Patient SatisfactionNCT05904756
Patient Satisfaction and Oral Healthy Related Quality of Life of Polyetherketoneketone and Metal Framework.
An observational study of Patient Satisfaction, run by Mansoura University at 1 site in Egypt.
Trial summary
The patients' satisfaction and oral health related quality of life (OHRQL) of different framework material remains uncertain. Thus, the aim of this clinical cross over study was to compare patient satisfaction and OHRQL OF polyetherketoneketone and metal framework for All-on-four implant supported fixed prosthesis Read more about this study
- Who is it for?
- Ages 50 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Patient Satisfaction
- What is being tested?
- framework for implant supported prosthesis, fabricated from metal of polyetherketoneketone
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 15 May 2023to 15 May 2024
- 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 50 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Sample size calculation was based on difference in OHIP between CD \& MB groups retrived from previous research using 2-tailed test , α error =0.05 and power = 90.0% , the total calculated sample size will be 10 cases in each group.
Who may be able to join
- Sufficient available restorative space (from the proposed occlusal plane to soft tissue • covering residual ridge) of at least 20 mm to accommodate all types of tested prosthesis.
- They had completely edentulous maxilla and mandible at least six months after the last extraction.
- Sufficient residual alveolar ridge quantity and quality (D2-D3)
- Maxillary and mandibular residual alveolar ridges covered by healthy non-inflamed mucosa with even compressibility.
- Normal maxillo-mandibular relationship.
Who cannot join
- All diseases or syndromes are contraindicated with implant surgery such as:
- General contraindications for surgical procedures such as patients with head and neck radio therapy, patients with bleeding disorders, hepatic patients.
- Patients with metabolic disorders that affect Osseo integration such as diabetes mellitus, and osteoporosis.
- Long term immunosuppressive and corticosteroid drug therapy.
- Abnormal detrimental habits, e.g. bruxism and clenching.
- Heavy smokers and alcoholic patients.
- All patients will be informed about the steps involved in this research and they will sign a
- written consent form of the ethical committee of faculty of dentistry Mansoura University for approval to take part in this research and come to the follow up visits.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of dentistry , Mansoura University
Al Mansurah
Salah A. Hegazy, PhD, 00201227690209, salahhegazy2003@yahoo.com
mohamed Elsawy, PhD, 01061314522, Dr_sawy@std.mans.edu.eg
About this study
Official title: Patient Satisfaction and Oral Healthy Related Quality of Life of Polyetherketoneketone and Metal Framework for All-on-four Implant Supported Fixed Detachable Prosthesis: A Crossover Study.
The patients' satisfaction and oral health related quality of life (OHRQL) of different framework material remains uncertain. Thus, the aim of this clinical cross over study was to compare patient satisfaction and OHRQL OF polyetherketoneketone and metal framework for All-on-four implant supported fixed prosthesis
Read the detailed description
10 completely edentulous patients around age of 50-60 years will be selected for this study from the Outpatient Clinic, Faculty of Dentistry, Mansoura University.
All selected participants will receive a new complete dentures (CD) fabricated with bilateral balanced occlusion utilizing semi-anatomical acrylic teeth. The patients were instructed to wear the dentures for 3 months to develop adequate neuromuscular control, and then, clinical performance and patient satisfaction will be evaluated.
Each participant will receive 4 implants according to the "All-on-4 concept," and the implants will be immediately loaded with mandibular denture. Three months after osseointegration, patients received a definitive fixed detachable prosthesis either from PEKK or metal with composite teeth in a crossover designs. Two sets of patients will be made (10 patients/set) using random-generated numbers created by a computer program (Excel sheet). The first 10 participants will recieve metal framework first. After 3 months, patient satisfaction and OHRQoL will be measured and metal framework will be replaced by PEKK framework. After another 3 months, measurements will be repeated. The second 10 patients received PEKK first, and after 3 months, measurements will be made. Then, PEKK framework was replaced by Metal framework and measurements were repeated after another 3 months.
- Conditions
- Patient Satisfaction
- Being tested
- framework for implant supported prosthesis, fabricated from metal of polyetherketoneketone
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
framework for implant supported prosthesis, fabricated from metal of polyetherketoneketoneDevice
evaluation of patient satisfaction and oral healty related quality of life
| Study group | Role | What they receive |
|---|---|---|
| Metal framework group | Two sets of patients were made (10 patients/set) using random-generated numbers created by a computer program (Excel sheet). Conventional complete denture will be fabricated first and patient will wear the denture for 3 months. Then 4 implants will be placed according to all in 4 concept.after 3 months of asseointegration,the first 10 participants will recieve metal framework first. After 3 months, patient satisfaction and oral healthy related quality of lifewill be measured. Receives: Device: framework for implant supported prosthesis, fabricated from metal of polyetherketoneketone | |
| PEKK framework group | metal framework will be replaced by PEKK framework. After another 3 months, measurements will be repeated. The second 10 patients received polyetherketoneketone first, and after 3 months, measurements will be made. Then, polyetherketoneketone framework will be replaced by Metal framework and measurements( Patient satisfaction and oral healty related quality of life) will be repeated after another 3 months in across over design. Receives: Device: framework for implant supported prosthesis, fabricated from metal of polyetherketoneketone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The patients' satisfaction using a visual analog scale (VAS)
VAS score include, comfort with prosthesis, ease of cleaning appearance, decreased embarrassment, ease of speaking, general satisfaction of mandibular prosthesis compared to teeth and prosthesis apart of you, and decreased embracing. Higher score indicating increase satisfaction, and lower scores indicating less satisfaction.
Measured: 1 year
Secondary outcomes (1)
Oral healthy related quality of life (OHRQoL)
The arabic version of OHRQoL such as, functional limitation, physical pain, psychologic discomfort, psychologic disability, and social disability. For each item of the 14 items were never (= 1), hardly ever (= 2), occasionally (= 3), fairly often (= 4), and very often (= 5). Lower scores indicated higher OHRQoL, vice versa
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start15 May 2023
- Primary completion4 Jan 2024 (estimated)
- Study completion15 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient SatisfactionStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Elsawy, Mansoura University
- Investigators
- Mohammed E Sawy, Study director, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05904756
- Sponsor's protocol ID
- A0105023RP
- Status last verified
- Oct 2023
- First submitted
- 6 Jun 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- 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 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Satisfaction and Oral Healthy Related Quality of Life of Polyetherketoneketone and Metal Framework for All-on-four Implant Supported Fixed Detachable Prosthesis: A Crossover Study.
- ClinicalTrials.gov ID
- NCT05904756
- Acronym / sponsor ID
- A0105023RP
- Conditions
- Patient Satisfaction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 15 May 2023 (actual)
- Primary completion
- 4 Jan 2024 (estimated)
- Study completion
- 15 May 2024 (estimated)
- First posted
- 15 Jun 2023 (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.
The patients' satisfaction and oral health related quality of life (OHRQL) of different framework material remains uncertain. Thus, the aim of this clinical cross over study was to compare patient satisfaction and OHRQL OF polyetherketoneketone and metal framework for All-on-four implant supported fixed prosthesis
Detailed description
10 completely edentulous patients around age of 50-60 years will be selected for this study from the Outpatient Clinic, Faculty of Dentistry, Mansoura University.
All selected participants will receive a new complete dentures (CD) fabricated with bilateral balanced occlusion utilizing semi-anatomical acrylic teeth. The patients were instructed to wear the dentures for 3 months to develop adequate neuromuscular control, and then, clinical performance and patient satisfaction will be evaluated.
Each participant will receive 4 implants according to the "All-on-4 concept," and the implants will be immediately loaded with mandibular denture. Three months after osseointegration, patients received a definitive fixed detachable prosthesis either from PEKK or metal with composite teeth in a crossover designs. Two sets of patients will be made (10 patients/set) using random-generated numbers created by a computer program (Excel sheet). The first 10 participants will recieve metal framework first. After 3 months, patient satisfaction and OHRQoL will be measured and metal framework will be replaced by PEKK framework. After another 3 months, measurements will be repeated. The second 10 patients received PEKK first, and after 3 months, measurements will be made. Then, PEKK framework was replaced by Metal framework and measurements were repeated after another 3 months.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metal framework group | – | Device: framework for implant supported prosthesis, fabricated from metal of polyetherketoneketoneTwo sets of patients were made (10 patients/set) using random-generated numbers created by a computer program (Excel sheet). Conventional complete denture will be fabricated first and patient will wear the denture for 3 months. Then 4 implants will be placed according to all in 4 concept.after 3 months of asseointegration,the first 10 participants will recieve metal framework first. After 3 months, patient satisfaction and oral healthy related quality of lifewill be measured. |
| PEKK framework group | – | Device: framework for implant supported prosthesis, fabricated from metal of polyetherketoneketonemetal framework will be replaced by PEKK framework. After another 3 months, measurements will be repeated. The second 10 patients received polyetherketoneketone first, and after 3 months, measurements will be made. Then, polyetherketoneketone framework will be replaced by Metal framework and measurements( Patient satisfaction and oral healty related quality of life) will be repeated after another 3 months in across over design. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Sample size calculation was based on difference in OHIP between CD \& MB groups retrived from previous research using 2-tailed test , α error =0.05 and power = 90.0% , the total calculated sample size will be 10 cases in each group.
Key inclusion criteria (5 listed)
- Sufficient available restorative space (from the proposed occlusal plane to soft tissue • covering residual ridge) of at least 20 mm to accommodate all types of tested prosthesis.
- They had completely edentulous maxilla and mandible at least six months after the last extraction.
- Sufficient residual alveolar ridge quantity and quality (D2-D3)
- Maxillary and mandibular residual alveolar ridges covered by healthy non-inflamed mucosa with even compressibility.
- Normal maxillo-mandibular relationship.
Key exclusion criteria (8 listed)
- General contraindications for surgical procedures such as patients with head and neck radio therapy, patients with bleeding disorders, hepatic patients.
- Patients with metabolic disorders that affect Osseo integration such as diabetes mellitus, and osteoporosis.
- Long term immunosuppressive and corticosteroid drug therapy.
- Abnormal detrimental habits, e.g. bruxism and clenching.
- Heavy smokers and alcoholic patients.
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 |
|---|---|---|
| framework for implant supported prosthesis, fabricated from metal of polyetherketoneketoneevaluation of patient satisfaction and oral healty related quality of life | Device | Metal framework group, PEKK framework group |
Primary outcome
The patients' satisfaction using a visual analog scale (VAS)
Time frame: 1 year
VAS score include, comfort with prosthesis, ease of cleaning appearance, decreased embarrassment, ease of speaking, general satisfaction of mandibular prosthesis compared to teeth and prosthesis apart of you, and decreased embracing. Higher score indicating increase satisfaction, and lower scores indicating less satisfaction.
1 secondary outcome
Oral healthy related quality of life (OHRQoL)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- 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.
Mohammed E Sawy study director
Mansoura University
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 Patient Satisfaction, run by Mansoura University at 1 site in Egypt.
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 5 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: status not confirmed, as of the sponsor's last update on 23 Oct 2023. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammed E Sawy, PhD (+201061314522, Dr_sawy@windowslive.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The patients' satisfaction using a visual analog scale (VAS) (time frame: 1 year). 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 23 Oct 2023.