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Completed

NCT Number: NCT03581565

Cementation Techniques for Single-tooth Implant Crowns

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hacettepe University Faculty of Dentistry Department of Prosthodontics

Ankara, 06100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

zinc polycarboxylate (with the requirements of ISO 9917)

Other

intraoral cementation of single-tooth implant crowns with three different technique, intraoral removal of cement excess upon setting

Primary outcomes

  1. visual assessment of residual cement on crown-abutment complex

    Time frame: 15 minutes

    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

  2. measurement of residual cement area and distribution

    Time frame: 30 minutes

    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

Secondary outcomes

  1. visual assessment of residual cement around the peri-implant soft tissue

    Time frame: 15 minutes

    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

Other outcomes

  1. correlation of abutment margin and crown-abutment contour with 'Outcome 2' measures

    Time frame: 30 minutes

    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

  2. recognition of residual cement on radiographs

    Time frame: 20 minutes

    evaluation of peri-apical radiographs of cemented crowns to detect presence of excess cement on mesial and distal surfaces scoring: presence or absence

Sponsors and collaborators

Lead sponsor

Kıvanç Akça

Other

Collaborators

  • Hacettepe University

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 10, 2018
Registry last updated
Jul 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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