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Comparison of the Effect of Teflon vs Non-Teflon Hand Scalers in the Maintenance of Peri-Implant Tissue

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ClinicalTrials.gov Identifier: NCT03316937
Recruitment Status : Recruiting
First Posted : October 23, 2017
Last Update Posted : May 3, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Dayna Roemermann, University of Manitoba

Brief Summary:

The buccal and lingual surface of the 23 participants' crowns will be randomly assigned to receive scaling and root planing with either Teflon scalers, or non-Teflon scalers after implant crown delivery. Each patient will act as their own control.

Patients will receive scaling and root planing at 3, 6, 9 and 12 months by a calibrated dental hygienist. All surfaces of the implant will be debrided for 1 minute using a transversal movement. Each patient will receive oral hygiene instructions by the hygienist at the end of each maintenance therapy appointment. The participants will be instructed to use a Modified Stillman brushing technique twice per day and cross shoe shine flossing motion once per day. Each patient will be provided with a three-month home care kit with dental aids. These aids will consist of toothpaste, a toothbrush and implant floss.

Measurements will be taken at 0, 3, 6, 9 and 12 months by a calibrated periodontal resident. The parameters assessed at the implant site and patient level will be modified plaque index (IPI) by Mombelli, modified gingival index (IBOP) by Mombelli, implant probing depths (PD) at six sites, presence of keratinized gingiva (KT), recession (REC), Full mouth plaque index (FPI) and Full mouth bleeding on probing (FBOP).

The Peri-implant Crevicular Fluid will be collected at 0, 3, and 12 months by isolating the implant site from saliva and introducing Periopaper strips into the buccal, mesial, distal and lingual sites of the implant sulcus for 30 seconds. The strips will be placed in a sealed Eppendorf tubes and transported by portable freezer to the laboratory where they will be stored at -86 degrees Celsius. The Periopaper samples will be treated for the detection and quantification of the following cytokines: Interleukin-2, Interleukin-4, Interleukin-6, Interleukin-8, Interleukin-10, Tumor Necrosis Factor alpha and Interferon gamma.

Periapicals will be taken at baseline and 12 months. All radiographs will be standardized.

After 12 months, the implant crown will be removed and the implant crown's surface alterations will be evaluated using atomic force microscopy (AFM) using the RA, or average roughness, and the RZ, or mean roughness depth, scores. The implant crown surface will then be repolished/reglazed and delivered back to the patient's mouth. Crowns will be evaluated before delivery to determine adequate level of smoothness.

Based on the presence of cytokines in the Peri-implant Crevicular Fluid, the degree of surface alterations, the modified plaque index, implant probing depths, full mouth plaque index, and full mouth bleeding on probing, we can determine if scratching affects the inflammation around the screw retained dental implant.


Condition or disease Intervention/treatment Phase
Surface Roughness Maintenance of Dental Implants Inflammation Procedure: Types of scalers Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: The buccal and lingual surface of the 23 participants' crowns will be randomly assigned to receive scaling and root planing with either Teflon scalers, or non-Teflon scalers after implant crown delivery. Each patient will act as their own control.
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Comparison of the Effect of Teflon vs Non-Teflon Hand Scalers in the Maintenance of Peri-Implant Tissue: A Randomized Clinical Trial
Actual Study Start Date : January 10, 2018
Estimated Primary Completion Date : May 1, 2018
Estimated Study Completion Date : June 1, 2019

Arm Intervention/treatment
Experimental: Teflon Scaler
The buccal and lingual surface of the 23 participants' crowns will be randomly assigned to receive scaling and root planing with either Teflon scalers, or non-Teflon scalers after implant crown delivery. Each patient will act as their own control.
Procedure: Types of scalers
Scaling

Experimental: Non Teflon Scaler
The buccal and lingual surface of the 23 participants' crowns will be randomly assigned to receive scaling and root planing with either Teflon scalers, or non-Teflon scalers after implant crown delivery. Each patient will act as their own control.
Procedure: Types of scalers
Scaling




Primary Outcome Measures :
  1. Degree of surface roughness [ Time Frame: 12 months ]
    The implant crown's surface alterations will be evaluated using atomic force microscopy (AFM) using the average roughness (Ra) and the mean roughness depth (Rz), scores. Crowns will be evaluated before delivery to determine adequate level of smoothness. For our study, Ra and Rz should range from 0.1µm to 0.5µm. Higher values represent more scratching.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • patients who require a single unit implant crown
  • patients requiring a single, screw retained, zirconia implant supported crown
  • patient who are non-smokers

Exclusion Criteria:

  • patients on corticosteroids
  • patients who have used antibiotics within the preceding 3 months
  • patients with uncontrolled diabetes mellitus
  • patients on daily nonsteroidal anti-inflammatory drugs
  • patients who are smokers.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03316937


Contacts
Contact: Dayna L Roemermann, DMD 204-792-1044 droemermann@gmail.com

Locations
Canada, Manitoba
University of Manitoba; College of Dentistry; Faculty of Periodontics Recruiting
Winnipeg, Manitoba, Canada, R3E0W2
Contact: Dayna Roemermann, DMD    204-792-1044    droemermann@gmail.com   
Contact: Anastasia Cholakis    204-975-7765    anastasia.cholakis@umanitoba.ca   
Sponsors and Collaborators
University of Manitoba

Publications:

Responsible Party: Dr. Dayna Roemermann, Principal Investigator - Periodontics Resident, University of Manitoba
ClinicalTrials.gov Identifier: NCT03316937     History of Changes
Other Study ID Numbers: B2017:124
First Posted: October 23, 2017    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Inflammation
Pathologic Processes