Clinical trial NCT03316937: Comparison of the Effect of Teflon vs Non-Teflon Hand Scalers in the Maintenance of Peri-Implant Tissue
Official title: Comparison of the Effect of Teflon vs Non-Teflon Hand Scalers in the Maintenance of Peri-Implant Tissue: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surface Roughness
Maintenance of Dental Implants
Inflammation
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2017-10-23
Enrollment: 13
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
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.
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Degree of surface roughness
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: University of Manitoba; College of Dentistry; Faculty of Periodontics
state: Manitoba
Study officials:
References:
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