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

Missing Teeth Clinical Trial

— 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05861921
• Other study ID #: 5223
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: August 30, 2024

Study information

• Verified date: August 2023
• Source: Cairo University
• Contact: Catherine A. Mounir, Asst. lect.
• Phone: +2-01200115799
• Email: catherine.attef[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: August 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Anodontia
• Missing Teeth
• Tooth Loss

Intervention

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.

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

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