Cementation (MeSH Unique ID: D002484)NCT03581565
Cementation Techniques for Single-tooth Implant Crowns
A study testing zinc polycarboxylate (with the requirements of ISO 9917) in people with Cementation (MeSH Unique ID: D002484) and Dental Implant-Abutment Design (MeSH Unique ID: D059605), run by Kıvanç Akça at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cementation (MeSH Unique ID: D002484), Dental Implant-Abutment Design (MeSH Unique ID: D059605), Crown (MeSH Unique ID: D003442) Surfaces
- What is being tested?
- zinc polycarboxylate (with the requirements of ISO 9917)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Oct 2017to 25 May 2018
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University Faculty of Dentistry Department of Prosthodontics
Ankara, 06100
About this study
Official title: Effect of Cementation Technique Applied for Single-tooth Implant Crowns on Residual Cement: A Three-arm Parallel-group Randomized Clinical Trial
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.
Read the detailed description
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
- 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
- Being tested
- zinc polycarboxylate (with the requirements of ISO 9917)
- Keywords
- cementation, dental implant, crown, periimplantitis
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Other: zinc polycarboxylate (with the requirements of ISO 9917) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 30 minutes
Secondary outcomes (1)
visual assessment of residual cement around the peri-implant soft tissue
removal of cemented crown-abutment complex to detect excess cement on the peri-implant soft tissue contacting the mesial, distal, buccal and lingual surfaces of crown-implant complex scoring: presence or absence
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2018
- Study start16 Oct 2017
- Primary completion19 Mar 2018
- Study completion25 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cementation (MeSH Unique ID: D002484)Studies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kıvanç Akça
- Sponsor type
- University, hospital or other
- Collaborators
- Hacettepe University
- Responsible party
- Sponsor-investigator, Kıvanç Akça, Hacettepe University
- Investigators
- Kıvanç Akça, Prof.Dr., Study director, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03581565
- Sponsor's protocol ID
- KA-17043
- Other IDs
- THD-2018-16143
- Status last verified
- Jun 2018
- First submitted
- 6 Jun 2018
- Last updated
- 10 Jul 2018
- 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 10 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cementation Technique Applied for Single-tooth Implant Crowns on Residual Cement: A Three-arm Parallel-group Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03581565
- Acronym / sponsor ID
- KA-17043
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Kıvanç AkçaUniversity, hospital or other
- Collaborators
- Hacettepe University
- Study start
- 16 Oct 2017 (actual)
- Primary completion
- 19 Mar 2018 (actual)
- Study completion
- 25 May 2018 (actual)
- First posted
- 10 Jul 2018 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Technique I | Active comparator | Other: zinc polycarboxylate (with the requirements of ISO 9917)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 |
| Technique II | Active comparator | Other: zinc polycarboxylate (with the requirements of ISO 9917)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 |
| Technique III | Active comparator | Other: zinc polycarboxylate (with the requirements of ISO 9917)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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
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 |
|---|---|---|
| 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 | Other | Technique I, Technique II, Technique III |
Primary outcome
visual assessment of residual cement on crown-abutment complex
Time frame: 15 minutes
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
measurement of residual cement area and distribution
Time frame: 30 minutes
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
1 secondary outcome
visual assessment of residual cement around the peri-implant soft tissue
Time frame: 15 minutes
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 10 Jul 2018.
- Individual participant dataSharing planned: No
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.
Kıvanç Akça, Prof.Dr. study director
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing zinc polycarboxylate (with the requirements of ISO 9917) in people with Cementation (MeSH Unique ID: D002484) and Dental Implant-Abutment Design (MeSH Unique ID: D059605), run by Kıvanç Akça at 1 site in Turkey (Türkiye).
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 7 inclusion and 3 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 10 Jul 2018. 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 Turkey (Türkiye). 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?
visual assessment of residual cement on crown-abutment complex (time frame: 15 minutes). The study lists 2 primary outcomes in all. 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 10 Jul 2018.