An interventional study of Types of scalers in Surface Roughness, Maintenance of Dental Implants and Inflammation, sponsored by University of Manitoba. Completed at 1 site in Canada. Open to participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-16.
Sponsored by University of Manitoba · Not applicable, Interventional, and Treatment
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.
3,536 studies on the registry are indexed under Inflammation; 642 are open to participants now.
This study's enrollment of 13 is below the median of 50 across 2,577 interventional studies indexed under Inflammation.
Browse Inflammation studies →University of Manitoba is the lead sponsor of 555 studies on the registry; 89 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
Time frame: 12 months
Plan to share: No
Ran from Jan 2018 to primary completion in Jun 2019, 16 months.
Of 877 non-industry interventional studies with no phase under Inflammation, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 36. This study's 16 months is below that.
Counting every sponsor, half of 924 studies reached it within 18 months; a quarter within 8 and three quarters within 36.
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This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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