PEEK vs Metal Bar Attachments

NCT07323628 | Completed

• 1 other identifier: 02-02-23
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Edentulism in Lower Jaw

Keywords

Mandibular Implant Overdenture; PEEK Bar Attachment; Metal Bar Attachment; Patient Satisfaction; Edentulous Mandible; Marginal Bone Loss

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (at overdenture insertion), and at 3, 6, 9, and 12 months post-insertion

Secondary Outcomes (1)

• Marginal Bone Loss Around Dental Implants

  Baseline (at overdenture insertion), and at 3, 6, 9, and 12 months post-insertion

Study Arms (2)

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.

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.

Device: Metal Bar Attachment

Interventions

PEEK Bar Attachment 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.

PEEK Bar Attachment Group

Metal Bar Attachment 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.

Metal Bar Attachment Group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sherif Aly Sadek: lead

Study Sites (1)

Nahda University

Banī Suwayf, Egypt

Location

Related Publications (5)

• 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.

  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.

  PMID: 21905892 BACKGROUND

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

  PMID: 6576140 BACKGROUND

• 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.

  PMID: 12170858 BACKGROUND

• 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.

  PMID: 11074027 BACKGROUND

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Radiographic measurements of marginal bone loss and analysis of patient satisfaction scores are performed by an independent assessor who is blinded to group allocation. Participants and care providers are not blinded due to visible differences in bar materials and clinical procedures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: January 7, 2026
• Study Start: May 5, 2024
• Primary Completion: October 10, 2025
• Study Completion: November 10, 2025
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)