Back to resultsAnterior Resin Bonded Restorations for Adolescent
Primary Purpose
Missing Teeth
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
resin bonded bridge with no preparation
resin bonded bridge with minimal preparation
Sponsored by
About this trial
This is an interventional treatment trial for Missing Teeth focused on measuring missing incisors, resin bonded bridge
Eligibility Criteria
Inclusion Criteria:
- 12-18 years old
- Full set of permanent teeth.
- Missing upper incisor
- Controlled dental disease - no active caries or periodontal diseases
- Patients will be available to be clinically reviewed up to 1 year
Exclusion Criteria:
- Patients with uncontrolled active tooth decay or periodontal disease (i.e. 4+ mm probing depth and bleeding on probing).
- Patients with teeth missing opposite to the planned RBB
- Abutment tooth mobility of 2 or greater (Millers classification)
- Patients with debilitating illnesses or complicating medical conditions
- Heavily restored tooth abutment not suitable for an RBB
Sites / Locations
- October university for modern sciences and artsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
resin bonded bridge with no preparation
resin bonded bridge with minimal preparation
Arm Description
resin bonded bridge without enamel preparation
resin bonded bridge with minimal preparation on tooth enamel
Outcomes
Primary Outcome Measures
resin bonded bridge retention/survival
Presence of the prosthesis in patient's mouth (Yes/No) by clinical visual examination.
Secondary Outcome Measures
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).
Full Information
NCT ID
NCT05362591
First Posted
April 23, 2022
Last Updated
May 7, 2022
Sponsor
October University for Modern Sciences and Arts
1. Study Identification
Unique Protocol Identification Number
NCT05362591
Brief Title
Anterior Resin Bonded Restorations for Adolescent
Official Title
Biomimetic Anterior Resin Bonded Restorations for Adolescent Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 8, 2022 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
October University for Modern Sciences and Arts
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Missing Teeth
Keywords
missing incisors, resin bonded bridge
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
resin bonded bridge with no preparation
Arm Type
Experimental
Arm Description
resin bonded bridge without enamel preparation
Arm Title
resin bonded bridge with minimal preparation
Arm Type
Active Comparator
Arm Description
resin bonded bridge with minimal preparation on tooth enamel
Intervention Type
Procedure
Intervention Name(s)
resin bonded bridge with no preparation
Intervention Description
resin bonded bridge without enamel preparation
Intervention Type
Procedure
Intervention Name(s)
resin bonded bridge with minimal preparation
Intervention Description
resin bonded bridge with minimal preparation of tooth enamel
Primary Outcome Measure Information:
Title
resin bonded bridge retention/survival
Description
Presence of the prosthesis in patient's mouth (Yes/No) by clinical visual examination.
Time Frame
12 month
Secondary Outcome Measure Information:
Title
Patient's satisfaction
Description
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).
Time Frame
12 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
12-18 years old
Full set of permanent teeth.
Missing upper incisor
Controlled dental disease - no active caries or periodontal diseases
Patients will be available to be clinically reviewed up to 1 year
Exclusion Criteria:
Patients with uncontrolled active tooth decay or periodontal disease (i.e. 4+ mm probing depth and bleeding on probing).
Patients with teeth missing opposite to the planned RBB
Abutment tooth mobility of 2 or greater (Millers classification)
Patients with debilitating illnesses or complicating medical conditions
Heavily restored tooth abutment not suitable for an RBB
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Naglaa Ezzeldin, associate proffesor
Phone
+201001984184
Email
niezz@msa.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Aya Salama, lecturer
Phone
+201002676347
Email
ayasaad@msa.edu.eg
Facility Information:
Facility Name
October university for modern sciences and arts
City
Cairo
ZIP/Postal Code
12573
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naglaa Ezzeldin
Email
niezz@msa.edu.eg
First Name & Middle Initial & Last Name & Degree
Aya Salama
Email
ayasaad@msa.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Anterior Resin Bonded Restorations for Adolescent
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