Clinical trial NCT06711237: Resin-Cement Type Influence on Cement Remnants in Implant-Supported Restorations
Official title: Comparison of Two Different Excess Cement Clean-up Options for Cementing Metal-free Ceramic Restorations on Dental Implants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Cements
Keywords: cemented restoration
implant-supported fixed dental prosthesis
cement remnants
peri-implant health
Lead sponsor: Vilniaus Implantologijos Centro (VIC) Klinika
Sponsor class: NETWORK
Collaborators: name: Harvard School of Dental Medicine
First posted: 2024-12-02
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: sequential design with a washout period
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Relative ratio between the detectable area covered by cement remnants per crown site and the total crown
timeFrame: Crowns were retrieved for analysis immediately after intraoral cementation and residual cement removal.
Secondary outcomes:
Other outcomes:
Locations:
city: Vilnius
country: Lithuania
facility: Vilnius Implantology Center
Study officials:
affiliation: Vilnius Implantology Center
name: Eglė Vindašiūtė-Narbutė
role: PRINCIPAL_INVESTIGATOR
References: