PEEK vs Metal Bar Attachments

NCT ID: NCT07323628

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-05
• Study Completion Date: 2025-11-10

Brief 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. 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.

Conditions

Edentulism in Lower Jaw

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

PEEK Bar Attachment Group

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.

Group Type: EXPERIMENTAL

PEEK Bar Attachment

Intervention Type: DEVICE

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 Attachment Group

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.

Group Type: ACTIVE_COMPARATOR

Metal Bar Attachment

Intervention Type: DEVICE

A conventional metal alloy bar used to retain a mandibular implant-supported overdenture on two implants placed in the canine regions of the mandible.

Interventions

PEEK Bar Attachment

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.

Intervention Type: DEVICE

Metal Bar Attachment

A conventional metal alloy bar used to retain a mandibular implant-supported overdenture on two implants placed in the canine regions of the mandible.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• Bruxism or severe parafunctional habits
• Previous implant placement in the mandible
• Pregnant or lactating women

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sherif Aly Sadek

OTHER

Sponsor Role: lead

Responsible Party

Sherif Aly Sadek

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Nahda University

Banī Suwayf, , Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 21905892 (View on PubMed)

Skalak R. Biomechanical considerations in osseointegrated prostheses. J Prosthet Dent. 1983 Jun;49(6):843-8. doi: 10.1016/0022-3913(83)90361-x.

Reference Type: BACKGROUND

PMID: 6576140 (View on PubMed)

Feine 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.

Reference Type: BACKGROUND

PMID: 12170858 (View on PubMed)

Burns 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.

Reference Type: BACKGROUND

PMID: 11074027 (View on PubMed)

Other Identifiers

02-02-23

Identifier Type: -

Identifier Source: org_study_id