Single-retainer Lithium Di-silicate Versus Zirconia Resin Bonded Bridge for Replacement of an Anterior Missing Tooth.

NCT05861921 | Completed DMC

• 1 other identifier: 5223
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

First, Participants in this study will be recruit according to inclusion criteria. Proper examination for the participants (clinically and radiographically). Preparation for abutment tooth for Resin bonded fixed partial denture. Checking and verification for the restoration (trying). Clinical assessment and survival evaluation of the final restoration on delivery and on follow-up every 12 weeks for 12 months.

Conditions

Missing Teeth

Outcome Measures

Primary Outcomes (1)

• Clinical assessment in the term of fracture.

  United States Public Health Service (USPHS) criteria index in Discrete scores

  1 year

Secondary Outcomes (3)

• Clinical assessment in the term of De-bonding.

  1 year

• Success and survival rates

  1 year

• Patient satisfaction

  1 year

Study Arms (2)

Single-retainer Lithium Di-silicate Resin Bonded Fixed Partial Denture

EXPERIMENTAL

Intervention will be the delivery of Lithium Di-silicate resin bonded fixed partial denture as final prosthetic restorative material for replacing missing upper anterior tooth.

Other: Single-retainer Lithium Di-silicate Resin Bonded Fixed Partial Denture

Single-retainer Zirconia Resin Bonded Fixed Partial Denture

ACTIVE COMPARATOR

Comparator will be the delivery of Zirconia resin bonded fixed partial denture as final prosthetic restorative material for replacing missing upper anterior tooth.

Other: Single-retainer Lithium Di-silicate Resin Bonded Fixed Partial Denture

Interventions

Single-retainer Lithium Di-silicate Resin Bonded Fixed Partial Denture OTHER

Lithium Di-silicate as final restorative material for resin bonded Fixed Partial Denture replacing missing upper anterior tooth.

Single-retainer Lithium Di-silicate Resin Bonded Fixed Partial Denture; Single-retainer Zirconia Resin Bonded Fixed Partial Denture

Eligibility Criteria

• Age: 15 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• All subjects are required to be:
• From 15-50 years old, to be able to read and sign the informed consent document.
• Have no active periodontal or pulpal diseases.
• Psychologically and physically able to withstand conventional dental procedures
• Maintenance of good oral hygiene.
• Able to return for follow-up examinations and evaluation
• Patients have missing upper incisor tooth.

You may not qualify if:

• Patient less than 15 or more than 50 years old
• Patient with active resistant periodontal diseases
• Patients with poor oral hygiene and uncooperative patients
• Pregnant women
• Patients in the growth stage with partially erupted teeth
• Psychiatric problems or unrealistic expectations
• Lack of opposing dentition in the area of interest
• More than one missing tooth in the area of interest

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Anodontia

Condition Hierarchy (Ancestors)

Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Catherine A. Mounir, Asst. lect.

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participants and recruiters will not know the study group to which the next participant will be assigned. The trial participants, outcome assessors, and data analysis will be blinded after assignment to interventions. Emergency un-blinding: In cases of emergency to decrease or prevent any harms for the participants.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: May 7, 2023
• First Posted: May 17, 2023
• Study Start: July 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: October 30, 2024
• Last Updated: March 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)