Implant Supported Telescopic OverdentureNCT04032223
Patient Satisfaction and Retention in Implant Supported Telescopic Overdenture With Different Copings
A study testing Implant placemet in the mandibular canine regions in people with Implant Supported Telescopic Overdenture, run by Cairo University.
Trial summary
Implant retained overdentures provided more satisfaction with regard to conventional denture related problems such as esthetics, speech, chewing, fit and retention, function and quality of life. Read more about this study
- Who is it for?
- Ages 45 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Implant Supported Telescopic Overdenture
- What is being tested?
- Implant placemet in the mandibular canine regions
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2019to 1 Jul 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
- Patients' age ranging from 45 -65 years old Patients are males or females Completely edentulous maxilla and mandible. Sufficient restorative space ( Not less than 12mm) Co-operative patient that should show motivation to follow up. Sufficient bone to receive Dental implant 3.7mm diameter and 10 mm length in the interforaminal region.
- Exclusion criteria: Patients having any bony undercuts. Patients having any disease affecting muscle coordination as Parkinsonism. Uncontrolled diabetic patients. Patients having limited mouth opening. Patients having bad oral hygiene.
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Patient Satisfaction and Retention in Cast Metal Versus 3D Printed Metal Copings in Implant Supported Mandibular Telescopic Overdenture
Implant retained overdentures provided more satisfaction with regard to conventional denture related problems such as esthetics, speech, chewing, fit and retention, function and quality of life. Evaluation of patient satisfaction allows direct quantification of patients' opinions on different aspects of a given treatment.
Studies have indicated that conventional complete denture wearers rehabilitated with mandibular implant supported overdenture experience better retention and stability, improved overall function and satisfaction.
Read more
Patient satisfaction is one factor that influences the success of overdenture treatment(Naert, Alsaadi et al. 2004). Previous studies have shown a difference between patients' satisfaction with their dental prostheses and clinicians' assessments of patients' oral condition.(Emami, Heydecke et al. 2009).This indicates that clinical assessments of dentures are not valid predictors of patient satisfaction.
The two primary methods used to fabricate these restorations may be subtractive (milling and grinding) or additive manufacturing (Rapid Prototype, RP or 3D printing), The 3D printing technology has been incorporated into dentistry, but does not include ceramics and is limited to polymers.
3D printing by rapid prototyping has many advantages which are the availability of high production rate where the technician can easily produce over 150 units per hour. Also the quality control of wax copings which results in high precision fit and constant wall thickness. This will result in better stability and retention and consequently patient satisfaction. Finally is the reduced finishing work needed on cast copings. The irregularities in wax coping thickness can be avoided.
Read the detailed description
Cast metal coping is the comparator. Because of their parallel walled design, telescopic crowns provide horizontal stability, thus stabilizing the prosthesis against lateral dislodging forces. The overdenture's self finding mechanism in telescopic constructions facilitates prosthesis insertion considerably.
Telescopic constructions seem to be easy to care for as they do not possess areas of difficult access for maintenance. This is why this construction also seems to be an effective treatment modality for geriatric patients with serious systemic diseases, which affect the degree of dexterity.
Despite rapid development in overdenture attachments and implant-supported overdentures with cast metal copings remain a viable and usable modality in dental practice. There is limited clinical follow-up data of the complications associated with overdentures and abutment teeth restored with metal copings, including post-procedural and prosthetic problems.
- Conditions
- Implant Supported Telescopic Overdenture
- Being tested
- Implant placemet in the mandibular canine regions
- Keywords
- 3D printed coping , overdenture, Implant , cast metal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implant placemet in the mandibular canine regionsProcedure or surgery
Also called Metal copings different designs in implant supported telescopic overdenture
Implant placemet in the mandibular canine regions retained by cast metal copings or 3D printed metal copings to deliver Implant Supported telescopic overdenture in the mandible
| Study group | Role | What they receive |
|---|---|---|
| 3D printed metal copings | Experimental | 3D printed primary and secondary metal copings inderctly from 3D printed resin in mandibular implant supported telescopic overdenture , Single Implants are placed in the interforaminal region bilaterally . Receives: Procedure: Implant placemet in the mandibular canine regions |
| Cast metal copings | Active comparator | Cast metal primary and secondary metal copings in mandibular implant supported telescopic overdenture , Single Implants are placed in the interforaminal region bilaterally . Receives: Procedure: Implant placemet in the mandibular canine regions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction
Patients will be recalled on their scheduled dates to the Prosthodontics department ,Faculty of Dentistry , Cairo University. The patient-based outcomes that will be used in this thesis included the variables measured on the 100-mm VAS (Visual Analogue Scale) and on Category Scales (CAT) that had been previously validated
Measured: 3 months
Secondary outcomes (1)
Retention
small perpendicular metal tubes were placed a few millimetres underneath the canines in the mandibular denture base.
In this manner the denture could be rigidly and reproducibly connected to the retention-measuring device. Retention measuring device is a device that was developed to apply an increasing, vertical force on the denture The force was administered througha straight metal bar that was fitted withstrain gauges (Measurements Group Inc.,Raleigh, NC, USA). The bar was rigidly connected to the denture.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2019
- Study start1 Oct 2019 (estimated)
- Primary completion1 Apr 2022 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Implant Supported Telescopic OverdentureStudies 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
- Model description
- It is Randomized Controlled Trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Amr Abdelmoez Abosabaa, Cairo University
- Investigators
- Yusr O Mady, PHD, Study chair, Cairo UniversityNancy N Elsherbini, PHD, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04032223
- Sponsor's protocol ID
- PRO305
- Status last verified
- Jul 2019
- First submitted
- 23 Jul 2019
- Last updated
- 25 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: I will check with my study chair.
Publications
Yunus N, Saub R, Taiyeb Ali TB, Salleh NM, Baig MR. Patient-based and clinical outcomes of implant telescopic attachment-retained mandibular overdentures: a 1-year longitudinal prospective study. Int J Oral Maxillofac Implants. 2014 Sep-Oct;29(5):1149-56. doi: 10.11607/jomi.3328.
PubMed 25216142
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Satisfaction and Retention in Cast Metal Versus 3D Printed Metal Copings in Implant Supported Mandibular Telescopic Overdenture
- ClinicalTrials.gov ID
- NCT04032223
- Acronym / sponsor ID
- PRO305
- Conditions
- Implant Supported Telescopic Overdenture
- Keywords
- 3D printed coping , overdenture, Implant , cast metal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (estimated)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 25 Jul 2019 (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.
Implant retained overdentures provided more satisfaction with regard to conventional denture related problems such as esthetics, speech, chewing, fit and retention, function and quality of life. Evaluation of patient satisfaction allows direct quantification of patients' opinions on different aspects of a given treatment.
Studies have indicated that conventional complete denture wearers rehabilitated with mandibular implant supported overdenture experience better retention and stability, improved overall function and satisfaction.
Patient satisfaction is one factor that influences the success of overdenture treatment(Naert, Alsaadi et al. 2004). Previous studies have shown a difference between patients' satisfaction with their dental prostheses and clinicians' assessments of patients' oral condition.(Emami, Heydecke et al. 2009).This indicates that clinical assessments of dentures are not valid predictors of patient satisfaction.
The two primary methods used to fabricate these restorations may be subtractive (milling and grinding) or additive manufacturing (Rapid Prototype, RP or 3D printing), The 3D printing technology has been incorporated into dentistry, but does not include ceramics and is limited to polymers.
3D printing by rapid prototyping has many advantages which are the availability of high production rate where the technician can easily produce over 150 units per hour. Also the quality control of wax copings which results in high precision fit and constant wall thickness. This will result in better stability and retention and consequently patient satisfaction. Finally is the reduced finishing work needed on cast copings. The irregularities in wax coping thickness can be avoided.
Detailed description
Cast metal coping is the comparator. Because of their parallel walled design, telescopic crowns provide horizontal stability, thus stabilizing the prosthesis against lateral dislodging forces. The overdenture's self finding mechanism in telescopic constructions facilitates prosthesis insertion considerably.
Telescopic constructions seem to be easy to care for as they do not possess areas of difficult access for maintenance. This is why this construction also seems to be an effective treatment modality for geriatric patients with serious systemic diseases, which affect the degree of dexterity.
Despite rapid development in overdenture attachments and implant-supported overdentures with cast metal copings remain a viable and usable modality in dental practice. There is limited clinical follow-up data of the complications associated with overdentures and abutment teeth restored with metal copings, including post-procedural and prosthetic problems.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- It is Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| 3D printed metal copings | Experimental | Procedure: Implant placemet in the mandibular canine regions3D printed primary and secondary metal copings inderctly from 3D printed resin in mandibular implant supported telescopic overdenture , Single Implants are placed in the interforaminal region bilaterally . |
| Cast metal copings | Active comparator | Procedure: Implant placemet in the mandibular canine regionsCast metal primary and secondary metal copings in mandibular implant supported telescopic overdenture , Single Implants are placed in the interforaminal region bilaterally . |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients' age ranging from 45 -65 years old Patients are males or females Completely edentulous maxilla and mandible. Sufficient restorative space ( Not less than 12mm) Co-operative patient that should show motivation to follow up. Sufficient bone to receive Dental implant 3.7mm diameter and 10 mm length in the interforaminal region.
- Exclusion criteria: Patients having any bony undercuts. Patients having any disease affecting muscle coordination as Parkinsonism. Uncontrolled diabetic patients. Patients having limited mouth opening. Patients having bad oral hygiene.
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 |
|---|---|---|
| Implant placemet in the mandibular canine regionsAlso: Metal copings different designs in implant supported telescopic overdentureImplant placemet in the mandibular canine regions retained by cast metal copings or 3D printed metal copings to deliver Implant Supported telescopic overdenture in the mandible | Procedure or surgery | 3D printed metal copings, Cast metal copings |
Primary outcome
Patient Satisfaction
Time frame: 3 months
Patients will be recalled on their scheduled dates to the Prosthodontics department ,Faculty of Dentistry , Cairo University. The patient-based outcomes that will be used in this thesis included the variables measured on the 100-mm VAS (Visual Analogue Scale) and on Category Scales (CAT) that had been previously validated
1 secondary outcome
Retention
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2019.
- Background: PubMed 25216142Yunus N, Saub R, Taiyeb Ali TB, Salleh NM, Baig MR. Patient-based and clinical outcomes of implant telescopic attachment-retained mandibular overdentures: a 1-year longitudinal prospective study. Int J Oral Maxillofac Implants. 2014 Sep-Oct;29(5):1149-56. doi: 10.11607/jomi.3328.
- Individual participant dataSharing planned: Undecided. I will check with my study chair.
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.
Yusr O Mady, PHD study chair
Cairo University
Nancy N Elsherbini, PHD study chair
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Implant placemet in the mandibular canine regions in people with Implant Supported Telescopic Overdenture, run by Cairo University.
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 2 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: status not confirmed, as of the sponsor's last update on 25 Jul 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed M Abosabaa, MSC (00201128223399, aabosabaa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Satisfaction (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04032223, which also lists 1 linked publication.
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 25 Jul 2019.