Diseases

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Air Flow Master Piezon®, EMS SA, Nyon, Swiss
Gracey curettes, American Eagle, Missoula, MT, USA
Air-flow® Powder Perio, EMS SA, Nyon, Swiss
Sponsored by
University of Roma La Sapienza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Diseases focused on measuring Residual cementum, root surface instrumentation, ultrasonic scaling, air polishing with glycine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • systemic factors (no systemic diseases; no medications affecting periodontal status in the previous 6 months; no pregnancy or lactation;
  • behavioral factors (no smoking habits);
  • dental and periodontal factors not to have had previous periodontal therapy; no class III dental mobility;
  • a periodontal probing depth (PPD) ≥ 4 mm in at least two sites per tooth with single rooted ;
  • have no caries or restorations on the mesial and distal surfaces and bleeding on probing.

Exclusion Criteria:

  • systemic diseases; medications affecting periodontal status in the previous 6 months; pregnancy or lactation
  • smoking habits
  • have caries or restorations on the mesial and distal surfaces and bleeding on probing.
  • have had previous periodontal therapy; class III dental mobility;

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Ultrasonic instrumentation

    Hand instrumentation

    subgingival airpolishing with glycine

    ultrasonic following airpolishing

    Arm Description

    Prior to extraction, the teeth (N = 12) were randomly included into ultrasonic instrumentation (Air Flow Master Piezon®, EMS SA, Nyon - Swiss) treatment group

    Prior to extraction, the teeth (N = 12) were randomly included into hand curette (Gracey curettes, American Eagle, Missoula, MT, USA) treatment group hand instrumentation (Gracey curettes 5/6, 11/12, 13/14 American Eagle, Missoula, MT, USA)

    Prior to extraction, the teeth (N = 12) were randomly included into air-polishing (Air Flow Master Piezon®, EMS SA, Nyon - Swiss) with the glycine powder (Air-flow® Powder Perio, EMS) treatment group. subgingival airpolishing with glycine(Air-flow® Powder Perio, EMS SA, Nyon, Swiss)

    Prior to extraction, the teeth (N = 12) were randomly included into ultrasonic following airpolishing ( Air Flow Master Piezon®, EMS SA, Nyon, Swiss) (Air-flow® Powder Perio, EMS SA, Nyon, Swiss) with the glycine powder treatment group

    Outcomes

    Primary Outcome Measures

    thickness of cementum
    After instrumentations the teeth extractions (n=48) were done and the teeth were stored in the solution of NaCl. Upon extracting the teeth were sectioned perpendicularly to the root axis with a microtome (Leica, RM2245, Wetzlar, Germany) between 10 and 15 µm thickness and stained with hematoxylin and eosin (Leica Autostainer XL, Wetzlar, Germany). Two horizontally root sections of each tooth were taken from coronal and apical part of instrumented area for a total 96 histologic specimens. Coronal sections were taken 1 mm apically from the gingival margin, whereas apical sections were taken 1 mm coronally from the endpoint of periodontal pocket. The teeth were examined by an optic microscope (Nikon Eclipse i5, Tokyo, Japan) connected to a camera (Nikon, DS-Filc, Tokyo, Japan) and finally to a dedicated computer. The thickness of the cementum was measured by a specific software (Nikon, NIS Elements 4.0, Tokyo, Japan).

    Secondary Outcome Measures

    Remaining calculus index (RCI) with SEM evaluation
    Before sectioning, the root surface characteristics of 20 randomly selected teeth were analyzed under scanning electron microscopy (LEO, EO 435 VP, Marvell Nanofabrication, Berkeley, CA, USA). The roots were gold-sputtered with a sputtering device (Agar Sputter Coater, 108 Supply 230, Frequency 50, Essex, UK). Micrographs were taken at magnifications from x48 to x210. Remaining calculus index (RCI) were scored as:0: No calculus remaining on the root surface 1: Small patches of extraneous material, probably consisting of calculus 2: Definite patches of calculus confined to relatively small areas 3: Considerable amount of remaining calculus, appearing as one or a few voluminous patches or as several smaller patches scattered on the treated surface.However, calculus appearance was provided with qualitative information on the mineral and organic composition of the root surface. Additionally, damages, scratches, gouges, cracks, cementum presence and changes in the cementum were noted.

    Full Information

    First Posted
    July 24, 2014
    Last Updated
    July 29, 2014
    Sponsor
    University of Roma La Sapienza
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02205619
    Brief Title
    Amount of Cementum After Scaling, Root Planing and Glycine Air Polishing
    Official Title
    Remaining Root Substance Comparing a New Ultrasonic Scaling Device, Hand Instrumentation and Subgingival Air Polishing With Glycine. An in Vivo and in Vitro Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2013 (undefined)
    Primary Completion Date
    January 2014 (Actual)
    Study Completion Date
    July 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Roma La Sapienza

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study was to evaluate the residual cementum with the histological measurements and root surface topography with SEM evaluation using four periodontal treatment methods.
    Detailed Description
    Cementum is a component of the periodontium, and its major role is to serve as the site of attachment for principal collagen fibers (Sharpey' s fibers). In particular, cementum, by virtue of its structural and dynamic qualities, provides tooth attachment and maintenance of occlusal relationships between the jaws. Its multiple functions are fulfilled by the biological activity and reactivity of cementoblasts, which deposits two collagen-containing varieties of cementum with completely different properties. Periodontal disease is the local inflammation of the supporting tissues of teeth, it causes destruction of gingival tissues, bone loss and loss of connective tissue attachment to cementum. Since the relationship between local bacteria and periodontal disease has been proved and widely recognised, it is generally accepted that removal of pathogenic microorganisms that form plaque and calculus is the major goal of periodontal treatment. This therapy currently consists of scaling and root planing, but in addition to mechanical instrumentation, regeneration and restoration of various periodontal components to their original form, function and consistency should be performed. Previously it was accepted that bacterial endotoxins or bacteria penetrate the cementum of periodontally diseased root surfaces. Therefore, besides the removal of the subgingival plaque and calculus deposits, the removal of all or most of the cementum was one of the primary endpoints of periodontal healing. The goal of periodontal therapy was to attain a planed root surface with a smooth and hard surface characteristics and free of endotoxins as the cementum of a tooth prior to eruption. While some studies have reported that endotoxins are not located within cementum it has been accepted that the removal of 'diseased' cementum was not necessary for a successful periodontal treatment. Saygin et al. reported that cementum is the site where soft-tissue attachment has to be re-established, and cementum matrix is a rich source of many growth factors which influence the activities of various periodontal cell types and Grzesik et al. stated that cementum plays a regulatory role in periodontal regeneration. From these studies it can be concluded that non-aggressive periodontal treatment is necessary for optimal periodontal health as well as for periodontal regeneration. During periodontal therapy subgingival instrumentation by means of the removal of root cementum can be eventually lead to exposure of dentinal tubules, pulp injury and dentin hypersensitivity. The in vitro studies including establishing in vitro experimental models under standardized experimental conditions evaluated the amount of cementum with various instruments or force combinations. Several studies, which showed the effects of different instruments on root surfaces, emphasized that periodontal treatment can be performed less aggressively with respect to the removal of cementum. Previously reported that the teeth treated by HC and US can present a surface without cementum and the open dentinal tubules.They reported that root surfaces treated by US showed a scaly and rough topography whether the teeth treated with HC presented smooth surfaces. Kawashima and co-workers compared two different piezoelectric US (VectorTM and EnacR scaler) and HC and found that both US groups had significantly more remaining cementum than the HC group. However they observed some areas with thin or absent cementum in the HC group. Ruhling et al. compared the effects of the piezoelectric US, sonic scaler (SS), sonic scaler insert coated with Teflon tube, Periotor insert and HC. They showed that HC and SS group presented greater removal of root cementum and nearly all cementum was removed in 25% of the samples treated with HC. Tomasi et al. reported that biofilm and calculus certainly should be removed but also they questioned the requirement for removal of contaminated root cementum by root planing. US with new shaped tips and AP devices as alternative to HC designed for subgingival access have been developed for minimal root damage. In recent years, there are newly developed instruments presenting clinically efficient results in the treatment of chronic periodontitis. Subgingival AP has been suggested as a treatment modality for root debridement. Two recent studies have investigated the clinical and microbiological efficacy of subgingival AP by glycine powder in periodontal pockets and they revealed probing depth reductions and removal of subgingival biofilm. Today there is no scientific research evidence showing the loss of root substance or surface roughness by subgingival AP or US instrumentation with AP. The aim of the present study was to compare the effect of in vivo root instrumentation using a new piezoelectric US instrument, HC and air polishing by glycine powder, under routine clinical conditions, on the thickness and surface characteristics of cementum. Forty-eight periodontally involved caries free, single rooted teeth with advanced periodontitis scheduled for extraction treated in four different methods. The teeth were instrumented subgingivally at one approximal site either by hand curettes (HC), piezoelectric ultrasonic scaler (US), piezoelectric ultrasonic scaler following air polishing, air polishing (AP) alone. Upon extracting the teeth, instrumented and other non-instrumented sites analyzed with a dissecting microscope and SEM for the measurement of amount and surface characteristics of residual cementum.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dental Diseases
    Keywords
    Residual cementum, root surface instrumentation, ultrasonic scaling, air polishing with glycine

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Factorial Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    48 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Ultrasonic instrumentation
    Arm Type
    Experimental
    Arm Description
    Prior to extraction, the teeth (N = 12) were randomly included into ultrasonic instrumentation (Air Flow Master Piezon®, EMS SA, Nyon - Swiss) treatment group
    Arm Title
    Hand instrumentation
    Arm Type
    Experimental
    Arm Description
    Prior to extraction, the teeth (N = 12) were randomly included into hand curette (Gracey curettes, American Eagle, Missoula, MT, USA) treatment group hand instrumentation (Gracey curettes 5/6, 11/12, 13/14 American Eagle, Missoula, MT, USA)
    Arm Title
    subgingival airpolishing with glycine
    Arm Type
    Experimental
    Arm Description
    Prior to extraction, the teeth (N = 12) were randomly included into air-polishing (Air Flow Master Piezon®, EMS SA, Nyon - Swiss) with the glycine powder (Air-flow® Powder Perio, EMS) treatment group. subgingival airpolishing with glycine(Air-flow® Powder Perio, EMS SA, Nyon, Swiss)
    Arm Title
    ultrasonic following airpolishing
    Arm Type
    Experimental
    Arm Description
    Prior to extraction, the teeth (N = 12) were randomly included into ultrasonic following airpolishing ( Air Flow Master Piezon®, EMS SA, Nyon, Swiss) (Air-flow® Powder Perio, EMS SA, Nyon, Swiss) with the glycine powder treatment group
    Intervention Type
    Device
    Intervention Name(s)
    Air Flow Master Piezon®, EMS SA, Nyon, Swiss
    Other Intervention Name(s)
    Piezoelectric ultrasonic instrumentation
    Intervention Description
    comparison of different instruments on root cementum: Instrumentations with US devices ( Air Flow Master Piezon®, EMS SA, Nyon, Swiss) were performed with medium power settings and with the use of water cooling (as instructed by the manufacturer). One approximal root surface (distal and mesial) of each tooth was randomly subjected to debridement and the other approximal surface was used as control. All the instrumentations of teeth were performed by a single operator. The criteria for adequate treatment were smooth, hard root surfaces, with no remnants of calculus. The cleanliness and smoothness of the root surface were checked using a fine dental explorer. The instrumentations were done under local anesthesia.
    Intervention Type
    Device
    Intervention Name(s)
    Gracey curettes, American Eagle, Missoula, MT, USA
    Other Intervention Name(s)
    hand instrumentation
    Intervention Description
    comparison of different instruments on root cementum Hand instruments (Gracey curettes 5/6, 11/12, 13/14 American Eagle, Missoula, MT, USA) were used for subgingival root instrumentation. The criteria for adequate treatment were smooth, hard root surfaces, with no remnants of calculus. The cleanliness and smoothness of the root surface were checked using a fine dental explorer. The instrumentations were done under local anesthesia.
    Intervention Type
    Device
    Intervention Name(s)
    Air-flow® Powder Perio, EMS SA, Nyon, Swiss
    Other Intervention Name(s)
    subgingival airpolishing with glycine
    Intervention Description
    comparison of different instruments on root cementum: Instrumentations with air polishing (Air-flow® Powder Perio, EMS SA, Nyon, Swiss) were performed with a special nozzle and medium power settings and with the use of water cooling (as instructed by the manufacturer). One approximal root surface (distal and mesial) of each tooth was randomly subjected to debridement and the other approximal surface was used as control. All the measurements and instrumentations of teeth were performed by a single operator. The criteria for adequate treatment were smooth, hard root surfaces, with no remnants of calculus. The cleanliness and smoothness of the root surface were checked using a fine dental explorer. The instrumentations were done under local anesthesia
    Primary Outcome Measure Information:
    Title
    thickness of cementum
    Description
    After instrumentations the teeth extractions (n=48) were done and the teeth were stored in the solution of NaCl. Upon extracting the teeth were sectioned perpendicularly to the root axis with a microtome (Leica, RM2245, Wetzlar, Germany) between 10 and 15 µm thickness and stained with hematoxylin and eosin (Leica Autostainer XL, Wetzlar, Germany). Two horizontally root sections of each tooth were taken from coronal and apical part of instrumented area for a total 96 histologic specimens. Coronal sections were taken 1 mm apically from the gingival margin, whereas apical sections were taken 1 mm coronally from the endpoint of periodontal pocket. The teeth were examined by an optic microscope (Nikon Eclipse i5, Tokyo, Japan) connected to a camera (Nikon, DS-Filc, Tokyo, Japan) and finally to a dedicated computer. The thickness of the cementum was measured by a specific software (Nikon, NIS Elements 4.0, Tokyo, Japan).
    Time Frame
    within the first 60 days after extractions
    Secondary Outcome Measure Information:
    Title
    Remaining calculus index (RCI) with SEM evaluation
    Description
    Before sectioning, the root surface characteristics of 20 randomly selected teeth were analyzed under scanning electron microscopy (LEO, EO 435 VP, Marvell Nanofabrication, Berkeley, CA, USA). The roots were gold-sputtered with a sputtering device (Agar Sputter Coater, 108 Supply 230, Frequency 50, Essex, UK). Micrographs were taken at magnifications from x48 to x210. Remaining calculus index (RCI) were scored as:0: No calculus remaining on the root surface 1: Small patches of extraneous material, probably consisting of calculus 2: Definite patches of calculus confined to relatively small areas 3: Considerable amount of remaining calculus, appearing as one or a few voluminous patches or as several smaller patches scattered on the treated surface.However, calculus appearance was provided with qualitative information on the mineral and organic composition of the root surface. Additionally, damages, scratches, gouges, cracks, cementum presence and changes in the cementum were noted.
    Time Frame
    within 30 days after extractions
    Other Pre-specified Outcome Measures:
    Title
    Roughness Loss of Tooth Substance Index (RLTSI) with SEM evaluation
    Description
    Before sectioning, the root surface characteristics of 20 randomly selected teeth were analyzed under scanning electron microscopy (LEO, EO 435 VP, Marvell Nanofabrication, Berkeley, CA, USA). The roots were gold-sputtered with a sputtering device (Agar Sputter Coater, 108 Supply 230, Frequency 50, Essex, UK). Micrographs were taken at magnifications from x48 to x210. Roughness Loss of Tooth Substance Index (RLTSI) were scored as:0: Smooth or even root surface, without marks from the instrumentation and with no loss of tooth substance 1: Slightly roughened or corrugated local areas confined to the cementum 2: Definitely corrugated local areas where the cementum may be completely removed, although most of the cementum is still present 3: Considerable loss of tooth substance, with instrumentation marks extending into the dentin. The cementum is completely removed in large areas or there are a considerable number of lesions due to the instrumentation
    Time Frame
    within 30 days after teeth extractions

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: systemic factors (no systemic diseases; no medications affecting periodontal status in the previous 6 months; no pregnancy or lactation; behavioral factors (no smoking habits); dental and periodontal factors not to have had previous periodontal therapy; no class III dental mobility; a periodontal probing depth (PPD) ≥ 4 mm in at least two sites per tooth with single rooted ; have no caries or restorations on the mesial and distal surfaces and bleeding on probing. Exclusion Criteria: systemic diseases; medications affecting periodontal status in the previous 6 months; pregnancy or lactation smoking habits have caries or restorations on the mesial and distal surfaces and bleeding on probing. have had previous periodontal therapy; class III dental mobility;
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Esra Bozbay, Dr
    Organizational Affiliation
    *Department of Dentistry and Maxillofacial Surgery, Section of Periodontics, School of Dentistry, Sapienza University of Rome, Rome, Italy.
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Francesco Dominici, Dr
    Organizational Affiliation
    *Department of Dentistry and Maxillofacial Surgery, Section of Periodontics, School of Dentistry, Sapienza University of Rome, Rome, Italy.
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Serdar Cintan, Prof
    Organizational Affiliation
    †Department of Periodontology, Faculty of Dentistry, Istanbul University, Istanbul, Turkey.
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Aslan Yasar Gokbuget, Prof
    Organizational Affiliation
    †Department of Periodontology, Faculty of Dentistry, Istanbul University, Istanbul, Turkey.
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Luigi Guida, Prof
    Organizational Affiliation
    ‡Department of Odontostomatological, Orthodontic and Surgical Disciplines, Second University of Naples, Naples, Italy.
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Mehmet Serif Aydin, MSc Bio
    Organizational Affiliation
    §Department of Histology and Embryology, Faculty of Medicine, Bezmialem Vakif University, Istanbul, Turkey.
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Andrea Pilloni, Prof
    Organizational Affiliation
    *Department of Dentistry and Maxillofacial Surgery, Section of Periodontics, School of Dentistry, Sapienza University of Rome, Rome, Italy.
    Official's Role
    Study Director

    12. IPD Sharing Statement

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    Amount of Cementum After Scaling, Root Planing and Glycine Air Polishing

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