Marginal Bone Changes in Fixed All-on-Four Mandibular Prosthesis Using OT Bridge Attachment System

NCT05924386 | Recruiting DMC

• 1 other identifier: 4223
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

Group I (control) Edentulous mandible receiving all on four fixed mandibular prosthesis using conventionally screw retained multiunit abutments. Group II (intervention) Edentulous mandible receiving all on four fixed prostheses using OT bridge attachments system. For both groups, the implant sites will be prepared aided by the surgical template. 4 implants with length 11-13 mm will be placed, two anterior implants will be aligned in an axial orientation and two posterior implants will be distally aligned according to the all-on-four concept in the inter foraminal area. Implants will be ideally placed at bone level. For both groups: After implant placement and surgical guide removal, healing abutments ( will be connected during healing periods (eight to twelve weeks). Group I ( control) After eight to twelve weeks from implant placement, multiunit abutments with appropriate heights and angulations will be connected to the implants. Group II ( intervention) After eight to twelve weeks from implant placement, narrow- and low-profile OT Equator abutment will be screwed onto the implants according to the manufacturer. marginal bone changes and prosthetic complications are the outcomes Radiographic follow up will be performed for marginal bone changes Serial of standardized digital periapical radiographs using will be taken at the time fixed prosthesis insertion (baseline), 3,6,9,12 months. Type and incidence of prosthetic complications for the prothesis for each group will be evaluated in 3, 6,9 and 12 months, these complications included: loosening or fracture of the prosthetic screw, prosthesis mobility and fracture of the prosthesis.

Conditions

Edentulous Jaw

Keywords

OTbridge attachment; ALL ON 4; fixed supported implant prosthesis; conventional screw retained fixed prosthesis

Outcome Measures

Primary Outcomes (1)

• marginal bone loss

  Radiographic follow up will be performed for marginal bone changes. Serial of standardized digital periapical radiographs using; long cone paralleling technique, XCP periapical film holder and an individually constructed radiographic acrylic template will be taken at the time fixed prosthesis insertion (baseline), 3,6,9,12 months. The software of the Digora system will be used for evaluation of the marginal bone changes. Lines parallel to the long axis of the mesial and distal surface of each abutment will be made. The distance in mm from the crest of alveolar bone to the apex of the tooth will be measured and the marginal bone changes in the subsequent measurements will be calculated.

  1 year follow up

Secondary Outcomes (1)

• prosthetic complications

  1 year follow up

Study Arms (2)

All-on-four fixed mandibular prosthesis using conventionally screw retained multiunit abutments.

ACTIVE COMPARATOR

Edentulous patients receiving All-on-four fixed mandibular prosthesis using conventionally screw retained multiunit abutments.

Procedure: patients reciveing all on 4 fixed mandibular prosthesis usimg conventionally screw retained multiunit abutments

All-on-four fixed mandibular prosthesis using OT bridge attachment system

EXPERIMENTAL

Edentulous patients receiving All-on-four fixed mandibular prosthesis using OT bridge attachment system

Procedure: all on 4 fixed mandibular prosthesis using OTbridge attachment system

Interventions

patients reciveing all on 4 fixed mandibular prosthesis usimg conventionally screw retained multiunit abutments PROCEDURE

Multiunit abutments is considered a gold standard screw retained abutments. Multi-unit abutments are used to correct for varying heights among the implants, to establish a level restorative platform for the prosthesis, as well as to situate the implant connection even with or just below the gingival surface. Also they are used to correct the angulation of implants, helping to keep the screw access holes away from the facial surfaces of the restoration, and facilitate the path of insertion of prosthesis.

All-on-four fixed mandibular prosthesis using conventionally screw retained multiunit abutments.

all on 4 fixed mandibular prosthesis using OTbridge attachment system PROCEDURE

The OT bridge attachment system introduced by (Rhein 83) is a global, well-established system used in the removable prosthetic protocols, the presence of seeger acetal ring placed between the sub-equatorial area of the OT Equator and the cylindrical "Extragrade" abutment compensates the space between the extragrade abutment and the OT equator attachment correcting the minor misalignments that produced during the prosthetic procedure and resulting in more passive fit.

All-on-four fixed mandibular prosthesis using OT bridge attachment system

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with completely edentulous patients
• Aged 40 years or older.
• Sufficient inter -arch space not less than 13 mm.
• Good oral hygiene
• Minimum bone height 10 mm and minimum bone diameter should be 6 mm

You may not qualify if:

• General contraindications for oral surgery
• Heavy smokers (greater than 20 cigarettes a
• Local acute or chronic infections
• Substance abuse (drugs or alcohol)
• Patients with neuromuscular or psychiatric disorders.
• Treatment with intravenous bisphosphonates
• Irradiation of the neck or head area in the past 5 years
• Diabetic patients (HbA1c\>7.5%)

Sponsors & Collaborators

• Cairo University: lead
• British University In Egypt: collaborator

Study Sites (2)

Faculty of Oral and Dental Medicine, Cairo University

Cairo, 002, Egypt

RECRUITING

Faculty of Oral and Dental Medicine, Cairo University

Cairo, 002, Egypt

RECRUITING

MeSH Terms

Conditions

Jaw, Edentulous

Condition Hierarchy (Ancestors)

Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth, Edentulous; Mouth Diseases; Tooth Diseases

Study Officials

• nesma O elmosallamy

  CAIRO UNIVERISTY

  PRINCIPAL INVESTIGATOR

Central Study Contacts

nesma O elmosallamy, LECTURER ASSISTANT

CONTACT

20+01007702271; nesma.osama@dentistry.edu.eg

nada O elmosallamy

CONTACT

20+01000107914; nesma.elmosallamy@bue.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Model Details: edentulous patients

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: June 29, 2023
• Study Start: December 1, 2024
• Primary Completion: May 28, 2025
• Study Completion: January 31, 2026
• Last Updated: April 25, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)