Dental ImplantNCT03888339
Influence of Abutment Shape on Peri-implant Marginal Bone Loss
A study testing Commercially available high abutments placement and Modified shape abutments in people with Dental Implant and Bone Resorption, run by University of Valencia at 1 site in Spain.
Trial summary
A study designed as a randomized controlled trial of parallel group design will be conducted at the Dental clinic of the University of Valencia to evaluate the influence of 2.5 mm high abutments with different shapes (commercially available high abutments vs high abutments with modified shape to imitate short… 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, Bone Resorption
- What is being tested?
- Commercially available high abutments placement and Modified shape abutments
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteSpain
- Study dates
- 5 Nov 2018to 31 May 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
- Any subject requiring two implants in the posterior mandible or maxilla, being at least 18 years old and able to sign an informed consent. Final patient inclusion will be made after flap elevation during the implant placement surgery to be able to confirm the presence of a vertical thickness ≥ 3mm of keratinized soft tissues.
- Bone volumes should allow the placement of implants at least 8 mm long (i.e, 10 mm bone height to the inferior alveolar nerve) and 4.2 mm wide (7 mm wide bone crest) without bone regeneration procedures.
- Patients will be grouped into: 1) non smokers; 2) light smokers (≤ 10 cigarettes/day); 3) heavy smokers (≥ 11 cigarettes/day)
Who cannot join
- Patients unable to commit to follow-up.
- General contraindications to implant surgery.
- Immuno-suppressed/immune-compromised patients.
- Patients irradiated in the head and/or neck.
- Uncontrolled diabetes.
- Pregnancy or lactation.
Show all 14Show fewer
- Untreated periodontal disease.
- Poor oral hygiene and motivation.
- Addiction to alcohol or drugs.
- Psychiatric problems and/or unrealistic expectations.
- Patients with an acute infection (abscess) or suppuration in the site intended for implant placement.
- Patients treated or under treatment with intravenous amino-bisphosphonates.
- Patients referred only for implant placement if the follow-up cannot be done at the treatment center.
- Patients participating in other studies, if the present protocol could not be fully adhered to.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Clínica Odontológica de la Universitat de Valencia, Fundación Lluis Alcanyis
Valencia, 46010
About this study
Official title: Influence of Different Abutment Shape on Peri-implant Marginal Bone Loss: A Randomized Clinical Trial.
A study designed as a randomized controlled trial of parallel group design will be conducted at the Dental clinic of the University of Valencia to evaluate the influence of 2.5 mm high abutments with different shapes (commercially available high abutments vs high abutments with modified shape to imitate short abutments) on peri-implant bone loss around bone level implants with platform switching in partially edentulous patients that require a fixed rehabilitation supported by two implants in the posterior mandible or maxilla and in fixed rehabilitation supported by one implant in the anterior mandible or maxilla.
Read the detailed description
A study designed as a randomized controlled trial of parallel group design will be conducted at the Dental clinic of the University of Valencia to evaluate the influence of 2.5 mm high abutments with different shapes (commercially available high abutments vs high abutments with modified shape to imitate short abutments) on peri-implant bone loss around bone level implants with platform switching in partially edentulous patients that require a fixed rehabilitation supported by two implants in the posterior mandible or maxilla and in fixed rehabilitation supported by one implant in the anterior mandible or maxilla (from premolar to premolar).
- Conditions
- Dental Implant, Bone Resorption
- Being tested
- Commercially available high abutments placement, Modified shape abutments
- Medical subject headings
- Bone Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Commercially available high abutments placementProcedure or surgery
Patients will be randomly selected for the commercially available high abutments option. Two or three implants will be placed following the drilling protocol suggested by the manufacturer. Implants will be placed 0.5mm subcrestal. Once the implants have been placed, periapical radiographs and clinical pictures will be taken. Implants will be uncovered 10 weeks after being placed. After performing the incision and elevation a minimal flap, conventional high transmucosal abutments will be screwed using the torque recommended by the manufacturer. Once the abutments have been screwed, periapical radiographs and clinical pictures will be taken. The abutments will not be unscrewed thereafter throughout the study.
Modified shape abutmentsProcedure or surgery
Patients will be randomly selected for the modified shape abutments option. Two or three implants will be placed following the drilling protocol suggested by the manufacturer. Implants will be placed 0.5mm subcrestal. Once the implants have been placed, periapical radiographs and clinical pictures will be taken. Implants will be uncovered 10 weeks after being placed. After performing the incision and elevation a minimal flap, modified high transmucosal abutments will be screwed using the torque recommended by the manufacturer. Once the abutments have been screwed, periapical radiographs and clinical pictures will be taken. The abutments will not be unscrewed thereafter throughout the study.
| Study group | Role | What they receive |
|---|---|---|
| Control group - Commercially available high abutments | Active comparator | Commercially available 2.5mm high abutments Receives: Procedure: Commercially available high abutments placement |
| Test group - Modified shape abutments | Experimental | Modified shape 2.5mm high abutments (imitating the shape of 0.5mm short abutments) Receives: Procedure: Modified shape abutments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peri-implant bone level changes
Assessed on digital periapical radiographs taken with the paralleling technique at delivery of crowns (implant loading) and 12 months afterwards.
Measured: 12 months after implant loading
Secondary outcomes (4)
Implant survival rate
% of implants in function
Measured: 12 months after implant loading
Probing pocket depth
Measured in millimeters with a millimetered periodontal probe
Measured: 12 months after implant loading
Bleeding on probing
Positive or negative bleeding after having probed with a millimetered periodontal probe
Measured: 12 months after implant loading
Peri-implant soft tissue recession
Measured in millimeters with a millimetered periodontal probe
Measured: 12 months after implant loading
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2019
- Study start5 Nov 2018
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Peñarrocha Oltra, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03888339
- Sponsor's protocol ID
- H1524219380739
- Status last verified
- Jun 2022
- First submitted
- 11 Dec 2018
- Last updated
- 24 Jun 2022
- 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 24 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Different Abutment Shape on Peri-implant Marginal Bone Loss: A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT03888339
- Acronym / sponsor ID
- H1524219380739
- Conditions
- Dental Implant, Bone Resorption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 5 Nov 2018 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 25 Mar 2019 (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.
A study designed as a randomized controlled trial of parallel group design will be conducted at the Dental clinic of the University of Valencia to evaluate the influence of 2.5 mm high abutments with different shapes (commercially available high abutments vs high abutments with modified shape to imitate short abutments) on peri-implant bone loss around bone level implants with platform switching in partially edentulous patients that require a fixed rehabilitation supported by two implants in the posterior mandible or maxilla and in fixed rehabilitation supported by one implant in the anterior mandible or maxilla.
Detailed description
A study designed as a randomized controlled trial of parallel group design will be conducted at the Dental clinic of the University of Valencia to evaluate the influence of 2.5 mm high abutments with different shapes (commercially available high abutments vs high abutments with modified shape to imitate short abutments) on peri-implant bone loss around bone level implants with platform switching in partially edentulous patients that require a fixed rehabilitation supported by two implants in the posterior mandible or maxilla and in fixed rehabilitation supported by one implant in the anterior mandible or maxilla (from premolar to premolar).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group - Commercially available high abutments | Active comparator | Procedure: Commercially available high abutments placementCommercially available 2.5mm high abutments |
| Test group - Modified shape abutments | Experimental | Procedure: Modified shape abutmentsModified shape 2.5mm high abutments (imitating the shape of 0.5mm short abutments) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Any subject requiring two implants in the posterior mandible or maxilla, being at least 18 years old and able to sign an informed consent. Final patient inclusion will be made after flap elevation during the implant placement surgery to be able to confirm the presence of a vertical thickness ≥ 3mm of keratinized soft tissues.
- Bone volumes should allow the placement of implants at least 8 mm long (i.e, 10 mm bone height to the inferior alveolar nerve) and 4.2 mm wide (7 mm wide bone crest) without bone regeneration procedures.
- Patients will be grouped into: 1) non smokers; 2) light smokers (≤ 10 cigarettes/day); 3) heavy smokers (≥ 11 cigarettes/day)
Key exclusion criteria (14 listed)
- Patients unable to commit to follow-up.
- General contraindications to implant surgery.
- Immuno-suppressed/immune-compromised patients.
- Patients irradiated in the head and/or neck.
- Uncontrolled diabetes.
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 |
|---|---|---|
| Commercially available high abutments placementPatients will be randomly selected for the commercially available high abutments option. Two or three implants will be placed following the drilling protocol suggested by the manufacturer. Implants will be placed 0.5mm subcrestal. Once the implants have been placed, periapical radiographs and clinical pictures will be taken. Implants will be uncovered 10 weeks after being placed. After performing the incision and elevation a minimal flap, conventional high transmucosal abutments will be screwed using the torque recommended by the manufacturer. Once the abutments have been screwed, periapical radiographs and clinical pictures will be taken. The abutments will not be unscrewed thereafter throughout the study. | Procedure or surgery | Control group - Commercially available high abutments |
| Modified shape abutmentsPatients will be randomly selected for the modified shape abutments option. Two or three implants will be placed following the drilling protocol suggested by the manufacturer. Implants will be placed 0.5mm subcrestal. Once the implants have been placed, periapical radiographs and clinical pictures will be taken. Implants will be uncovered 10 weeks after being placed. After performing the incision and elevation a minimal flap, modified high transmucosal abutments will be screwed using the torque recommended by the manufacturer. Once the abutments have been screwed, periapical radiographs and clinical pictures will be taken. The abutments will not be unscrewed thereafter throughout the study. | Procedure or surgery | Test group - Modified shape abutments |
Primary outcome
Peri-implant bone level changes
Time frame: 12 months after implant loading
Assessed on digital periapical radiographs taken with the paralleling technique at delivery of crowns (implant loading) and 12 months afterwards.
4 secondary outcomes
Implant survival rate
Time frame: 12 months after implant loading
Probing pocket depth
Time frame: 12 months after implant loading
Bleeding on probing
Time frame: 12 months after implant loading
Peri-implant soft tissue recession
Time frame: 12 months after implant loading
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 24 Jun 2022.
Related trials for Dental Implant
Not yet recruiting
Free Soft Tissue Grafts (FSTG) Using Autograft Palatal Donor Tissue vs. Xenograft Collagen Matrix (Zderm™)
Gingival Recession Localized Moderate, Dental Implant
Not yet recruiting
Safety Assessment of Placing a Single Dental Implant Without Antibiotic Prophylaxis in Simple Cases: A Pilot Study
Tooth Loss and Rehabillitation, Dental Implant Failure
Active, not recruiting
L-PRF Block vs Composite Graft for Horizontal Ridge Augmentation
Alveolar Ridge Resorption After Extraction, Alveolar Bone Loss
RecruitingObservational study
Clinical and Radiographic Evaluation of Dentsply Sirona PrimeTaper Implants
Dental Implants
Active, not recruiting
The Aim of the Study Will be Clinically and Radio Graphically Comparison of Two Implant Designs Used to Treat Atrophied Mandible . Implant Design Comparison Will Done for Implant Stability,Peri-implant Soft Tissue Health Changes and Bone Changes .Patients Will be Divided Randomly Into Two Group
Dental Implant Bone Loss, Peri-Implant Health
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 Commercially available high abutments placement and Modified shape abutments in people with Dental Implant and Bone Resorption, run by University of Valencia 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 3 inclusion and 14 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 24 Jun 2022. 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. 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?
Peri-implant bone level changes (time frame: 12 months after implant loading). 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 24 Jun 2022.