Edentulous MaxillaNCT02957487
Maxillary 3-implant Removable Prostheses Without Palatal Coverage on Locator Abutments
An observational study of Edentulous Maxilla, run by University of Tromso at 1 site in Norway.
Trial summary
The aims of this clinical study conducted at a dental specialty clinic in Drammen, Norway are to assess the clinical outcomes of patients with an edentate upper jaw having been treated with a removable full prosthesis supported by 3 implants to restore function and aesthetics. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Edentulous Maxilla
- What is being tested?
- Denture supported by 3 dental implants
- Type of treatment
- Medical device
- How many people
- 32 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2013to 28 Sep 2018
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients treated in a private dental clinic in Drammen, Norway
Who may be able to join
- Edentulous maxilla Competence to sign the informed consent form describing the study
Who cannot join
- Lack of jaw bone for the placement of dental implants without the need for bone regeneration.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Maxillary 3-implant Removable Prostheses Without Palatal Coverage on Locator Abutments - a Prospective Cohort Study
The aims of this clinical study conducted at a dental specialty clinic in Drammen, Norway are to assess the clinical outcomes of patients with an edentate upper jaw having been treated with a removable full prosthesis supported by 3 implants to restore function and aesthetics. Clinical variables beyond implant dimensions and intraoral location, such as recall routines, maintenance needs, patient satisfaction and quality of life, will also be appraised and contrasted with an aim to elucidate their association with clinical outcomes. Specific evaluation will be done with regard to the following outcome criteria:
- crestal bone levels and periodontal conditions around implants
- incidence rates of biological, technical, traumatic failures / complications related to implants
- incidence rates of biological, technical, mechanical, esthetic failures/complications with prosthesis and prosthetic components A secondary objective is to identify the different risk factors for biological failures / complications, including the influence of medical conditions and tobacco use.
Read the detailed description
Materials and Methods The protocol is submitted to the Research Ethics Board of the Northern Norway in order to obtain ethics approval prior to commencing the study. All patients will obtain an invitation letter detailing the objectives of the study and requested to sign a consent letter prior to clinical examinations according to principles for good research practice. All patients will be offered a free implant hygiene session and prosthesis cleaning.
Study population All patients treated in a private dental clinic in Drammen, Norway having received a maxillary removable full prosthesis supported on 3 dental implants will be invited to attend evaluations of their intra-oral status annually after implant installation and solicited about treatment satisfaction and daily oral functions. These patients were initially not offered maintenance care at the completion of their treatment.
The implants that have been used are made from titanium with a microrough surface (Astra Tech Implant System, Dentsply Implants, Mølndal, Sweden). All implants have been placed according to the manufacturer's instructions (http://www.dentsplyimplants.no/nb-NO/Implantatsystem/Prosedyrer/Treatment-planning) and fitted with precision attachments (Locator, ZEST Anchors, Escondido, CA, USA. The removable prostheses were made from heat cured poly-methyl-metacrylate (PMMA) incorporating three active matrices).
Recall Procedure Each patient will be invited by letter followed up by a phone call to attend an examination visit. The patients will complete a questionnaire related to changes in general health aspects, their experiences and satisfaction with the reconstructions and eventual need for repair sessions during the last year. Specifically, the medical history and the smoking history (e.g. pack/years) will be assessed. Recordings will be made of general and local factors which may affect the prognosis of the implants and prosthesis. This includes the occurrence of systemic disease since implant placement, regular medication used by patients, smoking status, dental treatment received since implant placement, recall frequency at the dental hygienist and the last dental examination appointment.
Collection of Data from Patients' Charts
General information will be gathered from the patients' charts. Patients' age, self-reported smoking habits and the number of cigarettes per day, medical history, medication intake, reason for tooth loss and the date of prosthesis insertion will be recorded in "patient's summary forms". Type and distribution of implants will be retrieved from patients' charts. Cases with a chart documentation of an incidence of biological or mechanical complications during the follow-up period will be closely reviewed and recorded as following:
- History of implant loss (Biological complication): Period of service before failure is traced in months for each lost implant. Lost implants will be categorized in three groups: 1) "Early Failure" which refers to implants lost before the insertion of the definite prosthesis. 2) "One-year Failure" addressing implants failed within the first year of loading. 3) "Late Failure" including implants lost more than one year following the insertion of the final prosthesis (Roos-Jansåker et al 2006).
- History of peri-implant mucositis or peri-implantitis (biological complication): Any recorded incidence of inflammation and suppuration related to the gingival tissue surrounding implants in patients' charts will be gathered and transferred to "patients' summary forms".
- History of various technical problems encountered following the insertion of the removable prosthesis (mechanical complications):
Any history of mechanical complications such as attachment loosening/fracture and incidences of cracks, chippings and fractures in resin teeth, acrylic body and prosthesis will be recorded in "patients' summary forms".
Post-operation peri-apical radiographs, taken at the day of "stage-one" surgery, will be retrieved from patient's charts and used as the reference point of supporting bone level for each implant. Reference bone levels on mesial and distal sides are determined by measuring the distance between implant platform and the most apical point of the alveolar crestal bone surrounding implant. A mean value between the mesial and distal sides is used for each implant as the reference marginal bone level.
- Conditions
- Edentulous Maxilla
- Being tested
- Denture supported by 3 dental implants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Denture supported by 3 dental implantsDevice
Metal-reinforced denture without palatal coverage incorporating nylon rings retained by friction to Locator abutments fitted on top of dental implants
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-oral status
The radiographic examination will comprise periapical radiographs or an orthopantomogram. The clinical examination include a basic periodontal examination with the use of an UNC-15 (University of North Carolina) manual periodontal probe. Outcomes measured will be presence or absence of peri-implant suppuration or fistula, the modified plaque and sulcus bleeding indices) and the probing depths.
Measured: 3 years
Condition of prosthesis and implants
The removable prosthesis will be examined for any technical flaws. Adverse technical events include loss of retention, or fracture and/or chipping of the removable prosthesis. Adverse mechanical events include loosening of the male attachment or fracture of an implant. The stability of all implants will be assessed, and any sign of mobility along with pain and discomfort will be interpreted as a definitive sign of implant failure.
Measured: 3 years
Secondary outcomes (3)
Implant bone level changes
Reference bone levels on the mesial and distal sides will be measured relative to baseline measurements made at the time of delivery of denture
Measured: 3 years
Patient-reported satisfaction outcome
A self-reported Denture Satisfaction Scale questionnaire (Allen et al. 2001).
Measured: 5 years
Patient-reported quality of life outcome
The short form version of the Oral Health Impact Profile questionnaire (OHIP-20) (Allen \& Locker 2002).
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2016 (estimated)
- Study startSep 2013
- Primary completion28 Sep 2018
- Study completion28 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Edentulous MaxillaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tromso
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Asbjørn Jokstad, DDS, PhD, Principal investigator, UiT The Arctic University of Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02957487
- Sponsor's protocol ID
- REK 2013/1446
- Status last verified
- Apr 2019
- First submitted
- 21 Oct 2016
- Last updated
- 16 May 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Mo A, Hjortsjo C, Olsen-Bergem H, Jokstad A. Maxillary 3-implant removable prostheses without palatal coverage on Locator abutments - a case series. Clin Oral Implants Res. 2016 Oct;27(10):1193-1199. doi: 10.1111/clr.12724. Epub 2015 Nov 14.
PubMed 26566604
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maxillary 3-implant Removable Prostheses Without Palatal Coverage on Locator Abutments - a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT02957487
- Acronym / sponsor ID
- REK 2013/1446
- Conditions
- Edentulous Maxilla
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of TromsoUniversity, hospital or other
- Study start
- Sep 2013 (actual)
- Primary completion
- 28 Sep 2018 (actual)
- Study completion
- 28 Sep 2018 (actual)
- First posted
- 7 Nov 2016 (estimated)
- 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 aims of this clinical study conducted at a dental specialty clinic in Drammen, Norway are to assess the clinical outcomes of patients with an edentate upper jaw having been treated with a removable full prosthesis supported by 3 implants to restore function and aesthetics. Clinical variables beyond implant dimensions and intraoral location, such as recall routines, maintenance needs, patient satisfaction and quality of life, will also be appraised and contrasted with an aim to elucidate their association with clinical outcomes. Specific evaluation will be done with regard to the following outcome criteria:
- crestal bone levels and periodontal conditions around implants
- incidence rates of biological, technical, traumatic failures / complications related to implants
- incidence rates of biological, technical, mechanical, esthetic failures/complications with prosthesis and prosthetic components A secondary objective is to identify the different risk factors for biological failures / complications, including the influence of medical conditions and tobacco use.
Detailed description
Materials and Methods The protocol is submitted to the Research Ethics Board of the Northern Norway in order to obtain ethics approval prior to commencing the study. All patients will obtain an invitation letter detailing the objectives of the study and requested to sign a consent letter prior to clinical examinations according to principles for good research practice. All patients will be offered a free implant hygiene session and prosthesis cleaning.
Study population All patients treated in a private dental clinic in Drammen, Norway having received a maxillary removable full prosthesis supported on 3 dental implants will be invited to attend evaluations of their intra-oral status annually after implant installation and solicited about treatment satisfaction and daily oral functions. These patients were initially not offered maintenance care at the completion of their treatment.
The implants that have been used are made from titanium with a microrough surface (Astra Tech Implant System, Dentsply Implants, Mølndal, Sweden). All implants have been placed according to the manufacturer's instructions (http://www.dentsplyimplants.no/nb-NO/Implantatsystem/Prosedyrer/Treatment-planning) and fitted with precision attachments (Locator, ZEST Anchors, Escondido, CA, USA. The removable prostheses were made from heat cured poly-methyl-metacrylate (PMMA) incorporating three active matrices).
Recall Procedure Each patient will be invited by letter followed up by a phone call to attend an examination visit. The patients will complete a questionnaire related to changes in general health aspects, their experiences and satisfaction with the reconstructions and eventual need for repair sessions during the last year. Specifically, the medical history and the smoking history (e.g. pack/years) will be assessed. Recordings will be made of general and local factors which may affect the prognosis of the implants and prosthesis. This includes the occurrence of systemic disease since implant placement, regular medication used by patients, smoking status, dental treatment received since implant placement, recall frequency at the dental hygienist and the last dental examination appointment.
Collection of Data from Patients' Charts
General information will be gathered from the patients' charts. Patients' age, self-reported smoking habits and the number of cigarettes per day, medical history, medication intake, reason for tooth loss and the date of prosthesis insertion will be recorded in "patient's summary forms". Type and distribution of implants will be retrieved from patients' charts. Cases with a chart documentation of an incidence of biological or mechanical complications during the follow-up period will be closely reviewed and recorded as following:
- History of implant loss (Biological complication): Period of service before failure is traced in months for each lost implant. Lost implants will be categorized in three groups: 1) "Early Failure" which refers to implants lost before the insertion of the definite prosthesis. 2) "One-year Failure" addressing implants failed within the first year of loading. 3) "Late Failure" including implants lost more than one year following the insertion of the final prosthesis (Roos-Jansåker et al 2006).
- History of peri-implant mucositis or peri-implantitis (biological complication): Any recorded incidence of inflammation and suppuration related to the gingival tissue surrounding implants in patients' charts will be gathered and transferred to "patients' summary forms".
- History of various technical problems encountered following the insertion of the removable prosthesis (mechanical complications):
Any history of mechanical complications such as attachment loosening/fracture and incidences of cracks, chippings and fractures in resin teeth, acrylic body and prosthesis will be recorded in "patients' summary forms".
Post-operation peri-apical radiographs, taken at the day of "stage-one" surgery, will be retrieved from patient's charts and used as the reference point of supporting bone level for each implant. Reference bone levels on mesial and distal sides are determined by measuring the distance between implant platform and the most apical point of the alveolar crestal bone surrounding implant. A mean value between the mesial and distal sides is used for each implant as the reference marginal bone level.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients treated in a private dental clinic in Drammen, Norway
Key inclusion criteria (1 listed)
- Edentulous maxilla Competence to sign the informed consent form describing the study
Key exclusion criteria (1 listed)
- Lack of jaw bone for the placement of dental implants without the need for bone regeneration.
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 |
|---|---|---|
| Denture supported by 3 dental implantsMetal-reinforced denture without palatal coverage incorporating nylon rings retained by friction to Locator abutments fitted on top of dental implants | Device | – |
Primary outcome
Intra-oral status
Time frame: 3 years
The radiographic examination will comprise periapical radiographs or an orthopantomogram. The clinical examination include a basic periodontal examination with the use of an UNC-15 (University of North Carolina) manual periodontal probe. Outcomes measured will be presence or absence of peri-implant suppuration or fistula, the modified plaque and sulcus bleeding indices) and the probing depths.
Condition of prosthesis and implants
Time frame: 3 years
The removable prosthesis will be examined for any technical flaws. Adverse technical events include loss of retention, or fracture and/or chipping of the removable prosthesis. Adverse mechanical events include loosening of the male attachment or fracture of an implant. The stability of all implants will be assessed, and any sign of mobility along with pain and discomfort will be interpreted as a definitive sign of implant failure.
3 secondary outcomes
Implant bone level changes
Time frame: 3 years
Patient-reported satisfaction outcome
Time frame: 5 years
Patient-reported quality of life outcome
Time frame: 5 years
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 16 May 2019.
- Background: PubMed 26566604Mo A, Hjortsjo C, Olsen-Bergem H, Jokstad A. Maxillary 3-implant removable prostheses without palatal coverage on Locator abutments - a case series. Clin Oral Implants Res. 2016 Oct;27(10):1193-1199. doi: 10.1111/clr.12724. Epub 2015 Nov 14.
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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.
Asbjørn Jokstad, DDS, PhD principal investigator
UiT The Arctic University of Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Edentulous Maxilla, run by University of Tromso at 1 site in Norway.
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 1 inclusion and 1 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 16 May 2019. 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 Norway. 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?
Intra-oral status (time frame: 3 years). The study lists 2 primary outcomes in all. 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 NCT02957487, which also lists 1 linked publication.
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 16 May 2019.