Edentulous JawNCT06201169
PEEK Bar Versus Titanium Bar Fabricated by CAD-CAM in Mandibular Hybrid Prostheses: A Comparative Study
A study testing implant placement in people with Edentulous Jaw, run by Amr Azab Abd El-Fattah at 2 sites in Egypt.
Trial summary
CAD/CAM-fabricated PEEK bar exhibited greater dimensional deviation in comparison to its titanium counterpart. Nevertheless, patients with PEEK bars reported higher satisfaction levels and lower marginal bone loss when compared to those with titanium bars. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Edentulous Jaw
- What is being tested?
- implant placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 2 sitesEgypt
- Study dates
- 15 Apr 2021to 25 Apr 2023
- 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 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Completely edentulous mandibular arch for at least six months have almost of the natural teeth in the maxillary arch with a ranged of age from 40- 60 years old.
- and normal class Ӏ maxilla-mandibular relationship with a minimum 12-15 mm inter-arch space
Who cannot join
- All patient had systemic disorders that may influence soft or hard tissue healing were excluded as:
- History of radiation therapy in the head and neck region.
- Active infection or inflammation or flabby tissue in the mandibular arch
- Bone diseases as osteoporosis.
- Clenching or bruxism, temporomandibular joint troubles
- Neurological or psychiatric handicap conditions that could interfere with good oral hygiene.
- Heavy smoking and drug abusing
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Faculty of dentistry tanta university
Al Gharbī Bahjūrah, Tanta, 31527
Tanta University
Al Gharbī Bahjūrah, Tanta, 31527
About this study
Official title: Comparative Study of PEEK Bar Versus Titanium Bar Fabricated by CAD-CAM in Mandibular Hybrid Prostheses
CAD/CAM-fabricated PEEK bar exhibited greater dimensional deviation in comparison to its titanium counterpart. Nevertheless, patients with PEEK bars reported higher satisfaction levels and lower marginal bone loss when compared to those with titanium bars.
Read the detailed description
Fourteen patients with completely edentulous mandibular arch opposing natural dentition were selected and divided into two groups, seven patients in each. All patients received implant-supported hybrid prostheses with a bar fabricated by CAD/CAM milling technique. In group I (control), bar was fabricated from titanium, while in group ӀӀ, the bar was fabricated from PEEK. The evaluation of the study was done at 6 and 12 follow-up periods according to the following: 1- Experimentally by Geomagic (Geomagic, Japan) to detect any dimensional deviation of PEEK bars compared to titanium bars. 2-Clinically by questionnaire to evaluate the patient satisfaction. 3- Radiographically (digital periapical) to measure marginal bone loss around the implants.
- Conditions
- Edentulous Jaw
- Being tested
- implant placement
- Keywords
- Hybrid prosthesis, Polyether-ether-ketone,
- Medical subject headings
- Jaw, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
implant placementProcedure or surgery
All patients received four implants in the lower arch
| Study group | Role | What they receive |
|---|---|---|
| group I (control) | Active comparator | The bars are fabricated from titanium. the participants received implant supported hybrid prosthesis with CAD/CAM fabricated titanium bars Receives: Procedure: implant placement |
| group II | Experimental | The bars are fabricated from PEEK . the participants received implant supported hybrid prosthesis with CAD/CAM fabricated PEEK bars Receives: Procedure: implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographically (digital periapical)
marginal bone loss around the implants
Measured: six and twelve months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start15 Apr 2021
- Primary completion20 May 2022
- Study completion25 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous JawStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- completely edentulous mandibular arch opposing natural dentition were selected
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amr Azab Abd El-Fattah
- Sponsor type
- University, hospital or other
- Collaborators
- Tanta University
- Responsible party
- Sponsor-investigator, Amr Azab Abd El-Fattah, Tanta University
- Investigators
- Research Ethics committee, Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06201169
- Sponsor's protocol ID
- REC 02-21 4
- Status last verified
- Jan 2024
- First submitted
- 30 Dec 2023
- Last updated
- 12 Jan 2024
- 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 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of PEEK Bar Versus Titanium Bar Fabricated by CAD-CAM in Mandibular Hybrid Prostheses
- ClinicalTrials.gov ID
- NCT06201169
- Acronym / sponsor ID
- REC 02-21 4
- Conditions
- Edentulous Jaw
- Keywords
- Hybrid prosthesis, Polyether-ether-ketone,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Amr Azab Abd El-FattahUniversity, hospital or other
- Collaborators
- Tanta University
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 20 May 2022 (actual)
- Study completion
- 25 Apr 2023 (actual)
- First posted
- 11 Jan 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.
CAD/CAM-fabricated PEEK bar exhibited greater dimensional deviation in comparison to its titanium counterpart. Nevertheless, patients with PEEK bars reported higher satisfaction levels and lower marginal bone loss when compared to those with titanium bars.
Detailed description
Fourteen patients with completely edentulous mandibular arch opposing natural dentition were selected and divided into two groups, seven patients in each. All patients received implant-supported hybrid prostheses with a bar fabricated by CAD/CAM milling technique. In group I (control), bar was fabricated from titanium, while in group ӀӀ, the bar was fabricated from PEEK. The evaluation of the study was done at 6 and 12 follow-up periods according to the following: 1- Experimentally by Geomagic (Geomagic, Japan) to detect any dimensional deviation of PEEK bars compared to titanium bars. 2-Clinically by questionnaire to evaluate the patient satisfaction. 3- Radiographically (digital periapical) to measure marginal bone loss around the implants.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- completely edentulous mandibular arch opposing natural dentition were selected
| Arm | Type | Receives |
|---|---|---|
| group I (control) | Active comparator | Procedure: implant placementThe bars are fabricated from titanium. the participants received implant supported hybrid prosthesis with CAD/CAM fabricated titanium bars |
| group II | Experimental | Procedure: implant placementThe bars are fabricated from PEEK . the participants received implant supported hybrid prosthesis with CAD/CAM fabricated PEEK bars |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Completely edentulous mandibular arch for at least six months have almost of the natural teeth in the maxillary arch with a ranged of age from 40- 60 years old.
- and normal class Ӏ maxilla-mandibular relationship with a minimum 12-15 mm inter-arch space
Key exclusion criteria (7 listed)
- All patient had systemic disorders that may influence soft or hard tissue healing were excluded as:
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 placementAll patients received four implants in the lower arch | Procedure or surgery | group I (control), group II |
Primary outcome
Radiographically (digital periapical)
Time frame: six and twelve months
marginal bone loss around the implants
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 12 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for Edentulous Jaw
Active, not recruiting
L-PRF Block vs Composite Graft for Horizontal Ridge Augmentation
Alveolar Ridge Resorption After Extraction, Alveolar Bone Loss
Not yet recruitingObservational study
Digital and Conventional Clasp-retained Partial Dentures (DIGICLASP)
Partial Edentulism
Recruiting
Dynamic vs. Static Jaw Relations in Implant-Supported Prostheses: Chewing Efficiency
Chewing Efficiency in Completely Edentulous Patients Rehabilitated With Implant-Supported Full-Arch Prostheses
Active, not recruiting
Multicenter Study to Evaluate the Clinical Outcome of PrimeTaper EV Implant in Single Tooth Restorations
Jaw, Edentulous, Partially
Recruiting
Clinical and Radiographic Evaluation of UV-Treated Dental Implants With or Without Melatonin in the Upper Posterior Jaw
Jaw, Edentulous, Partially, Bone Resorption
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.
Research Ethics committee principal investigator
Tanta University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing implant placement in people with Edentulous Jaw, run by Amr Azab Abd El-Fattah at 2 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 2 inclusion and 7 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 12 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Radiographically (digital periapical) (time frame: six and twelve months). 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 12 Jan 2024.