Dental Implant Failed(PSG)NCT03796494
Peri-implant Tissues on Aesthetic Slim Abutment Galimplant (PSG)
A study testing Straight abutment and Slim abutment in people with Dental Implant Failed and Dental Prosthesis Failure, run by University of Santiago de Compostela at 1 site in Spain.
Trial summary
This is a randomized, single-blind, split-mouth clinical trial to evaluate the performance of peri-implant tissues (bone and soft tissues) in conventionally loaded Galimplant implants, using a classic multi-position, anti-rotational abutment, comparing it to the new multi-abutment aesthetic slim anti-rotational placed… Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Implant Failed, Dental Prosthesis Failure
- What is being tested?
- Straight abutment and Slim abutment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2019to 8 Jan 2020
- Phase
- Interventional
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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients without systemic pathology that are grounds for absolute contraindication
- Older adults who agree to be part of the study and sign the informed consent
- Consumption of tobacco less than 5 cigarettes / day
- Do not be completely toothless
- Absences of at least two pieces in posterior area with or without free ends to distal, maxillary or mandibular that do not require regenerative techniques. In case of odd absences (3,5,7), a Slim pillar will be placed, being the group to always be the majority.
- Area of mature bone healed at least 6 months post-extraction.
- Patients with a sufficient amount of bone to place implants 4 mm in diameter and 10 mm long
Who cannot join
- Immunosuppressed
- Aesthetic edentulous areas of 13-23 and 33-43
- Smokers of more than 5 cigarettes
- Index of bleeding greater than 30%
- Patients with less than 2 mm of keratinized gingiva
- Implants with primary stability with ISQ <55
- Implants with ISQ index <55 at 8 weeks
- When a margin of safety can not be assumed to the inferior dental nerve of at least 1 mm
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Behavior of the Peri-implant Tissues on the Multiposition Abutment Straight Aesthetic Slim Anti-rotational Galimplant
This is a randomized, single-blind, split-mouth clinical trial to evaluate the performance of peri-implant tissues (bone and soft tissues) in conventionally loaded Galimplant implants, using a classic multi-position, anti-rotational abutment, comparing it to the new multi-abutment aesthetic slim anti-rotational placed both at the time of the implant surgery. To this end, 80 Galimplant implants with a diameter of 4 mm and 10 mm in length will be placed in areas of mature scarred post-extraction bone. Patients be divided into 2 study groups, group C: straight pillar; Group T: Slim pillar. The bone and clinical radiological stability of the peri-implant tissues will be evaluated at 6 weeks post-surgery and at 6-12-24 months post-prosthetic loading.
- Conditions
- Dental Implant Failed, Dental Prosthesis Failure
- Being tested
- Straight abutment, Slim abutment
- Keywords
- dental implant, periimplant tissues
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Straight abutmentProcedure or surgery
This is the classic abutment, straight and anti-rotational for dental implants which have been tested before
Slim abutmentProcedure or surgery
This is the new concept of the prostheses abutment, slim and anti-rotational to improve the width of biologic space
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | The control group is considered, using the company's classic multi-position straight anti-rotational abutment Receives: Procedure: Straight abutment |
| Test group | Experimental | The test group is considered, where the new multi-position straight esthetic anti-rotational slim abutment is used Receives: Procedure: Slim abutment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary stability of implants and peri-implant tissues
Randomly and following the inclusion and exclusion criteria, the implants will be placed with the normal preparation protocol. Investigators will evaluate the immediate post-surgical stability of implants and peri-implant tissues through the Ostell system, based on the resonance frequency analysis (RFA). The implant stability quotient (ISQ) is the value on a scale that indicates the level of stability and osseointegration in dental implants. The scale ranges from 1 to 100, with higher values indicating greater stability. The acceptable stability range lies between 55-85 ISQ
Measured: 10 months
Secondary outcomes (6)
Basal Peri-implant tissue level: implant stability
Randomly and following the inclusion and exclusion criteria, the implants will be placed with the normal preparation protocol. We will load the crowns 8 weeks after implant surgery. Investigators will evaluate the stability at different moments, 8 weeks, 6 months, 12 months and 24 months. The implant stability quotient (ISQ) is the value on a scale that indicates the level of stability and osseointegration in dental implants. The scale ranges from 1 to 100, with higher values indicating greater stability. The acceptable stability range lies between 55-85 ISQ. ISQ values are obtained using resonance frequency analysis (RFA).
Measured: 1 day
Basal Radiological Bone Implant level
At the moment of placing the implant, clinical variables will be evaluated: depth of probing (distance from the peri-implant margin to the most depth of the peri-implant sulcus). This will be the basal measure of the implant stability and peri-implant tissue levels. Investigators will calculate the difference between the basal measure and the future measurements.
Measured: 1 day
Basal Peri-implant tissue level: probing depth
At the moment of placing the implant, clinical variables will be evaluated: depth of probing (distance from the peri-implant margin to the most depth of the peri-implant sulcus). This will be the basal measure of the implant stability and peri-implant tissue levels. Investigators will calculate the difference between the basal measure and the future measurements.
Measured: 1 day
Radiological bone implant stability
After the implantation, we´ll load the temporary 8 weeks after the implantation. Investigators will evaluate the bone level stability at 6 weeks in both groups, through a dental X-ray radiography. The bone stability will be measured as a difference between de basal bone level and the actual one in mm.
Measured: 8 weeks
Peri-implant tissue stability: probing depth
After the implantation, we´ll load the definitive prostheses in 8 weeks. Investigators will evaluate the peri-implant tissue stability by measuring the probing depth or just in case, the recession of the gingival margin. The stability will be given by the differences between both measures, basal and actual in mm.
Measured: 8 weeks
Peri-implant tissue stability: ISQ
After the implantation, we´ll load the temporary prostheses in 8 weeks. Investigators will evaluate the peri-implant tissue stability by measuring the ISQ through RFA. The stability will be given by the differences between both measures, basal and actual.
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 posted8 Jan 2019
- Study start1 Mar 2019
- Primary completion1 Apr 2019
- Study completion8 Jan 2020
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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Santiago de Compostela
- Sponsor type
- University, hospital or other
- Collaborators
- Galimplant Dental Implants
- Responsible party
- Principal investigator, Mario Pérez Sayáns, University of Santiago de Compostela
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03796494
- Sponsor's protocol ID
- CT-2019-01
- Acronym
- (PSG)
- Status last verified
- Mar 2020
- First submitted
- 3 Jan 2019
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will anonymize and categorize the clinical and radiological data of the patients to share the information with the other researchers of the group