Partial EdentulismNCT03471000
The Influence of the Crown-implant Ratio on the Crestal Bone Level and Implant Secondary Stability
A study testing Short implants Treatment and Regular implants Treatment in people with Partial Edentulism and Tooth Loss, run by Jakub Hadzik.
Trial summary
The aim of the study was to determine whether implant length and the crown-to-implant (C/I) ratio influence implant stability and the loss of the surrounding marginal bone, and whether short implants can be used instead of sinus augmentation procedures. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Partial Edentulism, Tooth Loss
- What is being tested?
- Short implants Treatment and Regular implants Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2012to 1 Jan 2016
- 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
- Non-smoking patients with no systemic or local diseases were qualified.
- Additional inclusion criteria were as follows:
- minimal apicocoronal height of the alveolar ridge of 6 mm in the region of the implant insertion in the pre-surgical qualification
- minimal width of the alveolar ridge of 6-7 mm in the region of interest
- HKT (height of the keratinized tissue) higher than 2 mm
- API ≤ 35 (Approximal Plaque Index)
Show all 9Show fewer
- PI ≤ 25. (Plaque Index)
- Bone Type III or D2 were included in the study
- No graft procedures in the area of interest,
Who cannot join
- -
About this study
Official title: The Influence of the Crown-implant Ratio on the Crestal Bone Level and Implant Secondary Stability - 36 Months Clinical Study
The aim of the study was to determine whether implant length and the crown-to-implant (C/I) ratio influence implant stability and the loss of the surrounding marginal bone, and whether short implants can be used instead of sinus augmentation procedures.
Read the detailed description
The patients participating in the study (n=30) had one single tooth implant - a short (OsseoSpeed™ L6Ø4 mm, Implants) or a regular implant (OsseoSpeed™ L11 and L13Ø4 mm, DENTSPLY Implants) - placed in the maxilla. The evaluation was based on clinical and radiological examination.
The crown-to-implant ratio was determined by dividing the length of the crown together with the abutment by the length of the implant placed crestally. Mean crown-to-implant ratios were calculated separately for each group and its correlation with the MBL (marginal bone loss) and stability was assessed. The authors compared the correlation between the C/I ratio values, MBL and secondary implant stability.
- Conditions
- Partial Edentulism, Tooth Loss
- Being tested
- Short implants Treatment, Regular implants Treatment
- Keywords
- implant, dental implant
- Medical subject headings
- Tooth Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short implants TreatmentOther
Short implants are placed in the alveolar bone and a clinical Ostell and Periotest evaluation of the implants after a period of time is done. Analysis of periapical radiographs and CBCT images after a period of time. Bone around the implant was measured, marginal bone level loss is determined.
Regular implants TreatmentOther
Sinus lift procedure is done and regular implants are placed in the alveolar bone and a clinical Ostell and Periotest evaluation of the implants after a period of time is done. Analysis of periapical radiographs and CBCT images after a period of time. Bone around the implant was measured, marginal bone level loss is determined.
| Study group | Role | What they receive |
|---|---|---|
| Short implants Treatment | Experimental | Group 2 (G2; n=15 patients) had short implants (OsseoSpeed ™ L6mm Ø4 mm) [DENTSPLY Implants, Waltham, MA, USA] placed without sinus lift and augmentation procedure. Receives: Other: Short implants Treatment |
| Regular Implants Treatment | Active comparator | Group 1 (G1; n=15 patients) had conventional dental implants (OsseoSpeed ™ L11 Ø4 mm and L13 Ø4 mm) [DENTSPLY Implants, Waltham, MA, USA] placed, preceded by the sinus lift procedure from a lateral window approach with the application of the xenogeneic bone graft Geistlich Bio-Oss® [Geistlich AG, Wolhusen, Switzerland]. The lateral window approach sinus lift surgery was performed 6 weeks prior to the implant placement by the same surgeon. Receives: Other: Regular implants Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical measurement of implant stability
Evaluation of implant secondary stability in both groups. Stability measured and evaluated with Periotest(R) device - after 36 months.
Measured: 36 months
Secondary outcomes (1)
Radiological measurement of marginal bone loss around implant
Evalation if there is difference in marginal bone level around the implants in both groups. Periapical radiographs and CBCT images taken and the begining and at the end of the observation period will be compared and bone level will be measured. Loss of marginal bone will be calculated.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2018
- Study start1 Jan 2012
- Primary completion1 Jan 2016
- Study completion1 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Partial EdentulismStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jakub Hadzik
- Sponsor type
- University, hospital or other
- Collaborators
- Dentsply Sirona Implants and Consumables, Wroclaw Medical University
- Responsible party
- Sponsor-investigator, Jakub Hadzik, Medical Innovation Center Wroclaw
- Investigators
- Marzena Dominiak, Prof, Principal investigator, Medical University Wrocław
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03471000
- Sponsor's protocol ID
- crown-implant ratio
- Status last verified
- Jan 2020
- First submitted
- 5 Mar 2018
- Last updated
- 14 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hadzik J, Krawiec M, Slawecki K, Kunert-Keil C, Dominiak M, Gedrange T. The Influence of the Crown-Implant Ratio on the Crestal Bone Level and Implant Secondary Stability: 36-Month Clinical Study. Biomed Res Int. 2018 May 16;2018:4246874. doi: 10.1155/2018/4246874. eCollection 2018.
PubMed 29862269
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of the Crown-implant Ratio on the Crestal Bone Level and Implant Secondary Stability - 36 Months Clinical Study
- ClinicalTrials.gov ID
- NCT03471000
- Acronym / sponsor ID
- crown-implant ratio
- Conditions
- Partial Edentulism, Tooth Loss
- Keywords
- implant, dental implant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Jakub HadzikUniversity, hospital or other
- Collaborators
- Dentsply Sirona Implants and Consumables, Wroclaw Medical University
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 1 Jan 2016 (actual)
- Study completion
- 1 Jan 2016 (actual)
- First posted
- 20 Mar 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.
The aim of the study was to determine whether implant length and the crown-to-implant (C/I) ratio influence implant stability and the loss of the surrounding marginal bone, and whether short implants can be used instead of sinus augmentation procedures.
Detailed description
The patients participating in the study (n=30) had one single tooth implant - a short (OsseoSpeed™ L6Ø4 mm, Implants) or a regular implant (OsseoSpeed™ L11 and L13Ø4 mm, DENTSPLY Implants) - placed in the maxilla. The evaluation was based on clinical and radiological examination.
The crown-to-implant ratio was determined by dividing the length of the crown together with the abutment by the length of the implant placed crestally. Mean crown-to-implant ratios were calculated separately for each group and its correlation with the MBL (marginal bone loss) and stability was assessed. The authors compared the correlation between the C/I ratio values, MBL and secondary implant stability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short implants Treatment | Experimental | Other: Short implants TreatmentGroup 2 (G2; n=15 patients) had short implants (OsseoSpeed ™ L6mm Ø4 mm) [DENTSPLY Implants, Waltham, MA, USA] placed without sinus lift and augmentation procedure. |
| Regular Implants Treatment | Active comparator | Other: Regular implants TreatmentGroup 1 (G1; n=15 patients) had conventional dental implants (OsseoSpeed ™ L11 Ø4 mm and L13 Ø4 mm) [DENTSPLY Implants, Waltham, MA, USA] placed, preceded by the sinus lift procedure from a lateral window approach with the application of the xenogeneic bone graft Geistlich Bio-Oss® [Geistlich AG, Wolhusen, Switzerland]. The lateral window approach sinus lift surgery was performed 6 weeks prior to the implant placement by the same surgeon. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Non-smoking patients with no systemic or local diseases were qualified.
- minimal apicocoronal height of the alveolar ridge of 6 mm in the region of the implant insertion in the pre-surgical qualification
- minimal width of the alveolar ridge of 6-7 mm in the region of interest
- HKT (height of the keratinized tissue) higher than 2 mm
- API ≤ 35 (Approximal Plaque Index)
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Short implants TreatmentShort implants are placed in the alveolar bone and a clinical Ostell and Periotest evaluation of the implants after a period of time is done. Analysis of periapical radiographs and CBCT images after a period of time. Bone around the implant was measured, marginal bone level loss is determined. | Other | Short implants Treatment |
| Regular implants TreatmentSinus lift procedure is done and regular implants are placed in the alveolar bone and a clinical Ostell and Periotest evaluation of the implants after a period of time is done. Analysis of periapical radiographs and CBCT images after a period of time. Bone around the implant was measured, marginal bone level loss is determined. | Other | Regular Implants Treatment |
Primary outcome
Clinical measurement of implant stability
Time frame: 36 months
Evaluation of implant secondary stability in both groups. Stability measured and evaluated with Periotest(R) device - after 36 months.
1 secondary outcome
Radiological measurement of marginal bone loss around implant
Time frame: 36 months
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 14 Jan 2020.
- Results publication: PubMed 29862269Hadzik J, Krawiec M, Slawecki K, Kunert-Keil C, Dominiak M, Gedrange T. The Influence of the Crown-Implant Ratio on the Crestal Bone Level and Implant Secondary Stability: 36-Month Clinical Study. Biomed Res Int. 2018 May 16;2018:4246874. doi: 10.1155/2018/4246874. eCollection 2018.
- 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.
Marzena Dominiak, Prof principal investigator
Medical University Wrocław
Questions about this trial
What is this clinical trial studying?
A study testing Short implants Treatment and Regular implants Treatment in people with Partial Edentulism and Tooth Loss, run by Jakub Hadzik.
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 9 inclusion and 1 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 14 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Clinical measurement of implant stability (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03471000, which also lists 1 linked publication.
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 14 Jan 2020.