Attachment DisorderNCT06434142
Wear Assessment of Novel PEEK Telescopic Attachment for Overdenture
A study testing implant overdenture in people with Attachment Disorder and Stress Disorder, run by Hamada Zaki Mahross Atia at 1 site in Egypt.
Trial summary
To assess the wear of Zirconia-PEEK versus cobalt-chromium-PEEK telescopic attachments for implant retained complete mandibular overdenture. The wear of Zirconia-PEEK telescopic attachments can affect the retention of implant retained complete mandibular overdenture. 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
- Attachment Disorder, Stress Disorder
- What is being tested?
- implant overdenture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Feb 2024to 1 May 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 50 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- completely edentulous
- free from any dental or systemic diseases
Who cannot join
- medically ill fit patient
- female patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Wear Assessment of Novel PEEK Telescopic Attachment for Implant Retained Mandibular Overdenture
To assess the wear of Zirconia-PEEK versus cobalt-chromium-PEEK telescopic attachments for implant retained complete mandibular overdenture. The wear of Zirconia-PEEK telescopic attachments can affect the retention of implant retained complete mandibular overdenture.
Read the detailed description
Twelve completely edentulous patients were randomly chosen for implant retained telescopic overdentures construction and divided into two groups, where group I was a patient with zirconia copy, and group II was with cobalt chromium CoCr copy. The PEEK was constructed for both groups as a secondary coping telescopic attachment for the denture. The wear measurements of PEEK were performed optically by using a USB digital microscope with a built-in camera connected to a compatible personal computer at different intervals of baseline, 3, 6, and 9 months. The data was statistically analyzed and compared using student t-test, ANOVA, and Post Hoc Test.
- Conditions
- Attachment Disorder, Stress Disorder
- Being tested
- implant overdenture
- Keywords
- Telescopic attachment, Attachment Wear, Zirconia
- Medical subject headings
- Stress Disorders, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
implant overdentureProcedure or surgery
Following the two-stage surgical protocol, two dental implant fixtures with a length of 10 mm and a diameter of 3.7 mm were inserted at the canine area of the mandibular alveolar ridge.
| Study group | Role | What they receive |
|---|---|---|
| patient with zirconia copy | Experimental | Group I (study group) was the group of patients with zirconia as a primary copings that attach to the abutment and PEEK as a secondary coping telescopic attachment that attaches to the fitting surface of the denture. Receives: Procedure: implant overdenture |
| patients with cobalt chromium (CoCr) as primary copings | Experimental | Group II (control group) was the group of patients with cobalt chromium (CoCr) as primary copings attached to the abutment and PEEK as a secondary coping's telescopic attachment attached to the fitting surface of the denture. Receives: Procedure: implant overdenture |
What is being measured
The primary outcome is the main question the study is designed to answer.
the mean wear values
measurement of the mean of wear between two test groups
Measured: at baseline
the mean wear values
measurement of the mean of wear between two test groups
Measured: after 3 months interval
the mean wear values
measurement of the mean of wear between two test groups
Measured: after 6 months interval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start11 Feb 2024
- Primary completion20 Apr 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attachment DisorderStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamada Zaki Mahross Atia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hamada Zaki Mahross Atia, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06434142
- Sponsor's protocol ID
- 751/306
- Status last verified
- May 2024
- First submitted
- 19 May 2024
- Last updated
- 30 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wear Assessment of Novel PEEK Telescopic Attachment for Implant Retained Mandibular Overdenture
- ClinicalTrials.gov ID
- NCT06434142
- Acronym / sponsor ID
- 751/306
- Conditions
- Attachment Disorder, Stress Disorder
- Keywords
- Telescopic attachment, Attachment Wear, Zirconia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hamada Zaki Mahross AtiaUniversity, hospital or other
- Study start
- 11 Feb 2024 (actual)
- Primary completion
- 20 Apr 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 30 May 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.
To assess the wear of Zirconia-PEEK versus cobalt-chromium-PEEK telescopic attachments for implant retained complete mandibular overdenture. The wear of Zirconia-PEEK telescopic attachments can affect the retention of implant retained complete mandibular overdenture.
Detailed description
Twelve completely edentulous patients were randomly chosen for implant retained telescopic overdentures construction and divided into two groups, where group I was a patient with zirconia copy, and group II was with cobalt chromium CoCr copy. The PEEK was constructed for both groups as a secondary coping telescopic attachment for the denture. The wear measurements of PEEK were performed optically by using a USB digital microscope with a built-in camera connected to a compatible personal computer at different intervals of baseline, 3, 6, and 9 months. The data was statistically analyzed and compared using student t-test, ANOVA, and Post Hoc Test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patient with zirconia copy | Experimental | Procedure: implant overdentureGroup I (study group) was the group of patients with zirconia as a primary copings that attach to the abutment and PEEK as a secondary coping telescopic attachment that attaches to the fitting surface of the denture. |
| patients with cobalt chromium (CoCr) as primary copings | Experimental | Procedure: implant overdentureGroup II (control group) was the group of patients with cobalt chromium (CoCr) as primary copings attached to the abutment and PEEK as a secondary coping's telescopic attachment attached to the fitting surface of the denture. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- completely edentulous
- free from any dental or systemic diseases
Key exclusion criteria (2 listed)
- medically ill fit patient
- female patient
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 overdentureFollowing the two-stage surgical protocol, two dental implant fixtures with a length of 10 mm and a diameter of 3.7 mm were inserted at the canine area of the mandibular alveolar ridge. | Procedure or surgery | patient with zirconia copy, patients with cobalt chromium (CoCr) as primary copings |
Primary outcome
the mean wear values
Time frame: at baseline
measurement of the mean of wear between two test groups
the mean wear values
Time frame: after 3 months interval
measurement of the mean of wear between two test groups
the mean wear values
Time frame: after 6 months interval
measurement of the mean of wear between two test groups
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 30 May 2024.
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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 implant overdenture in people with Attachment Disorder and Stress Disorder, run by Hamada Zaki Mahross Atia 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 2 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 30 May 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?
the mean wear values (time frame: at baseline). The study lists 3 primary outcomes in all. 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 30 May 2024.