Edentulous JawILODNCT04930835
Treatment Outcomes With Full Arch Rehabilitations Retained by Immediate or Conventionally Loaded Implants
A study testing Implant supported dentures in people with Edentulous Jaw and Missing Teeth, run by University of Salamanca at 1 site in Spain.
Trial summary
This study aims to assess the treatment outcomes (clinical, functional and subjective) of full arch rehabilitations supported by implants with or without an immediate loading protocol. In this randomized clinical trial 20 fully edentulous patients were treated with full arch rehabilitations on dental implants. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Edentulous Jaw, Missing Teeth
- What is being tested?
- Implant supported dentures
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 11 Jan 2018to 11 Jan 2021
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- completely edentulous individuals who had lacked teeth for more than 10 years, routine users of conventional complete prostheses.
- sufficient amount of remaining bone to receive the implants in the region of the mandibular canines (minimum height=15 mm/minimum ridge width= 5mm)
- no evidence of systemic or psychic pathology that might contraindicate the implant treatment.
Who cannot join
- Those in which oral surgery or cognitive evaluations are contraindicated
Trial locations and contacts
1 site in 1 country.
Spain1 site
Clinica Odontológica de la Universidad de Salamanca
Salamanca, 37007
About this study
Official title: Treatment Outcomes With Full Arch Rehabilitations Supported by Immediate or Conventionally Loaded Implants: A Randomized Clinical Trial
This study aims to assess the treatment outcomes (clinical, functional and subjective) of full arch rehabilitations supported by implants with or without an immediate loading protocol. In this randomized clinical trial 20 fully edentulous patients were treated with full arch rehabilitations on dental implants. In half of the sample, the implants were loaded immediately by means of abutments after emplacement of the implant; but in the counterparts these abutments were connected to implants two months after the surgery (conventional protocol), and until that time the dentures were retained by healing abutments. Treatment outcomes were assessed at 2, 6 and 12 months after surgery. Clinical outcomes were quantified on the basis of implant failure rate, marginal bone loss and the peri-implant gingival index. Functional outcomes were calculated according to masticatory performance, estimated by the mixed fraction of a two-coloured chewing gum after 5, 10 and 15 chewing strokes, by the occlusal force recorded by pressure-sensitive sheets and by the bioelectrical muscular activity. The subjective outcomes of the treatment were assessed using both the oral satisfaction scale (visual analogue scale) and the Spanish version of the Oral Health Impact Profile (OHIP-20).
- Conditions
- Edentulous Jaw, Missing Teeth
- Being tested
- Implant supported dentures
- Medical subject headings
- Jaw, Edentulous, Anodontia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implant supported denturesProcedure or surgery
Placement of dental implants with different loading protocols for supporting full arch dentures.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Loading | Active comparator | implants are loaded at least after two months of healing Receives: Procedure: Implant supported dentures |
| Immediate Loading | Experimental | implants are loaded the same day of surgery Receives: Procedure: Implant supported dentures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Performance of Dental implants
Implant failure rate
Measured: One year after treatment
Oral health-related quality of life
impact according to the OHIP-20 (Oral Health Impact Profile) instrument. The score range from 0 to 20, being 20 the worst outcome.
Measured: One year after treatment
Mastication
Mixing ability tests
Measured: One year after treatment
Area of Occlusal Occlusion
According to pressure-sensitive colorimetric sheets it is recorded the area in square millimeters
Measured: One year after treatment
Occlusal Load
According to the pressure-sensitive colorimetric sheets , the load in both the anterior and posterior region of the arch are calculated.
Measured: One year after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start11 Jan 2018
- Primary completion11 Jan 2018
- Study completion11 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous JawStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Salamanca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JAVIER MONTERO, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04930835
- Sponsor's protocol ID
- ILOD
- Acronym
- ILOD
- Status last verified
- Jun 2021
- First submitted
- 10 Jun 2021
- Last updated
- 18 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Outcomes With Full Arch Rehabilitations Supported by Immediate or Conventionally Loaded Implants: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04930835
- Acronym / sponsor ID
- ILOD / ILOD
- Conditions
- Edentulous Jaw, Missing Teeth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of SalamancaUniversity, hospital or other
- Study start
- 11 Jan 2018 (actual)
- Primary completion
- 11 Jan 2018 (actual)
- Study completion
- 11 Jan 2021 (actual)
- First posted
- 18 Jun 2021 (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 aims to assess the treatment outcomes (clinical, functional and subjective) of full arch rehabilitations supported by implants with or without an immediate loading protocol. In this randomized clinical trial 20 fully edentulous patients were treated with full arch rehabilitations on dental implants. In half of the sample, the implants were loaded immediately by means of abutments after emplacement of the implant; but in the counterparts these abutments were connected to implants two months after the surgery (conventional protocol), and until that time the dentures were retained by healing abutments. Treatment outcomes were assessed at 2, 6 and 12 months after surgery. Clinical outcomes were quantified on the basis of implant failure rate, marginal bone loss and the peri-implant gingival index. Functional outcomes were calculated according to masticatory performance, estimated by the mixed fraction of a two-coloured chewing gum after 5, 10 and 15 chewing strokes, by the occlusal force recorded by pressure-sensitive sheets and by the bioelectrical muscular activity. The subjective outcomes of the treatment were assessed using both the oral satisfaction scale (visual analogue scale) and the Spanish version of the Oral Health Impact Profile (OHIP-20).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Loading | Active comparator | Procedure: Implant supported denturesimplants are loaded at least after two months of healing |
| Immediate Loading | Experimental | Procedure: Implant supported denturesimplants are loaded the same day of surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- completely edentulous individuals who had lacked teeth for more than 10 years, routine users of conventional complete prostheses.
- sufficient amount of remaining bone to receive the implants in the region of the mandibular canines (minimum height=15 mm/minimum ridge width= 5mm)
- no evidence of systemic or psychic pathology that might contraindicate the implant treatment.
Key exclusion criteria (1 listed)
- Those in which oral surgery or cognitive evaluations are contraindicated
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 |
|---|---|---|
| Implant supported denturesPlacement of dental implants with different loading protocols for supporting full arch dentures. | Procedure or surgery | Conventional Loading, Immediate Loading |
Primary outcome
Clinical Performance of Dental implants
Time frame: One year after treatment
Implant failure rate
Oral health-related quality of life
Time frame: One year after treatment
impact according to the OHIP-20 (Oral Health Impact Profile) instrument. The score range from 0 to 20, being 20 the worst outcome.
Mastication
Time frame: One year after treatment
Mixing ability tests
Area of Occlusal Occlusion
Time frame: One year after treatment
According to pressure-sensitive colorimetric sheets it is recorded the area in square millimeters
Occlusal Load
Time frame: One year after treatment
According to the pressure-sensitive colorimetric sheets , the load in both the anterior and posterior region of the arch are calculated.
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 18 Jun 2021.
- Individual participant dataSharing planned: No
Related trials for Edentulous Jaw
Active, not recruiting
L-PRF Block vs Composite Graft for Horizontal Ridge Augmentation
Alveolar Ridge Resorption After Extraction, Alveolar Bone Loss
Not yet recruitingObservational study
Digital and Conventional Clasp-retained Partial Dentures (DIGICLASP)
Partial Edentulism
Recruiting
Dynamic vs. Static Jaw Relations in Implant-Supported Prostheses: Chewing Efficiency
Chewing Efficiency in Completely Edentulous Patients Rehabilitated With Implant-Supported Full-Arch Prostheses
Active, not recruiting
Multicenter Study to Evaluate the Clinical Outcome of PrimeTaper EV Implant in Single Tooth Restorations
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Recruiting
Clinical and Radiographic Evaluation of UV-Treated Dental Implants With or Without Melatonin in the Upper Posterior Jaw
Jaw, Edentulous, Partially, Bone Resorption
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 Implant supported dentures in people with Edentulous Jaw and Missing Teeth, run by University of Salamanca 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 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 18 Jun 2021. 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?
Clinical Performance of Dental implants (time frame: One year after treatment). The study lists 5 primary outcomes in all. 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 18 Jun 2021.