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Clinical Trials/NCT06711237
NCT06711237
Completed
Not Applicable

Comparison of Two Different Excess Cement Clean-up Options for Cementing Metal-free Ceramic Restorations on Dental Implants

Vilniaus Implantologijos Centro (VIC) Klinika1 site in 1 country30 target enrollmentSeptember 1, 2021
ConditionsDental Cements

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dental Cements
Sponsor
Vilniaus Implantologijos Centro (VIC) Klinika
Enrollment
30
Locations
1
Primary Endpoint
Relative ratio between the detectable area covered by cement remnants per crown site and the total crown
Status
Completed
Last Updated
last year

Overview

Brief Summary

This study quantitatively compared cement residues of two resin cement types around implant-supported restorations (ISR) with a crown-abutment margin located at the gingival level. This prospective, single-blinded, cross-over clinical trial compared optically detectable cement remnants between Self-Adhesive Resin Cement (RC) and Resin-Modified Glass Ionomer Cement (RMGIC).

Detailed Description

This prospective, two-arm, non-randomized, clinical trial compared detectable cement remnants on 30 patients and 60 ISR. Two cements were compared; self-adhesive resin (RC) and resin-modified glass ionomer (RMGIC). Comparisons were carried out on identical pairs of ISR tested within the same patients with a 1-week healing interval. The primary outcome variable was the ratio of cement-covered area to total crown area. Areas were analyzed ex-situ by standardized digital image analysis.

Registry
clinicaltrials.gov
Start Date
September 1, 2021
End Date
September 1, 2022
Last Updated
last year
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Sponsor
Vilniaus Implantologijos Centro (VIC) Klinika
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • physical and psychological ability to undergo implant therapy (ASA I or II)
  • presence of a single mandibular molar indicated for extraction with adjacent healthy and present natural teeth or implant-supported restoration
  • presence of ≥ 6 mm width and ≥ 10 mm height native bone ridge - presence of intact alveolar bone walls after tooth extraction and presence of interradicular bone \> 4 mm to achieve primary implant stability
  • presence of ≥ 1.5 mm distance to adjacent teeth at the bone level
  • overall healthy, non-inflamed keratinized soft tissues.

Exclusion Criteria

  • Presence of general conditions contributory to dental implant treatment comprising but not limited to:
  • presence of active periodontitis 25
  • poor oral hygiene as determined by the Oral Health Index (OHI)
  • pregnant or lactating
  • presence of uncontrolled medical systemic conditions, e.g. diabetes;
  • ongoing or past medical treatments affecting wound healing, terminated less than 3 months prior to the study-related intervention

Outcomes

Primary Outcomes

Relative ratio between the detectable area covered by cement remnants per crown site and the total crown

Time Frame: Crowns were retrieved for analysis immediately after intraoral cementation and residual cement removal.

Digital photographs of the specimens were obtained using custom-made equipment with a standardized distance. The images were analyzed as follows: the contours of the area covered by residual cement were identified visually after optical magnification and marked; the contours comprising the entire surface area of the prosthetic superstructure, i.e. abutment and crown, were determined; the ratio between the area covered with cement and the total surface area per aspect of the specimen was calculated.

Study Sites (1)

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