Complete EdentulismIDEFIXNCT06698978
Simplified Technique in Removable Complete Prosthesis Versus Conventional Technique in Edentulous Patients
A study testing Simplified protocol (PS)/Conventional protocol (PC) and Conventional protocol (PC)/Simplified protocol (PS) in people with Complete Edentulism, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
This study compares a simplified complete removable denture technique (PS) to the conventional approach (PC) in edentulous patients. The goal is to demonstrate that the simplified technique is not inferior to the conventional method in terms of quality of life, measured by the OHIP-20 scale over three months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complete Edentulism
- What is being tested?
- Simplified protocol (PS)/Conventional protocol (PC) and Conventional protocol (PC)/Simplified protocol (PS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 1 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years
- Complete single-maxillary (upper or lower arcade) or bimaxillar (upper and lower arcade) edentesis paired with non-iatrogenic removable full dentures (possibly readapted)
- Edentulous arcade with healthy or sanitized mucosa
- Sufficient inter arcade space
- Free and informed consent
- Adequate understanding of written and spoken French
- Membership of a social security scheme
Who cannot join
- Patient unable to cooperate
- Presence of pathological lesions of the oral mucosa
- Parkinson's disease
- Gougerot-Sjögren's disease,
- Patient with cancer of the upper aerogribogastic tract
- Patient in psychiatric care
Show all 12Show fewer
- Patient with neurological disease (vascular algia of the face, trigeminal neuralgia,...)
- Patient with xerostomia
- Allergy identified to resin
- Patient deprived of liberty by judicial or administrative decision
- Patient under legal protection (guardianship, curatorship)
- Patient under AME (State Medical Aid)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Interest of a Simplified Technique in Removable Complete Prosthesis Versus Conventional Technique in Edentulous Patients: a Multicenter Randomized Clinical Trial in Cross-over.
This study compares a simplified complete removable denture technique (PS) to the conventional approach (PC) in edentulous patients. The goal is to demonstrate that the simplified technique is not inferior to the conventional method in terms of quality of life, measured by the OHIP-20 scale over three months. The trial also examines time, satisfaction, denture quality, cost, and masticatory performance.
Design:
Read more
This is a multicenter, randomized, cross-over study with 62 patients over 11 months of participation, including a one-month washout between treatments. Patients will receive both types of dentures, with the order randomized.
Population:
The trial targets edentulous patients, both uni- and bi-maxillary, aged 18 or older, with certain health and dental conditions.
Key Assessments:
Quality of Life: OHIP-20 scores are collected pre-treatment and after three months for each denture type.
Patient Satisfaction and Denture Quality: Assessed using modified Kapur criteria and patient satisfaction surveys.
Masticatory Performance: Evaluated with a chewing gum test. Medical Economic Impact: Cost analysis of each denture type.
Anticipated Outcomes:
Benefits include reducing costs and treatment times, enhancing accessibility to dentures, particularly for elderly and underserved populations, and adapting dental education to teach this simplified technique.
Centers Involved:
Seven centers across France, including AP-HP hospitals and private practices.
Timeline:
The inclusion period is 24 months, with a total study duration of 35 months.
Read the detailed description
Despite the progress made in preventing caries and periodontal disease, edentury remains a major disability affecting function, nutrition, aesthetics and quality of life. In France, there were about two million edentulous in 2003 (HAS). It is estimated that the proportion of single-maxillary edentulous people in 65-74 years was 16.3% and 14.3% for bimaxillary edentulum. The population of complete edentulous is a fragile, often elderly population at risk of undernutrition and social isolation.
Since January 2021, the CCAM has imposed a RAC0 (remaining charge 0) for complete removable prostheses (PAC) with capped fees. These blocked fees make it difficult to produce high quality prostheses according to the conventional protocol. The blocked fees encourage liberal dentists to refer these patients to medical centres or hospital services. In addition, in areas of medical desertification, a shorter treatment time would be beneficial for patients and practitioners.
During the last five years, international literature has brought out simplified protocols to achieve PACs, shorter and more economical than conventional protocols. According to these studies there is no significant difference in quality of life for completely edentulous patients. However, these simplified AHRC implementation protocols are not harmonized and the simplification does not involve the same steps according to the protocols or the same classes of complete edentulous. In addition, these simplified protocols are not taught because they are too recent and with insufficient evidence from well-conducted clinical trials.
The hypothesis is that a new prosthetic realization technique with a single imprint, according to an innovative protocol, is not inferior in terms of quality of life than the conventional realization technique with two impressions in PAC.
The main objective of this study is to demonstrate the non-inferiority of a complete removable prosthesis made according to the simplified protocol compared to a complete removable prosthesis made according to the conventional protocol on quality of life, after 3 months of use of each prosthesis, in patients with complete single-maxillary or bi-maxillary edentesis (upper and/or lower arcada).
Primary Assessment Criterion : Variation in the total score on the OHIP-20 (Oral Health Impact Profile-20) questionnaire between inclusion and 3 months after prosthesis placement.
The OHIP 20 is a scale of oral quality of life, specific to total edentulousness, validated in French. It has 20 items rated from 1 to 6 (minimum score 20-maximum score 120). For each item, a score of 6 corresponds to an optimal quality of life.
Secondary objectives of research
- Compare the chair time between the two prostheses
- Compare patient satisfaction for each prosthesis using the Celebic \& Knezovic-Zlataric questionnaire
- Compare the quality of prostheses using modified KAPUR criteria (retention and stability)
- Compare the cost of simplified restoration with that of conventional technique, estimate the national impact of the diffusion of simplified technique, and estimate the differential cost ratio results.
- Compare the patient's chewing performance between the two prostheses
Secondary evaluation criteria :
- Cumulative measurement of time spent (in minutes) at the chair for prosthesis fabrication and adjustment steps
- Measurement of patient satisfaction on different items for each prosthesis using the Celebic \& Knezovic-Zlataric questionnaire at the beginning of each sequence and after 3 months of wearing each prosthesis
- Measurement of the quality of prostheses according to the Kapur score Modified (retention: 0 to 2; stability: 0 to 3)
- The full cost of manufacturing each prosthesis
- The additional cost per OHIP-20 point
- Measurement of masticatory performance after 3 months, for each prosthesis
Acts or Product being researched: Second PAC under the simplified protocol (PS)
This is a randomized, cross-over clinical trial consisting of two 3-month treatment periods spaced out by a 1-month wash-out period.
For complete bi-maxillary edentuses, a single arch is considered in the study but the other antagonist arch is performed according to a conventional protocol. The arcade considered will be randomized in case of bi-maxillary edentury and then randomization will be performed by minimization according to the following criteria: edentury arcade considered (maxillary or mandibular), center, complete edentury class (Grade 1-2 versus 3-4 according to the American College of Prosthodontists).
The cross-over test can be applied to complete edentulous disease as it is a chronic condition.
It should be noted that during the prosthetic realization stages, patients are carriers of their old removable prosthesis, possibly readapted.
A quality of life measurement (OHIP-20) will be performed with the old prosthesis before each of the prostheses (M4, M8) and 3 months after each of the PC or PS prostheses (M7, M11).
The time taken to complete each prosthesis will be measured in minutes from the imprint stage to the placement stage. In addition, the time spent on adjustments and focus will also be measured in minutes from the time of installation to 30 days after the insertion of new prostheses.
The patient will have to complete a specific satisfaction questionnaire using the Celebic \& Knezovic-Zlataric questionnaire with the old prosthesis before wearing each of the prostheses (M4, M8) and 3 months after wearing each of the PC or PS prostheses (M7, M11).
The quality of the old prosthesis will be evaluated at PAC 1 to 4 months (M4) and the quality of each new prosthesis (PC or PS) after 3 months of wearing each of the prostheses (M7, M11). The quality of the prosthesis will be measured with the modified Kapur score: from 0 to 3 for retention and from 0 to 2 for stability, or an overall score of 0 to 5.
The chewing performance will be evaluated with the old prosthesis before wearing each of the prostheses (M4, M8) and 3 months after wearing each of the prostheses PC or PS (M7, M11). The chewing performance will be assessed using specific chewing gum. After 20 chewing cycles, we will collect the mixture of a two-coloured gum that is crushed in a calibrated way. The evaluation of the colour mix is evaluated with a grid that allows to assign a masticatory performance score on a scale from 1 to 5
At the end of the study, the patient chooses his or her preferred prosthesis. The other prosthesis is used as a back-up prosthesis.
Statistical analysis : The main analysis will be performed in the per-protocol (PP) and intent to treat (ITT) population. An interaction between effect period and treatment will be first sought; then, in the absence of interaction, the effect treatment will be analyzed. If an interaction is found, only the first period will be analyzed. Sensitivity analyses with adjustment to the initial quality of life level and adjustment to minimization criteria will also be performed.
The total OHIP-20 score at the end of each period will be compared between the two prostheses. The variation in OHIP-20 score will be expressed in each PC and PS prosthesis group by the mean standard deviation and the difference between the two prostheses will be calculated
- Conditions
- Complete Edentulism
- Being tested
- Simplified protocol (PS)/Conventional protocol (PC), Conventional protocol (PC)/Simplified protocol (PS)
- Keywords
- removable prosthesis, simplified technique, cross-over, edentulous patients, conventional technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simplified protocol (PS)/Conventional protocol (PC)Other
Complete removable denture according to the simplified protocol (PS) in period 1 (3 months), 1 month of wash-out then complete removable denture according to the conventional protocol (PC) in period 2 (3 months).
Conventional protocol (PC)/Simplified protocol (PS)Other
Complete removable denture according to the conventional protocol (PC) in period 1 (3 months), 1 month of wash-out then complete removable denture according to the simplified protocol (PS)in period 2 (3 months).
| Study group | Role | What they receive |
|---|---|---|
| Simplified(PS)/Conventional(PC) | Other | Complete removable denture according to the simplified protocol (PS) in period 1 (3 months), 1 month of wash-out then complete removable denture according to the conventional protocol (PC) in period 2 (3 months). Receives: Other: Simplified protocol (PS)/Conventional protocol (PC) |
| Conventional(PC)/Simplified (PS) | Other | Complete removable denture according to the conventional protocol (PC) in period 1 (3 months), 1 month of wash-out then complete removable denture according to the simplified protocol (PS) in period 2 (3 months). Receives: Other: Conventional protocol (PC)/Simplified protocol (PS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation in total OHIP-20 questionnaire score (Oral Health Impact Profile-20) between inclusion and 3 months after the prosthesis is inserted.
The OHIP 20 is a scale of oral quality of life, specific to total edentulousness, validated in French. It has 20 items rated from 1 to 6 (minimum score 20-maximum score 120). For each item, a score of 6 corresponds to an optimal quality of life.
Measured: 3 months
Secondary outcomes (5)
Compare the chair-based completion times between the two prostheses
Measurement of time spent (in minutes) at the chair for the stages of prosthesis construction and adjustment
Measured: up to 4 months
Compare patient satisfaction for each prosthesis
Measurement of patient satisfaction on different items for each prosthesis using the Celebic and Knezovic-Zlataric questionnaire (Grade 1 to 5:Grade 1 Insufficient, Grade 2 Fair,Grade 3 Good, Grade 4 Very good, Grade 5 Excellent ) at the beginning of each sequence and after 3 months of wearing each prosthesis
Measured: 11 months
Compare the quality of prostheses
Measurement of prosthesis quality according to the Kapur score Modified (retention: 0 to 2; stability: 0 to 3)
Measured: 11 months
Compare the cost of simplified restoration with conventional technique, estimate the national impact of the diffusion of simplified technique and estimate the differential cost ratio results
compare the full cost of manufacturing each prosthesis
Measured: 11 months
Masticatory performance between the two prostheses
Masticatory performance will be assessed with the old prosthesis before wearing each prosthesis (M4, M8) and 3 months after wearing each PC or PS prosthesis (M7, M11). Masticatory performance will be assessed using specific chewing gums. After 20 masticatory cycles, we will collect the mixture of a two-tone chewing-gum which is crushed in a calibrated manner.
Measured: 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start1 Jan 2025 (estimated)
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complete EdentulismStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The research consists of two 3-month treatment periods, spaced out by a 1-month wash-out period: Arm with complete removable denture according to the simplified protocol (PS) in period 1 (3 months), 1 month of wash-out then complete removable denture according to the conventional protocol (PC) in period 2 (3 months) Arm with complete removable denture according to the conventional protocol (PC) in period 1 (3 months), 1 month of wash-out then complete removable denture according to the simplified protocol (PS) in period 2 (3 months)
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christophe RIGNON-BRET, Study director, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06698978
- Sponsor's protocol ID
- AOR22023
- Acronym
- IDEFIX
- Status last verified
- Oct 2024
- First submitted
- 12 Nov 2024
- Last updated
- 21 Nov 2024
- 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 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of a Simplified Technique in Removable Complete Prosthesis Versus Conventional Technique in Edentulous Patients: a Multicenter Randomized Clinical Trial in Cross-over.
- ClinicalTrials.gov ID
- NCT06698978
- Acronym / sponsor ID
- IDEFIX / AOR22023
- Conditions
- Complete Edentulism
- Keywords
- removable prosthesis, simplified technique, cross-over, edentulous patients, conventional technique
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 21 Nov 2024 (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 compares a simplified complete removable denture technique (PS) to the conventional approach (PC) in edentulous patients. The goal is to demonstrate that the simplified technique is not inferior to the conventional method in terms of quality of life, measured by the OHIP-20 scale over three months. The trial also examines time, satisfaction, denture quality, cost, and masticatory performance.
Design:
This is a multicenter, randomized, cross-over study with 62 patients over 11 months of participation, including a one-month washout between treatments. Patients will receive both types of dentures, with the order randomized.
Population:
The trial targets edentulous patients, both uni- and bi-maxillary, aged 18 or older, with certain health and dental conditions.
Key Assessments:
Quality of Life: OHIP-20 scores are collected pre-treatment and after three months for each denture type.
Patient Satisfaction and Denture Quality: Assessed using modified Kapur criteria and patient satisfaction surveys.
Masticatory Performance: Evaluated with a chewing gum test. Medical Economic Impact: Cost analysis of each denture type.
Anticipated Outcomes:
Benefits include reducing costs and treatment times, enhancing accessibility to dentures, particularly for elderly and underserved populations, and adapting dental education to teach this simplified technique.
Centers Involved:
Seven centers across France, including AP-HP hospitals and private practices.
Timeline:
The inclusion period is 24 months, with a total study duration of 35 months.
Detailed description
Despite the progress made in preventing caries and periodontal disease, edentury remains a major disability affecting function, nutrition, aesthetics and quality of life. In France, there were about two million edentulous in 2003 (HAS). It is estimated that the proportion of single-maxillary edentulous people in 65-74 years was 16.3% and 14.3% for bimaxillary edentulum. The population of complete edentulous is a fragile, often elderly population at risk of undernutrition and social isolation.
Since January 2021, the CCAM has imposed a RAC0 (remaining charge 0) for complete removable prostheses (PAC) with capped fees. These blocked fees make it difficult to produce high quality prostheses according to the conventional protocol. The blocked fees encourage liberal dentists to refer these patients to medical centres or hospital services. In addition, in areas of medical desertification, a shorter treatment time would be beneficial for patients and practitioners.
During the last five years, international literature has brought out simplified protocols to achieve PACs, shorter and more economical than conventional protocols. According to these studies there is no significant difference in quality of life for completely edentulous patients. However, these simplified AHRC implementation protocols are not harmonized and the simplification does not involve the same steps according to the protocols or the same classes of complete edentulous. In addition, these simplified protocols are not taught because they are too recent and with insufficient evidence from well-conducted clinical trials.
The hypothesis is that a new prosthetic realization technique with a single imprint, according to an innovative protocol, is not inferior in terms of quality of life than the conventional realization technique with two impressions in PAC.
The main objective of this study is to demonstrate the non-inferiority of a complete removable prosthesis made according to the simplified protocol compared to a complete removable prosthesis made according to the conventional protocol on quality of life, after 3 months of use of each prosthesis, in patients with complete single-maxillary or bi-maxillary edentesis (upper and/or lower arcada).
Primary Assessment Criterion : Variation in the total score on the OHIP-20 (Oral Health Impact Profile-20) questionnaire between inclusion and 3 months after prosthesis placement.
The OHIP 20 is a scale of oral quality of life, specific to total edentulousness, validated in French. It has 20 items rated from 1 to 6 (minimum score 20-maximum score 120). For each item, a score of 6 corresponds to an optimal quality of life.
Secondary objectives of research
- Compare the chair time between the two prostheses
- Compare patient satisfaction for each prosthesis using the Celebic \& Knezovic-Zlataric questionnaire
- Compare the quality of prostheses using modified KAPUR criteria (retention and stability)
- Compare the cost of simplified restoration with that of conventional technique, estimate the national impact of the diffusion of simplified technique, and estimate the differential cost ratio results.
- Compare the patient's chewing performance between the two prostheses
Secondary evaluation criteria :
- Cumulative measurement of time spent (in minutes) at the chair for prosthesis fabrication and adjustment steps
- Measurement of patient satisfaction on different items for each prosthesis using the Celebic \& Knezovic-Zlataric questionnaire at the beginning of each sequence and after 3 months of wearing each prosthesis
- Measurement of the quality of prostheses according to the Kapur score Modified (retention: 0 to 2; stability: 0 to 3)
- The full cost of manufacturing each prosthesis
- The additional cost per OHIP-20 point
- Measurement of masticatory performance after 3 months, for each prosthesis
Acts or Product being researched: Second PAC under the simplified protocol (PS)
This is a randomized, cross-over clinical trial consisting of two 3-month treatment periods spaced out by a 1-month wash-out period.
For complete bi-maxillary edentuses, a single arch is considered in the study but the other antagonist arch is performed according to a conventional protocol. The arcade considered will be randomized in case of bi-maxillary edentury and then randomization will be performed by minimization according to the following criteria: edentury arcade considered (maxillary or mandibular), center, complete edentury class (Grade 1-2 versus 3-4 according to the American College of Prosthodontists).
The cross-over test can be applied to complete edentulous disease as it is a chronic condition.
It should be noted that during the prosthetic realization stages, patients are carriers of their old removable prosthesis, possibly readapted.
A quality of life measurement (OHIP-20) will be performed with the old prosthesis before each of the prostheses (M4, M8) and 3 months after each of the PC or PS prostheses (M7, M11).
The time taken to complete each prosthesis will be measured in minutes from the imprint stage to the placement stage. In addition, the time spent on adjustments and focus will also be measured in minutes from the time of installation to 30 days after the insertion of new prostheses.
The patient will have to complete a specific satisfaction questionnaire using the Celebic \& Knezovic-Zlataric questionnaire with the old prosthesis before wearing each of the prostheses (M4, M8) and 3 months after wearing each of the PC or PS prostheses (M7, M11).
The quality of the old prosthesis will be evaluated at PAC 1 to 4 months (M4) and the quality of each new prosthesis (PC or PS) after 3 months of wearing each of the prostheses (M7, M11). The quality of the prosthesis will be measured with the modified Kapur score: from 0 to 3 for retention and from 0 to 2 for stability, or an overall score of 0 to 5.
The chewing performance will be evaluated with the old prosthesis before wearing each of the prostheses (M4, M8) and 3 months after wearing each of the prostheses PC or PS (M7, M11). The chewing performance will be assessed using specific chewing gum. After 20 chewing cycles, we will collect the mixture of a two-coloured gum that is crushed in a calibrated way. The evaluation of the colour mix is evaluated with a grid that allows to assign a masticatory performance score on a scale from 1 to 5
At the end of the study, the patient chooses his or her preferred prosthesis. The other prosthesis is used as a back-up prosthesis.
Statistical analysis : The main analysis will be performed in the per-protocol (PP) and intent to treat (ITT) population. An interaction between effect period and treatment will be first sought; then, in the absence of interaction, the effect treatment will be analyzed. If an interaction is found, only the first period will be analyzed. Sensitivity analyses with adjustment to the initial quality of life level and adjustment to minimization criteria will also be performed.
The total OHIP-20 score at the end of each period will be compared between the two prostheses. The variation in OHIP-20 score will be expressed in each PC and PS prosthesis group by the mean standard deviation and the difference between the two prostheses will be calculated
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The research consists of two 3-month treatment periods, spaced out by a 1-month wash-out period: Arm with complete removable denture according to the simplified protocol (PS) in period 1 (3 months), 1 month of wash-out then complete removable denture according to the conventional protocol (PC) in period 2 (3 months) Arm with complete removable denture according to the conventional protocol (PC) in period 1 (3 months), 1 month of wash-out then complete removable denture according to the simplified protocol (PS) in period 2 (3 months)
| Arm | Type | Receives |
|---|---|---|
| Simplified(PS)/Conventional(PC) | Other | Other: Simplified protocol (PS)/Conventional protocol (PC)Complete removable denture according to the simplified protocol (PS) in period 1 (3 months), 1 month of wash-out then complete removable denture according to the conventional protocol (PC) in period 2 (3 months). |
| Conventional(PC)/Simplified (PS) | Other | Other: Conventional protocol (PC)/Simplified protocol (PS)Complete removable denture according to the conventional protocol (PC) in period 1 (3 months), 1 month of wash-out then complete removable denture according to the simplified protocol (PS) in period 2 (3 months). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients 18 years
- Complete single-maxillary (upper or lower arcade) or bimaxillar (upper and lower arcade) edentesis paired with non-iatrogenic removable full dentures (possibly readapted)
- Edentulous arcade with healthy or sanitized mucosa
- Sufficient inter arcade space
- Free and informed consent
Key exclusion criteria (12 listed)
- Patient unable to cooperate
- Presence of pathological lesions of the oral mucosa
- Parkinson's disease
- Gougerot-Sjögren's disease,
- Patient with cancer of the upper aerogribogastic tract
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 |
|---|---|---|
| Simplified protocol (PS)/Conventional protocol (PC)Complete removable denture according to the simplified protocol (PS) in period 1 (3 months), 1 month of wash-out then complete removable denture according to the conventional protocol (PC) in period 2 (3 months). | Other | Simplified(PS)/Conventional(PC) |
| Conventional protocol (PC)/Simplified protocol (PS)Complete removable denture according to the conventional protocol (PC) in period 1 (3 months), 1 month of wash-out then complete removable denture according to the simplified protocol (PS)in period 2 (3 months). | Other | Conventional(PC)/Simplified (PS) |
Primary outcome
Variation in total OHIP-20 questionnaire score (Oral Health Impact Profile-20) between inclusion and 3 months after the prosthesis is inserted.
Time frame: 3 months
The OHIP 20 is a scale of oral quality of life, specific to total edentulousness, validated in French. It has 20 items rated from 1 to 6 (minimum score 20-maximum score 120). For each item, a score of 6 corresponds to an optimal quality of life.
5 secondary outcomes
Compare the chair-based completion times between the two prostheses
Time frame: up to 4 months
Compare patient satisfaction for each prosthesis
Time frame: 11 months
Compare the quality of prostheses
Time frame: 11 months
Compare the cost of simplified restoration with conventional technique, estimate the national impact of the diffusion of simplified technique and estimate the differential cost ratio results
Time frame: 11 months
Masticatory performance between the two prostheses
Time frame: 11 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
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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.
Christophe RIGNON-BRET study director
APHP
Questions about this trial
What is this clinical trial studying?
A study testing Simplified protocol (PS)/Conventional protocol (PC) and Conventional protocol (PC)/Simplified protocol (PS) in people with Complete Edentulism, run by Assistance Publique - Hôpitaux de Paris.
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 7 inclusion and 12 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: opening soon, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christophe RIGNON-BRET (06 79 17 67 30, rignonbret@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation in total OHIP-20 questionnaire score (Oral Health Impact Profile-20) between inclusion and 3 months after the prosthesis is inserted. (time frame: 3 months). 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 21 Nov 2024.