Implant-abutment ConnectionNCT02840773
OPG-RANKL Levels Around Short Implants
A study testing Peri-implanter sulcus fluid sampling, Probing depth and Crestal bone loss in people with Implant-abutment Connection and Microleakage, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the present study was to determine the levels of sRANKL and OPG as well as their relative ratio in PICF surrounding the two different types of implant-abutment connections on short implants after a 12-month monitoring period. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Implant-abutment Connection, Microleakage, Short Implant
- What is being tested?
- Peri-implanter sulcus fluid sampling, Probing depth and Crestal bone loss
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Feb 2010to Jun 2012
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- sufficient bone height for a 6 mm implant and sufficient bone width for a minimum 5.5 mm implant without any augmentation techniques
- no history of periodontitis.
Who cannot join
- Patients with any systemic diseases
- Smokers were excluded
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege University, School of Dentistry, Department of Periodontology
Izmir, 35100
About this study
Official title: Impact of Implant-abutment Connection on Osteoimmunological Parameters in Short Implants: a Randomised Controlled Clinical Trial
The aim of the present study was to determine the levels of sRANKL and OPG as well as their relative ratio in PICF surrounding the two different types of implant-abutment connections on short implants after a 12-month monitoring period. Additionally, their association with clinical findings and microbiological markers in plaque samples were assessed in the present study.
Read the detailed description
The peri-implant crevicular fluid (PICF) contains several inflammatory mediators; the level of these mediators can provide information on the inflammatory state of the tissue, including the activation of mechanisms of bone destruction. In this context, soluble receptor activator of nuclear factor кB ligand (sRANKL) and osteoprotegerin (OPG) have been suggested as molecular determinants of bone resorption. However, currently, there are only limited studies on the molecular responses of healthy peri-implant tissues following placement of implants on function. The null hypothesis of the present study was that there are no significant differences in the levels of sRANKL and OPG in PICF or in the respective levels of six bacterial species or total bacteria levels in submucosal biofilm samples taken from TIF- and TIS-type implants. Therefore, the aim of the present study was to determine the levels of sRANKL and OPG as well as their relative ratio in PICF surrounding the two different types of implant-abutment connections on short implants after a 12-month monitoring period. Additionally, their association with clinical findings and microbiological markers in plaque samples were assessed in the present study.Thirty short implants were randomly placed in posterior maxillary edentulous sites using a split-mouth design in 15 periodontally healthy subjects. Tapered interference fit (TIF) and taper integrated screwed-in (TIS) types of implant-abutment connections were selected for investigation. PICF and submucosal biofilm samples were collected one month after surgery and repeated 12 months after prosthetic loading. Clinical parameters, including probing depth, dichotomous presence of bleeding on probing, and plaque index, were recorded and digital periapical radiographs were taken at each time point. sRANKL and OPG levels in PICF were analyzed using an enzyme-linked immunosorbent assay. Total bacterial levels, as well as levels of Fusobacterium nucleatum, Porphyromonas gingivalis, Treponema denticola, Tannerella forsythia, Prevotella intermedia, and Streptococcus oralis, were analyzed in corresponding submucosal biofilm samples using quantitative real-time polymerase chain reaction.
- Conditions
- Implant-abutment Connection, Microleakage, Short Implant
- Being tested
- Peri-implanter sulcus fluid sampling, Probing depth, Crestal bone loss, Presence of bleeding on probing, Plaque index levels
- Keywords
- RANKL, OPG, Peri-implant crevicular fluid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peri-implanter sulcus fluid samplingOther
PISF sampling was made twice
Probing depthOther
The change of probing depth between baseline and 12 month after prosthetic loading. Probing depth was measured with a plastic periodontal probe (mm)
Crestal bone lossOther
Crestal bone loss was measured on digital radiographs at baseline and after 1 year of prosthetic loading with a Java program me (Image-J 3.0 NIH, Bethesda, USA)
Presence of bleeding on probingOther
The change bleeding on probing of between baseline and 12 month after prosthetic loading. Presence of bleeding on probing were performed at four sites of implants.
Plaque index levelsOther
The change of plaque index level between baseline and 12 month after prosthetic loading. Presence of plaque index was performed at four sites of implants.
| Study group | Role | What they receive |
|---|---|---|
| Test group-baseline | Active comparator | Press-fit implant connection was monitored at baseline Receives: Other: Peri-implanter sulcus fluid sampling; Other: Probing depth; Other: Crestal bone loss; Other: Presence of bleeding on probing; Other: Plaque index levels |
| Test group-12 month | Active comparator | Press-fit implant connection was monitored at 12 month after prosthesis delivered. Receives: Other: Peri-implanter sulcus fluid sampling; Other: Probing depth; Other: Crestal bone loss; Other: Presence of bleeding on probing; Other: Plaque index levels |
| Control group-baseline | Active comparator | Screw-retained connection was monitored at baseline Receives: Other: Peri-implanter sulcus fluid sampling; Other: Probing depth; Other: Crestal bone loss; Other: Presence of bleeding on probing; Other: Plaque index levels |
| Control group-12 month | Active comparator | Screw-retained connection was monitored at 12 month after prosthesis delivered. Receives: Other: Peri-implanter sulcus fluid sampling; Other: Probing depth; Other: Crestal bone loss; Other: Presence of bleeding on probing; Other: Plaque index levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peri-implanter sulcus fluid levels of RANKL
Peri-implanter sulcus fluid were sampled at baseline (without prosthetic loading).
Measured: Baseline
Peri-implanter sulcus fluid levels of RANKL
Peri-implanter sulcus fluid were sampled at 1 year after prosthetic loading.
Measured: 12 month
Peri-implanter sulcus fluid levels of OPG
Peri-implanter sulcus fluid were sampled at baseline (without prosthetic loading).
Measured: Baseline
Peri-implanter sulcus fluid levels of OPG
Peri-implanter sulcus fluid were sampled at 1 year after prosthetic loading.
Measured: 12 month
Secondary outcomes (7)
Probing depth
The level of probing depth at baseline. Probing depth was measured with a plastic periodontal probe.
Measured: Baseline
Probing depth
The level of probing depth at 12 month. Probing depth was measured with a plastic periodontal probe.
Measured: 12 month
Bleeding on probing
The level of clinical parameters bleeding on probing at baseline without prosthetic loading. The presence of bleeding on probing were performed at four sites of implants after 10 sec. of probing.
Measured: Baseline
Bleeding on probing
The level of clinical parameters bleeding on probing at 12 month after prosthetic loading. The presence of bleeding on probing were performed at four sites of implants after 10 sec. of probing.
Measured: 12 month
Plaque index
The level of plaque index at baseline without prosthetic loading. The dichotomous presence of supra gingival plaque was recorded at four sites of implants
Measured: Baseline
Plaque index
The level of plaque index at 12 month after prosthetic loading. The dichotomous presence of supra gingival plaque was recorded at four sites of implants
Measured: 12 month
Crestal bone loss
Crestal bone loss measured by digital periapikal radiographs at same time of PISF sampling
Measured: Between baseline and 1 year after prosthetic loading
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2016 (estimated)
- Study startFeb 2010
- Primary completionJan 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implant-abutment ConnectionStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Veli Özgen Öztürk, Aydin Adnan Menderes University
- Investigators
- Veli Özgen Öztürk, PhD,DDS, Principal investigator, Ege University, School of Dentistry, Department of Periodontology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02840773
- Sponsor's protocol ID
- BAP-03-2014
- Status last verified
- Jul 2016
- First submitted
- 10 Jun 2016
- Last updated
- 21 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Implant-abutment Connection on Osteoimmunological Parameters in Short Implants: a Randomised Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02840773
- Acronym / sponsor ID
- BAP-03-2014
- Conditions
- Implant-abutment Connection, Microleakage, Short Implant
- Keywords
- RANKL, OPG, Peri-implant crevicular fluid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 21 Jul 2016 (estimated)
- 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 present study was to determine the levels of sRANKL and OPG as well as their relative ratio in PICF surrounding the two different types of implant-abutment connections on short implants after a 12-month monitoring period. Additionally, their association with clinical findings and microbiological markers in plaque samples were assessed in the present study.
Detailed description
The peri-implant crevicular fluid (PICF) contains several inflammatory mediators; the level of these mediators can provide information on the inflammatory state of the tissue, including the activation of mechanisms of bone destruction. In this context, soluble receptor activator of nuclear factor кB ligand (sRANKL) and osteoprotegerin (OPG) have been suggested as molecular determinants of bone resorption. However, currently, there are only limited studies on the molecular responses of healthy peri-implant tissues following placement of implants on function. The null hypothesis of the present study was that there are no significant differences in the levels of sRANKL and OPG in PICF or in the respective levels of six bacterial species or total bacteria levels in submucosal biofilm samples taken from TIF- and TIS-type implants. Therefore, the aim of the present study was to determine the levels of sRANKL and OPG as well as their relative ratio in PICF surrounding the two different types of implant-abutment connections on short implants after a 12-month monitoring period. Additionally, their association with clinical findings and microbiological markers in plaque samples were assessed in the present study.Thirty short implants were randomly placed in posterior maxillary edentulous sites using a split-mouth design in 15 periodontally healthy subjects. Tapered interference fit (TIF) and taper integrated screwed-in (TIS) types of implant-abutment connections were selected for investigation. PICF and submucosal biofilm samples were collected one month after surgery and repeated 12 months after prosthetic loading. Clinical parameters, including probing depth, dichotomous presence of bleeding on probing, and plaque index, were recorded and digital periapical radiographs were taken at each time point. sRANKL and OPG levels in PICF were analyzed using an enzyme-linked immunosorbent assay. Total bacterial levels, as well as levels of Fusobacterium nucleatum, Porphyromonas gingivalis, Treponema denticola, Tannerella forsythia, Prevotella intermedia, and Streptococcus oralis, were analyzed in corresponding submucosal biofilm samples using quantitative real-time polymerase chain reaction.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Test group-baseline | Active comparator | Other: Peri-implanter sulcus fluid sampling, Other: Probing depth, Other: Crestal bone loss, Other: Presence of bleeding on probing, Other: Plaque index levelsPress-fit implant connection was monitored at baseline |
| Test group-12 month | Active comparator | Other: Peri-implanter sulcus fluid sampling, Other: Probing depth, Other: Crestal bone loss, Other: Presence of bleeding on probing, Other: Plaque index levelsPress-fit implant connection was monitored at 12 month after prosthesis delivered. |
| Control group-baseline | Active comparator | Other: Peri-implanter sulcus fluid sampling, Other: Probing depth, Other: Crestal bone loss, Other: Presence of bleeding on probing, Other: Plaque index levelsScrew-retained connection was monitored at baseline |
| Control group-12 month | Active comparator | Other: Peri-implanter sulcus fluid sampling, Other: Probing depth, Other: Crestal bone loss, Other: Presence of bleeding on probing, Other: Plaque index levelsScrew-retained connection was monitored at 12 month after prosthesis delivered. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- sufficient bone height for a 6 mm implant and sufficient bone width for a minimum 5.5 mm implant without any augmentation techniques
- no history of periodontitis.
Key exclusion criteria (2 listed)
- Patients with any systemic diseases
- Smokers were excluded
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 |
|---|---|---|
| Peri-implanter sulcus fluid samplingPISF sampling was made twice | Other | Control group-12 month, Control group-baseline, Test group-12 month, Test group-baseline |
| Probing depthThe change of probing depth between baseline and 12 month after prosthetic loading. Probing depth was measured with a plastic periodontal probe (mm) | Other | Control group-12 month, Control group-baseline, Test group-12 month, Test group-baseline |
| Crestal bone lossCrestal bone loss was measured on digital radiographs at baseline and after 1 year of prosthetic loading with a Java program me (Image-J 3.0 NIH, Bethesda, USA) | Other | Control group-12 month, Control group-baseline, Test group-12 month, Test group-baseline |
| Presence of bleeding on probingThe change bleeding on probing of between baseline and 12 month after prosthetic loading. Presence of bleeding on probing were performed at four sites of implants. | Other | Control group-12 month, Control group-baseline, Test group-12 month, Test group-baseline |
| Plaque index levelsThe change of plaque index level between baseline and 12 month after prosthetic loading. Presence of plaque index was performed at four sites of implants. | Other | Control group-12 month, Control group-baseline, Test group-12 month, Test group-baseline |
Primary outcome
Peri-implanter sulcus fluid levels of RANKL
Time frame: Baseline
Peri-implanter sulcus fluid were sampled at baseline (without prosthetic loading).
Peri-implanter sulcus fluid levels of RANKL
Time frame: 12 month
Peri-implanter sulcus fluid were sampled at 1 year after prosthetic loading.
Peri-implanter sulcus fluid levels of OPG
Time frame: Baseline
Peri-implanter sulcus fluid were sampled at baseline (without prosthetic loading).
Peri-implanter sulcus fluid levels of OPG
Time frame: 12 month
Peri-implanter sulcus fluid were sampled at 1 year after prosthetic loading.
7 secondary outcomes
Probing depth
Time frame: Baseline
Probing depth
Time frame: 12 month
Bleeding on probing
Time frame: Baseline
Bleeding on probing
Time frame: 12 month
Plaque index
Time frame: Baseline
Plaque index
Time frame: 12 month
Crestal bone loss
Time frame: Between baseline and 1 year after prosthetic loading
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 21 Jul 2016.
- Individual participant dataSharing planned: Yes
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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.
Veli Özgen Öztürk, PhD,DDS principal investigator
Ege University, School of Dentistry, Department of Periodontology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peri-implanter sulcus fluid sampling, Probing depth and Crestal bone loss in people with Implant-abutment Connection and Microleakage, run by Aydin Adnan Menderes University 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 2 inclusion and 2 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 21 Jul 2016. 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?
Peri-implanter sulcus fluid levels of RANKL (time frame: Baseline). The study lists 4 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 21 Jul 2016.