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

NCT02205619 | Completed Phase 2 DMC

• 1 other identifier: ABT-1233-RV
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dental Diseases

Keywords

Residual cementum; root surface instrumentation; ultrasonic scaling; air polishing with glycine

Outcome Measures

Primary Outcomes (1)

• 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).

  within the first 60 days after extractions

Secondary Outcomes (1)

• Remaining calculus index (RCI) with SEM evaluation

  within 30 days after extractions

Other Outcomes (1)

• Roughness Loss of Tooth Substance Index (RLTSI) with SEM evaluation

  within 30 days after teeth extractions

Study Arms (4)

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

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)

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)

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

Device: Air Flow Master Piezon®, EMS SA, Nyon, Swiss; Device: Air-flow® Powder Perio, EMS SA, Nyon, Swiss

Interventions

Air Flow Master Piezon®, EMS SA, Nyon, Swiss DEVICE

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.

Also known as: Piezoelectric ultrasonic instrumentation

Ultrasonic instrumentation; ultrasonic following airpolishing

Gracey curettes, American Eagle, Missoula, MT, USA DEVICE

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.

Also known as: hand instrumentation

Hand instrumentation

Air-flow® Powder Perio, EMS SA, Nyon, Swiss DEVICE

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

Also known as: subgingival airpolishing with glycine

subgingival airpolishing with glycine; ultrasonic following airpolishing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• University of Roma La Sapienza: lead

MeSH Terms

Conditions

Stomatognathic Diseases

Study Officials

• Esra Bozbay, Dr

  *Department of Dentistry and Maxillofacial Surgery, Section of Periodontics, School of Dentistry, Sapienza University of Rome, Rome, Italy.

  PRINCIPAL INVESTIGATOR

• Francesco Dominici, Dr

  *Department of Dentistry and Maxillofacial Surgery, Section of Periodontics, School of Dentistry, Sapienza University of Rome, Rome, Italy.

  STUDY CHAIR

• Serdar Cintan, Prof

  †Department of Periodontology, Faculty of Dentistry, Istanbul University, Istanbul, Turkey.

  STUDY CHAIR

• Aslan Yasar Gokbuget, Prof

  †Department of Periodontology, Faculty of Dentistry, Istanbul University, Istanbul, Turkey.

  STUDY CHAIR

• Luigi Guida, Prof

  ‡Department of Odontostomatological, Orthodontic and Surgical Disciplines, Second University of Naples, Naples, Italy.

  STUDY CHAIR

• Mehmet Serif Aydin, MSc Bio

  §Department of Histology and Embryology, Faculty of Medicine, Bezmialem Vakif University, Istanbul, Turkey.

  STUDY CHAIR

• Andrea Pilloni, Prof

  *Department of Dentistry and Maxillofacial Surgery, Section of Periodontics, School of Dentistry, Sapienza University of Rome, Rome, Italy.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Study Record Dates

• First Submitted: July 24, 2014
• First Posted: July 31, 2014
• Study Start: September 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: July 1, 2014
• Last Updated: July 31, 2014

Record last verified: 2014-07