Clinical trial NCT03581565: Cementation Techniques for Single-tooth Implant Crowns
Official title: Effect of Cementation Technique Applied for Single-tooth Implant Crowns on Residual Cement: A Three-arm Parallel-group Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cementation (MeSH Unique ID: D002484)
Dental Implant-Abutment Design (MeSH Unique ID: D059605)
Crown (MeSH Unique ID: D003442) Surfaces
Contour: Crown (MeSH Unique ID: D003442) - Dental Implant (MeSH Unique ID: D015921) Abutment
Keywords: cementation
dental implant
crown
periimplantitis
Lead sponsor: Hacettepe University
Sponsor class: OTHER
Collaborators: name: Hacettepe University
First posted: 2018-07-10
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Cement retention has been widely used for implant-supported fixed partial dentures in daily dental practice. The cementation approach indeed offers straightforward clinical application protocol which is basically conceptualized for tooth/teeth supported fixed restorations. However, removal of excess cement around implant restorations presents specific difficulties. More importantly, there are certain biological consequences due to residual cement leftover in peri-implant sulcus. There is no evidence based guidance with regards to cementation techniques applied for implant supported fixed restorations due to limited clinical studies. Therefore the aim of this clinical trial is to compare three different cementation technique with regards to removal of excess cement and other clinical subsidiaries (abutment margin, crown surface and contour) involving indirectly as well.

Detailed description: Single-tooth implant crowns to replace missing molar tooth were addressed to qualify and quantify residual cement on implant-abutment complex and peri-implant soft tissue following cementation. Thirty bone-level dental implants of one kind enrolled in the study. Prior to delivery of screw-retained crowns completed for usual treatment, implants were allocated randomly to a trial comparison group. Three different cement loading approach, ten in each group, was applied using cement-retained trial crowns on prefabricated metal abutments. Following completion of the assigned cementation technique, the trial crown was removed with its abutment accessing from the occlusal hole prepared after removal of excess cement. Then, the presence of residual cement on implant-abutment complex and implant soft tissue in accordance with axial and proximal surfaces was qualified. To quantify the amount of residual cement in accordance with location and distribution, the crown-abutment complex was digitized three-dimensionally using an intra-oral scanner. The output of surface data was evaluated in virtual 3-D image for cement excess, when detected location in the abutment-crown complex is recorded, area and distribution was calculated using a software. The frequency of occurrence and quantity of residual cement of 3-different cementation techniques was statistically evaluated using logistic and linear regression model separately considering abutment margin, crown surface and contour.

Eligibility criteria: Inclusion Criteria:

* completed growth and development
* periodontally and dentally healthy conditions
* missing single molar tooth without free-end edentulism
* bone-level standard diameter of a specific implant from one manufacturer
* complication free healing period for osseointegration following straightforward surgical implant placement
* natural dentition or fixed restoration in dental arch
* signing of informed consent form

Exclusion Criteria:

* absolute systemic contraindications for implant surgery (e.g. bone cancer, radiation therapy)
* relative systemic contraindications for implant surgery (e.g. diabetes, steroid therapy)
* risk factors (e.g. smoking, limited mouth opening)

Primary outcomes:
measure: visual assessment of residual cement on crown-abutment complex
timeFrame: 15 minutes
measure: measurement of residual cement area and distribution
timeFrame: 30 minutes
Secondary outcomes:
measure: visual assessment of residual cement around the peri-implant soft tissue
timeFrame: 15 minutes
Other outcomes:
measure: correlation of abutment margin and crown-abutment contour with 'Outcome 2' measures
timeFrame: 30 minutes
measure: recognition of residual cement on radiographs
timeFrame: 20 minutes
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University Faculty of Dentistry Department of Prosthodontics
Study officials:
affiliation: Hacettepe University
name: Kıvanç Akça, Prof.Dr.
role: STUDY_DIRECTOR
References: