Edentulous Alveolar RidgeNCT06554041
Soft Tissue Response to Different Restorative Materials Used in Implant Dentistry
A study testing Dental Crown with Titanium-Abutment, Dental Crown with PEEK (Polyetheretherketone)-Abutment and Dental Crown with Zirconia-Abutment in people with Edentulous Alveolar Ridge and Peri-Implantitis, run by Harvard Medical School (HMS and HSDM) at 1 site in Lithuania.
Trial summary
The goal of this clinical trial is to learn how different materials used in dental implants affect the surrounding gum tissue in adults who need dental implants. The main questions it aims to answer are: How do different materials (titanium, PEEK, zirconia, and lithium disilicate) affect inflammation around dental… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Edentulous Alveolar Ridge, Peri-Implantitis, Peri-implant Mucositis
- What is being tested?
- Dental Crown with Titanium-Abutment, Dental Crown with PEEK (Polyetheretherketone)-Abutment and Dental Crown with Zirconia-Abutment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteLithuania
- Study dates
- 23 Aug 2023to 1 Jan 2026
- 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
- Participants must be 18 years or older.
- Participants must be edentulous with at least four missing teeth in the posterior region of the mandible or maxillae.
- Participants must have appropriate oral hygiene and periodontal status of natural teeth, with a pocket depth of 4mm or less and no bleeding.
- Dental implants must be fully integrated with no bone resorption or inflammation after three months of implant placement, confirmed by X-ray and clinical examination.
- Implant placement must be into natural bone without additional procedures such as sinus lift or bone augmentation.
- The procedure must be a standard implantation with no immediate implant placement.
- The height of the gingiva must be at least 3mm or more.
Who cannot join
- Patients with systemic diseases such as malignancy, diabetes, osteoporosis, or rheumatoid arthritis.
- Patients with a history of periodontal treatment.
- Patients who smoke or use tobacco.
- Patients who have received antibiotic treatment within three months prior to implantation.
- Pregnant individuals.
Trial locations and contacts
1 site in 1 country.
Lithuania1 site, 1 recruiting
- Recruiting
VIC Clinic
Vilnius, 01362
Algirdas Puisys, DMD, +370 5 276 0725, algirdas@vicklinika.lt
About this study
The goal of this clinical trial is to learn how different materials used in dental implants affect the surrounding gum tissue in adults who need dental implants. The main questions it aims to answer are:
How do different materials (titanium, PEEK, zirconia, and lithium disilicate) affect inflammation around dental implants? What changes occur in inflammation markers in the gum tissue after 3 and 6 months? Researchers will compare the different materials to see which one causes the least amount of inflammation.
Read more
Participants will:
Receive dental implants made from different materials. Have samples of fluid from around their implants collected for analysis at 3 and 6 months.
Undergo regular dental check-ups to measure gum health, such as bleeding and pocket depth around the implants.
Read the detailed description
The study will involve a total of 40 edentulous patients, each missing four teeth in the posterior region of the mandible or maxillae. Each patient will receive four dental implants and single crowns made from different materials. The primary objectives are to evaluate biomarkers in peri-implant crevicular fluid and to assess the changes in these biomarkers after three and six months of loading. This research will help determine the biocompatibility of the materials and their potential to cause peri-implantitis.
- Conditions
- Edentulous Alveolar Ridge, Peri-Implantitis, Peri-implant Mucositis, Prosthetic Infection, Prosthetic Complication
- Being tested
- Dental Crown with Titanium-Abutment, Dental Crown with PEEK (Polyetheretherketone)-Abutment, Dental Crown with Zirconia-Abutment, Dental Crown with Lithium-Disilicate-Abutment (e.max)
- Keywords
- Dental Implants, Peri-Implant Soft Tissue, Prosthetic Materials, Inflammation Markers, Oral Health
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental Crown with Titanium-AbutmentDevice
Participants in this clinical trial will receive dental implants and single screw-retained crowns made from one of four different materials: titanium, PEEK (Polyetheretherketone), zirconia, or lithium disilicate (e.max). The implants will be placed in the posterior region of the mandible or maxillae. The study will evaluate the impact of these materials on peri-implant soft tissue health by measuring inflammatory markers in the peri-implant crevicular fluid and assessing clinical outcomes such as bleeding on probing and pocket depth at 3 and 6 months post-implantation.
Dental Crown with PEEK (Polyetheretherketone)-AbutmentDevice
Participants in this clinical trial will receive dental implants and single screw-retained crowns made from one of four different materials: titanium, PEEK (Polyetheretherketone), zirconia, or lithium disilicate (e.max). The implants will be placed in the posterior region of the mandible or maxillae. The study will evaluate the impact of these materials on peri-implant soft tissue health by measuring inflammatory markers in the peri-implant crevicular fluid and assessing clinical outcomes such as bleeding on probing and pocket depth at 3 and 6 months post-implantation.
Dental Crown with Zirconia-AbutmentDevice
Participants in this clinical trial will receive dental implants and single screw-retained crowns made from one of four different materials: titanium, PEEK (Polyetheretherketone), zirconia, or lithium disilicate (e.max). The implants will be placed in the posterior region of the mandible or maxillae. The study will evaluate the impact of these materials on peri-implant soft tissue health by measuring inflammatory markers in the peri-implant crevicular fluid and assessing clinical outcomes such as bleeding on probing and pocket depth at 3 and 6 months post-implantation.
Dental Crown with Lithium-Disilicate-Abutment (e.max)Device
Participants in this clinical trial will receive dental implants and single screw-retained crowns made from one of four different materials: titanium, PEEK (Polyetheretherketone), zirconia, or lithium disilicate (e.max). The implants will be placed in the posterior region of the mandible or maxillae. The study will evaluate the impact of these materials on peri-implant soft tissue health by measuring inflammatory markers in the peri-implant crevicular fluid and assessing clinical outcomes such as bleeding on probing and pocket depth at 3 and 6 months post-implantation.
| Study group | Role | What they receive |
|---|---|---|
| Dental Crown with Titanium-Abutment | Experimental | Participants in this arm will receive dental implants and single crowns made from titanium. The impact of titanium on peri-implant soft tissue health will be evaluated by measuring inflammatory markers and clinical outcomes such as bleeding on probing and pocket depth at 3 and 6 months post-implantation. Receives: Device: Dental Crown with Titanium-Abutment |
| Dental Crown with PEEK (Polyetheretherketone)-Abutment | Experimental | Participants in this arm will receive dental implants and single crowns made from PEEK. The study will assess the biocompatibility of PEEK by examining inflammatory responses and clinical outcomes, including bleeding on probing and pocket depth, at 3 and 6 months post-implantation. Receives: Device: Dental Crown with PEEK (Polyetheretherketone)-Abutment |
| Dental Crown with Zirconia-Abutment | Experimental | Participants in this arm will receive dental implants and single crowns made from zirconia. The effects of zirconia on peri-implant soft tissue will be analyzed by measuring the levels of inflammatory markers and observing clinical outcomes such as bleeding on probing and pocket depth at 3 and 6 months post-implantation. Receives: Device: Dental Crown with Zirconia-Abutment |
| Dental Crown with Lithium-Disilicate-Abutment (e.max) | Experimental | Participants in this arm will receive dental implants and single crowns made from lithium disilicate (e.max). The study will evaluate the biocompatibility of e.max by measuring inflammatory markers and clinical outcomes, including bleeding on probing and pocket depth, at 3 and 6 months post-implantation. Receives: Device: Dental Crown with Lithium-Disilicate-Abutment (e.max) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of Inflammatory Biomarkers in Peri-Implant Crevicular Fluid
The primary outcome measure will evaluate the concentration of inflammatory biomarkers in the peri-implant crevicular fluid, including IL-6, IL-8, IL-10, IL-17, TNF-alpha, IL-12, IL-1-beta, and IL-4. These biomarkers all have the same unit and will be measured to assess the inflammatory response of peri-implant soft tissue to different prosthetic materials (titanium, PEEK, zirconia, and lithium disilicate). The goal is to determine which material induces the least amount of inflammation, indicating better biocompatibility and a lower risk of peri-implantitis.
Measured: 3 and 6 months post-implantation
Secondary outcomes (2)
Clinical Measurements of Bleeding on Probing (BOP) and Pocket Depth
The secondary outcome measure will assess the clinical health of the peri-implant tissue by measuring bleeding on probing (BOP) around the dental implants. These clinical parameters will provide additional insights into the soft tissue response to the different prosthetic materials used in the implants (titanium, PEEK, zirconia, and lithium disilicate). Improved clinical outcomes, such as reduced bleeding and shallower pocket depths, will indicate better biocompatibility and integration of the implant materials.
Measured: 3 and 6 months post-implantation
Clinical Measurements of Pocket Depth
The secondary outcome measure will assess the clinical health of the peri-implant tissue by measuring pocket depth around the dental implants. These clinical parameter will provide additional insights into the soft tissue response to the different prosthetic materials used in the implants (titanium, PEEK, zirconia, and lithium disilicate). Improved clinical outcomes, such as reduced bleeding and shallower pocket depths, will indicate better biocompatibility and integration of the implant materials.
Measured: 3 and 6 months post-implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2024
- Study start23 Aug 2023
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous Alveolar RidgeStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This clinical trial employs an interventional study model with a parallel assignment. A total of 40 edentulous patients, will be randomized into four groups. The study is open-label, meaning that both the researchers and the participants will know which material is being used for each patient. This design is intended to evaluate the impact of these different materials on the health of the peri-implant soft tissue by measuring inflammatory markers and clinical outcomes such as bleeding on probing and pocket depth over a six-month period.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harvard Medical School (HMS and HSDM)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samuel Akhondi, Harvard Medical School (HMS and HSDM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06554041
- Sponsor's protocol ID
- BE-2-106
- Status last verified
- Aug 2024
- First submitted
- 5 Aug 2024
- Last updated
- 14 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) will be made available to other researchers upon reasonable request. The data will include de-identified participant data, relevant clinical and biochemical measurements, and any other pertinent data collected during the study.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soft Tissue Response to Different Restorative Materials Used in Implant Dentistry
- ClinicalTrials.gov ID
- NCT06554041
- Acronym / sponsor ID
- BE-2-106
- Conditions
- Edentulous Alveolar Ridge, Peri-Implantitis, Peri-implant Mucositis, Prosthetic Infection, Prosthetic Complication
- Keywords
- Dental Implants, Peri-Implant Soft Tissue, Prosthetic Materials, Inflammation Markers, Oral Health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Harvard Medical School (HMS and HSDM)University, hospital or other
- Study start
- 23 Aug 2023 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 14 Aug 2024 (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 goal of this clinical trial is to learn how different materials used in dental implants affect the surrounding gum tissue in adults who need dental implants. The main questions it aims to answer are:
How do different materials (titanium, PEEK, zirconia, and lithium disilicate) affect inflammation around dental implants? What changes occur in inflammation markers in the gum tissue after 3 and 6 months? Researchers will compare the different materials to see which one causes the least amount of inflammation.
Participants will:
Receive dental implants made from different materials. Have samples of fluid from around their implants collected for analysis at 3 and 6 months.
Undergo regular dental check-ups to measure gum health, such as bleeding and pocket depth around the implants.
Detailed description
The study will involve a total of 40 edentulous patients, each missing four teeth in the posterior region of the mandible or maxillae. Each patient will receive four dental implants and single crowns made from different materials. The primary objectives are to evaluate biomarkers in peri-implant crevicular fluid and to assess the changes in these biomarkers after three and six months of loading. This research will help determine the biocompatibility of the materials and their potential to cause peri-implantitis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This clinical trial employs an interventional study model with a parallel assignment. A total of 40 edentulous patients, will be randomized into four groups. The study is open-label, meaning that both the researchers and the participants will know which material is being used for each patient. This design is intended to evaluate the impact of these different materials on the health of the peri-implant soft tissue by measuring inflammatory markers and clinical outcomes such as bleeding on probing and pocket depth over a six-month period.
| Arm | Type | Receives |
|---|---|---|
| Dental Crown with Titanium-Abutment | Experimental | Device: Dental Crown with Titanium-AbutmentParticipants in this arm will receive dental implants and single crowns made from titanium. The impact of titanium on peri-implant soft tissue health will be evaluated by measuring inflammatory markers and clinical outcomes such as bleeding on probing and pocket depth at 3 and 6 months post-implantation. |
| Dental Crown with PEEK (Polyetheretherketone)-Abutment | Experimental | Device: Dental Crown with PEEK (Polyetheretherketone)-AbutmentParticipants in this arm will receive dental implants and single crowns made from PEEK. The study will assess the biocompatibility of PEEK by examining inflammatory responses and clinical outcomes, including bleeding on probing and pocket depth, at 3 and 6 months post-implantation. |
| Dental Crown with Zirconia-Abutment | Experimental | Device: Dental Crown with Zirconia-AbutmentParticipants in this arm will receive dental implants and single crowns made from zirconia. The effects of zirconia on peri-implant soft tissue will be analyzed by measuring the levels of inflammatory markers and observing clinical outcomes such as bleeding on probing and pocket depth at 3 and 6 months post-implantation. |
| Dental Crown with Lithium-Disilicate-Abutment (e.max) | Experimental | Device: Dental Crown with Lithium-Disilicate-Abutment (e.max)Participants in this arm will receive dental implants and single crowns made from lithium disilicate (e.max). The study will evaluate the biocompatibility of e.max by measuring inflammatory markers and clinical outcomes, including bleeding on probing and pocket depth, at 3 and 6 months post-implantation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participants must be 18 years or older.
- Participants must be edentulous with at least four missing teeth in the posterior region of the mandible or maxillae.
- Participants must have appropriate oral hygiene and periodontal status of natural teeth, with a pocket depth of 4mm or less and no bleeding.
- Dental implants must be fully integrated with no bone resorption or inflammation after three months of implant placement, confirmed by X-ray and clinical examination.
- Implant placement must be into natural bone without additional procedures such as sinus lift or bone augmentation.
Key exclusion criteria (5 listed)
- Patients with systemic diseases such as malignancy, diabetes, osteoporosis, or rheumatoid arthritis.
- Patients with a history of periodontal treatment.
- Patients who smoke or use tobacco.
- Patients who have received antibiotic treatment within three months prior to implantation.
- Pregnant individuals.
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 |
|---|---|---|
| Dental Crown with Titanium-AbutmentParticipants in this clinical trial will receive dental implants and single screw-retained crowns made from one of four different materials: titanium, PEEK (Polyetheretherketone), zirconia, or lithium disilicate (e.max). The implants will be placed in the posterior region of the mandible or maxillae. The study will evaluate the impact of these materials on peri-implant soft tissue health by measuring inflammatory markers in the peri-implant crevicular fluid and assessing clinical outcomes such as bleeding on probing and pocket depth at 3 and 6 months post-implantation. | Device | Dental Crown with Titanium-Abutment |
| Dental Crown with PEEK (Polyetheretherketone)-AbutmentParticipants in this clinical trial will receive dental implants and single screw-retained crowns made from one of four different materials: titanium, PEEK (Polyetheretherketone), zirconia, or lithium disilicate (e.max). The implants will be placed in the posterior region of the mandible or maxillae. The study will evaluate the impact of these materials on peri-implant soft tissue health by measuring inflammatory markers in the peri-implant crevicular fluid and assessing clinical outcomes such as bleeding on probing and pocket depth at 3 and 6 months post-implantation. | Device | Dental Crown with PEEK (Polyetheretherketone)-Abutment |
| Dental Crown with Zirconia-AbutmentParticipants in this clinical trial will receive dental implants and single screw-retained crowns made from one of four different materials: titanium, PEEK (Polyetheretherketone), zirconia, or lithium disilicate (e.max). The implants will be placed in the posterior region of the mandible or maxillae. The study will evaluate the impact of these materials on peri-implant soft tissue health by measuring inflammatory markers in the peri-implant crevicular fluid and assessing clinical outcomes such as bleeding on probing and pocket depth at 3 and 6 months post-implantation. | Device | Dental Crown with Zirconia-Abutment |
| Dental Crown with Lithium-Disilicate-Abutment (e.max)Participants in this clinical trial will receive dental implants and single screw-retained crowns made from one of four different materials: titanium, PEEK (Polyetheretherketone), zirconia, or lithium disilicate (e.max). The implants will be placed in the posterior region of the mandible or maxillae. The study will evaluate the impact of these materials on peri-implant soft tissue health by measuring inflammatory markers in the peri-implant crevicular fluid and assessing clinical outcomes such as bleeding on probing and pocket depth at 3 and 6 months post-implantation. | Device | Dental Crown with Lithium-Disilicate-Abutment (e.max) |
Primary outcome
Concentration of Inflammatory Biomarkers in Peri-Implant Crevicular Fluid
Time frame: 3 and 6 months post-implantation
The primary outcome measure will evaluate the concentration of inflammatory biomarkers in the peri-implant crevicular fluid, including IL-6, IL-8, IL-10, IL-17, TNF-alpha, IL-12, IL-1-beta, and IL-4. These biomarkers all have the same unit and will be measured to assess the inflammatory response of peri-implant soft tissue to different prosthetic materials (titanium, PEEK, zirconia, and lithium disilicate). The goal is to determine which material induces the least amount of inflammation, indicating better biocompatibility and a lower risk of peri-implantitis.
2 secondary outcomes
Clinical Measurements of Bleeding on Probing (BOP) and Pocket Depth
Time frame: 3 and 6 months post-implantation
Clinical Measurements of Pocket Depth
Time frame: 3 and 6 months post-implantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) will be made available to other researchers upon reasonable request. The data will include de-identified participant data, relevant clinical and biochemical measurements, and any other pertinent data collected during the study.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dental Crown with Titanium-Abutment, Dental Crown with PEEK (Polyetheretherketone)-Abutment and Dental Crown with Zirconia-Abutment in people with Edentulous Alveolar Ridge and Peri-Implantitis, run by Harvard Medical School (HMS and HSDM) at 1 site in Lithuania.
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 5 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: status not confirmed, as of the sponsor's last update on 14 Aug 2024. 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 Lithuania. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of Inflammatory Biomarkers in Peri-Implant Crevicular Fluid (time frame: 3 and 6 months post-implantation). 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 14 Aug 2024.