Edentulism in Lower JawNCT07323628
PEEK vs Metal Bar Attachments
A study testing PEEK Bar Attachment and Metal Bar Attachment in people with Edentulism in Lower Jaw, run by Sherif Aly Sadek at 1 site in Egypt.
Trial summary
This study is being conducted to compare two types of bar attachments used to support lower dentures in patients who have lost all their lower teeth. Many people who wear a single lower denture experience problems with stability, chewing, and comfort. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Edentulism in Lower Jaw
- What is being tested?
- PEEK Bar Attachment and Metal Bar Attachment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 5 May 2024to 10 Nov 2025
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 40 to 70 years
- Mandibular single complete denture with complaints of poor retention or stability
- Adequate bone volume in the mandibular canine regions to receive two dental implants without the need for bone grafting
- Good general health allowing dental implant surgery
- Willingness to participate and comply with study procedures and follow-up visits
- Signed written informed consent
Who cannot join
- Presence of uncontrolled systemic diseases (e.g., uncontrolled diabetes mellitus)
- History of head and neck radiotherapy
- Metabolic bone diseases or conditions affecting bone healing
- Current smokers or tobacco users
- Poor oral hygiene or inability to maintain oral hygiene
- Active oral infections or untreated periodontal disease
Show all 9Show fewer
- Bruxism or severe parafunctional habits
- Previous implant placement in the mandible
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient Satisfaction After Prosthetic Rehabilitation of Mandibular Single Denture With Two Implants Using Different Attachments: A Randomized Clinical Trial
This study is being conducted to compare two types of bar attachments used to support lower dentures in patients who have lost all their lower teeth. Many people who wear a single lower denture experience problems with stability, chewing, and comfort. Placing two implants in the lower jaw and attaching the denture to a bar can greatly improve how well the denture stays in place.
Traditionally, these bars have been made from metal. While effective, metal bars can place higher stress on the bone around the implants, which may lead to more bone loss over time. A newer material, PEEK (polyetheretherketone), is lighter and has flexibility closer to natural bone. This may reduce stress on the implants and help protect the surrounding bone.
Read more
In this randomized clinical trial, patients are assigned to receive either a PEEK bar or a metal bar to retain their lower denture. All participants receive two implants placed in the canine region of the lower jaw, followed by a bar-retained overdenture after healing.
The study follows patients for 12 months and measures:
Marginal bone loss: how much bone is lost around each implant, assessed through radiographs.
Patient satisfaction: how comfortable and functional the denture feels, including stability, chewing, speech, hygiene, and overall handling.
Early results show that both types of bars support the denture well, but implants connected to PEEK bars tend to show less bone loss after several months compared to those connected to metal bars. Patient satisfaction is high in both groups, with slightly higher scores reported by patients using PEEK bars, although not significantly different.
This study may help dentists choose the best bar material to improve long-term implant health and denture comfort.
Read the detailed description
This randomized, parallel-group clinical trial evaluates the clinical performance of CAD/CAM-fabricated PEEK bars compared with traditional metal bars for retaining mandibular single overdentures supported by two implants. The study includes 20 fully edentulous mandibular patients aged 40-70 years who report functional difficulties with a single lower denture.
All participants undergo placement of two dental implants in the mandibular canine regions using a two-stage surgical protocol. After osseointegration, patients are randomly assigned to one of two groups:
PEEK bar group: overdentures retained using a digitally designed and milled PEEK bar.
Metal bar group: overdentures retained using a conventional metal alloy bar.
The scientific rationale for evaluating PEEK is based on its lower elastic modulus, which may allow more favorable stress distribution to peri-implant bone compared with the higher stiffness of metal bars. This biomechanical difference may influence implant survival, marginal bone remodeling, and perceived comfort.
Clinical outcomes are assessed at insertion and at 3, 6, 9, and 12 months. Marginal bone loss is measured radiographically using standardized periapical images. Patient-reported satisfaction is captured using a validated Visual Analogue Scale across major functional domains.
The statistical approach uses Aligned Rank Transform ANOVA due to non-normal data distribution, with Tukey post-hoc testing for pairwise comparison.
This trial contributes new data on material selection for bar attachments in implant-retained mandibular overdentures. The findings suggest that PEEK bars may offer biomechanical advantages by reducing bone loss while maintaining patient satisfaction comparable to metal bars. Further long-term studies with larger sample sizes are recommended to validate these results and support broader clinical adoption.
- Conditions
- Edentulism in Lower Jaw
- Being tested
- PEEK Bar Attachment, Metal Bar Attachment
- Keywords
- Mandibular Implant Overdenture, PEEK Bar Attachment, Metal Bar Attachment, Patient Satisfaction, Edentulous Mandible, Marginal Bone Loss
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEEK Bar AttachmentDevice
A CAD/CAM-fabricated polyetheretherketone (PEEK) bar used to retain a mandibular implant-supported overdenture on two implants placed in the canine regions of the mandible.
Metal Bar AttachmentDevice
A conventional metal alloy bar used to retain a mandibular implant-supported overdenture on two implants placed in the canine regions of the mandible.
| Study group | Role | What they receive |
|---|---|---|
| PEEK Bar Attachment Group | Experimental | Participants receive two dental implants placed in the mandibular canine regions. After osseointegration, the mandibular overdenture is retained using a CAD/CAM-fabricated polyetheretherketone (PEEK) bar attachment. Clinical and patient-reported outcomes are evaluated over a 12-month follow-up period. Receives: Device: PEEK Bar Attachment |
| Metal Bar Attachment Group | Active comparator | Participants receive two dental implants placed in the mandibular canine regions. After osseointegration, the mandibular overdenture is retained using a conventional metal alloy bar attachment. Clinical and patient-reported outcomes are evaluated over a 12-month follow-up period. Receives: Device: Metal Bar Attachment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction With Mandibular Implant-Retained Overdentures
Description: Patient satisfaction will be evaluated using a Visual Analogue Scale (VAS). Participants will rate comfort, chewing efficiency, denture stability, speech, hygiene, ease of handling, and overall satisfaction. Scores will be recorded on a numerical scale and compared between intervention groups over the follow-up period.
Measured: Baseline (at overdenture insertion), and at 3, 6, 9, and 12 months post-insertion
Secondary outcomes (1)
Marginal Bone Loss Around Dental Implants
Description: Marginal bone loss around the two mandibular implants will be assessed radiographically using standardized periapical radiographs. Measurements will be recorded as the vertical distance (in millimeters) from the implant shoulder to the first bone-to-implant contact on the mesial and distal aspects of each implant. Mean bone loss per implant will be calculated and compared between the PEEK bar and metal bar attachment groups.
Measured: Baseline (at overdenture insertion), and at 3, 6, 9, and 12 months post-insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start5 May 2024
- Primary completion10 Oct 2025
- Study completion10 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Edentulism in Lower 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to one of two parallel intervention arms. Each participant receives two mandibular implants followed by prosthetic rehabilitation using either a CAD/CAM fabricated PEEK bar attachment or a conventional metal bar attachment. Outcomes are assessed longitudinally over a 12-month follow-up period without crossover between groups.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sherif Aly Sadek
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sherif Aly Sadek, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07323628
- Sponsor's protocol ID
- 02-02-23
- Status last verified
- Jan 2026
- First submitted
- 19 Dec 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tada, S., Stegaroiu, R., Kitamura, E., Miyakawa, O., & Kusakari, H. (2003). Influence of implant design on stress around implants. Journal of Prosthetic Dentistry, 90(2), 164-170.
Schwitalla A, Muller WD. PEEK dental implants: a review of the literature. J Oral Implantol. 2013 Dec;39(6):743-9. doi: 10.1563/AAID-JOI-D-11-00002. Epub 2011 Sep 9.
PubMed 21905892Skalak R. Biomechanical considerations in osseointegrated prostheses. J Prosthet Dent. 1983 Jun;49(6):843-8. doi: 10.1016/0022-3913(83)90361-x.
PubMed 6576140Feine JS, Carlsson GE, Awad MA, Chehade A, Duncan WJ, Gizani S, Head T, Lund JP, MacEntee M, Mericske-Stern R, Mojon P, Morais J, Naert I, Payne AG, Penrod J, Stoker GT Jr, Tawse-Smith A, Taylor TD, Thomason JM, Thomson WM, Wismeijer D. The McGill Consensus Statement on Overdentures. Montreal, Quebec, Canada. May 24-25, 2002. Int J Prosthodont. 2002 Jul-Aug;15(4):413-4. No abstract available.
PubMed 12170858Burns DR. Mandibular implant overdenture treatment: consensus and controversy. J Prosthodont. 2000 Mar;9(1):37-46. doi: 10.1111/j.1532-849x.2000.00037.x.
PubMed 11074027
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Satisfaction After Prosthetic Rehabilitation of Mandibular Single Denture With Two Implants Using Different Attachments: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07323628
- Acronym / sponsor ID
- 02-02-23
- Conditions
- Edentulism in Lower Jaw
- Keywords
- Mandibular Implant Overdenture, PEEK Bar Attachment, Metal Bar Attachment, Patient Satisfaction, Edentulous Mandible, Marginal Bone Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Sherif Aly SadekUniversity, hospital or other
- Study start
- 5 May 2024 (actual)
- Primary completion
- 10 Oct 2025 (actual)
- Study completion
- 10 Nov 2025 (actual)
- First posted
- 7 Jan 2026 (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 is being conducted to compare two types of bar attachments used to support lower dentures in patients who have lost all their lower teeth. Many people who wear a single lower denture experience problems with stability, chewing, and comfort. Placing two implants in the lower jaw and attaching the denture to a bar can greatly improve how well the denture stays in place.
Traditionally, these bars have been made from metal. While effective, metal bars can place higher stress on the bone around the implants, which may lead to more bone loss over time. A newer material, PEEK (polyetheretherketone), is lighter and has flexibility closer to natural bone. This may reduce stress on the implants and help protect the surrounding bone.
In this randomized clinical trial, patients are assigned to receive either a PEEK bar or a metal bar to retain their lower denture. All participants receive two implants placed in the canine region of the lower jaw, followed by a bar-retained overdenture after healing.
The study follows patients for 12 months and measures:
Marginal bone loss: how much bone is lost around each implant, assessed through radiographs.
Patient satisfaction: how comfortable and functional the denture feels, including stability, chewing, speech, hygiene, and overall handling.
Early results show that both types of bars support the denture well, but implants connected to PEEK bars tend to show less bone loss after several months compared to those connected to metal bars. Patient satisfaction is high in both groups, with slightly higher scores reported by patients using PEEK bars, although not significantly different.
This study may help dentists choose the best bar material to improve long-term implant health and denture comfort.
Detailed description
This randomized, parallel-group clinical trial evaluates the clinical performance of CAD/CAM-fabricated PEEK bars compared with traditional metal bars for retaining mandibular single overdentures supported by two implants. The study includes 20 fully edentulous mandibular patients aged 40-70 years who report functional difficulties with a single lower denture.
All participants undergo placement of two dental implants in the mandibular canine regions using a two-stage surgical protocol. After osseointegration, patients are randomly assigned to one of two groups:
PEEK bar group: overdentures retained using a digitally designed and milled PEEK bar.
Metal bar group: overdentures retained using a conventional metal alloy bar.
The scientific rationale for evaluating PEEK is based on its lower elastic modulus, which may allow more favorable stress distribution to peri-implant bone compared with the higher stiffness of metal bars. This biomechanical difference may influence implant survival, marginal bone remodeling, and perceived comfort.
Clinical outcomes are assessed at insertion and at 3, 6, 9, and 12 months. Marginal bone loss is measured radiographically using standardized periapical images. Patient-reported satisfaction is captured using a validated Visual Analogue Scale across major functional domains.
The statistical approach uses Aligned Rank Transform ANOVA due to non-normal data distribution, with Tukey post-hoc testing for pairwise comparison.
This trial contributes new data on material selection for bar attachments in implant-retained mandibular overdentures. The findings suggest that PEEK bars may offer biomechanical advantages by reducing bone loss while maintaining patient satisfaction comparable to metal bars. Further long-term studies with larger sample sizes are recommended to validate these results and support broader clinical adoption.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to one of two parallel intervention arms. Each participant receives two mandibular implants followed by prosthetic rehabilitation using either a CAD/CAM fabricated PEEK bar attachment or a conventional metal bar attachment. Outcomes are assessed longitudinally over a 12-month follow-up period without crossover between groups.
| Arm | Type | Receives |
|---|---|---|
| PEEK Bar Attachment Group | Experimental | Device: PEEK Bar AttachmentParticipants receive two dental implants placed in the mandibular canine regions. After osseointegration, the mandibular overdenture is retained using a CAD/CAM-fabricated polyetheretherketone (PEEK) bar attachment. Clinical and patient-reported outcomes are evaluated over a 12-month follow-up period. |
| Metal Bar Attachment Group | Active comparator | Device: Metal Bar AttachmentParticipants receive two dental implants placed in the mandibular canine regions. After osseointegration, the mandibular overdenture is retained using a conventional metal alloy bar attachment. Clinical and patient-reported outcomes are evaluated over a 12-month follow-up period. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged 40 to 70 years
- Mandibular single complete denture with complaints of poor retention or stability
- Adequate bone volume in the mandibular canine regions to receive two dental implants without the need for bone grafting
- Good general health allowing dental implant surgery
- Willingness to participate and comply with study procedures and follow-up visits
Key exclusion criteria (9 listed)
- Presence of uncontrolled systemic diseases (e.g., uncontrolled diabetes mellitus)
- History of head and neck radiotherapy
- Metabolic bone diseases or conditions affecting bone healing
- Current smokers or tobacco users
- Poor oral hygiene or inability to maintain oral hygiene
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 |
|---|---|---|
| PEEK Bar AttachmentA CAD/CAM-fabricated polyetheretherketone (PEEK) bar used to retain a mandibular implant-supported overdenture on two implants placed in the canine regions of the mandible. | Device | PEEK Bar Attachment Group |
| Metal Bar AttachmentA conventional metal alloy bar used to retain a mandibular implant-supported overdenture on two implants placed in the canine regions of the mandible. | Device | Metal Bar Attachment Group |
Primary outcome
Patient Satisfaction With Mandibular Implant-Retained Overdentures
Time frame: Baseline (at overdenture insertion), and at 3, 6, 9, and 12 months post-insertion
Description: Patient satisfaction will be evaluated using a Visual Analogue Scale (VAS). Participants will rate comfort, chewing efficiency, denture stability, speech, hygiene, ease of handling, and overall satisfaction. Scores will be recorded on a numerical scale and compared between intervention groups over the follow-up period.
1 secondary outcome
Marginal Bone Loss Around Dental Implants
Time frame: Baseline (at overdenture insertion), and at 3, 6, 9, and 12 months post-insertion
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 Jan 2026.
- BackgroundTada, S., Stegaroiu, R., Kitamura, E., Miyakawa, O., & Kusakari, H. (2003). Influence of implant design on stress around implants. Journal of Prosthetic Dentistry, 90(2), 164-170.
- Background: PubMed 21905892Schwitalla A, Muller WD. PEEK dental implants: a review of the literature. J Oral Implantol. 2013 Dec;39(6):743-9. doi: 10.1563/AAID-JOI-D-11-00002. Epub 2011 Sep 9.
- Background: PubMed 6576140Skalak R. Biomechanical considerations in osseointegrated prostheses. J Prosthet Dent. 1983 Jun;49(6):843-8. doi: 10.1016/0022-3913(83)90361-x.
- Background: PubMed 12170858Feine JS, Carlsson GE, Awad MA, Chehade A, Duncan WJ, Gizani S, Head T, Lund JP, MacEntee M, Mericske-Stern R, Mojon P, Morais J, Naert I, Payne AG, Penrod J, Stoker GT Jr, Tawse-Smith A, Taylor TD, Thomason JM, Thomson WM, Wismeijer D. The McGill Consensus Statement on Overdentures. Montreal, Quebec, Canada. May 24-25, 2002. Int J Prosthodont. 2002 Jul-Aug;15(4):413-4. No abstract available.
- Background: PubMed 11074027Burns DR. Mandibular implant overdenture treatment: consensus and controversy. J Prosthodont. 2000 Mar;9(1):37-46. doi: 10.1111/j.1532-849x.2000.00037.x.
- 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.
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 PEEK Bar Attachment and Metal Bar Attachment in people with Edentulism in Lower Jaw, run by Sherif Aly Sadek 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 6 inclusion and 9 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 Jan 2026. 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?
Patient Satisfaction With Mandibular Implant-Retained Overdentures (time frame: Baseline (at overdenture insertion), and at 3, 6, 9, and 12 months post-insertion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07323628, which also lists 5 linked publications.
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 Jan 2026.