Osseointegration Failure of Dental ImplantPhase 4NCT05507047
Emdogain Implementation With Transcrestal Sinus Lifting and Dental Implant Placement
A Phase 4 study testing Enamel Matrix Protein in people with Osseointegration Failure of Dental Implant and Bone Density Increased, run by T.C. Dumlupınar Üniversitesi at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the clinical and radiographic results of implants placed using osteotome sinus floor elevation (OSFE) with and without simultaneous enamel matrix derivative (EMD) application. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Osseointegration Failure of Dental Implant, Bone Density Increased
- What is being tested?
- Enamel Matrix Protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2017to Dec 2020
- Phase
- Phase 4
- 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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- partial edentulism in the maxillary posterior region for at least 4 months from tooth loss and require implant treatment
- adequate bone thickness for primary stabilization
- residual bone height ranged from 4 mm to 6 mm
- systemic and local conditions compatible with implant placement and sinus floor elevation
- antagonist teeth
Who cannot join
- uncontrolled diabetes mellitus or other systemic disorders (such as; hepatitis, tuberculosis, AIDS)
- pregnancy
- untreated periodontal disease
- endodontic lesions or other oral disorders
- heavy smokers (≥10 cigarettes per day)
- acute or chronic rhinitis
Show all 11Show fewer
- sinusitis or pathology in sinus
- inadequate residual bone height and quality to achieve implant stability
- previous implant treatment/failure or bone augmentation in the implant site
- sinus perforation as confirmed via Valsalva maneuver
- insufficient primary implant stability measured by RFA
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi University Faculty of Dentistry
Ankara, 06100
About this study
Official title: The Evaluation of Enamel Matrix Derivative on the Bone Regenerative Potential of the Dental Implant With Transcrestal Sinus Lifting Technique: Randomized-Controlled CBCT Study
The aim of this study is to evaluate the clinical and radiographic results of implants placed using osteotome sinus floor elevation (OSFE) with and without simultaneous enamel matrix derivative (EMD) application.
Read the detailed description
Twenty-four patients will be randomly assigned into two groups: Group I: (EMD+OSFE) (n=20 implants, 13 patients) OSFE with EMD application, and Group II 8OSFE): (n=20 implants, 11 patients) OSFE without EMD application. The patients will be recall at 3- and 12- months after surgery. The residual bone height (RBH), implant protrusion length (IPL), peri-implant sinus bone level (SBL), endo-sinus bone gain (ESBG), implant stability and peri-implant bone density values (Hounsfield units) will be assessed.
- Being tested
- Enamel Matrix Protein
- Keywords
- enamel matrix derivated, maxillary sinus
- Medical subject headings
- Osteosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enamel Matrix ProteinDrug
Also called emdogain
Enamel matrix derivated is used with transcrestal sinus lifting treatment
| Study group | Role | What they receive |
|---|---|---|
| Transcrestal Sinus Lifting with Emdogain | Experimental | Osteotome sinus floor elevation with enamel matrix derivated Receives: Drug: Enamel Matrix Protein |
| Transcrestal Sinus Lifting | Active comparator | Osteotome sinus floor elevation Receives: Drug: Enamel Matrix Protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
endo-sinus bone gain
New bone formation into sinus (NB) following OSFE- measured by endo-sinus bone gain
Measured: CBCT will be evaluated at initiation of study (T0), at 3th month (T1) and 12th month (T2)
Secondary outcomes (5)
radiographic measurements
The residual bone height (RBH)
Measured: CBCT will be evaluated at initiation of study (T0), at 3th month (T1) and 12th month (T2)
implant stability
resonance frequency analysis
Measured: It will be measured at initiated at implant placement and third month follow-up
Radiographic measurements
implant protrusion length into the sinus
Measured: CBCT will be evaluated at initiation of study (T0), and at 12th month (T2)
peri-implant sinus bone level
the distance between the groove most coronal to the implant and the bone-implant connection most apical to the implant
Measured: CBCT will be evaluated at initiation of study (T0), at 3th month (T1) and 12th month (T2)
Densitometric Analysis
CBCT allows sectional analysis. Each axial image is 260000 megapixels, and each pixel has a CT number (Hounsfield unit). The higher the CT number, the denser the object
Measured: Bone Density was measured at baseline, 3- and 12-months by CBCT scans
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2022
- Study startJan 2017
- Primary completionJan 2020
- Study completionDec 2020
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 Osseointegration Failure of Dental ImplantStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- T.C. Dumlupınar Üniversitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berceste Guler, T.C. Dumlupınar Üniversitesi
- Investigators
- Deniz Ozbay, DDS PhD, Principal investigator, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05507047
- Sponsor's protocol ID
- 14/4
- Status last verified
- Aug 2022
- First submitted
- 15 Aug 2022
- Last updated
- 18 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vincent-Bugnas S, Charbit Y, Charbit M, Dard M, Pippenger B. Maxillary Sinus Floor Elevation Surgery With BioOss Mixed With Enamel Matrix Derivative: A Human Randomized Controlled Clinical and Histologic Study. J Oral Implantol. 2020 Oct 1;46(5):507-513. doi: 10.1563/aaid-joi-D-19-00119.
PubMed 32299097
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Enamel Matrix Derivative on the Bone Regenerative Potential of the Dental Implant With Transcrestal Sinus Lifting Technique: Randomized-Controlled CBCT Study
- ClinicalTrials.gov ID
- NCT05507047
- Acronym / sponsor ID
- 14/4
- Keywords
- enamel matrix derivated, maxillary sinus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- T.C. Dumlupınar ÜniversitesiUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Jan 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 18 Aug 2022 (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 this study is to evaluate the clinical and radiographic results of implants placed using osteotome sinus floor elevation (OSFE) with and without simultaneous enamel matrix derivative (EMD) application.
Detailed description
Twenty-four patients will be randomly assigned into two groups: Group I: (EMD+OSFE) (n=20 implants, 13 patients) OSFE with EMD application, and Group II 8OSFE): (n=20 implants, 11 patients) OSFE without EMD application. The patients will be recall at 3- and 12- months after surgery. The residual bone height (RBH), implant protrusion length (IPL), peri-implant sinus bone level (SBL), endo-sinus bone gain (ESBG), implant stability and peri-implant bone density values (Hounsfield units) will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcrestal Sinus Lifting with Emdogain | Experimental | Drug: Enamel Matrix ProteinOsteotome sinus floor elevation with enamel matrix derivated |
| Transcrestal Sinus Lifting | Active comparator | Drug: Enamel Matrix ProteinOsteotome sinus floor elevation |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- partial edentulism in the maxillary posterior region for at least 4 months from tooth loss and require implant treatment
- adequate bone thickness for primary stabilization
- residual bone height ranged from 4 mm to 6 mm
- systemic and local conditions compatible with implant placement and sinus floor elevation
- antagonist teeth
Key exclusion criteria (11 listed)
- uncontrolled diabetes mellitus or other systemic disorders (such as; hepatitis, tuberculosis, AIDS)
- pregnancy
- untreated periodontal disease
- endodontic lesions or other oral disorders
- heavy smokers (≥10 cigarettes per day)
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 |
|---|---|---|
| Enamel Matrix ProteinAlso: emdogainEnamel matrix derivated is used with transcrestal sinus lifting treatment | Drug | Transcrestal Sinus Lifting, Transcrestal Sinus Lifting with Emdogain |
Primary outcome
endo-sinus bone gain
Time frame: CBCT will be evaluated at initiation of study (T0), at 3th month (T1) and 12th month (T2)
New bone formation into sinus (NB) following OSFE- measured by endo-sinus bone gain
5 secondary outcomes
radiographic measurements
Time frame: CBCT will be evaluated at initiation of study (T0), at 3th month (T1) and 12th month (T2)
implant stability
Time frame: It will be measured at initiated at implant placement and third month follow-up
Radiographic measurements
Time frame: CBCT will be evaluated at initiation of study (T0), and at 12th month (T2)
peri-implant sinus bone level
Time frame: CBCT will be evaluated at initiation of study (T0), at 3th month (T1) and 12th month (T2)
Densitometric Analysis
Time frame: Bone Density was measured at baseline, 3- and 12-months by CBCT scans
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 18 Aug 2022.
- Results publication: PubMed 32299097Vincent-Bugnas S, Charbit Y, Charbit M, Dard M, Pippenger B. Maxillary Sinus Floor Elevation Surgery With BioOss Mixed With Enamel Matrix Derivative: A Human Randomized Controlled Clinical and Histologic Study. J Oral Implantol. 2020 Oct 1;46(5):507-513. doi: 10.1563/aaid-joi-D-19-00119.
- Maxillary Sinus Floor Elevation Surgery With BioOss Mixed With Enamel Matrix DerivativeLink provided by the sponsor.
- Effect of enamel matrix derivative on alveolar ridge preservation in the posterior maxillaLink provided by the sponsor.
- 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.
Deniz Ozbay, DDS PhD principal investigator
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Enamel Matrix Protein in people with Osseointegration Failure of Dental Implant and Bone Density Increased, run by T.C. Dumlupınar Üniversitesi 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 5 inclusion and 11 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 18 Aug 2022. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
endo-sinus bone gain (time frame: CBCT will be evaluated at initiation of study (T0), at 3th month (T1) and 12th month (T2)). 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 NCT05507047, 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 18 Aug 2022.