Dental DiseasesPhase 2/3NCT02205619
Amount of Cementum After Scaling, Root Planing and Glycine Air Polishing
A Phase 2/3 study testing Air Flow Master Piezon®, EMS SA, Nyon, Swiss, Gracey curettes, American Eagle, Missoula, MT, USA and Air-flow® Powder Perio, EMS SA, Nyon, Swiss in people with Dental Diseases, run by University of Roma La Sapienza.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Diseases
- What is being tested?
- Air Flow Master Piezon®, EMS SA, Nyon, Swiss, Gracey curettes, American Eagle, Missoula, MT, USA and Air-flow® Powder Perio, EMS SA, Nyon, Swiss
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to Jul 2014
- Phase
- Phase 2/3
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
About this study
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
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.
Read the 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.
- Conditions
- Dental Diseases
- Being tested
- Air Flow Master Piezon®, EMS SA, Nyon, Swiss, Gracey curettes, American Eagle, Missoula, MT, USA, Air-flow® Powder Perio, EMS SA, Nyon, Swiss
- Keywords
- Residual cementum, root surface instrumentation, ultrasonic scaling, air polishing with glycine
- Medical subject headings
- Stomatognathic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Air Flow Master Piezon®, EMS SA, Nyon, SwissDevice
Also called Piezoelectric ultrasonic instrumentation
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.
Gracey curettes, American Eagle, Missoula, MT, USADevice
Also called hand instrumentation
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.
Air-flow® Powder Perio, EMS SA, Nyon, SwissDevice
Also called subgingival airpolishing with glycine
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
| Study group | Role | What they receive |
|---|---|---|
| Ultrasonic instrumentation | Experimental | Prior to extraction, the teeth (N = 12) were randomly included into ultrasonic instrumentation (Air Flow Master Piezon®, EMS SA, Nyon - Swiss) treatment group Receives: Device: Air Flow Master Piezon®, EMS SA, Nyon, Swiss |
| Hand instrumentation | Experimental | 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) Receives: Device: Gracey curettes, American Eagle, Missoula, MT, USA |
| subgingival airpolishing with glycine | Experimental | 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) Receives: Device: Air-flow® Powder Perio, EMS SA, Nyon, Swiss |
| ultrasonic following airpolishing | Experimental | 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 Receives: Device: Air Flow Master Piezon®, EMS SA, Nyon, Swiss; Device: Air-flow® Powder Perio, EMS SA, Nyon, Swiss |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: within the first 60 days after extractions
Secondary outcomes (1)
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.
Measured: within 30 days after extractions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2014 (estimated)
- Study startSep 2013
- Primary completionJan 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental DiseasesStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.Esra Bozbay, University of Roma La Sapienza
- Investigators
- Esra Bozbay, Dr, Principal investigator, *Department of Dentistry and Maxillofacial Surgery, Section of Periodontics, School of Dentistry, Sapienza University of Rome, Rome, Italy.Francesco Dominici, Dr, Study chair, *Department of Dentistry and Maxillofacial Surgery, Section of Periodontics, School of Dentistry, Sapienza University of Rome, Rome, Italy.Serdar Cintan, Prof, Study chair, †Department of Periodontology, Faculty of Dentistry, Istanbul University, Istanbul, Turkey.Aslan Yasar Gokbuget, Prof, Study chair, †Department of Periodontology, Faculty of Dentistry, Istanbul University, Istanbul, Turkey.Luigi Guida, Prof, Study chair, ‡Department of Odontostomatological, Orthodontic and Surgical Disciplines, Second University of Naples, Naples, Italy.Mehmet Serif Aydin, MSc Bio, Study chair, §Department of Histology and Embryology, Faculty of Medicine, Bezmialem Vakif University, Istanbul, Turkey.Andrea Pilloni, Prof, Study director, *Department of Dentistry and Maxillofacial Surgery, Section of Periodontics, School of Dentistry, Sapienza University of Rome, Rome, Italy.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02205619
- Sponsor's protocol ID
- ABT-1233-RV
- Status last verified
- Jul 2014
- First submitted
- 24 Jul 2014
- Last updated
- 31 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02205619
- Acronym / sponsor ID
- ABT-1233-RV
- Conditions
- Dental Diseases
- Keywords
- Residual cementum, root surface instrumentation, ultrasonic scaling, air polishing with glycine
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 31 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ultrasonic instrumentation | Experimental | Device: Air Flow Master Piezon®, EMS SA, Nyon, SwissPrior to extraction, the teeth (N = 12) were randomly included into ultrasonic instrumentation (Air Flow Master Piezon®, EMS SA, Nyon - Swiss) treatment group |
| Hand instrumentation | Experimental | Device: Gracey curettes, American Eagle, Missoula, MT, USAPrior 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) |
| subgingival airpolishing with glycine | Experimental | Device: Air-flow® Powder Perio, EMS SA, Nyon, SwissPrior 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) |
| ultrasonic following airpolishing | Experimental | Device: Air Flow Master Piezon®, EMS SA, Nyon, Swiss, Device: Air-flow® Powder Perio, EMS SA, Nyon, SwissPrior 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Air Flow Master Piezon®, EMS SA, Nyon, SwissAlso: Piezoelectric ultrasonic instrumentationcomparison 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. | Device | Ultrasonic instrumentation, ultrasonic following airpolishing |
| Gracey curettes, American Eagle, Missoula, MT, USAAlso: hand instrumentationcomparison 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. | Device | Hand instrumentation |
| Air-flow® Powder Perio, EMS SA, Nyon, SwissAlso: subgingival airpolishing with glycinecomparison 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 | Device | subgingival airpolishing with glycine, ultrasonic following airpolishing |
Primary outcome
thickness of cementum
Time frame: within the first 60 days after extractions
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).
1 secondary outcome
Remaining calculus index (RCI) with SEM evaluation
Time frame: within 30 days after extractions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esra Bozbay, Dr principal investigator
*Department of Dentistry and Maxillofacial Surgery, Section of Periodontics, School of Dentistry, Sapienza University of Rome, Rome, Italy.
Francesco Dominici, Dr study chair
*Department of Dentistry and Maxillofacial Surgery, Section of Periodontics, School of Dentistry, Sapienza University of Rome, Rome, Italy.
Serdar Cintan, Prof study chair
†Department of Periodontology, Faculty of Dentistry, Istanbul University, Istanbul, Turkey.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Air Flow Master Piezon®, EMS SA, Nyon, Swiss, Gracey curettes, American Eagle, Missoula, MT, USA and Air-flow® Powder Perio, EMS SA, Nyon, Swiss in people with Dental Diseases, run by University of Roma La Sapienza.
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 5 inclusion and 4 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 31 Jul 2014. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
thickness of cementum (time frame: within the first 60 days after extractions). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jul 2014.