Cementation Techniques for Single-tooth Implant Crowns

NCT03581565 | Completed

• 2 other identifiers: KA-17043THD-2018-16143
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

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

  15 minutes

Other Outcomes (2)

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

  30 minutes

• recognition of residual cement on radiographs

  20 minutes

Study Arms (3)

Technique I

ACTIVE COMPARATOR

Loading of a zinc polycarboxylate (with the requirements of ISO 9917) cement to fulfill the crown Cement: Poly-F, DentsplySirona, York, Pennsylvania, United States Mixing Ratio: 1 scoop powder: 2 drops liquid Mixing Time (extraoral): 30 seconds Working Time (extraoral): 45 seconds Application (extraoral): placement of mixture into crown using a heidemann Spatula Setting Time (intraoral): 2-8 minutes

Other: zinc polycarboxylate (with the requirements of ISO 9917)

Technique II

ACTIVE COMPARATOR

Loading of a zinc polycarboxylate (with the requirements of ISO 9917) to fill the coronal half of the crown Cement: Poly-F, DentsplySirona, York, Pennsylvania, United States Mixing Ratio: 1 scoop powder: 2 drops liquid Mixing Time (extraoral): 30 seconds Working Time (extraoral): 45 seconds Application (extraoral): placement of mixture into crown using a heidemann Spatula Setting Time (intraoral): 2-8 minutes

Other: zinc polycarboxylate (with the requirements of ISO 9917)

Technique III

ACTIVE COMPARATOR

Application of a zinc polycarboxylate (with the requirements of ISO 9917) to the axial walls of internal surface of crown Cement: Poly-F, DentsplySirona, York, Pennsylvania, United States Mixing Ratio: 1 scoop powder: 2 drops liquid Mixing Time (extraoral): 30 seconds Working Time (extraoral): 45 seconds Application (extraoral): application of mixture into crown using a bonding applicator tip Setting Time (intraoral): 2-8 minutes

Other: zinc polycarboxylate (with the requirements of ISO 9917)

Interventions

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

Technique I; Technique II; Technique III

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Kıvanç Akça: lead
• Hacettepe University: collaborator

Study Sites (1)

Hacettepe University Faculty of Dentistry Department of Prosthodontics

Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Kıvanç Akça, Prof.Dr.

  Hacettepe University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: June 6, 2018
• First Posted: July 10, 2018
• Study Start: October 16, 2017
• Primary Completion: March 19, 2018
• Study Completion: May 25, 2018
• Last Updated: July 10, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)