Tooth LossNCT07633665
PMCF Study on the Effectiveness and Safety of BIODENTOSS® and DWC® Dental Implants and Superstructures
A study testing BIODENTOSS Bone-Level Dental Implant and Superstructures and DWC Bone-Level Dental Implant and Superstructures in people with Tooth Loss and Edentulism, run by Değirmenci Otomotiv ve Metal Endüstri A.Ş. at 1 site in Turkey (Türkiye).
Trial summary
This prospective, single-center, interventional post-market clinical follow-up (PMCF) study aims to evaluate the early-term (24 months post-implantation) safety and efficacy of CE-marked BIODENTOSS® and DWC ® Dental Implants and Superstructures in patients requiring dental restoration for tooth loss. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tooth Loss, Edentulism
- What is being tested?
- BIODENTOSS Bone-Level Dental Implant and Superstructures and DWC Bone-Level Dental Implant and Superstructures
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Dec 2024to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older,
- Male or female,
- Subjects with missing tooth who require dental implant treatment,
- At least 2 months elapsed since tooth extraction,
- General health status suitable for implantation,
- Not legally restricted (e.g., soldier, convict),
- Provision of signed Informed Consent Form (ICF)
Who cannot join
- Suspected or confirmed pregnancy or breastfeeding,
- Disorders preventing adequate daily oral hygiene,
- Hypersensitivity/allergy to titanium or implant components,
- Inappropriate interarch relationship or parafunction (e.g., bruxism),
- Bone/soft tissue deficiency requiring augmentation,
- Active periodontal infection or untreated oral pathologies,
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- Unstable systemic diseases affecting wound healing (e.g., diabetes),
- Use of immunosuppressive drug therapy due to systemic disorders, organ transplantation, or any other medical conditions,
- Hematological disorders or current use of anticoagulants (such as Warfarin, dabigatran or related therapies),
- Presence of osteoporosis and/or any disease condition affecting bone metabolism,
- Presence of an active systemic infection, or any health condition or ongoing treatment (e.g., radiotherapy, bisphosphonate therapy) that contraindicates elective surgery,
- Recent myocardial infarction or cerebrovascular event,
- Individuals who consume high doses of alcohol, cigarettes, or tobacco products and are unable to control their usage,
- Participation in another interventional clinical study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Selcuk University, Faculty of Dentistry, Dept. of Oral and Maxillofacial Surgery.
Konya, 42130
Abdullah Kalayci, Professor, +90 (536) 543 25 87, abdullahkalayci@hotmail.com
Serhan Akman, Professor
About this study
Official title: Post-Market Clinical Follow-Up (PMCF) Study on the Effectiveness and Safety of BIODENTOSS® and DWC® Dental Implants and Superstructures
This prospective, single-center, interventional post-market clinical follow-up (PMCF) study aims to evaluate the early-term (24 months post-implantation) safety and efficacy of CE-marked BIODENTOSS® and DWC ® Dental Implants and Superstructures in patients requiring dental restoration for tooth loss.
Read the detailed description
The study evaluates safety by monitoring the incidence of complications and adverse events, while efficacy is assessed through implant survival/success rates, implant stability, marginal bone loss (MBL), chewing function, and oral health-related quality of life (OHRQoL). Participants will be followed across 10 visits (baseline and 9 follow-up visits) including prosthetic restoration at 3-4 months and final evaluation at 24 months post-implantation.
- Conditions
- Tooth Loss, Edentulism
- Being tested
- BIODENTOSS Bone-Level Dental Implant and Superstructures, DWC Bone-Level Dental Implant and Superstructures
- Keywords
- Post-Market Clinical Follow-Up (PMCF), Dental Implants, Osseointegration, Implant Stability, Marginal Bone Loss (MBL)
- Medical subject headings
- Tooth Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIODENTOSS Bone-Level Dental Implant and SuperstructuresDevice
Surgical placement of CE-marked BIODENTOSS bone-level dental implants, available in conical or cylindrical models, with diameters ranging from 3.4 mm to 6.0 mm and lengths from 7.5 mm to 13 mm. Implants feature an SLA (Sandblasted, Large-grit, Acid-etched) surface texture and a 22-degree conical internal hex connection. Following an osseointegration period, prosthetic restoration will be completed using compatible superstructures, including cover screws, healing abutments, and various types of prosthetic abutments based on clinical indications.
DWC Bone-Level Dental Implant and SuperstructuresDevice
Surgical placement of CE-marked DWC bone-level dental implants, available in cylindrical or active threaded models, with diameters ranging from 3.3 mm to 4.8 mm and lengths from 8 mm to 15 mm. Implants feature an SLA (Sandblasted, Large-grit, Acid-etched) surface texture and a 22-degree conical internal hex connection. Following an osseointegration period, prosthetic restoration will be completed using compatible superstructures, including cover screws, healing abutments, and various types of prosthetic abutments based on clinical indications.
| Study group | Role | What they receive |
|---|---|---|
| BIODENTOSS Cohort | Experimental | This cohort includes participants receiving BIODENTOSS bone-level dental implants (conical or cylindrical models) and compatible superstructures for the restoration of missing teeth. Patients will undergo standard surgical implantation followed by prosthetic restoration at 3 to 4 months post-implantation. Safety and efficacy outcomes-including implant survival/success rates, stability, marginal bone loss, chewing function, and oral health-related quality of life-will be monitored prospectively across a 24-month follow-up period. Data collected for this cohort will be analyzed and reported independently via descriptive and longitudinal statistics, with no statistical comparison intended against other cohorts. Receives: Device: BIODENTOSS Bone-Level Dental Implant and Superstructures |
| DWC Cohort | Experimental | This cohort includes participants receiving DWC bone-level dental implants (cylindrical or active threaded) and compatible superstructures for the restoration of missing teeth. Patients will undergo standard surgical implantation followed by prosthetic restoration at 3 to 4 months post-implantation. Safety and efficacy outcomes-including implant survival/success rates, stability, marginal bone loss, chewing function, and oral health-related quality of life-will be monitored prospectively across a 24-month follow-up period. Data collected for this cohort will be analyzed and reported independently via descriptive and longitudinal statistics, with no statistical comparison intended against other cohorts. Receives: Device: DWC Bone-Level Dental Implant and Superstructures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant Success and Satisfactory Survival Rate
The percentage of functional implants in each cohort meeting the 2007 International Congress of Oral Implantologists (ICOI) Pisa Consensus Conference Health Scale criteria. Multiple clinical/radiographic parameters (pain, mobility, bone loss, exudate) are aggregated to classify each implant into a single category: Group I (Success: no pain/mobility, <2mm bone loss, no exudate); Group II (Satisfactory Survival: no pain/mobility, 2-4mm bone loss, no exudate); Group III (Compromised Survival: potential sensitivity, no mobility, >4mm bone loss [<50% of implant body], pocket depth >7mm, potential exudate); or Group IV (Failure: pain, mobility, bone loss >1/2 implant length, or uncontrolled exudate).
To arrive at the single reported value, data are aggregated by calculating the combined percentage of implants classified into Group I and Group II out of the total implants evaluated in each cohort.
Measured: 6, 12, 18, and 24 months post-implantation.
Implant Stability Measured by Resonance Frequency Analysis
Quantitative assessment of implant stability within each independent cohort using non-invasive Resonance Frequency Analysis (RFA). Individual implant stability will be reported based on the Implant Stability Quotient (ISQ) scale, ranging from 1 to 100. Higher values indicate greater stability, with an ISQ score ≥ 70 reflecting high stability.
Measured: Immediate post-implantation (baseline) and pre-loading (at 3 months for mandibular implants or 4 months for maxillary implants)
Percentage of Implants With Zero Clinical Mobility
Assessment of post-loading implant stability evaluated via manual clinical examination. Clinical stability is measured by vertical and horizontal forces and graded using Mühlemann's Mobility Index, which ranges from 0 to 4 (where 0 indicates normal/physiological movement and 4 indicates vertical mobility). The single reported value will be the percentage of implants within each independent cohort achieving a mobility index score of "0" (lack of clinical mobility), indicating successful osseointegration.
Measured: At 6, 12, 18, and 24 months post-implantation (all post-loading follow-up visits).
Incidence of Complications and Adverse Events
Safety data will be collected by recording all adverse events (AEs) and complications encountered during the 24-month follow-up period. This includes intraoperative complications (e.g., bone fenestration/dehiscence, nerve injury), device-related failures (e.g., implant fracture, loss of stability), and any postoperative adverse events (e.g., infection, peri-implant mucositis, or prosthetic component loosening).
Measured: Throughout the 24-month follow-up period.
Secondary outcomes (3)
Marginal Bone Loss (MBL)
Radiographic assessment of bone level changes (mesial/distal) using digital panoramic/periapical radiographs.
Measured: 6, 12, 18, and 24 months post-implantation.
Chewing Function and Chewing Satisfaction
Assessed independently within each cohort. Chewing function will be verified via clinical occlusion control using articulation paper. Patient chewing satisfaction will be scored directly by the participant using a 5-point Likert scale (ranging from 1: not satisfied at all, to 5: very satisfied).
Measured: Baseline and 6, 12, 18, 24 months.
Oral Health-Related Quality of Life (OHRQoL)
Assessed independently within each cohort using the Oral Health Impact Profile-14 (OHIP-14) questionnaire. The scale consists of 14 items scored on a Likert scale, with total scores ranging from 0 to 56. Lower overall scores indicate superior OHRQoL and better clinical outcomes.
Measured: Baseline and 6, 12, 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start11 Dec 2024
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth LossStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This study is designed to independently evaluate the safety and efficacy of devices in two distinct post-market cohorts. Each arm will be analyzed independently using descriptive and longitudinal statistics; no between-arm hypothesis testing or direct statistical comparison is intended.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Değirmenci Otomotiv ve Metal Endüstri A.Ş.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Abdullah Kalayci, Professor, Principal investigator, Selcuk University Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07633665
- Sponsor's protocol ID
- INFO_CLC_2301
- Other IDs
- 2024-170
- Status last verified
- May 2026
- First submitted
- 31 May 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will not be shared due to confidentiality and intellectual property policies of the sponsor.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market Clinical Follow-Up (PMCF) Study on the Effectiveness and Safety of BIODENTOSS® and DWC® Dental Implants and Superstructures
- ClinicalTrials.gov ID
- NCT07633665
- Acronym / sponsor ID
- INFO_CLC_2301
- Conditions
- Tooth Loss, Edentulism
- Keywords
- Post-Market Clinical Follow-Up (PMCF), Dental Implants, Osseointegration, Implant Stability, Marginal Bone Loss (MBL)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Değirmenci Otomotiv ve Metal Endüstri A.Ş.Industry (pharma, biotech, devices)
- Study start
- 11 Dec 2024 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 8 Jun 2026 (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.
This prospective, single-center, interventional post-market clinical follow-up (PMCF) study aims to evaluate the early-term (24 months post-implantation) safety and efficacy of CE-marked BIODENTOSS® and DWC ® Dental Implants and Superstructures in patients requiring dental restoration for tooth loss.
Detailed description
The study evaluates safety by monitoring the incidence of complications and adverse events, while efficacy is assessed through implant survival/success rates, implant stability, marginal bone loss (MBL), chewing function, and oral health-related quality of life (OHRQoL). Participants will be followed across 10 visits (baseline and 9 follow-up visits) including prosthetic restoration at 3-4 months and final evaluation at 24 months post-implantation.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is designed to independently evaluate the safety and efficacy of devices in two distinct post-market cohorts. Each arm will be analyzed independently using descriptive and longitudinal statistics; no between-arm hypothesis testing or direct statistical comparison is intended.
| Arm | Type | Receives |
|---|---|---|
| BIODENTOSS Cohort | Experimental | Device: BIODENTOSS Bone-Level Dental Implant and SuperstructuresThis cohort includes participants receiving BIODENTOSS bone-level dental implants (conical or cylindrical models) and compatible superstructures for the restoration of missing teeth. Patients will undergo standard surgical implantation followed by prosthetic restoration at 3 to 4 months post-implantation. Safety and efficacy outcomes-including implant survival/success rates, stability, marginal bone loss, chewing function, and oral health-related quality of life-will be monitored prospectively across a 24-month follow-up period. Data collected for this cohort will be analyzed and reported independently via descriptive and longitudinal statistics, with no statistical comparison intended against other cohorts. |
| DWC Cohort | Experimental | Device: DWC Bone-Level Dental Implant and SuperstructuresThis cohort includes participants receiving DWC bone-level dental implants (cylindrical or active threaded) and compatible superstructures for the restoration of missing teeth. Patients will undergo standard surgical implantation followed by prosthetic restoration at 3 to 4 months post-implantation. Safety and efficacy outcomes-including implant survival/success rates, stability, marginal bone loss, chewing function, and oral health-related quality of life-will be monitored prospectively across a 24-month follow-up period. Data collected for this cohort will be analyzed and reported independently via descriptive and longitudinal statistics, with no statistical comparison intended against other cohorts. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years of age or older,
- Male or female,
- Subjects with missing tooth who require dental implant treatment,
- At least 2 months elapsed since tooth extraction,
- General health status suitable for implantation,
Key exclusion criteria (14 listed)
- Suspected or confirmed pregnancy or breastfeeding,
- Disorders preventing adequate daily oral hygiene,
- Hypersensitivity/allergy to titanium or implant components,
- Inappropriate interarch relationship or parafunction (e.g., bruxism),
- Bone/soft tissue deficiency requiring augmentation,
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 |
|---|---|---|
| BIODENTOSS Bone-Level Dental Implant and SuperstructuresSurgical placement of CE-marked BIODENTOSS bone-level dental implants, available in conical or cylindrical models, with diameters ranging from 3.4 mm to 6.0 mm and lengths from 7.5 mm to 13 mm. Implants feature an SLA (Sandblasted, Large-grit, Acid-etched) surface texture and a 22-degree conical internal hex connection. Following an osseointegration period, prosthetic restoration will be completed using compatible superstructures, including cover screws, healing abutments, and various types of prosthetic abutments based on clinical indications. | Device | BIODENTOSS Cohort |
| DWC Bone-Level Dental Implant and SuperstructuresSurgical placement of CE-marked DWC bone-level dental implants, available in cylindrical or active threaded models, with diameters ranging from 3.3 mm to 4.8 mm and lengths from 8 mm to 15 mm. Implants feature an SLA (Sandblasted, Large-grit, Acid-etched) surface texture and a 22-degree conical internal hex connection. Following an osseointegration period, prosthetic restoration will be completed using compatible superstructures, including cover screws, healing abutments, and various types of prosthetic abutments based on clinical indications. | Device | DWC Cohort |
Primary outcome
Implant Success and Satisfactory Survival Rate
Time frame: 6, 12, 18, and 24 months post-implantation.
The percentage of functional implants in each cohort meeting the 2007 International Congress of Oral Implantologists (ICOI) Pisa Consensus Conference Health Scale criteria. Multiple clinical/radiographic parameters (pain, mobility, bone loss, exudate) are aggregated to classify each implant into a single category: Group I (Success: no pain/mobility, <2mm bone loss, no exudate); Group II (Satisfactory Survival: no pain/mobility, 2-4mm bone loss, no exudate); Group III (Compromised Survival: potential sensitivity, no mobility, >4mm bone loss [<50% of implant body], pocket depth >7mm, potential exudate); or Group IV (Failure: pain, mobility, bone loss >1/2 implant length, or uncontrolled exudate). To arrive at the single reported value, data are aggregated by calculating the combined percentage of implants classified into Group I and Group II out of the total implants evaluated in each cohort.
Implant Stability Measured by Resonance Frequency Analysis
Time frame: Immediate post-implantation (baseline) and pre-loading (at 3 months for mandibular implants or 4 months for maxillary implants)
Quantitative assessment of implant stability within each independent cohort using non-invasive Resonance Frequency Analysis (RFA). Individual implant stability will be reported based on the Implant Stability Quotient (ISQ) scale, ranging from 1 to 100. Higher values indicate greater stability, with an ISQ score ≥ 70 reflecting high stability.
Percentage of Implants With Zero Clinical Mobility
Time frame: At 6, 12, 18, and 24 months post-implantation (all post-loading follow-up visits).
Assessment of post-loading implant stability evaluated via manual clinical examination. Clinical stability is measured by vertical and horizontal forces and graded using Mühlemann's Mobility Index, which ranges from 0 to 4 (where 0 indicates normal/physiological movement and 4 indicates vertical mobility). The single reported value will be the percentage of implants within each independent cohort achieving a mobility index score of "0" (lack of clinical mobility), indicating successful osseointegration.
Incidence of Complications and Adverse Events
Time frame: Throughout the 24-month follow-up period.
Safety data will be collected by recording all adverse events (AEs) and complications encountered during the 24-month follow-up period. This includes intraoperative complications (e.g., bone fenestration/dehiscence, nerve injury), device-related failures (e.g., implant fracture, loss of stability), and any postoperative adverse events (e.g., infection, peri-implant mucositis, or prosthetic component loosening).
3 secondary outcomes
Marginal Bone Loss (MBL)
Time frame: 6, 12, 18, and 24 months post-implantation.
Chewing Function and Chewing Satisfaction
Time frame: Baseline and 6, 12, 18, 24 months.
Oral Health-Related Quality of Life (OHRQoL)
Time frame: Baseline and 6, 12, 24 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Individual participant dataSharing planned: No. Data will not be shared due to confidentiality and intellectual property policies of the sponsor.
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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.
Abdullah Kalayci, Professor principal investigator
Selcuk University Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BIODENTOSS Bone-Level Dental Implant and Superstructures and DWC Bone-Level Dental Implant and Superstructures in people with Tooth Loss and Edentulism, run by Değirmenci Otomotiv ve Metal Endüstri A.Ş. 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 14 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: looking for participants now, as of the sponsor's last update on 8 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abdullah Sari, Met. Eng. (+90 (332) 516 16 91, kaliteyonetimi@dome.com.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant Success and Satisfactory Survival Rate (time frame: 6, 12, 18, and 24 months post-implantation.). 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 8 Jun 2026.