Complications ImplantsNCT05815589
Maintenance Assessment For Implant Fixed Complete Dentures With Implant Overdentures. A RCT
A study testing screw retained prosthesis group in people with Complications Implants, run by Cairo University at 3 sites in Egypt.
Trial summary
There are two types of complications in implant prosthesis: biologic and prosthetic . Biologic complications refer to disorders in implant function that disturb the supporting peri-implant tissues resulting in mucositis or periimplantitis in severe conditions, the technical complications refer to subjecting the… Read more about this study
- Who is it for?
- Ages 50 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Complications Implants
- What is being tested?
- screw retained prosthesis group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 3 sitesEgypt
- Study dates
- 12 Feb 2019to 30 Nov 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 50 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- completely edentulous male patients between the age of 50-70 years. patients with HB=bA1C up to 8 with normal blood sugar (79-110) Sufficient bone width (≥ 6 mm) It could be either normally present or achieved by bone plateauing. This will be confirmed by cone beam computed tomographic (CBCT) scans.
- Residual bone height ranging from 11-15 mm Patients seeking to install implant and for whom new dentures will be constructed.
- Patients, who are dissatisfied with the retention and stability of their technically satisfactory dentures.
- Patients providing written informed consents to participate in the trial and this will be done before the scheduled date for implant installation.
Who cannot join
- Any systemic disease that may interfere with dental implants placement and/or Osseointegration as; uncontrolled diabetes, hypertension, osteoporosis and irradiation. Heavy smoker (more than 20 cigarette / day) Patients with parafuctional habits as bruxism and clenching
- -
Trial locations and contacts
3 sites in 1 country.
Egypt3 sites
Cairo university
Cairo, 11351
Doaa Mahmoud Elkady
Cairo, 11351
Nesma Mohamed Awaad
Cairo, 11351
About this study
Official title: Prosthetic Maintenance Assessment For Implant Fixed Complete Dentures With Implant Overdentures. A Randomized Clinical Trial
There are two types of complications in implant prosthesis: biologic and prosthetic . Biologic complications refer to disorders in implant function that disturb the supporting peri-implant tissues resulting in mucositis or periimplantitis in severe conditions, the technical complications refer to subjecting the implant, implant parts and /or the superstructures to a damage ,such as screw loosening ,attachment wear, fracture to part of the prosthesis or some of its teeth. Prosthetic complications after the insertion of the final prosthesis may or may not lead to implant loss but lead to an increase demand for repair and maintenance.
This study aimed to assess whether the telescopic overdenture as a removable prosthesis would necessitate maintaince at frequency similar to that with screw retained hybrid overdenture as a fixed prosthesis.
Read the detailed description
Sample size calculation This power analysis used frequency of implant complications as the primary outcome. Based upon the results of Ragheb NA et al (2021) [15];the proportions of complications were 0.407 and 0.037 in the two groups, respectively. Using alpha (α) level of (5%) and Beta (β) level of (20%) i.e., power = 80%; the minimum estimated sample size was 19 implants per group. Sample size was increased to twenty-two implants per group to compensate for a drop-out rate of 30% after two years. Sample size calculation was performed using G*Power Version 3.1.9.2.
Patients were recruited in the study from the Outpatient Clinic of the Prosthodontics Department, Faculty of Dentistry, Cairo University. All of which were dissatisfied from their previous denture experience and seeking better retention to their mandibular denture. Patients had received verbal and written information about the study procedures and a written informed consent was signed prior to participation.
This study is a randomized clinical trial which was approved by the Ethics Committee of Scientific Research of Cairo University.
In this study , all participants had to install four interforaminal implants to receive either telescopic over-denture or screw retained denture.
Before the prosthetic phase, both groups were randomly assigned according to a computerized random allocation program where data of randomization were entered by the secretary of the department who neither participated in recruitment nor in examination procedures.
Randomization and Allocation concealment was guaranteed as the randomization table was locked with the study coordinator who wasn't involved in any clinical intervention. operator was informed about the treatment modality in a sealed enveloped delivered by the secretary of the department before impression procedures.
Data collection was done by the study coordinator , Blinding of the operator or data collector was not applicable due to the clear difference between the two prostheses but collected data was coded prior to sending to the statistician (blinded statistician).
A preoperative CBCT scan was taken for the participant 's mandibular arch with a scan appliance .The surgical steps were explained for all the participants and an informed consent was signed before surgery.
Intra-foraminal root form tapered threaded dental implants (Neo Biotech Co. Ltd, Seoul, Korea) were installed with 3.5/ 11.5 mm for the anterior and 3.5/10 mm for posterior sites .
Three months later, the surgical stent was used to relocate the implants position for uncovering and the healing abutment was screwed with collar height 5mm to allow for proper gingival healing around the implants prior making the impression.
The impression was made with an open tray splinted implant level impression technique According to randomization, either a telescopic implant supported overdenture or a screw retained denture was fabricated for each case.
During the follow -up period, prosthetic complications were grouped and their frequency was documented according to the type of prosthesis . Both prosthetic and biological aspects were included.
Each complication was documented with stating the frequency of its occurrence, any complication was managed and repaired.
- Conditions
- Complications Implants
- Being tested
- screw retained prosthesis group
- Keywords
- Dental Prosthesis, Implant-Supported*, Denture, Overlay
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
screw retained prosthesis groupOther
Also called hybrid prosthesis
hybrid prosthesis screwed on four mandibular intra-foraminal implants
| Study group | Role | What they receive |
|---|---|---|
| experimental | Experimental | screw retained prosthesis group this group will received a mandibular screw retained hybrid prosthesis over four inra-foraminal implant Receives: Other: screw retained prosthesis group |
| active comparator | Active comparator | this group received a mandibular telescopic attached overdenture. Receives: Other: screw retained prosthesis group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maintenance
maintenance for complication assed through counting frequency of incidence
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start12 Feb 2019
- Primary completion10 Apr 2021
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complications ImplantsStudies 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
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nesma Mohamed awaad, Cairo University
- Investigators
- Doaa Elkady phd, Study director, lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05815589
- Sponsor's protocol ID
- 31922.
- Status last verified
- Apr 2023
- First submitted
- 4 Apr 2023
- Last updated
- 18 Apr 2023
- 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 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prosthetic Maintenance Assessment For Implant Fixed Complete Dentures With Implant Overdentures. A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05815589
- Acronym / sponsor ID
- 31922.
- Conditions
- Complications Implants
- Keywords
- Dental Prosthesis, Implant-Supported*, Denture, Overlay
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 12 Feb 2019 (actual)
- Primary completion
- 10 Apr 2021 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 18 Apr 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.
There are two types of complications in implant prosthesis: biologic and prosthetic . Biologic complications refer to disorders in implant function that disturb the supporting peri-implant tissues resulting in mucositis or periimplantitis in severe conditions, the technical complications refer to subjecting the implant, implant parts and /or the superstructures to a damage ,such as screw loosening ,attachment wear, fracture to part of the prosthesis or some of its teeth. Prosthetic complications after the insertion of the final prosthesis may or may not lead to implant loss but lead to an increase demand for repair and maintenance.
This study aimed to assess whether the telescopic overdenture as a removable prosthesis would necessitate maintaince at frequency similar to that with screw retained hybrid overdenture as a fixed prosthesis.
Detailed description
Sample size calculation This power analysis used frequency of implant complications as the primary outcome. Based upon the results of Ragheb NA et al (2021) [15];the proportions of complications were 0.407 and 0.037 in the two groups, respectively. Using alpha (α) level of (5%) and Beta (β) level of (20%) i.e., power = 80%; the minimum estimated sample size was 19 implants per group. Sample size was increased to twenty-two implants per group to compensate for a drop-out rate of 30% after two years. Sample size calculation was performed using G*Power Version 3.1.9.2.
Patients were recruited in the study from the Outpatient Clinic of the Prosthodontics Department, Faculty of Dentistry, Cairo University. All of which were dissatisfied from their previous denture experience and seeking better retention to their mandibular denture. Patients had received verbal and written information about the study procedures and a written informed consent was signed prior to participation.
This study is a randomized clinical trial which was approved by the Ethics Committee of Scientific Research of Cairo University.
In this study , all participants had to install four interforaminal implants to receive either telescopic over-denture or screw retained denture.
Before the prosthetic phase, both groups were randomly assigned according to a computerized random allocation program where data of randomization were entered by the secretary of the department who neither participated in recruitment nor in examination procedures.
Randomization and Allocation concealment was guaranteed as the randomization table was locked with the study coordinator who wasn't involved in any clinical intervention. operator was informed about the treatment modality in a sealed enveloped delivered by the secretary of the department before impression procedures.
Data collection was done by the study coordinator , Blinding of the operator or data collector was not applicable due to the clear difference between the two prostheses but collected data was coded prior to sending to the statistician (blinded statistician).
A preoperative CBCT scan was taken for the participant 's mandibular arch with a scan appliance .The surgical steps were explained for all the participants and an informed consent was signed before surgery.
Intra-foraminal root form tapered threaded dental implants (Neo Biotech Co. Ltd, Seoul, Korea) were installed with 3.5/ 11.5 mm for the anterior and 3.5/10 mm for posterior sites .
Three months later, the surgical stent was used to relocate the implants position for uncovering and the healing abutment was screwed with collar height 5mm to allow for proper gingival healing around the implants prior making the impression.
The impression was made with an open tray splinted implant level impression technique According to randomization, either a telescopic implant supported overdenture or a screw retained denture was fabricated for each case.
During the follow -up period, prosthetic complications were grouped and their frequency was documented according to the type of prosthesis . Both prosthetic and biological aspects were included.
Each complication was documented with stating the frequency of its occurrence, any complication was managed and repaired.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental | Experimental | Other: screw retained prosthesis groupscrew retained prosthesis group this group will received a mandibular screw retained hybrid prosthesis over four inra-foraminal implant |
| active comparator | Active comparator | Other: screw retained prosthesis groupthis group received a mandibular telescopic attached overdenture. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- completely edentulous male patients between the age of 50-70 years. patients with HB=bA1C up to 8 with normal blood sugar (79-110) Sufficient bone width (≥ 6 mm) It could be either normally present or achieved by bone plateauing. This will be confirmed by cone beam computed tomographic (CBCT) scans.
- Residual bone height ranging from 11-15 mm Patients seeking to install implant and for whom new dentures will be constructed.
- Patients, who are dissatisfied with the retention and stability of their technically satisfactory dentures.
- Patients providing written informed consents to participate in the trial and this will be done before the scheduled date for implant installation.
Key exclusion criteria (2 listed)
- Any systemic disease that may interfere with dental implants placement and/or Osseointegration as; uncontrolled diabetes, hypertension, osteoporosis and irradiation. Heavy smoker (more than 20 cigarette / day) Patients with parafuctional habits as bruxism and clenching
- -
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 |
|---|---|---|
| screw retained prosthesis groupAlso: hybrid prosthesishybrid prosthesis screwed on four mandibular intra-foraminal implants | Other | active comparator, experimental |
Primary outcome
Maintenance
Time frame: one year
maintenance for complication assed through counting frequency of incidence
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 18 Apr 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.
Doaa Elkady phd study director
lecturer
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing screw retained prosthesis group in people with Complications Implants, run by Cairo University at 3 sites 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 4 inclusion and 2 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 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Maintenance (time frame: one 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 18 Apr 2023.