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

NCT03316937 | Completed DMC

• 1 other identifier: B2017:124
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Surface Roughness; Maintenance of Dental Implants; Inflammation

Outcome Measures

Primary Outcomes (1)

• Degree of surface roughness

  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.

  12 months

Study Arms (2)

Teflon Scaler

EXPERIMENTAL

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

Non Teflon Scaler

EXPERIMENTAL

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

Interventions

Types of scalers PROCEDURE

Scaling

Non Teflon Scaler; Teflon Scaler

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

University of Manitoba; College of Dentistry; Faculty of Periodontics

Winnipeg, Manitoba, R3E0W2, Canada

Location

Related Publications (16)

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  PMID: 9663035 BACKGROUND

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  PMID: 22093039 BACKGROUND

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  PMID: 21488970 BACKGROUND

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  PMID: 22814556 BACKGROUND

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  PMID: 22976659 BACKGROUND

• Unursaikhan O, Lee JS, Cha JK, Park JC, Jung UW, Kim CS, Cho KS, Choi SH. Comparative evaluation of roughness of titanium surfaces treated by different hygiene instruments. J Periodontal Implant Sci. 2012 Jun;42(3):88-94. doi: 10.5051/jpis.2012.42.3.88. Epub 2012 Jun 30.

  PMID: 22803010 BACKGROUND

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  PMID: 17760537 BACKGROUND

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  PMID: 15515344 BACKGROUND

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  PMID: 9736367 BACKGROUND

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  PMID: 8820128 BACKGROUND

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  PMID: 9297646 BACKGROUND

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  PMID: 1290792 BACKGROUND

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  PMID: 7640340 BACKGROUND

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator - Periodontics Resident

Model Details: 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.

Study Record Dates

• First Submitted: October 17, 2017
• First Posted: October 23, 2017
• Study Start: January 10, 2018
• Primary Completion: June 6, 2019
• Study Completion: June 6, 2019
• Last Updated: August 16, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)