Anterior Resin Bonded Restorations for Adolescent

Missing Teeth Clinical Trial

Official title:

Biomimetic Anterior Resin Bonded Restorations for Adolescent Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05362591
• Other study ID #: REC-D124-2
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 8, 2022
• Est. completion date: June 1, 2024

Study information

• Verified date: April 2024
• Source: October University for Modern Sciences and Arts
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

a 24 Patients above 12 years old with missing upper incisor were divided into two groups, group 1: 12 patient will be treated by resin bonded bridge (RBB) with no preparation protocol, group 2: 12 patient will be treated by resin bonded bridge (RBB) with minimal preparation protocol. (RBB) retention/survival, patient's speech as well as thermal sensitivity and patient's satisfaction will be evaluated for 12 month at 3,6,9 and 12 month.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: June 1, 2024
• Est. primary completion date: May 4, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

Inclusion Criteria:

1. 12-18 years old

2. Full set of permanent teeth.

3. Missing upper incisor

4. Controlled dental disease - no active caries or periodontal diseases

5. Patients will be available to be clinically reviewed up to 1 year

Exclusion Criteria:

1. Patients with uncontrolled active tooth decay or periodontal disease (i.e. 4+ mm probing depth and bleeding on probing).

2. Patients with teeth missing opposite to the planned RBB

3. Abutment tooth mobility of 2 or greater (Millers classification)

4. Patients with debilitating illnesses or complicating medical conditions

5. Heavily restored tooth abutment not suitable for an RBB

Related Conditions & MeSH terms

• Anodontia
• Missing Teeth
• Tooth Loss

Intervention

Procedure:
• resin bonded bridge with no preparation
resin bonded bridge without enamel preparation
• resin bonded bridge with minimal preparation
resin bonded bridge with minimal preparation of tooth enamel

Locations

Country	Name	City	State
Egypt	October university for modern sciences and arts	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
October University for Modern Sciences and Arts

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	resin bonded bridge retention/survival	Presence of the prosthesis in patient's mouth (Yes/No) by clinical visual examination.	12 month
Secondary	Patient's satisfaction	Patient satisfaction outcome is including the following: comfort and stability, esthetics, ease of cleaning, ability to speak, self-esteem, and functionality. the outcome will be evaluated by a visual analogue scale ranging from 0 to 10, where 10 is the maximum (better outcome) and 0 is the minimum (worse outcome).	12 month