Dental CementsNCT06711237
Resin-Cement Type Influence on Cement Remnants in Implant-Supported Restorations
A study testing self-adhesive resin cement (RC) and resin-modified glass-ionomer cement (RMGIC) in people with Dental Cements, run by Vilniaus Implantologijos Centro (VIC) Klinika at 1 site in Lithuania.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dental Cements
- What is being tested?
- self-adhesive resin cement (RC) and resin-modified glass-ionomer cement (RMGIC)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteLithuania
- Study dates
- 1 Sep 2021to 1 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Two Different Excess Cement Clean-up Options for Cementing Metal-free Ceramic Restorations on Dental Implants
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).
Read the 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.
- Conditions
- Dental Cements
- Being tested
- self-adhesive resin cement (RC), resin-modified glass-ionomer cement (RMGIC)
- Keywords
- cemented restoration, implant-supported fixed dental prosthesis, cement remnants, peri-implant health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-adhesive resin cement (RC)Other
Single-unit implant-supported single crowns were cemented to the abutments using a self-adhesive resin cement (RC). Residual cement was removed, and the restorations were retrieved for analysis of cement remnants.
resin-modified glass-ionomer cement (RMGIC)Other
Single-unit implant-supported single crowns were cemented to the abutments using a resin-modified glass-ionomer cement (RMGIC). Residual cement was removed, and the restorations were retrieved for analysis of cement remnants.
| Study group | Role | What they receive |
|---|---|---|
| Self-Adhesive Resin Cement (RC) | Experimental | Single-unit implant-supported single crowns were cemented to the abutments using a self-adhesive resin cement (RC). Residual cement was removed, and the restorations were retrieved for analysis of cement remnants. Receives: Other: self-adhesive resin cement (RC); Other: resin-modified glass-ionomer cement (RMGIC) |
| Resin-modified Glass-Ionomer Cement (RMGIC) | Experimental | Single-unit implant-supported single crowns were cemented to the abutments using a resin-modified glass-ionomer cement (RMGIC). Residual cement was removed, and the restorations were retrieved for analysis of cement remnants. Receives: Other: self-adhesive resin cement (RC); Other: resin-modified glass-ionomer cement (RMGIC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative ratio between the detectable area covered by cement remnants per crown site and the total crown
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.
Measured: Crowns were retrieved for analysis immediately after intraoral cementation and residual cement removal.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study start1 Sep 2021
- Primary completion1 Mar 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CementsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- sequential design with a washout period
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vilniaus Implantologijos Centro (VIC) Klinika
- Sponsor type
- Research network
- Collaborators
- Harvard School of Dental Medicine
- Responsible party
- Sponsor
- Investigators
- Eglė Vindašiūtė-Narbutė, Principal investigator, Vilnius Implantology Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06711237
- Sponsor's protocol ID
- VIC1
- Status last verified
- Nov 2024
- First submitted
- 24 Nov 2024
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Different Excess Cement Clean-up Options for Cementing Metal-free Ceramic Restorations on Dental Implants
- ClinicalTrials.gov ID
- NCT06711237
- Acronym / sponsor ID
- VIC1
- Conditions
- Dental Cements
- Keywords
- cemented restoration, implant-supported fixed dental prosthesis, cement remnants, peri-implant health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Vilniaus Implantologijos Centro (VIC) KlinikaResearch network
- Collaborators
- Harvard School of Dental Medicine
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 2 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- sequential design with a washout period
| Arm | Type | Receives |
|---|---|---|
| Self-Adhesive Resin Cement (RC) | Experimental | Other: self-adhesive resin cement (RC), Other: resin-modified glass-ionomer cement (RMGIC)Single-unit implant-supported single crowns were cemented to the abutments using a self-adhesive resin cement (RC). Residual cement was removed, and the restorations were retrieved for analysis of cement remnants. |
| Resin-modified Glass-Ionomer Cement (RMGIC) | Experimental | Other: self-adhesive resin cement (RC), Other: resin-modified glass-ionomer cement (RMGIC)Single-unit implant-supported single crowns were cemented to the abutments using a resin-modified glass-ionomer cement (RMGIC). Residual cement was removed, and the restorations were retrieved for analysis of cement remnants. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| self-adhesive resin cement (RC)Single-unit implant-supported single crowns were cemented to the abutments using a self-adhesive resin cement (RC). Residual cement was removed, and the restorations were retrieved for analysis of cement remnants. | Other | Resin-modified Glass-Ionomer Cement (RMGIC), Self-Adhesive Resin Cement (RC) |
| resin-modified glass-ionomer cement (RMGIC)Single-unit implant-supported single crowns were cemented to the abutments using a resin-modified glass-ionomer cement (RMGIC). Residual cement was removed, and the restorations were retrieved for analysis of cement remnants. | Other | Resin-modified Glass-Ionomer Cement (RMGIC), Self-Adhesive Resin Cement (RC) |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eglė Vindašiūtė-Narbutė principal investigator
Vilnius Implantology Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing self-adhesive resin cement (RC) and resin-modified glass-ionomer cement (RMGIC) in people with Dental Cements, run by Vilniaus Implantologijos Centro (VIC) Klinika at 1 site in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2024.