Alveolar Bone LossNCT03290729
Wedge Implant Narrow Crests: Multi-center Clinical Study
A study testing wedge shape implants insertion in people with Alveolar Bone Loss, run by International Piezosurgery Academy at 1 site in Italy.
Trial summary
This study was designed as a multicentric prospective clinical trial to assess the clinical, biological and patient's perceived success of new wedge-shaped dental implants inserted in narrow ridges. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alveolar Bone Loss
- What is being tested?
- wedge shape implants insertion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteItaly
- Study dates
- 15 May 2017to 15 May 2020
- 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
- indications for prosthetic rehabilitation supported by implants in the upper or lower arch, based on accurate diagnosis and treatment planning;
- the bone crest must be completely healed (at least six months after the tooth loss);
- residual bone ridge width between 3.5 and 5 mm, at least 3 mm in apical direction;
- presence of at least 10 mm bone height available for implant placement;
- age of the patient> 18 years;
- The patient must not carry any removable prosthesis on the treated area;
- the patient must be able to follow the protocol of study;
- informed written consent
Who cannot join
- acute myocardial infarction over the last 2 months;
- uncontrolled coagulation disorders;
- unmanaged diabetes (HBA1c> 7.5);
- radiotherapy to the head area in the last 24 months;
- immunocompromised, HIV positive or chemotherapy patients over the past 5 years;
- present or past treatment with intravenous bisphosphonates;
Show all 9Show fewer
- psychological or psychiatric problems;
- abuse of alcohol or drugs;
- uncontrolled periodontal disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Wedge Implant for Minimally Invasive Treatment of Narrow Crests: a Prospective Multi-center Clinical Study
This study was designed as a multicentric prospective clinical trial to assess the clinical, biological and patient's perceived success of new wedge-shaped dental implants inserted in narrow ridges.
Read the detailed description
Due to the loss of dental elements, the bone crest undergoes a significant remodeling. Bone resorption begins immediately after dental extraction with a 40-60% reduction in horizontal and vertical direction of the alveolar ridge during the first 2 years. The most significant bone loss after tooth extraction occurs within the first 3 months, although modeling and remodeling of the alveoli have a great variability of time: bone structure and organization may not be complete even 24 weeks after dental extraction.
It is now known that crestal remodeling is closely related to the disappearance of the bundle bone, which is more representative of the buccal appearance of the alveolus. Its disappearance, especially in thin periodontal biotopes, can lead to significant recessions of hard and soft tissues.
Moreover, with a variable percentage, in many patients, crestal resorption continues over time due to a combination of factors involved: anatomical, metabolic and mechanical. Among these, the use of removable total or partial dentures can play an important role in accelerating the resurfacing process.
With these premises, it is common to find patients with atrophic crests when processing plans that provide implant support prosthetic rehabilitation.
A crestal bone thickness of at least 6 mm in the buco-lingual sense is considered sufficient to safely place a plant with a diameter of 4 mm. But when the width is lower, a variety of procedures and techniques have been proposed in literature that allow recreate the volumes needed for implant placement.
Horizontal lifting techniques with bone blocks (autologous, alloplastic, xeno-graft), guided bone regeneration, crest expansion technique have demonstrated a good long-term predictability of the inserted devices. However, some negatives related to these techniques need to be considered, such as increased morbidity for the patient, demand for advanced surgical skills for the operator, increased treatment costs, and increased therapy times.
Because of these observations, a new implant design has been proposed for specific use in narrow ridges. Its wedge shape and press-fit insertion make it possible to position it with a minimally invasive preparation of the implant site, performed with ultrasound technique.
Therefore, the use of this implant could allow effective and minimally invasive treatment of narrow edentulous crests up to 4 mm, with significant benefits to the patient in terms of morbidity, treatment costs and time.
Twelve clinical centers will treat patients with insertion of wedge-shaped implants in thin crests with a specific surgical protocol and clinical outcomes will be collected and analyzed.
The chosen medical device will be the Rex Tissue Level implant System. For each implant inserted, the clinical parameters will be recorded up to 5 years after insertion.
In addition, intermediate evaluations will be carried out at 1 year and 3 years after installation.
- Conditions
- Alveolar Bone Loss
- Being tested
- wedge shape implants insertion
- Keywords
- wedge implants; atrophic bone
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wedge shape implants insertionProcedure or surgery
Narrow dental implants inserted in narrow ridges
| Study group | Role | What they receive |
|---|---|---|
| narrow ridge | Experimental | edentulous site with crestal bone width comprised between 3,5 and 5 millimeters wedge shape implants insertion Receives: Procedure: wedge shape implants insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
implant survival rate
health of the inserted implants
Measured: 1 year after surgery
Secondary outcomes (12)
surgical procedure evaluation
handling assessment of the implant system by the surgeons
Measured: during surgery
surgical procedure evaluation
assessment of the invasivity of the surgical procedure from the patient
Measured: 1 hour after surgery
implant stability 14
resonance frequence analysis of the implant
Measured: 14 days after surgery
implant stability 1 month
resonance frequence analysis of the implant
Measured: 1 month after surgery
implant stability 2 months
resonance frequence analysis of the implant
Measured: 2 months after surgery
implant stability 3 months
resonance frequence analysis of the implant
Measured: 3 months after surgery
implant stability 4 months
resonance frequence analysis of the implant
Measured: 4 months after surgery
implant stability 5 months
resonance frequence analysis of the implant
Measured: 5 months after surgery
implant stability 6 months
resonance frequence analysis of the implant
Measured: 6 months after surgery
implant stability 1 year
resonance frequence analysis of the implant
Measured: 1 year after surgery
implant stability 3 years
resonance frequence analysis of the implant
Measured: 3 years after surgery
implant stability 5 years
resonance frequence analysis of the implant
Measured: 5 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2017
- Study start15 May 2017
- Primary completion15 Nov 2019
- Study completion15 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Alveolar Bone 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- multicenter single cohort prospective study
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Piezosurgery Academy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mr. Claudio Stacchi, DDS, MSc, International Piezosurgery Academy
- Investigators
- claudio stacchi, Dr., Principal investigator, Piezosurgery Academy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03290729
- Sponsor's protocol ID
- REX_i
- Status last verified
- Aug 2020
- First submitted
- 21 Jul 2017
- Last updated
- 26 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chiapasco M, Zaniboni M. Clinical outcomes of GBR procedures to correct peri-implant dehiscences and fenestrations: a systematic review. Clin Oral Implants Res. 2009 Sep;20 Suppl 4:113-23. doi: 10.1111/j.1600-0501.2009.01781.x.
PubMed 19663958Danza M, Guidi R, Carinci F. Comparison between implants inserted into piezo split and unsplit alveolar crests. J Oral Maxillofac Surg. 2009 Nov;67(11):2460-5. doi: 10.1016/j.joms.2009.04.041.
PubMed 19837318Schropp L, Wenzel A, Kostopoulos L, Karring T. Bone healing and soft tissue contour changes following single-tooth extraction: a clinical and radiographic 12-month prospective study. Int J Periodontics Restorative Dent. 2003 Aug;23(4):313-23.
PubMed 12956475
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wedge Implant for Minimally Invasive Treatment of Narrow Crests: a Prospective Multi-center Clinical Study
- ClinicalTrials.gov ID
- NCT03290729
- Acronym / sponsor ID
- REX_i
- Conditions
- Alveolar Bone Loss
- Keywords
- wedge implants; atrophic bone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- International Piezosurgery AcademyUniversity, hospital or other
- Study start
- 15 May 2017 (actual)
- Primary completion
- 15 Nov 2019 (actual)
- Study completion
- 15 May 2020 (actual)
- First posted
- 25 Sep 2017 (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 study was designed as a multicentric prospective clinical trial to assess the clinical, biological and patient's perceived success of new wedge-shaped dental implants inserted in narrow ridges.
Detailed description
Due to the loss of dental elements, the bone crest undergoes a significant remodeling. Bone resorption begins immediately after dental extraction with a 40-60% reduction in horizontal and vertical direction of the alveolar ridge during the first 2 years. The most significant bone loss after tooth extraction occurs within the first 3 months, although modeling and remodeling of the alveoli have a great variability of time: bone structure and organization may not be complete even 24 weeks after dental extraction.
It is now known that crestal remodeling is closely related to the disappearance of the bundle bone, which is more representative of the buccal appearance of the alveolus. Its disappearance, especially in thin periodontal biotopes, can lead to significant recessions of hard and soft tissues.
Moreover, with a variable percentage, in many patients, crestal resorption continues over time due to a combination of factors involved: anatomical, metabolic and mechanical. Among these, the use of removable total or partial dentures can play an important role in accelerating the resurfacing process.
With these premises, it is common to find patients with atrophic crests when processing plans that provide implant support prosthetic rehabilitation.
A crestal bone thickness of at least 6 mm in the buco-lingual sense is considered sufficient to safely place a plant with a diameter of 4 mm. But when the width is lower, a variety of procedures and techniques have been proposed in literature that allow recreate the volumes needed for implant placement.
Horizontal lifting techniques with bone blocks (autologous, alloplastic, xeno-graft), guided bone regeneration, crest expansion technique have demonstrated a good long-term predictability of the inserted devices. However, some negatives related to these techniques need to be considered, such as increased morbidity for the patient, demand for advanced surgical skills for the operator, increased treatment costs, and increased therapy times.
Because of these observations, a new implant design has been proposed for specific use in narrow ridges. Its wedge shape and press-fit insertion make it possible to position it with a minimally invasive preparation of the implant site, performed with ultrasound technique.
Therefore, the use of this implant could allow effective and minimally invasive treatment of narrow edentulous crests up to 4 mm, with significant benefits to the patient in terms of morbidity, treatment costs and time.
Twelve clinical centers will treat patients with insertion of wedge-shaped implants in thin crests with a specific surgical protocol and clinical outcomes will be collected and analyzed.
The chosen medical device will be the Rex Tissue Level implant System. For each implant inserted, the clinical parameters will be recorded up to 5 years after insertion.
In addition, intermediate evaluations will be carried out at 1 year and 3 years after installation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- multicenter single cohort prospective study
| Arm | Type | Receives |
|---|---|---|
| narrow ridge | Experimental | Procedure: wedge shape implants insertionedentulous site with crestal bone width comprised between 3,5 and 5 millimeters wedge shape implants insertion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- indications for prosthetic rehabilitation supported by implants in the upper or lower arch, based on accurate diagnosis and treatment planning;
- the bone crest must be completely healed (at least six months after the tooth loss);
- residual bone ridge width between 3.5 and 5 mm, at least 3 mm in apical direction;
- presence of at least 10 mm bone height available for implant placement;
- age of the patient> 18 years;
Key exclusion criteria (9 listed)
- acute myocardial infarction over the last 2 months;
- uncontrolled coagulation disorders;
- unmanaged diabetes (HBA1c> 7.5);
- radiotherapy to the head area in the last 24 months;
- immunocompromised, HIV positive or chemotherapy patients over the past 5 years;
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 |
|---|---|---|
| wedge shape implants insertionNarrow dental implants inserted in narrow ridges | Procedure or surgery | narrow ridge |
Primary outcome
implant survival rate
Time frame: 1 year after surgery
health of the inserted implants
12 secondary outcomes
surgical procedure evaluation
Time frame: during surgery
surgical procedure evaluation
Time frame: 1 hour after surgery
implant stability 14
Time frame: 14 days after surgery
implant stability 1 month
Time frame: 1 month after surgery
implant stability 2 months
Time frame: 2 months after surgery
implant stability 3 months
Time frame: 3 months after surgery
implant stability 4 months
Time frame: 4 months after surgery
implant stability 5 months
Time frame: 5 months after surgery
implant stability 6 months
Time frame: 6 months after surgery
implant stability 1 year
Time frame: 1 year after surgery
implant stability 3 years
Time frame: 3 years after surgery
implant stability 5 years
Time frame: 5 years after surgery
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 26 Aug 2020.
- Background: PubMed 19663958Chiapasco M, Zaniboni M. Clinical outcomes of GBR procedures to correct peri-implant dehiscences and fenestrations: a systematic review. Clin Oral Implants Res. 2009 Sep;20 Suppl 4:113-23. doi: 10.1111/j.1600-0501.2009.01781.x.
- Background: PubMed 19837318Danza M, Guidi R, Carinci F. Comparison between implants inserted into piezo split and unsplit alveolar crests. J Oral Maxillofac Surg. 2009 Nov;67(11):2460-5. doi: 10.1016/j.joms.2009.04.041.
- Background: PubMed 12956475Schropp L, Wenzel A, Kostopoulos L, Karring T. Bone healing and soft tissue contour changes following single-tooth extraction: a clinical and radiographic 12-month prospective study. Int J Periodontics Restorative Dent. 2003 Aug;23(4):313-23.
- 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.
claudio stacchi, Dr. principal investigator
Piezosurgery Academy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing wedge shape implants insertion in people with Alveolar Bone Loss, run by International Piezosurgery Academy at 1 site in Italy.
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 8 inclusion and 9 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 26 Aug 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 Italy. 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?
implant survival rate (time frame: 1 year after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03290729, which also lists 3 linked publications.
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 26 Aug 2020.