Implant Geometry, Osseointegration, Soft Tissue Volume, Marginal Bone Levels, Soft Tissue Recession, Volumetric AnalysisNCT04308083
The Influence of a New Implant Neck Configuration on Hard and Soft Tissue Healing
A study testing dental implant placement in people with Implant Geometry, Osseointegration, Soft Tissue Volume, Marginal Bone Levels, Soft Tissue Recession, Volumetric Analysis, run by PerioCentrum Research at 1 site in Spain.
Trial summary
Title: Randomized Controlled Clinical Trial comparing two dental implants with different neck configurations. Objective: To evaluate the changes in peri-implant soft tissues and marginal bone level when using a one-piece implant with a widening transgingival machined collar and a one-piece implant with a tapering… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Implant Geometry, Osseointegration, Soft Tissue Volume, Marginal Bone Levels, Soft Tissue Recession, Volumetric Analysis
- What is being tested?
- dental implant placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteSpain
- Study dates
- 17 Jun 2019to 17 Mar 2021
- 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
- Male or female ≥18 years old
- Each patient will have one missing tooth in the posterior mandible (positions 4-6). There must be a natural tooth mesially and distally to the implant site. Free end situation are not allowed.
- Adequate bone quality and quantity at the implant site to permit the insertion of a SWEDEN AND MARTINA® Prama Implant in the diameter of 4.25 mm and in the length of 8.5 mm, 10 mm or a Straumann Tissue Level in the diameter of 4.1 mm and in the length of 8 mm or 10mm.
- Opposing dentition must be natural teeth or teeth/implant supported fixed restoration(s).
- Patient has been informed of the follow-up visits and is willing to return to the clinical center for these follow-up visit.
Who cannot join
- These exclusion criteria might be systemic or local. In addition to the general contra-indication for dental implants the following exclusion criteria will be observed:
- Systemic exclusion criteria:
- Medical conditions requiring prolonged use of steroids and/or with medications that can interfere with bone metabolism
- History of leukocyte dysfunction and deficiencies
- History of neoplasic disease requiring the use of radiation or chemotherapy
- Patients with history of renal failure
Show all 26Show fewer
- Patients with metabolic bone disorders such as osteoporosis
- History of uncontrolled endocrine disorders
- Physical handicaps that would interfere with the ability to perform adequate oral hygiene
- Use of any investigational drug or device within the 30 day period immediately prior to implant surgery on study day 0
- Alcoholism or drug abuse
- History of immunodeficiency syndromes
- Patients who smoke >20 cigarettes per day or cigar equivalents.
- Conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, unreliability
- Local exclusion criteria:
- Any bone augmentation on the implant site which was performed in the previous 3 months
- Local inflammation, including untreated periodontitis
- Mucosal diseases such as erosive lichen planus
- History of local irradiation therapy
- Presence of osseous lesions
- Unhealed extraction sites (less than 6 weeks post extraction of teeth in intended sites)
- Severe bruxing or clenching habits
- Persistent intraoral infection
- Lack of primary stability of implant.
- Presence of vertical dehiscence
- Unable to place the implant according to the prosthetic requirements. In any of these instances the patient will not be included in the study and a new patient will be recruited and randomized.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
PerioCentrum Madrid
Madrid, 28020
Beatriz Sanchez, DDS
About this study
Official title: The Influence of a New Implant Neck Configuration on Hard and Soft Tissue Healing. A Randomized Controlled Clinical Trial
Title: Randomized Controlled Clinical Trial comparing two dental implants with different neck configurations.
Objective: To evaluate the changes in peri-implant soft tissues and marginal bone level when using a one-piece implant with a widening transgingival machined collar and a one-piece implant with a tapering transgingival machined collar.
Read more
Design: The study will be a prospective parallel randomized clinical trial with a 12 month follow up conducted in 5 private dental practices. A total of 50 patients meeting the inclusion criteria will be randomized in one of the two groups to receive 1 single implant placed in healed ridges. Radiographic and clinical measurements will be taken post-insertion, baseline (post-loading) 6 and 12 months after loading.
Study Hypothesis: The hypothesis of this study is that there will be no differences in the preservation of the peri-implant marginal bone level and peri-implant soft tissues between the two implant neck designs.
Read the detailed description
The study will be a prospective parallel randomized clinical trial (RCT) of approximately 20 months of duration, in which each patient will receive 1 implants placed in the posterior mandible. If the patients fulfill the inclusion criteria after implant site preparation, they will be randomized to either receive an implant with a one-piece tapering neck configuration (P) or with a widening neck configuration (TL).
52 patients, male or female, aged 18 or older, who are missing one tooth in the posterior mandible (positions 4-6).
A randomization list will determine which implant type has to be inserted. This randomization list will be generated by an independent investigator.
Patients will be recruited by the investigator consecutively. Prior to implant site preparation, the clinician will determine if the patient still meets the inclusion criteria at surgery in particular if the bone quantity is sufficient. Patients who do not meet the inclusion criteria will be excluded from the study and will therefore not be randomized. The patients will be randomized to receive P implant or TL implant.
For both groups, impression will be taken 8 weeks post insertion. Details with regard to the prosthetic procedures and materials used for the restoration of the implants will be provided in a separate section of this protocol.
Standardized peri-apical radiographs will be taken before and after prosthesis placement to document the crestal bone level at the day of loading.
Standardized photographs will be taken to measure the soft tissue at the time of loading.
The thickness of the soft tissue will be measured 2 mm apical to the gingival margin with a needle.
Routine controls are due at 6 and 12 months post loading. Peri-apical radiographs will be taken after implant placement, before/after loading and at 12 months post loading. Final impressions will be taken at 12 months post loading to evaluate volumetric changes.
- Being tested
- dental implant placement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dental implant placementProcedure or surgery
Implants will be placed according to the manufacturer recommendations. Implants will be placed at 1.5 to 2.0 mm from the adjacent natural tooth. However, these distances will be directed by the prosthetic crown needed and they will be recorded in the CRF.
| Study group | Role | What they receive |
|---|---|---|
| convergent neck | Active comparator | Group A Sweden \& Martina Prama (P). Transgingival tapering machined collar, 2.8 mm in height. Receives: Procedure: dental implant placement |
| divergent neck | Sham comparator | Group B Straumann Tissue Level (TL). Transgingival widening polished collar, 1.8 mm in height. Receives: Procedure: dental implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
soft tissue volumetric changes
soft tissue volumetric changes between baseline and one year
Measured: 1 year
Secondary outcomes (5)
marginal bone levels
marginal bone levels between baseline and at one year
Measured: 1 year
implant survival rate
no mobility at crown placement and at one year
Measured: 1 year
probing pocket depth
probing pocket depth at crown placement and at one year
Measured: 1 year
recession
recession at crown placement and at one year
Measured: 1 year
keratinized mucosa
keratinized mucosa at crown placement and at one year
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study start17 Jun 2019
- Primary completion17 Nov 2020 (estimated)
- Study completion17 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implant Geometry, Osseointegration, Soft Tissue Volume, Marginal Bone Levels, Soft Tissue Recession, Volumetric AnalysisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PerioCentrum Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabio Vignoletti, PhD, Principal investigator, PerioCentrum Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04308083
- Sponsor's protocol ID
- Sweden&Martina Prama project
- Status last verified
- Mar 2020
- First submitted
- 27 Oct 2019
- Last updated
- 13 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of a New Implant Neck Configuration on Hard and Soft Tissue Healing. A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04308083
- Acronym / sponsor ID
- Sweden&Martina Prama project
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- PerioCentrum ResearchUniversity, hospital or other
- Study start
- 17 Jun 2019 (actual)
- Primary completion
- 17 Nov 2020 (estimated)
- Study completion
- 17 Mar 2021 (estimated)
- First posted
- 13 Mar 2020 (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.
Title: Randomized Controlled Clinical Trial comparing two dental implants with different neck configurations.
Objective: To evaluate the changes in peri-implant soft tissues and marginal bone level when using a one-piece implant with a widening transgingival machined collar and a one-piece implant with a tapering transgingival machined collar.
Design: The study will be a prospective parallel randomized clinical trial with a 12 month follow up conducted in 5 private dental practices. A total of 50 patients meeting the inclusion criteria will be randomized in one of the two groups to receive 1 single implant placed in healed ridges. Radiographic and clinical measurements will be taken post-insertion, baseline (post-loading) 6 and 12 months after loading.
Study Hypothesis: The hypothesis of this study is that there will be no differences in the preservation of the peri-implant marginal bone level and peri-implant soft tissues between the two implant neck designs.
Detailed description
The study will be a prospective parallel randomized clinical trial (RCT) of approximately 20 months of duration, in which each patient will receive 1 implants placed in the posterior mandible. If the patients fulfill the inclusion criteria after implant site preparation, they will be randomized to either receive an implant with a one-piece tapering neck configuration (P) or with a widening neck configuration (TL).
52 patients, male or female, aged 18 or older, who are missing one tooth in the posterior mandible (positions 4-6).
A randomization list will determine which implant type has to be inserted. This randomization list will be generated by an independent investigator.
Patients will be recruited by the investigator consecutively. Prior to implant site preparation, the clinician will determine if the patient still meets the inclusion criteria at surgery in particular if the bone quantity is sufficient. Patients who do not meet the inclusion criteria will be excluded from the study and will therefore not be randomized. The patients will be randomized to receive P implant or TL implant.
For both groups, impression will be taken 8 weeks post insertion. Details with regard to the prosthetic procedures and materials used for the restoration of the implants will be provided in a separate section of this protocol.
Standardized peri-apical radiographs will be taken before and after prosthesis placement to document the crestal bone level at the day of loading.
Standardized photographs will be taken to measure the soft tissue at the time of loading.
The thickness of the soft tissue will be measured 2 mm apical to the gingival margin with a needle.
Routine controls are due at 6 and 12 months post loading. Peri-apical radiographs will be taken after implant placement, before/after loading and at 12 months post loading. Final impressions will be taken at 12 months post loading to evaluate volumetric changes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| convergent neck | Active comparator | Procedure: dental implant placementGroup A Sweden \& Martina Prama (P). Transgingival tapering machined collar, 2.8 mm in height. |
| divergent neck | Sham comparator | Procedure: dental implant placementGroup B Straumann Tissue Level (TL). Transgingival widening polished collar, 1.8 mm in height. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female ≥18 years old
- Each patient will have one missing tooth in the posterior mandible (positions 4-6). There must be a natural tooth mesially and distally to the implant site. Free end situation are not allowed.
- Adequate bone quality and quantity at the implant site to permit the insertion of a SWEDEN AND MARTINA® Prama Implant in the diameter of 4.25 mm and in the length of 8.5 mm, 10 mm or a Straumann Tissue Level in the diameter of 4.1 mm and in the length of 8 mm or 10mm.
- Opposing dentition must be natural teeth or teeth/implant supported fixed restoration(s).
- Patient has been informed of the follow-up visits and is willing to return to the clinical center for these follow-up visit.
Key exclusion criteria (26 listed)
- These exclusion criteria might be systemic or local. In addition to the general contra-indication for dental implants the following exclusion criteria will be observed:
- Medical conditions requiring prolonged use of steroids and/or with medications that can interfere with bone metabolism
- History of leukocyte dysfunction and deficiencies
- History of neoplasic disease requiring the use of radiation or chemotherapy
- Patients with history of renal failure
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 implant placementImplants will be placed according to the manufacturer recommendations. Implants will be placed at 1.5 to 2.0 mm from the adjacent natural tooth. However, these distances will be directed by the prosthetic crown needed and they will be recorded in the CRF. | Procedure or surgery | convergent neck, divergent neck |
Primary outcome
soft tissue volumetric changes
Time frame: 1 year
soft tissue volumetric changes between baseline and one year
5 secondary outcomes
marginal bone levels
Time frame: 1 year
implant survival rate
Time frame: 1 year
probing pocket depth
Time frame: 1 year
recession
Time frame: 1 year
keratinized mucosa
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2020.
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.
Fabio Vignoletti, PhD principal investigator
PerioCentrum Research
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 implant placement in people with Implant Geometry, Osseointegration, Soft Tissue Volume, Marginal Bone Levels, Soft Tissue Recession, Volumetric Analysis, run by PerioCentrum Research at 1 site in Spain.
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 26 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 13 Mar 2020. 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 Spain. 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. Some participants in this study may receive a placebo. 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?
Contact Beatriz Sanchez, DDS (+34659782398, beatrizsanchez@periocentrum.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
soft tissue volumetric changes (time frame: 1 year). 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 13 Mar 2020.