Clinical trial NCT05861921: Single-retainer Lithium Di-silicate Versus Zirconia Resin Bonded Bridge for Replacement of an Anterior Missing Tooth.
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
Overall status: COMPLETED
Phase: NA
Conditions: Missing Teeth
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-05-17
Enrollment: 44
Sex: ALL
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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:

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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical assessment in the term of fracture.
timeFrame: 1 year
Secondary outcomes:
measure: Clinical assessment in the term of De-bonding.
timeFrame: 1 year
measure: Success and survival rates
timeFrame: 1 year
measure: Patient satisfaction
timeFrame: 1 year
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Cairo University
name: Catherine A. Mounir, Asst. lect.
role: PRINCIPAL_INVESTIGATOR
References: