Cementation Techniques for Single-tooth Implant Crowns

Cementation (MeSH Unique ID: D002484) Clinical Trial

Official title:

Effect of Cementation Technique Applied for Single-tooth Implant Crowns on Residual Cement: A Three-arm Parallel-group Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03581565
• Other study ID #: KA-17043
• Secondary ID: THD-2018-16143
• Status: Completed
• Phase: N/A
• Start date: October 16, 2017
• Est. completion date: May 25, 2018

Study information

• Verified date: June 2018
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 25, 2018
• Est. primary completion date: March 19, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cementation (MeSH Unique ID: D002484)
• Contour: Crown (MeSH Unique ID: D003442) - Dental Implant (MeSH Unique ID: D015921) Abutment
• Crown (MeSH Unique ID: D003442) Surfaces
• Dental Implant-Abutment Design (MeSH Unique ID: D059605)

Intervention

Other:
• zinc polycarboxylate (with the requirements of ISO 9917)
intraoral cementation of single-tooth implant crowns with three different technique, intraoral removal of cement excess upon setting

Locations

Country	Name	City	State
Turkey	Hacettepe University Faculty of Dentistry Department of Prosthodontics	Ankara

Sponsors (2)

Lead Sponsor	Collaborator
Kivanç Akça	Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	correlation of abutment margin and crown-abutment contour with 'Outcome 2' measures	Recording of stock abutment margin location at mesial, distal, buccal and lingual surfaces in relation to peri-implant soft tissue level measurement in millimeters; Defining of abutment to crown transition angle at mesial, distal, buccal and lingual surfaces description as concave, convex or flat	30 minutes
Other	recognition of residual cement on radiographs	evaluation of peri-apical radiographs of cemented crowns to detect presence of excess cement on mesial and distal surfaces scoring: presence or absence	20 minutes
Primary	visual assessment of residual cement on crown-abutment complex	removal of cemented crown-abutment complex to detect excess cement on the mesial, distal, buccal and lingual surfaces of crown and abutment separately scoring: presence or absence	15 minutes
Primary	measurement of residual cement area and distribution	digitalization of the removed crown-abutment complexes those scored with cement presence, then using a software, virtual selection of existing cement to calculate the area in millimeter square and to define the direction and the extension in millimeters on the mesial, distal, buccal and lingual surfaces of crown and abutment separately	30 minutes
Secondary	visual assessment of residual cement around the peri-implant soft tissue	removal of cemented crown-abutment complex to detect excess cement on the peri-implant soft tissue contacting the mesial, distal, buccal and lingual surfaces of crown-implant complex scoring: presence or absence	15 minutes