Patient SatisfactionNCT04539210
Screw-retained Maxillary Complete Denture With Electric Welded Metal Framework Versus Cast One, Patient Satisfaction Assessment.
A study testing Electric Welded Metal Framework in people with Patient Satisfaction and Maintenance, run by Cairo University at 1 site in Egypt.
Trial summary
In this study the investigators are going to compare the effect of electric welded metal frame work and cast frame work on patient satisfaction and maintenance of the final prosthesis. Read more about this study
- Who is it for?
- Ages 45 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Patient Satisfaction, Maintenance
- What is being tested?
- Electric Welded Metal Framework
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2020to Feb 2022
- 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 45 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age range from 45 to 65 years old.
- Absence of any medical disorder that could complicate the surgical phase or affect osseointegration .
- The patients must be completely edentulous.
- The patient must have enough bone height for implants, minimum length of bone 10mm and a minimum diameter of bone 5 mm.
- Patients with good oral hygiene.
- Complete denture wearer.
- Adequate inter arch space for screw retained prosthesis.
- Absence of any intra-oral pathological condition.
Who cannot join
- Patients with recent extraction(less than three months).
- Patients with inflamed ridge or candida infection.
- Patients with flappy ridge.
- Para functional habits.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry
Cairo, 11553
faculty of dentistry cairo university, 02 23634965, dentmail@dentistry.cu.edu.eg
About this study
Official title: Completely Edentulous Patients Screw-retained Maxillary Complete Denture With Electric Welded Metal Framework Versus Cast One, Patient Satisfaction Assessment (Randomized Control, Split Mouth Trial)
In this study the investigators are going to compare the effect of electric welded metal frame work and cast frame work on patient satisfaction and maintenance of the final prosthesis.
Read the detailed description
In this study twelve completely edentulous patients will be enrolled and In each patient six implants will be inserted in the maxillary arch at crestal bone level in predefined positions (positions 15, 13, 11, 21, 23, 25) with the help of a surgical template following a submerged healing protocol and checked for primary stability clinically. After a 4-month osseointegration period, second-stage surgery will be performed and healing abutments will be placed. After the second-stage surgery, prosthetic procedures will be initiated.
then for one side (the intervention side) the metal framework will be constructed as follow: A preexisting or prepared flat surface area of the welding abutment of implant at central incisor position at one side (right or left) will serve as the welding point. A titanium bar will be shaped following the curvature of the implants positioned. At this point, temporary titanium implant abutments will be welded with the titanium bar in the oral cavity, using the Syncrystallization Unit .The welding process is electrical and protected by an argon gas supply (Syncrystallization). The equipment allows the welding of metallic elements directly in the mouth. Current flowing through the contact points, being in contact with the parts to weld, warms up to the point of fusion, achieving a solid, welded junction. Then will be placed between the two electrodes of a welding clamp. The energy contained in a previously unloaded battery of capacitors is transferred to the electrodes of the welding cycle is subdivided in three stages: Pre-gas, welding, and post-gas phase. While the pre-gas phase allows an oxygen-free welding point prior to the actual fusion, the post-gas phase ensures the absence of oxygen and subsequent oxidation during cooling. Finally, the prosthetic framework, created by welding the titanium bar to the implant abutments, will be removed and opaque will be applied in order to avoid metal shining through the acrylic resin.
for the other side :
At the day of second stage surgery restoration will be fabricated as follow:
For the cast metal framework group, CCM abutments (Titanium base abutments with a plastic cast able sleeve) will be fastened over the analogues of the placed implants, on a verified analogue model.
For the preparation of the verified model, open tray (pick-up) impression copings will be fastened to the placed implants, and an un splinted impression will be made using addition silicone impression material in a single step manner, using putty and light consistency addition silicone.
A stone model will be obtained after fastening of the implant analogues, fabrication of a gingival mask and pouring the impression using extra-hard dental stone. Over the obtained stone model, splinting of the open tray impression copings will be performed using duralay resin to obtain a jig that will be further separated and resplinted intra orally, over which a splinted pick-up impression will be remade. The new impression will be poured into extra-hard stone after fabricating a gingival mask.
On the verified master analogue model, occlusion blocks will be constructed for adjustment of vertical dimension and bite registration. Afterwards, CCM abutments will be fastened, followed by waxing, spruing and casting. The resultant framework will be inserted inside the patient's mouth on the following implants; right or left implants installed; central, canine, and second premolar to insure passivity of fit. In case of framework misfit, separation will be performed using a disc, followed by intraoral splinting using duralay resin and soldering. After framework soldering, another try-in will be done to insure framework fit, then the final pick-up of the framework into the denture will be performed. Then the final prosthesis will be sectioned at the midline resulting two separate super structures.
then Patient satisfaction will be assessed using Boerrigter's method questionnaire after 3,6 and 12 months.
During the 12 months follow-up period as follow(within 2weaks of delivery,6months after delivery and 12 months after delivery) , number of prosthodontic complications for the laser welded and cast metal framework supported over dentures will be registered and calculated according to the following events: screw loosening of the abutment, screw loosening of the prosthesis, fracture of the screw of the abutment, fracture of the screw of the prosthesis, abutment fracture, framework fracture, fracture of acrylic resin denture, loss of cover of access hole, prosthetic teeth fracture and remake of the prosthesis, occlusal discrepancies ,maxillary and mandibular denture relining if needed ,pain.
- Conditions
- Patient Satisfaction, Maintenance
- Being tested
- Electric Welded Metal Framework
- Keywords
- electric welding, metal framework
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electric Welded Metal FrameworkDevice
Screw-retained Maxillary Complete Denture With Electric Welded Metal Framework
| Study group | Role | What they receive |
|---|---|---|
| Electric Welded Metal Framework | Experimental | A preexisting or prepared flat surface area of the welding abutment of implant at central incisor position at one side (right or left) will serve as the welding point. A titanium bar will be shaped following the curvature of the implants positioned. At this point, temporary titanium implant abutments will be welded with the titanium bar in the oral cavity, using the Syncrystallization Unit. Finally, the prosthetic framework, created by welding the titanium bar to the implant abutments, will be removed and opaque will be applied in order to avoid metal shining through the acrylic resin. The framework is picked up to denture with hard liner, and screwed to the denture. Receives: Device: Electric Welded Metal Framework |
| cast metal framework | Experimental | On a verified analogue model, occlusion blocks will be constructed for adjustment of vertical dimension and bite registration. Afterwards, CCM abutments will be fastened over the analogues of the placed implants, followed by waxing, spruing and casting. The resultant cast metal framework will be inserted inside the patient's mouth on the right or left installed implants to insure passivity of fit. In case of framework misfit, separation will be performed using a disc, followed by intraoral splinting and soldering. After framework soldering, another try-in will be done to insure framework fit. Receives: Device: Electric Welded Metal Framework |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient satisfaction
satisfaction assessed by Boerrigter's method questionnaire.in this questionnaire, there are three aspects to consider:(1) problems with the denture itself;(2) masticating ability; and (3) overall denture performance. different answers to each question are assigned scores and the total score can be calculated for further evaluation and analysis.
Measured: 12 months
Secondary outcomes (1)
Maintenance of the final prosthesis
During the 12 months follow-up period as follow(within 2weaks of delivery,6months after delivery and 12 months after delivery) , number of prosthodontic complications for the laser welded and cast metal framework supported over dentures will be registered and calculated according to the following events: screw loosening of the abutment, screw loosening of the prosthesis, fracture of the screw of the abutment, fracture of the screw of the prosthesis, abutment fracture, framework fracture, fracture of acrylic resin denture, loss of cover of access hole, prosthetic teeth fracture and remake of the prosthesis, occlusal discrepancies ,maxillary and mandibular denture relining if needed ,pain.
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 Sep 2020
- Study startSep 2020 (estimated)
- Primary completionJan 2022 (estimated)
- Study completionFeb 2022 (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 Cairo 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, fatma hussein abd elmonem, Cairo University
- Investigators
- cairo university, Study director, cu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04539210
- Sponsor's protocol ID
- PRO6-2-1
- Status last verified
- Apr 2020
- First submitted
- 25 Aug 2020
- Last updated
- 4 Sep 2020
- 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 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Completely Edentulous Patients Screw-retained Maxillary Complete Denture With Electric Welded Metal Framework Versus Cast One, Patient Satisfaction Assessment (Randomized Control, Split Mouth Trial)
- ClinicalTrials.gov ID
- NCT04539210
- Acronym / sponsor ID
- PRO6-2-1
- Conditions
- Patient Satisfaction, Maintenance
- Keywords
- electric welding, metal framework
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Sep 2020 (estimated)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 4 Sep 2020 (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.
In this study the investigators are going to compare the effect of electric welded metal frame work and cast frame work on patient satisfaction and maintenance of the final prosthesis.
Detailed description
In this study twelve completely edentulous patients will be enrolled and In each patient six implants will be inserted in the maxillary arch at crestal bone level in predefined positions (positions 15, 13, 11, 21, 23, 25) with the help of a surgical template following a submerged healing protocol and checked for primary stability clinically. After a 4-month osseointegration period, second-stage surgery will be performed and healing abutments will be placed. After the second-stage surgery, prosthetic procedures will be initiated.
then for one side (the intervention side) the metal framework will be constructed as follow: A preexisting or prepared flat surface area of the welding abutment of implant at central incisor position at one side (right or left) will serve as the welding point. A titanium bar will be shaped following the curvature of the implants positioned. At this point, temporary titanium implant abutments will be welded with the titanium bar in the oral cavity, using the Syncrystallization Unit .The welding process is electrical and protected by an argon gas supply (Syncrystallization). The equipment allows the welding of metallic elements directly in the mouth. Current flowing through the contact points, being in contact with the parts to weld, warms up to the point of fusion, achieving a solid, welded junction. Then will be placed between the two electrodes of a welding clamp. The energy contained in a previously unloaded battery of capacitors is transferred to the electrodes of the welding cycle is subdivided in three stages: Pre-gas, welding, and post-gas phase. While the pre-gas phase allows an oxygen-free welding point prior to the actual fusion, the post-gas phase ensures the absence of oxygen and subsequent oxidation during cooling. Finally, the prosthetic framework, created by welding the titanium bar to the implant abutments, will be removed and opaque will be applied in order to avoid metal shining through the acrylic resin.
for the other side :
At the day of second stage surgery restoration will be fabricated as follow:
For the cast metal framework group, CCM abutments (Titanium base abutments with a plastic cast able sleeve) will be fastened over the analogues of the placed implants, on a verified analogue model.
For the preparation of the verified model, open tray (pick-up) impression copings will be fastened to the placed implants, and an un splinted impression will be made using addition silicone impression material in a single step manner, using putty and light consistency addition silicone.
A stone model will be obtained after fastening of the implant analogues, fabrication of a gingival mask and pouring the impression using extra-hard dental stone. Over the obtained stone model, splinting of the open tray impression copings will be performed using duralay resin to obtain a jig that will be further separated and resplinted intra orally, over which a splinted pick-up impression will be remade. The new impression will be poured into extra-hard stone after fabricating a gingival mask.
On the verified master analogue model, occlusion blocks will be constructed for adjustment of vertical dimension and bite registration. Afterwards, CCM abutments will be fastened, followed by waxing, spruing and casting. The resultant framework will be inserted inside the patient's mouth on the following implants; right or left implants installed; central, canine, and second premolar to insure passivity of fit. In case of framework misfit, separation will be performed using a disc, followed by intraoral splinting using duralay resin and soldering. After framework soldering, another try-in will be done to insure framework fit, then the final pick-up of the framework into the denture will be performed. Then the final prosthesis will be sectioned at the midline resulting two separate super structures.
then Patient satisfaction will be assessed using Boerrigter's method questionnaire after 3,6 and 12 months.
During the 12 months follow-up period as follow(within 2weaks of delivery,6months after delivery and 12 months after delivery) , number of prosthodontic complications for the laser welded and cast metal framework supported over dentures will be registered and calculated according to the following events: screw loosening of the abutment, screw loosening of the prosthesis, fracture of the screw of the abutment, fracture of the screw of the prosthesis, abutment fracture, framework fracture, fracture of acrylic resin denture, loss of cover of access hole, prosthetic teeth fracture and remake of the prosthesis, occlusal discrepancies ,maxillary and mandibular denture relining if needed ,pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electric Welded Metal Framework | Experimental | Device: Electric Welded Metal FrameworkA preexisting or prepared flat surface area of the welding abutment of implant at central incisor position at one side (right or left) will serve as the welding point. A titanium bar will be shaped following the curvature of the implants positioned. At this point, temporary titanium implant abutments will be welded with the titanium bar in the oral cavity, using the Syncrystallization Unit. Finally, the prosthetic framework, created by welding the titanium bar to the implant abutments, will be removed and opaque will be applied in order to avoid metal shining through the acrylic resin. The framework is picked up to denture with hard liner, and screwed to the denture. |
| cast metal framework | Experimental | Device: Electric Welded Metal FrameworkOn a verified analogue model, occlusion blocks will be constructed for adjustment of vertical dimension and bite registration. Afterwards, CCM abutments will be fastened over the analogues of the placed implants, followed by waxing, spruing and casting. The resultant cast metal framework will be inserted inside the patient's mouth on the right or left installed implants to insure passivity of fit. In case of framework misfit, separation will be performed using a disc, followed by intraoral splinting and soldering. After framework soldering, another try-in will be done to insure framework fit. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age range from 45 to 65 years old.
- Absence of any medical disorder that could complicate the surgical phase or affect osseointegration .
- The patients must be completely edentulous.
- The patient must have enough bone height for implants, minimum length of bone 10mm and a minimum diameter of bone 5 mm.
- Patients with good oral hygiene.
Key exclusion criteria (4 listed)
- Patients with recent extraction(less than three months).
- Patients with inflamed ridge or candida infection.
- Patients with flappy ridge.
- Para functional habits.
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 |
|---|---|---|
| Electric Welded Metal FrameworkScrew-retained Maxillary Complete Denture With Electric Welded Metal Framework | Device | Electric Welded Metal Framework, cast metal framework |
Primary outcome
patient satisfaction
Time frame: 12 months
satisfaction assessed by Boerrigter's method questionnaire.in this questionnaire, there are three aspects to consider:(1) problems with the denture itself;(2) masticating ability; and (3) overall denture performance. different answers to each question are assigned scores and the total score can be calculated for further evaluation and analysis.
1 secondary outcome
Maintenance of the final prosthesis
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2020.
- 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.
cairo university study director
cu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electric Welded Metal Framework in people with Patient Satisfaction and Maintenance, run by Cairo 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 8 inclusion and 4 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 4 Sep 2020. 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 faculty of dentistry,cairo university (02 35676105, dentmail@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patient satisfaction (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 4 Sep 2020.