Mandibular Implant Overdenture With OT Cap Bar vs Bar Attachment

NCT07067190 | Not Yet Recruiting

• 1 other identifier: MF-OTBarRCT2024
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical study is being conducted at Cairo University to evaluate two different types of attachments used with implant-supported dentures in the mandible. Patients who have lost all their teeth in the lower jaw receive implants to help hold their dentures in place. This study compares two types of attachments for connecting the denture to the implants:

1. 1.Bar attachment only, which is a traditional method.
2. 2.Bar with OT Cap attachment, which is a newer design that includes a small sphere (cap) to help with retention and comfort.
3. 3.How well the denture stays in place (retention)
4. 4.How much bone is lost around the implants over time (crestal bone loss)
5. 5.How much the attachment parts wear out (cap wear)
6. 6.How satisfied the patients are with their dentures

Conditions

Edentulous Mandible; Implant-Supported Overdentures

Keywords

Bar Attachment; OT Cap Attachment; Implant-Assisted Overdenture; Dental Implants; Mandibular Denture Retention; Crestal Bone Loss; Patient Satisfaction; Attachment Wear

Outcome Measures

Primary Outcomes (1)

• Retention of Mandibular Implant-Supported Overdenture

  Retention will be measured using a digital force gauge that applies a vertical dislodging force to the mandibular overdenture. The force required to dislodge the denture from the attachments will be recorded in Newtons. Measurements will be performed at two time points: at the time of prosthesis insertion (T0) and six months post-insertion (T6). The retention values will be used to compare the effectiveness of bar-only versus bar with OT Cap attachment systems.

  Baseline (T0) and 6 months after overdenture insertion (T6)

Secondary Outcomes (3)

• Crestal Bone Loss Around Implants

  Baseline (T0) and 6 months after overdenture insertion (T6)

• Attachment Cap Wear

  Baseline (T0) and 6 months after overdenture insertion (T6)

• Patient Satisfaction with Overdenture

  6 months after overdenture insertion (T6)

Study Arms (2)

Bar Attachment Group

ACTIVE COMPARATOR

Participants in this group will receive mandibular implant-supported overdentures retained by a conventional cast bar attachment. Three implants will be placed in the anterior mandible (midline and canine positions), and a single bar will be fabricated and attached to the implants. The overdenture will be adjusted to fit over the bar with no additional retentive components. This group represents the standard treatment modality for implant-retained overdentures.

Device: Conventional Bar Attachment

Bar with OT Cap Attachment Group

EXPERIMENTAL

Participants in this group will receive mandibular implant-supported overdentures using a bar combined with two OT Cap (sphere) attachments for added retention. The same implant placement protocol will be followed as in the comparator group. The bar will include OT Cap housings, and the overdenture will be relined to incorporate the corresponding female caps. This intervention is designed to improve denture retention, reduce component wear, and enhance patient satisfaction.

Device: Bar with OT Cap Attachment

Interventions

Conventional Bar Attachment DEVICE

A rigid cast bar attachment fabricated and screwed onto three mandibular implants (placed at the midline and canine areas). The bar connects the implants to provide splinting and retention for a mandibular overdenture without the use of additional retentive components such as OT Caps. The overdenture is adjusted to fit passively over the bar and picked up intraorally.

Bar Attachment Group

Bar with OT Cap Attachment DEVICE

A cast bar attachment fitted with two OT Cap attachments, which are designed to improve prosthesis retention and load distribution. This bar system is installed on three mandibular implants (midline and canine regions). The mandibular overdenture is relined to incorporate the female retentive caps that snap onto the OT Caps. This system combines the splinting benefits of the bar with the resilient retention of stud attachments.

Bar with OT Cap Attachment Group

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Completely edentulous healthy patients
• Age between 30 and 65 years
• Adequate bone volume in the anterior and premolar-molar region (minimum 11 mm)
• Adequate inter-arch space (12-14 mm)

You may not qualify if:

• Severe maxillomandibular skeletal discrepancy
• Parafunctional habits (e.g., clenching, bruxism)
• Temporomandibular joint disorders
• Heavy smokers (≥20 cigarettes/day)
• History of head and neck radiation
• History of chemotherapy
• Systemic conditions that may interfere with healing or bone quality (e.g., uncontrolled diabetes, osteoporosis, bisphosphonate therapy)
• Drug abuse or alcohol dependence

Sponsors & Collaborators

• Maisa Mohamed Farid Shaaban: lead

Study Sites (1)

Faculty of Oral and Dental Medicine, Cairo University

Cairo, Cairo Governorate, 11553, Egypt

Location

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Maisa MF Shaaban Gomaa, PhD candidate

  Faculty of Oral and Dental Medicine, Cairo University

  PRINCIPAL INVESTIGATOR

• Hamdy Abo El-Fotouh, Professor

  Faculty of Oral and Dental Medicine, Cairo University

  STUDY CHAIR

• Noha Ali, Assistant Professor

  Faculty of Oral and Dental Medicine, Cairo University

  STUDY DIRECTOR

• Ahmed Hamed, Lecturer

  Faculty of Oral and Dental Medicine, Cairo University

  STUDY DIRECTOR

Central Study Contacts

Maisa MF Shaaban Gomaa, PhD Candidate

CONTACT

+201002730928; maisa.gomaa@dentistry.cu.edu.eg

Maisa Farid

CONTACT

maisafarid2013@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Only the outcomes assessor (statistician) will be blinded to group allocation to reduce assessment bias. Neither the participant nor the care provider can be blinded due to the visible nature of the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD Candidate, Department of Prosthodontics, Faculty of Oral and Dental Medicine, Cairo University

Model Details: Two-arm randomized controlled clinical trial comparing bar-only attachment vs. bar with OT Cap attachment in mandibular implant-supported overdentures.

Study Record Dates

• First Submitted: July 5, 2025
• First Posted: July 16, 2025
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)