Dental Implant FailedNCT04340726
Periimplant Bone Changes in Different Abutment Heights and Insertion Timing in Posterior Mandibular Areas
A study testing One time abutment in people with Dental Implant Failed, run by Universidade Católica Portuguesa at 1 site in Portugal.
Trial summary
The aim of this study was to compare the influence of the abutment height and insertion timing on early marginal bone loss (MBL) in posterior mandibular partial implant-supported restorations. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Implant Failed
- What is being tested?
- One time abutment
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 sitePortugal
- Study dates
- 1 Jan 2015to 31 Dec 2015
- 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
- patients age > 18 years;
- American Society of Anaesthesiologists (ASA) status I;
- no systemic medication or condition known to potentially alter bone metabolism; - absense of acute periodontal condition.
Who cannot join
- lack of primary stability at implant surgery;
- need for bone regeneration procedures during surgery;
- inability to correct place the implant in accordance with the prosthetic requirements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Periimplant Bone Changes in Different Abutment Heights and Insertion Timing in Posterior Mandibular Areas: Results From a Randomized Prospective Clinical Trial
The aim of this study was to compare the influence of the abutment height and insertion timing on early marginal bone loss (MBL) in posterior mandibular partial implant-supported restorations.
Material and methods: The study was planned as a prospective, randomized, controlled parallel group including subjects in need of two implants for the restoration of an edentulous posterior mandibular area. Data were gathered on age, gender, attached gingiva height, bleeding on probing (BoP), smoking habits and previous periodontitis. The patients were allocated into three groups: Group A implants were immediately connected to 2 mm height abutments; Group B implants were immediately connected to 1 mm height abutments; Group C implants were left to heal in a sub-mucosal position and 2 mm abutments were inserted in a second stage surgery. Peri-apical radiographs were taken at the implant surgery (baseline), 4 weeks after surgery (T1), 16 weeks after implant placement at the final restoration delivery (T2) and 1-year after implant placement (T3).
- Conditions
- Dental Implant Failed
- Being tested
- One time abutment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One time abutmentProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal bone changes
Crestal bone changes that occur around the dental implant
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2020
- Study start1 Jan 2015
- Primary completion1 Dec 2015
- Study completion31 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Implant FailedStudies 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
Sponsor and investigators
- Lead sponsor
- Universidade Católica Portuguesa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tiago Borges, Universidade Católica Portuguesa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04340726
- Sponsor's protocol ID
- 02/2015
- Status last verified
- Apr 2020
- First submitted
- 3 Apr 2020
- Last updated
- 9 Apr 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 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periimplant Bone Changes in Different Abutment Heights and Insertion Timing in Posterior Mandibular Areas: Results From a Randomized Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT04340726
- Acronym / sponsor ID
- 02/2015
- Conditions
- Dental Implant Failed
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Universidade Católica PortuguesaUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Dec 2015 (actual)
- Study completion
- 31 Dec 2015 (actual)
- First posted
- 9 Apr 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.
The aim of this study was to compare the influence of the abutment height and insertion timing on early marginal bone loss (MBL) in posterior mandibular partial implant-supported restorations.
Material and methods: The study was planned as a prospective, randomized, controlled parallel group including subjects in need of two implants for the restoration of an edentulous posterior mandibular area. Data were gathered on age, gender, attached gingiva height, bleeding on probing (BoP), smoking habits and previous periodontitis. The patients were allocated into three groups: Group A implants were immediately connected to 2 mm height abutments; Group B implants were immediately connected to 1 mm height abutments; Group C implants were left to heal in a sub-mucosal position and 2 mm abutments were inserted in a second stage surgery. Peri-apical radiographs were taken at the implant surgery (baseline), 4 weeks after surgery (T1), 16 weeks after implant placement at the final restoration delivery (T2) and 1-year after implant placement (T3).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients age > 18 years;
- American Society of Anaesthesiologists (ASA) status I;
- no systemic medication or condition known to potentially alter bone metabolism; - absense of acute periodontal condition.
Key exclusion criteria (3 listed)
- lack of primary stability at implant surgery;
- need for bone regeneration procedures during surgery;
- inability to correct place the implant in accordance with the prosthetic requirements.
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 |
|---|---|---|
| One time abutment | Procedure or surgery | – |
Primary outcome
Marginal bone changes
Time frame: 60 months
Crestal bone changes that occur around the dental implant
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 9 Apr 2020.
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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 One time abutment in people with Dental Implant Failed, run by Universidade Católica Portuguesa at 1 site in Portugal.
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 3 inclusion and 3 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 9 Apr 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 Portugal. 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?
Marginal bone changes (time frame: 60 months). 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 9 Apr 2020.