Telescopic OverdenturesEarly Phase 1NCT06639893
Crestal Bone Loss in Mandibular Telescopic Overdentures. Overdenture with Milled Titanium, Milled Poly-ether Ketone Ketones and 3D Printed Chrome Cobalt Secondary Copings.
A Early Phase 1 study testing Telescopic overdenture in people with Telescopic Overdentures and Dental Implants, run by Cairo University at 1 site in Egypt.
Trial summary
The objective of this clinical trial is to evaluate crestal bone loss every three months at time of overdenture insertion, 3, 6, 9, 12 months from overdenture use. Also, to evaluate prosthesis satisfaction. All participants will receive conventional complete dentures, followed by two intraforaminal implants. Read more about this study
- Who is it for?
- Ages 55 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Telescopic Overdentures, Dental Implants, Customized Abutments
- What is being tested?
- Telescopic overdenture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2023to 1 Oct 2024
- Phase
- Early Phase 1
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Sufficient remaining bone in height, width and thickness in the interforaminal area to allow installation of at least 3.3 mm diameter and 8 mm length implants.
- Adequate amount of interarch space of at least 12mm.
- Age range from 55 to 75 years old age.
Who cannot join
- Systemic and metabolic diseases that may affect osseointegration.
- Patients receiving bisphosphonates therapy.
- Patients under radiotherapy or chemotherapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Crestal Bone Loss in Mandibular Telescopic Implant Retained Overdenture with Milled Titanium, Milled Poly-ether Ketone Ketones and 3D Printed Chrome Cobalt Secondary Copings
The objective of this clinical trial is to evaluate crestal bone loss every three months at time of overdenture insertion, 3, 6, 9, 12 months from overdenture use. Also, to evaluate prosthesis satisfaction.
All participants will receive conventional complete dentures, followed by two intraforaminal implants. After healing time, fabrication of secondary copings in all cases according to randomized groups for final overdenture insertion.
- Being tested
- Telescopic overdenture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telescopic overdentureProcedure or surgery
Telescopic overdenture with two dental implants in intraforaminal area for mandible.
| Study group | Role | What they receive |
|---|---|---|
| Milled Titanium secondary copings | Active comparator | Not described Receives: Procedure: Telescopic overdenture |
| 3D printed chrom cobalt copings. | Experimental | Not described Receives: Procedure: Telescopic overdenture |
| Milled Poly-ether Ketone Ketones copings. | Experimental | Not described Receives: Procedure: Telescopic overdenture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Crestal bone loss.
The aim of this study was to evaluate crestal peri implant bone loss in mandibular telescopic implant retained overdenture with milled titanium, milled poly-ether ketone ketones and 3D printed chrome cobalt secondary copings. Crestal bone loss evaluated every three months using standardized digital periapical radiograph at time of overdenture insertion, 3, 6, 9, and after 12 months from overdenture use.
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 posted15 Oct 2024
- Study start1 Aug 2023
- Primary completion1 Aug 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Telescopic OverdenturesStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Minia University
- Responsible party
- Principal investigator, Moustafa mohamed el maghraby, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06639893
- Sponsor's protocol ID
- Randomized clinical trial
- Other IDs
- 613
- Status last verified
- Oct 2024
- First submitted
- 9 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Crestal Bone Loss in Mandibular Telescopic Implant Retained Overdenture with Milled Titanium, Milled Poly-ether Ketone Ketones and 3D Printed Chrome Cobalt Secondary Copings
- ClinicalTrials.gov ID
- NCT06639893
- Acronym / sponsor ID
- Randomized clinical trial
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Minia University
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 15 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.
The objective of this clinical trial is to evaluate crestal bone loss every three months at time of overdenture insertion, 3, 6, 9, 12 months from overdenture use. Also, to evaluate prosthesis satisfaction.
All participants will receive conventional complete dentures, followed by two intraforaminal implants. After healing time, fabrication of secondary copings in all cases according to randomized groups for final overdenture insertion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Milled Titanium secondary copings | Active comparator | Procedure: Telescopic overdenture |
| 3D printed chrom cobalt copings. | Experimental | Procedure: Telescopic overdenture |
| Milled Poly-ether Ketone Ketones copings. | Experimental | Procedure: Telescopic overdenture |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Sufficient remaining bone in height, width and thickness in the interforaminal area to allow installation of at least 3.3 mm diameter and 8 mm length implants.
- Adequate amount of interarch space of at least 12mm.
- Age range from 55 to 75 years old age.
Key exclusion criteria (3 listed)
- Systemic and metabolic diseases that may affect osseointegration.
- Patients receiving bisphosphonates therapy.
- Patients under radiotherapy or chemotherapy.
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 overdentureTelescopic overdenture with two dental implants in intraforaminal area for mandible. | Procedure or surgery | 3D printed chrom cobalt copings., Milled Poly-ether Ketone Ketones copings., Milled Titanium secondary copings |
Primary outcome
Crestal bone loss.
Time frame: one year
The aim of this study was to evaluate crestal peri implant bone loss in mandibular telescopic implant retained overdenture with milled titanium, milled poly-ether ketone ketones and 3D printed chrome cobalt secondary copings. Crestal bone loss evaluated every three months using standardized digital periapical radiograph at time of overdenture insertion, 3, 6, 9, and after 12 months from overdenture use.
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 15 Oct 2024.
- Individual participant dataSharing planned: Undecided
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 Early Phase 1 study testing Telescopic overdenture in people with Telescopic Overdentures and Dental Implants, 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 3 inclusion and 3 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 15 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Crestal bone loss. (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 15 Oct 2024.