Dental ImplantsPISTINCT05843526
Influence of Implant Component Materials on Peri-implant Soft Tissue Horst Response.
A study testing Experimental healing abutment in people with Dental Implants and Soft Tissue Inflammation, run by University of Liege at 1 site in Belgium.
Trial summary
The aim of this study was to characterize the host-related response of peri-implant soft tissue induced by 3 different materials: titanium, resin and PEEK (polyetheretherketone) on man. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Implants, Soft Tissue Inflammation, Immunohistochemistry
- What is being tested?
- Experimental healing abutment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteBelgium
- Study dates
- 1 May 2019to 1 Oct 2022
- 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
- Needing implant therapy
- One or more missing teeth in the posterior area of either maxilla or mandible
- Good systemic health (ASA I/II)
- Full mouth plaque score (FMPI) lower than or equal to 25%
- The tooth at the implant site(s) had to be extracted or lost at least 12 weeks prior to implant placement
- 3 mm of keratinized mucosa in the bucco-lingual dimension with bone crest allowing at least a regular diameter implant (4.1 mm).
Who cannot join
- Autoimmune disease requiring medical treatment
- Medical conditions requiring prolonged use of steroids, use of bisphosphonates and denosumab intravenously or in oral use
- Pregnancy or breastfeeding women
- Alcoholism o chronical drug abuse
- Immunocompromised patients
- Uncontrolled diabetes
Show all 10Show fewer
- Smokers (more than 5 cigs/day)
- Implant diameter under 4 mm (narrow implant)
- Infection (systemic or local)
- The site was excluded if it was previously treated with socket preservation techniques, presented untreated local inflammation, mucosal diseases or oral lesions, history of local irradiation therapy or persistent intraoral infection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Implant Component Materials on Peri-implant Soft Tissue Host-response: A Randomized Clinical Trial.
The aim of this study was to characterize the host-related response of peri-implant soft tissue induced by 3 different materials: titanium, resin and PEEK (polyetheretherketone) on man.
The primary endpoint is to asses the histological data available: Histological analyses are carried out with immunohistology (CD68, CD3, CD20, macrophages), non decalcified histology to appreciate the structure of the peri implant soft tissues (Sulcus depth, junctional epithelium, connective tissue adhesion).
Read more
Moreover: scanning electronic microscope (SEM) of the experimental abutment is performed to juge the cell adhesion on the abutment surface.
The secondary endpoint is to assess clinical data, radiological bone remodeling regarding the different material.
The hypothesis is that resin abutment lead to more inflammation than PEEK or titanium.
Read the detailed description
The present study was designed as a randomized controlled trial. A total of 69 implants were placed and experimental abutments made of grade 5 titanium (Ti), dental resin (Optibond ™ FL, Kerr Dental)), polyetheretherketone (PEEK) were randomly allocated to each implant.
Study population: Patients needing tooth replacement in the posterior region (molars) are recruited from the Department of Periodontology and Oral and Implant Surgery of the University of Liege, Belgium.
Procedures
After a local anesthesia, implant procedure is carried out according to the recommendation of the manufacturer while considering the future position of the crown for a screw-retained restoration and the bone anatomy. Then, implants (Bone level or Bone level tapered, SLA active, Straumann Group, Basel, Switzerland) are placed with an insertion torque of at least 20 N/cm. The experimental abutment material is randomly allocated to the implant or two implants when it is possible: Titanium as a group control, PEEK (polyetheretherketone) or resin abutment.
The insertion is made at 15 N/cm and the access hole is obturated with teflon and Telio (Ivoclar vivadent, Schaan, Liechtenstein). A standardized parallel peri-apical radiograph is taken in order to record the baseline bone level. Each patient is instructed to rinse twice daily with an aqueous solution of 0,2% Chlorhexidine (Corsodyl®, GSK, Brentford, United Kingdom) and to avoid brushing of the area until the first recall 10-12 days later. Anti-inflammatories (Ibuprofen® 600 mg) as well as additional analgesics (Paracetamol® 500 mg) are recommended according to the patient's needs. Eight weeks after implantation, the buccal part of the abutment is marked with a drill, and a harvesting guide is placed on the experimental abutment. A punch device cut the soft tissue at 1mm from the abutment surface and both soft tissues and abutment are removed together. When the adherence between soft tissues and abutment is weak (soft tissues slide from the abutment), the abutment is analyzed alone on scanning electronic microscopy and the soft tissues alone are analyzed with immunohistochemistry. When adherence between the abutment and the soft tissues is sufficient, it goes to non decalcified histology. A screw retained abutment or a conventional healing abutment is placed after the harvesting procedure and the prosthetic rehabilitation is performed after 3 months of healing.
Follow-up evaluations and data recording are performed at inclusion visit (baseline), surgery and 8 weeks after implantation.
- Conditions
- Dental Implants, Soft Tissue Inflammation, Immunohistochemistry, Dental Implants, Single-Tooth, Histology, Dental Implantation
- Being tested
- Experimental healing abutment
- Keywords
- Dental implants, Soft Tissue Inflammation, Abutment materials, Immunohistochemistry, histometry, Peri implant tissues, dental material, Dental abutments, histology, peri implant tissue changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental healing abutmentDevice
Implant placement (Straumann) Experimental abutment made of titanium, PEEK polyetheretherketone, resin was randomly assessed to the implant site.
Abutment screw channel was filled with Teflon and closed with resin composite. Mouthwash based 0.2% chlorhexidine for 10 days and analgesics (ibuprofen 400 mg, up to 4/d) if necessary.
After 8 weeks, harvesting of the soft tissues around experimental abutment with experimental abutment using a custom-made guide was placed on the experimental abutment
| Study group | Role | What they receive |
|---|---|---|
| Titanium abutment | Active comparator | Titanium (Ti) grade 5 titanium abutment Receives: Device: Experimental healing abutment |
| Dental resin abutment | Experimental | Dental resin (Re) Optibond ™ FL, Kerr Dental abutment Receives: Device: Experimental healing abutment |
| Polyetheretherketone abutment | Experimental | Polyetheretherketone (PEEK) Polyetheretherketone abutment Receives: Device: Experimental healing abutment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Soft tissue inflammatory response
To evaluate the inflammatory response of the peri-implant soft tissue after 8 weeks in contact with the abutment material: Immunohistological analysis of the quantity of macrophages, neutrophils, B and T lymphocytes and blood vessels present in the different samples.
It has been evaluated using markers: CD3, CD20, CD68, CD34 and counting of marked cells.
Data are reported with semi quantitative scale.
Measured: 8 weeks
Characterization of peri implant soft tissues
To determine the composition and the length of different parts of the peri implant soft tissues depending on subgingival abutment material (regarding the data of sulcus depth, junctional epithelium and connective tissue in mm) using non decalcified histology.
Measured: 8 weeks
Secondary outcomes (5)
dental plaque accumulation
To assess the amount of plaque present on the abutments with SEM analysis. semi quantitative analyses are performed on the abutment.
Measured: 8 weeks
Peri-implant bone remodeling
Assessment of bone height changes using X-rays Radiographies are analyzed with software ImageJ and mesial and distal values of the bone remodeling (bone line to the implant shoulder) are collected in mm.
Measured: 8 weeks
Soft tissue health changes assessed by Plaque Index
Assessment of plaque percentage
Measured: 8 weeks
Soft tissue health changes assessed by Keratinized gingiva measure
Assessment of height of keratinized mucosa by probing in mm.
Measured: 8 weeks
Soft tissue health changes assessed by soft tissues height
Assessment of height of soft tissue by probing in mm.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start1 May 2019
- Primary completion1 May 2021
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study included 69 implants divided into 3 groups. The 1st control group with titanium abutments, a second test group on dental resin (Optibond ™ FL, Kerr Dental) and a last test group on polyetheretherketone (PEEK).
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Collaborators
- ITI International Team for Implantology, Switzerland
- Responsible party
- Principal investigator, Dr. France LAMBERT, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05843526
- Sponsor's protocol ID
- B707201628072
- Acronym
- PISTI
- Status last verified
- Apr 2023
- First submitted
- 5 Apr 2023
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Implant Component Materials on Peri-implant Soft Tissue Host-response: A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT05843526
- Acronym / sponsor ID
- PISTI / B707201628072
- Conditions
- Dental Implants, Soft Tissue Inflammation, Immunohistochemistry, Dental Implants, Single-Tooth, Histology, Dental Implantation
- Keywords
- Dental implants, Soft Tissue Inflammation, Abutment materials, Immunohistochemistry, histometry, Peri implant tissues, dental material, Dental abutments
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Collaborators
- ITI International Team for Implantology, Switzerland
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 6 May 2023 (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 was to characterize the host-related response of peri-implant soft tissue induced by 3 different materials: titanium, resin and PEEK (polyetheretherketone) on man.
The primary endpoint is to asses the histological data available: Histological analyses are carried out with immunohistology (CD68, CD3, CD20, macrophages), non decalcified histology to appreciate the structure of the peri implant soft tissues (Sulcus depth, junctional epithelium, connective tissue adhesion).
Moreover: scanning electronic microscope (SEM) of the experimental abutment is performed to juge the cell adhesion on the abutment surface.
The secondary endpoint is to assess clinical data, radiological bone remodeling regarding the different material.
The hypothesis is that resin abutment lead to more inflammation than PEEK or titanium.
Detailed description
The present study was designed as a randomized controlled trial. A total of 69 implants were placed and experimental abutments made of grade 5 titanium (Ti), dental resin (Optibond ™ FL, Kerr Dental)), polyetheretherketone (PEEK) were randomly allocated to each implant.
Study population: Patients needing tooth replacement in the posterior region (molars) are recruited from the Department of Periodontology and Oral and Implant Surgery of the University of Liege, Belgium.
Procedures
After a local anesthesia, implant procedure is carried out according to the recommendation of the manufacturer while considering the future position of the crown for a screw-retained restoration and the bone anatomy. Then, implants (Bone level or Bone level tapered, SLA active, Straumann Group, Basel, Switzerland) are placed with an insertion torque of at least 20 N/cm. The experimental abutment material is randomly allocated to the implant or two implants when it is possible: Titanium as a group control, PEEK (polyetheretherketone) or resin abutment.
The insertion is made at 15 N/cm and the access hole is obturated with teflon and Telio (Ivoclar vivadent, Schaan, Liechtenstein). A standardized parallel peri-apical radiograph is taken in order to record the baseline bone level. Each patient is instructed to rinse twice daily with an aqueous solution of 0,2% Chlorhexidine (Corsodyl®, GSK, Brentford, United Kingdom) and to avoid brushing of the area until the first recall 10-12 days later. Anti-inflammatories (Ibuprofen® 600 mg) as well as additional analgesics (Paracetamol® 500 mg) are recommended according to the patient's needs. Eight weeks after implantation, the buccal part of the abutment is marked with a drill, and a harvesting guide is placed on the experimental abutment. A punch device cut the soft tissue at 1mm from the abutment surface and both soft tissues and abutment are removed together. When the adherence between soft tissues and abutment is weak (soft tissues slide from the abutment), the abutment is analyzed alone on scanning electronic microscopy and the soft tissues alone are analyzed with immunohistochemistry. When adherence between the abutment and the soft tissues is sufficient, it goes to non decalcified histology. A screw retained abutment or a conventional healing abutment is placed after the harvesting procedure and the prosthetic rehabilitation is performed after 3 months of healing.
Follow-up evaluations and data recording are performed at inclusion visit (baseline), surgery and 8 weeks after implantation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The study included 69 implants divided into 3 groups. The 1st control group with titanium abutments, a second test group on dental resin (Optibond ™ FL, Kerr Dental) and a last test group on polyetheretherketone (PEEK).
| Arm | Type | Receives |
|---|---|---|
| Titanium abutment | Active comparator | Device: Experimental healing abutmentTitanium (Ti) grade 5 titanium abutment |
| Dental resin abutment | Experimental | Device: Experimental healing abutmentDental resin (Re) Optibond ™ FL, Kerr Dental abutment |
| Polyetheretherketone abutment | Experimental | Device: Experimental healing abutmentPolyetheretherketone (PEEK) Polyetheretherketone abutment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Needing implant therapy
- One or more missing teeth in the posterior area of either maxilla or mandible
- Good systemic health (ASA I/II)
- Full mouth plaque score (FMPI) lower than or equal to 25%
- The tooth at the implant site(s) had to be extracted or lost at least 12 weeks prior to implant placement
Key exclusion criteria (10 listed)
- Autoimmune disease requiring medical treatment
- Medical conditions requiring prolonged use of steroids, use of bisphosphonates and denosumab intravenously or in oral use
- Pregnancy or breastfeeding women
- Alcoholism o chronical drug abuse
- Immunocompromised patients
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 |
|---|---|---|
| Experimental healing abutmentImplant placement (Straumann) Experimental abutment made of titanium, PEEK polyetheretherketone, resin was randomly assessed to the implant site. Abutment screw channel was filled with Teflon and closed with resin composite. Mouthwash based 0.2% chlorhexidine for 10 days and analgesics (ibuprofen 400 mg, up to 4/d) if necessary. After 8 weeks, harvesting of the soft tissues around experimental abutment with experimental abutment using a custom-made guide was placed on the experimental abutment | Device | Dental resin abutment, Polyetheretherketone abutment, Titanium abutment |
Primary outcome
Soft tissue inflammatory response
Time frame: 8 weeks
To evaluate the inflammatory response of the peri-implant soft tissue after 8 weeks in contact with the abutment material: Immunohistological analysis of the quantity of macrophages, neutrophils, B and T lymphocytes and blood vessels present in the different samples. It has been evaluated using markers: CD3, CD20, CD68, CD34 and counting of marked cells. Data are reported with semi quantitative scale.
Characterization of peri implant soft tissues
Time frame: 8 weeks
To determine the composition and the length of different parts of the peri implant soft tissues depending on subgingival abutment material (regarding the data of sulcus depth, junctional epithelium and connective tissue in mm) using non decalcified histology.
5 secondary outcomes
dental plaque accumulation
Time frame: 8 weeks
Peri-implant bone remodeling
Time frame: 8 weeks
Soft tissue health changes assessed by Plaque Index
Time frame: 8 weeks
Soft tissue health changes assessed by Keratinized gingiva measure
Time frame: 8 weeks
Soft tissue health changes assessed by soft tissues height
Time frame: 8 weeks
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 6 May 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental healing abutment in people with Dental Implants and Soft Tissue Inflammation, run by University of Liege at 1 site in Belgium.
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 6 inclusion and 10 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 6 May 2023. 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 Belgium. 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?
Soft tissue inflammatory response (time frame: 8 weeks). The study lists 2 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 6 May 2023.