EdentulismOverdentureNCT06632548
Retention of Three Different Types of Telescopic Attachments
A study testing telescopic overdenture in people with Edentulism and Denture Retention, run by Moatz Aly Ahmed Hussien at 1 site in Egypt.
Trial summary
This study was conducted on thirty patients. These patients were divided into three groups in a random manner to compare the retention forces between three different types of secondary crowns used to stabilize two implant mandibular overdentures. Read more about this study
- Who is it for?
- Ages 55 to 75 years
- Conditions the study is for
- Edentulism, Denture Retention
- What is being tested?
- telescopic overdenture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Aug 2022to 30 Mar 2024
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- un-satisfaction with the retention of mandibular dentures due to mandibular ridge atrophy and desired to have more stable prosthesis,
- sufficient remaining bone in height, width and thickness in the interforaminal area to allow installation of at least 3.5mm diameter implants.
- Adequate amount of interarch space of at least 12mm from the occlusal plane of the mandibular denture to the mucosa of the ridge. Patients with the 4- age range 55 to 75 years.
- -
Who cannot join
- 1) systemic and metabolic disorders that may complicate osseointegration. 2) Patients receiving bisphosphonates. 3) patients receiving radiotherapy.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retention of Three Different Secondary Copings in Telescopic Attchments Used to Stabilize Implant Retained Mandibular Overdenture a Randomized Clinical Trial
This study was conducted on thirty patients. These patients were divided into three groups in a random manner to compare the retention forces between three different types of secondary crowns used to stabilize two implant mandibular overdentures. in all groups the primary coping was fabricated from milled titanium while the secondary coping was milled titanium in first group ,3D printed cobalt chromium in the second group and milled poly ether ketone ketone in the third group the retention forces was measured using forcemeter immediately after insertion and after 3,6, months
Read the detailed description
A thirty edentulous patients Was selected from outpatient clinic of
Exclusion criteria:
- systemic and metabolic disorders that may complicate osseointegration.
- Patients receiving bisphosphonates.
- patients receiving radiotherapy. The patients was assigned into three groups using balanced randomly. Patients was randomly allocated into one of three groups using random numbers generated using Excel program.
Group I included patients who received 2 implants and telescopic overdentures with milled titanium primary and secondary coping Group II included patients who received telescopic overdentures with milled titanium primary coping and three dimensionally printed secondary coping GroupIII patients recived milled titanium primary coping and poly ether ketone ketone secondary copings (PEKK) secondary coping All patients signed an informed consent.
Surgical and prosthetic protocols:
A radiographic stent with gutta percha markers at the canine region was fabricated and the patient was instructed to wear it during cone beam radiographic evaluation to evaluate proposed implant sites regarding bone height and thickness, and approximation to vital structures (mental foramen).
Radiographic template was converted to surgical template.
The two implants was inserted nearly parallel as possible. If inclination of the implants was inevitable buccally or lingually due to mandibular concavities, the inclination was compensated later during design of primary copings.
The implants was inserted in the canine region with two steps surgical protocol. After three months of the insertion and osseointegration implants was exposed and healing abutments was inserted after gingival healing implant level impression will be taken.
The metallic primary coping was milled with 2-degree convergence for all cases while the second coping was milled titanium or 3D printed cobalt chromium or milled PEKK according the patient group.
the primary copings was screwed to the implants and the secondary coping pick up was done and patient was instructed to follow oral hygiene measures and was scheduled for periodic follow up every 3 months.
Evaluation of overdenture retention:
Force meter device was used to measure the retention of the mandibular overdenture in Newton.
The patient was seated on upright position and asked to open his mouth until the occlusal surface of the lower denture is parallel to the floor and the maximum dislodging force to remove the denture is recorded using digital forcemeter.
Measurement of retention forces was made immediately after overdenture insertion and repeated at 3,6,9and 12 months after insertion after by independent dental personnel blinded to treatment groups.
- Conditions
- Edentulism, Denture Retention
- Being tested
- telescopic overdenture
- Keywords
- overdenture-telescopic attachment-poly ether ketoneketone-PEKK-, milled titanium, 3d printed cobalt chromium, implant retained overdenture, mandibular overdenture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telescopic overdentureDevice
two implant retained mandibular overdenture with telescopic attachment
| Study group | Role | What they receive |
|---|---|---|
| milled titanium secondary coping | Active comparator | group I patients received primary and secondary coping made of milled titanium Receives: Device: telescopic overdenture |
| 3D printed cobalt chromium secondary coping | Experimental | group II patients received primary coping made of milled titanium and secondary coping made of 3D printed cobalt chromium Receives: Device: telescopic overdenture |
| milled poly ether ketone ketone secondary coping | Experimental | group III patients received primary coping made of milled titanium and secondary coping made of milled poly ether ether ketone Receives: Device: telescopic overdenture |
What is being measured
The primary outcome is the main question the study is designed to answer.
retention forces
retention forces of three different type secondary coping telescopic attachments used to stabilize two implant mandibular overdenture these attachments are made of either milled titanium, 3D printed cobalt chromium or milled poly ether ketone ketone
Measured: from insertion time up to one year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start30 Aug 2022
- Primary completion30 Jan 2024
- Study completion30 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EdentulismStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moatz Aly Ahmed Hussien
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Moatz Aly Ahmed Hussien, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06632548
- Sponsor's protocol ID
- 612
- Acronym
- Overdenture
- Status last verified
- Jul 2022
- First submitted
- 7 Oct 2024
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: the values of retention of each individual plus age and sex
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retention of Three Different Secondary Copings in Telescopic Attchments Used to Stabilize Implant Retained Mandibular Overdenture a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06632548
- Acronym / sponsor ID
- Overdenture / 612
- Conditions
- Edentulism, Denture Retention
- Keywords
- overdenture-telescopic attachment-poly ether ketoneketone-PEKK-, milled titanium, 3d printed cobalt chromium, implant retained overdenture, mandibular overdenture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Moatz Aly Ahmed HussienUniversity, hospital or other
- Study start
- 30 Aug 2022 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 9 Oct 2024 (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.
This study was conducted on thirty patients. These patients were divided into three groups in a random manner to compare the retention forces between three different types of secondary crowns used to stabilize two implant mandibular overdentures. in all groups the primary coping was fabricated from milled titanium while the secondary coping was milled titanium in first group ,3D printed cobalt chromium in the second group and milled poly ether ketone ketone in the third group the retention forces was measured using forcemeter immediately after insertion and after 3,6, months
Detailed description
A thirty edentulous patients Was selected from outpatient clinic of
Exclusion criteria:
- systemic and metabolic disorders that may complicate osseointegration.
- Patients receiving bisphosphonates.
- patients receiving radiotherapy. The patients was assigned into three groups using balanced randomly. Patients was randomly allocated into one of three groups using random numbers generated using Excel program.
Group I included patients who received 2 implants and telescopic overdentures with milled titanium primary and secondary coping Group II included patients who received telescopic overdentures with milled titanium primary coping and three dimensionally printed secondary coping GroupIII patients recived milled titanium primary coping and poly ether ketone ketone secondary copings (PEKK) secondary coping All patients signed an informed consent.
Surgical and prosthetic protocols:
A radiographic stent with gutta percha markers at the canine region was fabricated and the patient was instructed to wear it during cone beam radiographic evaluation to evaluate proposed implant sites regarding bone height and thickness, and approximation to vital structures (mental foramen).
Radiographic template was converted to surgical template.
The two implants was inserted nearly parallel as possible. If inclination of the implants was inevitable buccally or lingually due to mandibular concavities, the inclination was compensated later during design of primary copings.
The implants was inserted in the canine region with two steps surgical protocol. After three months of the insertion and osseointegration implants was exposed and healing abutments was inserted after gingival healing implant level impression will be taken.
The metallic primary coping was milled with 2-degree convergence for all cases while the second coping was milled titanium or 3D printed cobalt chromium or milled PEKK according the patient group.
the primary copings was screwed to the implants and the secondary coping pick up was done and patient was instructed to follow oral hygiene measures and was scheduled for periodic follow up every 3 months.
Evaluation of overdenture retention:
Force meter device was used to measure the retention of the mandibular overdenture in Newton.
The patient was seated on upright position and asked to open his mouth until the occlusal surface of the lower denture is parallel to the floor and the maximum dislodging force to remove the denture is recorded using digital forcemeter.
Measurement of retention forces was made immediately after overdenture insertion and repeated at 3,6,9and 12 months after insertion after by independent dental personnel blinded to treatment groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| milled titanium secondary coping | Active comparator | Device: telescopic overdenturegroup I patients received primary and secondary coping made of milled titanium |
| 3D printed cobalt chromium secondary coping | Experimental | Device: telescopic overdenturegroup II patients received primary coping made of milled titanium and secondary coping made of 3D printed cobalt chromium |
| milled poly ether ketone ketone secondary coping | Experimental | Device: telescopic overdenturegroup III patients received primary coping made of milled titanium and secondary coping made of milled poly ether ether ketone |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- un-satisfaction with the retention of mandibular dentures due to mandibular ridge atrophy and desired to have more stable prosthesis,
- sufficient remaining bone in height, width and thickness in the interforaminal area to allow installation of at least 3.5mm diameter implants.
- Adequate amount of interarch space of at least 12mm from the occlusal plane of the mandibular denture to the mucosa of the ridge. Patients with the 4- age range 55 to 75 years.
- -
Key exclusion criteria (2 listed)
- 1) systemic and metabolic disorders that may complicate osseointegration. 2) Patients receiving bisphosphonates. 3) patients receiving radiotherapy.
- -
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 |
|---|---|---|
| telescopic overdenturetwo implant retained mandibular overdenture with telescopic attachment | Device | 3D printed cobalt chromium secondary coping, milled poly ether ketone ketone secondary coping, milled titanium secondary coping |
Primary outcome
retention forces
Time frame: from insertion time up to one year follow up
retention forces of three different type secondary coping telescopic attachments used to stabilize two implant mandibular overdenture these attachments are made of either milled titanium, 3D printed cobalt chromium or milled poly ether ketone ketone
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 9 Oct 2024.
- Individual participant dataSharing planned: Yes. the values of retention of each individual plus age and sex
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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 telescopic overdenture in people with Edentulism and Denture Retention, run by Moatz Aly Ahmed Hussien 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 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 9 Oct 2024. 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?
retention forces (time frame: from insertion time up to one year follow up). 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 9 Oct 2024.