Cementation Techniques for Single-tooth Implant Crowns

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-16

Study Completion Date

2018-05-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

To Compare Cemented Versus Screw-retained Implant-supported Single Crowns With Customized Zirconia Abutments

NCT01644630

Implant-supported Single Crowns

COMPLETED NA

Cement Excess at Single Implant Crowns Malmö/Lund

NCT04015427

Gingivitis and Periodontal Diseases Tooth Loss

COMPLETED NA

What is the Influence of a Different Thread Pitch Design on Bone Remodelling Around Conical Southern Oral Implants?

NCT01158664

Dental Implants

COMPLETED NA

Resin-Cement Type Influence on Cement Remnants in Implant-Supported Restorations

NCT06711237

Dental Cements

COMPLETED NA

Angulated Screw-retained Crowns Following Immediate Implant Placement

NCT04160247

Tooth Diseases

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Technique I

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

Group Type ACTIVE_COMPARATOR

zinc polycarboxylate (with the requirements of ISO 9917)

Intervention Type OTHER

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

Technique II

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

Group Type ACTIVE_COMPARATOR

zinc polycarboxylate (with the requirements of ISO 9917)

Intervention Type OTHER

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

Technique III

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

Group Type ACTIVE_COMPARATOR

zinc polycarboxylate (with the requirements of ISO 9917)

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

zinc polycarboxylate (with the requirements of ISO 9917)

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes