NCT07093853

Brief Summary

This 10-year retrospective study investigates residual ridge changes in edentulous patients treated with mandibular overdentures (ODs) retained by either four Locator attachments or a four-implant bar system. Although two-implant ODs are well established, four-implant configurations may offer enhanced stability and function. Locator and bar attachments are commonly used, but their long-term effects on bone resorption patterns-especially posterior mandibular and anterior maxillary resorption-remain unclear. By standardizing implant positions, this study aims to directly compare the two systems to help guide clinicians in selecting the most effective attachment type for long-term success.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 22, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 30, 2025

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

July 30, 2025

Status Verified

July 1, 2025

Enrollment Period

1.6 years

First QC Date

July 22, 2025

Last Update Submit

July 22, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Marginal Bone Loss (MBL)

    Crestal bone loss around dental implants

    10 years

Study Arms (2)

Group I - Locator Attachments

Patients received four implants were placed in the lateral incisor and first premolar regions. Overdentures were retained using unsplinted Locator attachments, processed chairside via direct intraoral pick-up, with vent holes to allow resin escape. These prostheses were implant-retained and tissue-supported.

Other: Four Locator Attachments, Four Bar Attachment System

Group II - Bar Attachments

Patient also received four implants in the same quadrilateral distribution. The implants were splinted with a custom-milled titanium bar, and overdentures were retained using clip attachments. These prostheses were designed to be fully implant-supported, minimizing soft tissue loading.

Other: Four Locator Attachments, Four Bar Attachment System

Interventions

This study retrospectively evaluated two types of implant-retained mandibular overdenture attachment systems placed in edentulous patients over a 10-year period. All patients received four dental implants placed in the interforaminal region (lateral incisor and first premolar areas). In the Locator group, each implant was restored with an individual Locator attachment, allowing for independent retention and easier hygiene access. In the Bar group, the four implants were splinted together with a rigid metal bar, and the overdenture was attached using clips that engaged the bar, offering splinted support and enhanced load distribution. Both interventions were designed to support mandibular overdentures and were compared in terms of their long-term effects on posterior mandibular ridge resorption, marginal bone loss around implants, and anterior maxillary ridge resorption.

Group I - Locator AttachmentsGroup II - Bar Attachments

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consisted of completely edentulous patients who received mandibular overdentures retained by four dental implants placed in the interforaminal region. Patients were selected retrospectively based on having been treated with either four Locator attachments or a four-implant bar attachment system and followed for a minimum period of 10 years. All participants had similar implant positioning (lateral incisor and first premolar areas) and were free from systemic conditions that could affect bone healing or implant success. Inclusion criteria required good oral hygiene compliance and regular follow-up records. Exclusion criteria included uncontrolled systemic diseases, history of head and neck radiation, and lack of long-term follow-up data.

You may qualify if:

  • Completely edentulous mandible and maxilla for at least 12 months.
  • Four interforaminal dental implants placed in the lateral incisor and first premolar regions.
  • Opposing maxillary complete denture constructed using a muco-compressive impression technique, with maximum denture base extension and lingualized occlusion.
  • Mandibular bone height between 15-25 mm at the symphysis region as measured on panoramic radiograph.
  • Minimum 10-year follow-up with adequate radiographic documentation.

You may not qualify if:

  • Systemic diseases affecting bone metabolism.
  • Parafunctional habits (e.g., bruxism).
  • Smokers of more than 10 cigarettes/day or those with alcohol abuse.
  • Patients with implant failures, missing follow-up data, or implants placed outside the interforaminal region.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry

Al Mansurah, Menoufia, Egypt

RECRUITING

MeSH Terms

Conditions

Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Mohammed El-Sawy, PhD

    Menoufia University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohammed El-Sawy, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

July 22, 2025

First Posted

July 30, 2025

Study Start

January 1, 2024

Primary Completion

August 1, 2025

Study Completion

October 1, 2025

Last Updated

July 30, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Upon reasonable request from the corresponding author

Locations