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

Clinical Assessment of Single-retainer Lithium Di-silicate Versus Zirconia Resin Bonded Fixed Partial Denture for Replacement of an Anterior Missing Tooth. (Randomized Clinical Trial)

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.

Study Overview

• Status: Recruiting
• Conditions: Missing Teeth
• Intervention / Treatment: Other: Single-retainer Lithium Di-silicate Resin Bonded Fixed Partial Denture

Detailed Description

Examination and diagnosis: Selection and examination of the patients according to inclusion and exclusion criteria. Diagnosis of the patient's chief complaint and teeth that will be involved in this study will be done.

Primary alginate impressions for diagnosis on primary casts and for mounting. The patients will be asked to maintain good oral hygiene measures by using tooth brush twice daily.

Taking a professional pre-operative photo.

Tooth preparation procedure:

1. Preparation of abutment tooth for Resin bonded fixed partial denture according to specific standardized design for both types of final restorations.
2. After tooth preparation, the final impression will be taken for each participant using the intraoral scanner.
3. Fabrication of temporary restoration using composite resin temporary material and cemented using Zinc Oxide eugenol free temporary cement.

Fabrication of final restoration:

Lithium Di-silicate or Zirconia Resin bonded fixed partial denture will be fabricated according to group.

Clinical assessment and survival evaluation of the final restoration on delivery and on follow-up every 12 weeks for 12 months following outcome measures.

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Catherine A. Mounir, Asst. lect.; Phone Number: +2-01200115799; Email: catherine.attef@dentistry.cu.edu.eg
• Study Contact Backup: Name: Catherine A. Mounir, Asst. lect.; Phone Number: +2-01285565278; Email: catherineattef@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Cairo University
    • Contact: Cairo University; Phone Number: (+202)23634965; Email: dentmail@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• All subjects are required to be:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single-retainer Lithium Di-silicate Resin Bonded Fixed Partial Denture; 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; Lithium Di-silicate as final restorative material for resin bonded Fixed Partial Denture replacing missing upper anterior tooth.
Active Comparator: Single-retainer Zirconia Resin Bonded Fixed Partial Denture; 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; Lithium Di-silicate as final restorative material for resin bonded Fixed Partial Denture replacing missing upper anterior tooth.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical assessment in the term of fracture.	United States Public Health Service (USPHS) criteria index in Discrete scores	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical assessment in the term of De-bonding.	United States Public Health Service (USPHS) criteria index in Discrete scores	1 year
Success and survival rates	Binary as in failed or no failed	1 year
Patient satisfaction	Questionnaire in discrete scores	1 year

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Catherine A. Mounir, Asst. lect., Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): August 30, 2024

Study Registration Dates

• First Submitted: May 7, 2023
• First Submitted That Met QC Criteria: May 16, 2023
• First Posted (Actual): May 17, 2023

Study Record Updates

• Last Update Posted (Actual): August 30, 2023
• Last Update Submitted That Met QC Criteria: August 28, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Tooth Diseases; Stomatognathic System Abnormalities; Tooth Abnormalities; Tooth Loss; Anodontia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Enzyme Inhibitors; Tranquilizing Agents; Psychotropic Drugs; Antidepressive Agents; Antimanic Agents; Lithium Carbonate
• Other Study ID Numbers: 5223

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No