Tooth LossPASI-PACNCT02762201
Clinical Evaluation of Implant-secured Removable Partial Denture
A study testing PASI and PAC in people with Tooth Loss, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
This study aims to compare the therapeutic efficiency of implant-secured removable partial denture (PASI) with the therapeutic efficiency of the metalic standard removable partial denture (PAC) in the treatment of intermediate extended-gap (4 adjacent teeth). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tooth Loss
- What is being tested?
- PASI and PAC
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteFrance
- Study dates
- 16 May 2014to 6 Jun 2019
- 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
- Patients with at least a 4 to 6 adjacent teeth intermediate extended-gap (excluding wisdom teeth) in the upper or lower jaw.
- Patients with at least 4 conservable teeth by dental arch, without major occlusal trouble.
- Patients with healthy periodontium, allowing metalic standard removable partial denture delivery : bleeding on periodontal probing for a duration less than 30 seconds, Osteolysis of the alveolar ridge less or equal to 50%, attachment loss less or equal to 5mm
- Patients with a sufficient bone volume for implant placement, without prior bone supply.
Who cannot join
- Patients with general counter-indications for implant placement.
- Patients suffering from a titanium allergy.
- Patients with an insufficient oral and dental hygiene - Patients smoking ten or more cigarettes per day.
- Patients with teeth extended-gap, which could be corrected by a fixed tooth-supported denture.
- Patient with an insufficient available bite level to deliver an attachment system (< 7mm).
- Patients with a severe generalized chronic periodontitis , an aggressive periodontitis or a periodontitis unresponsive to treatment.
- Women who have reported to be pregnant.
- Patients deprived of liberty
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of Therapeutic Efficiency of Implant-secured Removable Partial Denture: A Randomized, Controlled, Prospective Multicentric Study.
This study aims to compare the therapeutic efficiency of implant-secured removable partial denture (PASI) with the therapeutic efficiency of the metalic standard removable partial denture (PAC) in the treatment of intermediate extended-gap (4 adjacent teeth). The therapeutic efficiency will be assessed by the 5 years-prosthetic success rate.
- Conditions
- Tooth Loss
- Being tested
- PASI, PAC
- Medical subject headings
- Tooth Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PASIProcedure or surgery
Implant-secured removable partial denture will be delivered in 2 large steps: implant delivery followed by denture delivery.
- Implant delivery will take 4 dental consultations : a pre-implant study at Day14 after inclusion, the surgical implant insertion at D28 after inclusion, stitches removal at D35 after inclusion, and finally functional implant delivery between 3 or 6 month after surgery (to allow implant osteointegration).
- Denture delivery will take 6 weekly dental consultations between Week 3 and Week 8 after the functional implant delivery.
PACProcedure or surgery
Metalic standard removable partial denture, the standard treatment, will be delivered in 4 steps at Day 7, D14, D21, D28 after inclusion, as classically.
| Study group | Role | What they receive |
|---|---|---|
| PASI | Experimental | PASI dental prosthesis delivery Receives: Procedure: PASI |
| PAC | Active comparator | PAC dental prosthesis delivery Receives: Procedure: PAC |
What is being measured
The primary outcome is the main question the study is designed to answer.
prosthetic success rate
Measured: 5 years after prosthesis delivery
Secondary outcomes (1)
prosthetic success rate
Measured: 6 months, 1 year, 2 years, 3 years and 4 years after prosthesis delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2016 (estimated)
- Study start16 May 2014
- Primary completion6 Jun 2019
- Study completion6 Jun 2019
Why it stopped: Sponsor and principal investigator decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth LossStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02762201
- Sponsor's protocol ID
- 2012-726
- Acronym
- PASI-PAC
- Status last verified
- Aug 2019
- First submitted
- 3 May 2016
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Therapeutic Efficiency of Implant-secured Removable Partial Denture: A Randomized, Controlled, Prospective Multicentric Study.
- ClinicalTrials.gov ID
- NCT02762201
- Acronym / sponsor ID
- PASI-PAC / 2012-726
- Conditions
- Tooth Loss
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor and principal investigator decision
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 16 May 2014 (actual)
- Primary completion
- 6 Jun 2019 (actual)
- Study completion
- 6 Jun 2019 (actual)
- First posted
- 4 May 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.
This study aims to compare the therapeutic efficiency of implant-secured removable partial denture (PASI) with the therapeutic efficiency of the metalic standard removable partial denture (PAC) in the treatment of intermediate extended-gap (4 adjacent teeth). The therapeutic efficiency will be assessed by the 5 years-prosthetic success rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PASI | Experimental | Procedure: PASIPASI dental prosthesis delivery |
| PAC | Active comparator | Procedure: PACPAC dental prosthesis delivery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with at least a 4 to 6 adjacent teeth intermediate extended-gap (excluding wisdom teeth) in the upper or lower jaw.
- Patients with at least 4 conservable teeth by dental arch, without major occlusal trouble.
- Patients with healthy periodontium, allowing metalic standard removable partial denture delivery : bleeding on periodontal probing for a duration less than 30 seconds, Osteolysis of the alveolar ridge less or equal to 50%, attachment loss less or equal to 5mm
- Patients with a sufficient bone volume for implant placement, without prior bone supply.
Key exclusion criteria (8 listed)
- Patients with general counter-indications for implant placement.
- Patients suffering from a titanium allergy.
- Patients with an insufficient oral and dental hygiene - Patients smoking ten or more cigarettes per day.
- Patients with teeth extended-gap, which could be corrected by a fixed tooth-supported denture.
- Patient with an insufficient available bite level to deliver an attachment system (< 7mm).
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 |
|---|---|---|
| PASIImplant-secured removable partial denture will be delivered in 2 large steps: implant delivery followed by denture delivery. * Implant delivery will take 4 dental consultations : a pre-implant study at Day14 after inclusion, the surgical implant insertion at D28 after inclusion, stitches removal at D35 after inclusion, and finally functional implant delivery between 3 or 6 month after surgery (to allow implant osteointegration). * Denture delivery will take 6 weekly dental consultations between Week 3 and Week 8 after the functional implant delivery. | Procedure or surgery | PASI |
| PACMetalic standard removable partial denture, the standard treatment, will be delivered in 4 steps at Day 7, D14, D21, D28 after inclusion, as classically. | Procedure or surgery | PAC |
Primary outcome
prosthetic success rate
Time frame: 5 years after prosthesis delivery
1 secondary outcome
prosthetic success rate
Time frame: 6 months, 1 year, 2 years, 3 years and 4 years after prosthesis delivery
Results and safety
The study was stopped early (reason given: Sponsor and principal investigator decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Individual participant dataSharing planned: No
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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 PASI and PAC in people with Tooth Loss, run by Hospices Civils de Lyon at 1 site in France.
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 4 inclusion and 8 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: stopped early, as of the sponsor's last update on 28 Aug 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 France. 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 was stopped early (reason given: Sponsor and principal investigator decision). Results are not available in the source record.
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?
prosthetic success rate (time frame: 5 years after prosthesis delivery). 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 28 Aug 2019.