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

Primary Purpose

Missing Teeth

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Single-retainer Lithium Di-silicate Resin Bonded Fixed Partial Denture
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Missing Teeth

Eligibility Criteria

15 Years - 50 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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

Sites / Locations

  • Cairo UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

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

Single-retainer Zirconia Resin Bonded Fixed Partial Denture

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Clinical assessment in the term of fracture.
United States Public Health Service (USPHS) criteria index in Discrete scores

Secondary Outcome Measures

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

Full Information

First Posted
May 7, 2023
Last Updated
August 28, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05861921
Brief Title
Single-retainer Lithium Di-silicate Versus Zirconia Resin Bonded Bridge for Replacement of an Anterior Missing Tooth.
Acronym
RBFPD
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2023 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
August 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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: Preparation of abutment tooth for Resin bonded fixed partial denture according to specific standardized design for both types of final restorations. After tooth preparation, the final impression will be taken for each participant using the intraoral scanner. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Missing Teeth

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single-retainer Lithium Di-silicate Resin Bonded Fixed Partial Denture
Arm Type
Experimental
Arm Description
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.
Arm Title
Single-retainer Zirconia Resin Bonded Fixed Partial Denture
Arm Type
Active Comparator
Arm Description
Comparator will be the delivery of Zirconia resin bonded fixed partial denture as final prosthetic restorative material for replacing missing upper anterior tooth.
Intervention Type
Other
Intervention Name(s)
Single-retainer Lithium Di-silicate Resin Bonded Fixed Partial Denture
Intervention Description
Lithium Di-silicate as final restorative material for resin bonded Fixed Partial Denture replacing missing upper anterior tooth.
Primary Outcome Measure Information:
Title
Clinical assessment in the term of fracture.
Description
United States Public Health Service (USPHS) criteria index in Discrete scores
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Clinical assessment in the term of De-bonding.
Description
United States Public Health Service (USPHS) criteria index in Discrete scores
Time Frame
1 year
Title
Success and survival rates
Description
Binary as in failed or no failed
Time Frame
1 year
Title
Patient satisfaction
Description
Questionnaire in discrete scores
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Catherine A. Mounir, Asst. lect.
Phone
+2-01200115799
Email
catherine.attef@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Catherine A. Mounir, Asst. lect.
Phone
+2-01285565278
Email
catherineattef@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine A. Mounir, Asst. lect.
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo University
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cairo University
Phone
(+202)23634965
Email
dentmail@dentistry.cu.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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