Removable Partial DentureNCT04990453
PEEK Versus Metallic Framework for Extra Coronal Attachment
A study testing RPD frameworks fabricated from PEEK material in people with Removable Partial Denture, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
Purpose: The present study was aimed to evaluate the bone height changes around abutments with two different framework materials for extracoronal attachment mandibular bilateral distally extension removable partial denture (RPD) and compare patient satisfaction associated with its use. Read more about this study
- Who is it for?
- Ages 55 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Removable Partial Denture
- What is being tested?
- RPD frameworks fabricated from PEEK material
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Feb 2020to 15 May 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 55 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The average age of selected patients was from 55 -60 years .
- Completely edentulous maxillary arch opposed by partially edentulous mandible with only remaining mandibular anterior teeth.
- All selected patients were free from any systemic diseases,
- All patients had Angle class I maxillomandibular skeletal relation,
- The distal extension ridge was well formed and covered by healthful, firm mucosa,
- Suitable abutments with healthy periodontal ligament and appropriate crown/root ratio (CRR) as verified by periapical radiograph.
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- The exclusion criteria to the patients were:
- patients with any systemic disease that could affect the rate of bone resorption which confirmed by obtaining a medical history,
- Patients with Para-functional habits (Bruxism and clenching),
- Patients with any septic foci or impacted teeth as proved by panoramic radiograph,
- Patients with tilted or rotated abutments. Patients with soft tissue undercuts had involved in the design.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Oral & Dental Medicine,Kafr El-shiekh University, Kafr El-shiekh ,Egypt
Kafr El-shiekh
About this study
Official title: PEEK Versus Metallic Framework for Extra Coronal Attachment Mandibular Bilateral Distally Extension Removable Partial Denture- Evaluation of Abutments Bone Height Changes and Patient Satisfaction. A Randomized Clinical Trial.
Purpose: The present study was aimed to evaluate the bone height changes around abutments with two different framework materials for extracoronal attachment mandibular bilateral distally extension removable partial denture (RPD) and compare patient satisfaction associated with its use.
Materials and methods:
Ten partially edentulous patients (long span kennedy class I) were selected, for all patients splinting of remaining abutment were done by porcelain fused to metal bridges, after cementation the RPD frameworks were digitally designed by CAD software and printed into 3-D resin pattern after intra-oral try in of these patterns, the patients were divided into two equalized groups, the patients in first group received extracoronal attachment (RPD)with from milled PEEK (Juvora) framework. While patients in second group received extracoronal attachment (RPD) with conventional metal framework by lost wax technique. Digital radiography was used for bone height assessment of distal abutment at time of prosthesis insertion, 6 and 12 months later. Patient satisfaction was measured using VAS scale.
Read the detailed description
I-Patient selection For this study, ten patients (50-60) with mean age 55 years will be selected from out clinic patients Prosthodontic Department, Faculty of Dentistry, Kafr El_Sheikh University. The patients will have the following inclusion criteria:- Completely edentulous maxillary arch against partially edentulous mandible with only remaining mandibular anterior teeth. The selected patients will be free from any systemic diseases, the patients have Angle class I maxillomandibular skeletal relation, the distal extension ridge will be well formed and covered by healthy, firm mucosa, Good abutments with healthy periodontal ligament and suitable crown/root ratio (CRR) as verified by periapical radiograph.
The exclusion criteria to the patients were:
Patients with any systemic disease that could affect the rate of bone resorption which verified by obtaining a medical history, Patients with Para-functional habits (Bruxism and clenching), Patients with any septic foci or impacted teeth as verified by panoramic radiograph, Patients with tilted or rotated abutments. Patients with soft tissue undercuts involved in the design.
For every patient the following procedures were done:
- Diagnostic Digital panoramic X-ray will be done, then Diagnostic Long Cone standard Digital peri-apical radiographs for canines will be taken to determine crown /root ratio.
- Scaling and/or root planning for remaining mandibular anterior teeth will be carried out, follow up of good oral hygiene measures before start of treatment plan for one month
- Correction of irregular occlusal plane will be done either by enameloplasty for overerupted teeth or restoration by adding composite for infraerupted one if needed.
- All selected patients in this study will be informed about all procedures that will be done and the need for regular and frequent recalls. All patients will sign the consent form of ethical committee in Faculty of dentistry, Kafr El_Sheikh university.
II. Prosthetic procedures:
For each patient, the definitive mandibular extra coronal attachment removable partial denture will be designed using CAD/CAM technology
-Scanning the Master Model The mandibular master cast with porcelain crowns will be then fixed on the scanner table and scanned using the 3D scanner to obtain the standard triangulation file (STL) format.
(Master cast) will be fixed on the table of 3 Shape scanning machine dental system, after application of scan-able spray (Telescan Spray zur vorbereitong von oberflacohen .Teleskop kronen) over the stone teeth and porcelain crowns of master model.
- Digital process and CAD Design of Removable Partial Denture Frameworks Secondary surveying of the virtual master cast will be performed digitally according to the predetermined path of insertion which will be used
- STL file of the virtual framework will be used to print the resin pattern using 3D printer which checked on the master cast before intraoral try in. (A tentative resin frameworks will be constructed by utilizing rapid prototyping technique to examine the accuracy of the framework)
- Intraoral try in will be done to verify all the framework components and determine any needed corrections that would be done on the STL file.
- Framework construction:
According to the framework material and technique of construction, the patients will be equally divided in to two groups as the following:
Group A: Patients will receive RPD frameworks fabricated from PEEK material using milling machine (CAD/CAM technology).
Group B: Patients will receive RPD frameworks fabricated from Co-Cr material using casting machine.
For group (A) PEEK RPD framework construction will be done as follow:
The virtual 3D framework (STL) file will be sent to the milling machine to begin the milling process of PEEK discs to produce mandibular attachment removable partial denture PEEK framework.
The PEEK framework will be then finished and polished then reseated on the master cast to check its fitting. After that, the PEEK framework will be tried in the patient mouth to check its fitting.
For group (B) metallic RPD framework construction was done as follow:
The virtual 3D framework (STL) file with supporting bars and sprues will be printed with resin and then invested, burnt out, and casted with chromium cobalt alloy to produce mandibular attachment removable partial denture metallic framework.
The metallic RPD framework will be then finished, polished and reseated on the master cast to check its adaptation. After that, the metallic framework will be tried in the patient mouth to check its fitting.
For each patient the in the two groups:
- Maxillary auto polymerized resin special tray will be constructed.
- Altered cast impression technique will be made Record blocks were constructed on maxillary secondary cast and mandibular framework on the altered master cast.
- After registration of the jaw relation, the casts will be mounted on semi-adjustable articulator using maxillary face bow for mounting maxillary cast and centric inter-occlusal record for mandibular one.
- Semi-anatomic maxillary posterior teeth will be arranged against flat mandibular teeth to achieve balanced lingualized occlusion.
- After try-in in the patient mouth, the denture will be processed and the occlusion was refined.
- Matrix inserting instrument will be used to insert and push the matrix with desired friction in its place (green plastic matrix for light snap in friction was the selected matrix), and functional pick up will be done during cementaion of crowns by applying finger pressure during setting of cement with proper orientation provided by the two temporary indirect retainers.
- All crowns will be cemented by resin luting cement during insertion of the extracoronal precision attachment removable partial denture.
- Periapical radiographs of abutment teeth and implant will be taken and digital panoramic radiographs will be made at the time of insertion and after 6 and 12 months later
- Conditions
- Removable Partial Denture
- Being tested
- RPD frameworks fabricated from PEEK material
- Keywords
- Framework materials, Removable partial denture, Patient satisfaction, PEEK, Bone changes
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RPD frameworks fabricated from PEEK materialOther
extracoronal precision attachment RPD frameworks fabricated from PEEK material using milling machine (CAD/CAM technology)
| Study group | Role | What they receive |
|---|---|---|
| RPD frameworks fabricated from PEEK material | Other | 14 patients received extracoronal precision attachment RPD frameworks fabricated from PEEK material using milling machine (CAD/CAM technology) Receives: Other: RPD frameworks fabricated from PEEK material |
| RPD frameworks fabricated from Co-Cr | Other | 14 patients received extracoronal precision attachment RPD frameworks fabricated from Co-Cr material using casting machine Receives: Other: RPD frameworks fabricated from PEEK material |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation of bone height changes
An image plate was attached on a radiographic stent specially constructed for each patient to made a standardized periapical radiograph for the abutments by using the Dentsply/rinn XCP tools (long, round BID cone paralleling technique) according to:
Image analysis:
The linear measurement system contributed by the special software of the Vista-scan machine was used for measuring the mesial and distal marginal bone height around the canine abutments bilaterally in both groups.
Measured: 12 months
Secondary outcomes (1)
Patient satisfaction (VAS)
Patient satisfaction was assessed using a questionnaire based on visual analog scale (VAS). Satisfaction after six months follow up period was tested concerning comfort, esthetics, stability, speaking retention, general satisfaction. Patients were requested to mark their answer (amount of satisfaction) on a 100-mm line (with zero indicates to not satisfied at all and 100 indicates to completely satisfied). Higher VAS scores showed high satisfaction and lower scores indicated low satisfaction. The mean of the answers (length of the lines from zero to the marks in mm) for every question was subjected to statistical analysis.
All dimensions of this instrument are highly associated with the items of general satisfaction
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start2 Feb 2020
- Primary completion15 Apr 2021
- Study completion15 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Removable Partial DentureStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nourhan Ahmed Ragheb, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04990453
- Sponsor's protocol ID
- KD/12/21
- Status last verified
- Aug 2021
- First submitted
- 27 Jul 2021
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PEEK Versus Metallic Framework for Extra Coronal Attachment Mandibular Bilateral Distally Extension Removable Partial Denture- Evaluation of Abutments Bone Height Changes and Patient Satisfaction. A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT04990453
- Acronym / sponsor ID
- KD/12/21
- Conditions
- Removable Partial Denture
- Keywords
- Framework materials, Removable partial denture, Patient satisfaction, PEEK, Bone changes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 2 Feb 2020 (actual)
- Primary completion
- 15 Apr 2021 (actual)
- Study completion
- 15 May 2021 (actual)
- First posted
- 4 Aug 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.
Purpose: The present study was aimed to evaluate the bone height changes around abutments with two different framework materials for extracoronal attachment mandibular bilateral distally extension removable partial denture (RPD) and compare patient satisfaction associated with its use.
Materials and methods:
Ten partially edentulous patients (long span kennedy class I) were selected, for all patients splinting of remaining abutment were done by porcelain fused to metal bridges, after cementation the RPD frameworks were digitally designed by CAD software and printed into 3-D resin pattern after intra-oral try in of these patterns, the patients were divided into two equalized groups, the patients in first group received extracoronal attachment (RPD)with from milled PEEK (Juvora) framework. While patients in second group received extracoronal attachment (RPD) with conventional metal framework by lost wax technique. Digital radiography was used for bone height assessment of distal abutment at time of prosthesis insertion, 6 and 12 months later. Patient satisfaction was measured using VAS scale.
Detailed description
I-Patient selection For this study, ten patients (50-60) with mean age 55 years will be selected from out clinic patients Prosthodontic Department, Faculty of Dentistry, Kafr El_Sheikh University. The patients will have the following inclusion criteria:- Completely edentulous maxillary arch against partially edentulous mandible with only remaining mandibular anterior teeth. The selected patients will be free from any systemic diseases, the patients have Angle class I maxillomandibular skeletal relation, the distal extension ridge will be well formed and covered by healthy, firm mucosa, Good abutments with healthy periodontal ligament and suitable crown/root ratio (CRR) as verified by periapical radiograph.
The exclusion criteria to the patients were:
Patients with any systemic disease that could affect the rate of bone resorption which verified by obtaining a medical history, Patients with Para-functional habits (Bruxism and clenching), Patients with any septic foci or impacted teeth as verified by panoramic radiograph, Patients with tilted or rotated abutments. Patients with soft tissue undercuts involved in the design.
For every patient the following procedures were done:
- Diagnostic Digital panoramic X-ray will be done, then Diagnostic Long Cone standard Digital peri-apical radiographs for canines will be taken to determine crown /root ratio.
- Scaling and/or root planning for remaining mandibular anterior teeth will be carried out, follow up of good oral hygiene measures before start of treatment plan for one month
- Correction of irregular occlusal plane will be done either by enameloplasty for overerupted teeth or restoration by adding composite for infraerupted one if needed.
- All selected patients in this study will be informed about all procedures that will be done and the need for regular and frequent recalls. All patients will sign the consent form of ethical committee in Faculty of dentistry, Kafr El_Sheikh university.
II. Prosthetic procedures:
For each patient, the definitive mandibular extra coronal attachment removable partial denture will be designed using CAD/CAM technology
-Scanning the Master Model The mandibular master cast with porcelain crowns will be then fixed on the scanner table and scanned using the 3D scanner to obtain the standard triangulation file (STL) format.
(Master cast) will be fixed on the table of 3 Shape scanning machine dental system, after application of scan-able spray (Telescan Spray zur vorbereitong von oberflacohen .Teleskop kronen) over the stone teeth and porcelain crowns of master model.
- Digital process and CAD Design of Removable Partial Denture Frameworks Secondary surveying of the virtual master cast will be performed digitally according to the predetermined path of insertion which will be used
- STL file of the virtual framework will be used to print the resin pattern using 3D printer which checked on the master cast before intraoral try in. (A tentative resin frameworks will be constructed by utilizing rapid prototyping technique to examine the accuracy of the framework)
- Intraoral try in will be done to verify all the framework components and determine any needed corrections that would be done on the STL file.
- Framework construction:
According to the framework material and technique of construction, the patients will be equally divided in to two groups as the following:
Group A: Patients will receive RPD frameworks fabricated from PEEK material using milling machine (CAD/CAM technology).
Group B: Patients will receive RPD frameworks fabricated from Co-Cr material using casting machine.
For group (A) PEEK RPD framework construction will be done as follow:
The virtual 3D framework (STL) file will be sent to the milling machine to begin the milling process of PEEK discs to produce mandibular attachment removable partial denture PEEK framework.
The PEEK framework will be then finished and polished then reseated on the master cast to check its fitting. After that, the PEEK framework will be tried in the patient mouth to check its fitting.
For group (B) metallic RPD framework construction was done as follow:
The virtual 3D framework (STL) file with supporting bars and sprues will be printed with resin and then invested, burnt out, and casted with chromium cobalt alloy to produce mandibular attachment removable partial denture metallic framework.
The metallic RPD framework will be then finished, polished and reseated on the master cast to check its adaptation. After that, the metallic framework will be tried in the patient mouth to check its fitting.
For each patient the in the two groups:
- Maxillary auto polymerized resin special tray will be constructed.
- Altered cast impression technique will be made Record blocks were constructed on maxillary secondary cast and mandibular framework on the altered master cast.
- After registration of the jaw relation, the casts will be mounted on semi-adjustable articulator using maxillary face bow for mounting maxillary cast and centric inter-occlusal record for mandibular one.
- Semi-anatomic maxillary posterior teeth will be arranged against flat mandibular teeth to achieve balanced lingualized occlusion.
- After try-in in the patient mouth, the denture will be processed and the occlusion was refined.
- Matrix inserting instrument will be used to insert and push the matrix with desired friction in its place (green plastic matrix for light snap in friction was the selected matrix), and functional pick up will be done during cementaion of crowns by applying finger pressure during setting of cement with proper orientation provided by the two temporary indirect retainers.
- All crowns will be cemented by resin luting cement during insertion of the extracoronal precision attachment removable partial denture.
- Periapical radiographs of abutment teeth and implant will be taken and digital panoramic radiographs will be made at the time of insertion and after 6 and 12 months later
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RPD frameworks fabricated from PEEK material | Other | Other: RPD frameworks fabricated from PEEK material14 patients received extracoronal precision attachment RPD frameworks fabricated from PEEK material using milling machine (CAD/CAM technology) |
| RPD frameworks fabricated from Co-Cr | Other | Other: RPD frameworks fabricated from PEEK material14 patients received extracoronal precision attachment RPD frameworks fabricated from Co-Cr material using casting machine |
Who may qualify
- Ages
- 55 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- The average age of selected patients was from 55 -60 years .
- patients with any systemic disease that could affect the rate of bone resorption which confirmed by obtaining a medical history,
- Patients with Para-functional habits (Bruxism and clenching),
- Patients with any septic foci or impacted teeth as proved by panoramic radiograph,
- Patients with tilted or rotated abutments. Patients with soft tissue undercuts had involved in the design.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| RPD frameworks fabricated from PEEK materialextracoronal precision attachment RPD frameworks fabricated from PEEK material using milling machine (CAD/CAM technology) | Other | RPD frameworks fabricated from Co-Cr, RPD frameworks fabricated from PEEK material |
Primary outcome
evaluation of bone height changes
Time frame: 12 months
An image plate was attached on a radiographic stent specially constructed for each patient to made a standardized periapical radiograph for the abutments by using the Dentsply/rinn XCP tools (long, round BID cone paralleling technique) according to: Image analysis: The linear measurement system contributed by the special software of the Vista-scan machine was used for measuring the mesial and distal marginal bone height around the canine abutments bilaterally in both groups.
1 secondary outcome
Patient satisfaction (VAS)
Time frame: 12 months
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 5 Sep 2021.
- Individual participant dataSharing planned: Yes
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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 RPD frameworks fabricated from PEEK material in people with Removable Partial Denture, run by Kafrelsheikh 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 11 inclusion and 0 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 5 Sep 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 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?
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?
evaluation of bone height changes (time frame: 12 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 5 Sep 2021.