Clinical Assessment of All Ceramic Single-retainer Using Upper Canine as Abutment With Minimum Preparation on the Lingual Surface, to Replace the Upper Lateral Incisor and Will be Compared With the All Ceramic Single-retainer Using Upper Central Incisor.
July 16, 2025 updated by: mohamed abdalla belead, Cairo University
Clinical Assessment of Distal Versus Mesial Single-Retainer Resin Bonded Fixed Partial Denture for Replacement of an Upper Lateral Incisor: (Randomized Clinical Trial).
The Intervention Will be All Ceramic Single-retainer Resin Bonded Fixed Partial Denture Using the Upper Canine as Abutment With Minimum Preparation on the Lingual Surface Within the Enamel Providing Maximum Area for the Retainer Bonding, to Replace the Upper Lateral Incisor and Will be Compared With the Control/Comparator Group Which is the All Ceramic Single-retainer RBFPD Using the Upper Central Incisor.
The Participants in This Study Will be Recruited by the Researcher From the Clinic of Fixed Prosthodontics Department, Clinic of Orthodontics Department and Clinic of Diagnosis Department, Cairo University Without Any Financial or Non-financial Incentives.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The intervention will be all ceramic single-retainer Resin Bonded Fixed Partial Denture using the upper canine as abutment with minimum preparation on the lingual surface within the enamel providing maximum area for the retainer bonding, to replace the upper lateral incisor and will be compared with the control/comparator group which is the all ceramic single-retainer RBFPD using the upper central incisor.
This intervention will be done by one investigator in all study groups who has master degree in fixed prosthodontics with eight years of experience. The intervention will be carried out in the clinic of the department of Fixed Prosthodontics, Cairo University under supervision of PhD holder staff members. The self-adhesive dual cure resin cement will be used for cementation in all groups.
In the first session, the participant will be informed about all steps from the beginning to the end. All participants will be encouraged to maintain good oral hygiene and attend the regular follow up visits and in case of any complain related to the investigated restoration.
Study Type
Interventional
Enrollment (Actual)
54
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Cairo, Egypt, 35855
- Faculty of Dentistry, Cairo University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Patients who have unilateral or bilateral missing upper lateral incisor and need to replace them with the following criteria:
- From 14-30 years old and be able to read and sign the informed consent document.
- physically and psychologically able to withstand conventional dental procedure
- Sound or minimally restored abutment with enough enamel surface area for bonding and no periodontal diseases.
- If the patient had previously undergone orthodontic treatment, a stabilization period of at least 3 months before impression taking.
- Good oral hygiene.
- Able to return for follow-up examinations and evaluation.
- No signs and symptoms of bruxism.
Exclusion Criteria:
- Pregnant women
- Increased overbite
- Bruxism, clenching or abnormal habits like nail or pencil biting that create occlusal forces
- Any developmental anomaly affecting the enamel of upper central incisor or canine
- Uncontrolled caries and periodontal disease and uncooperative patients. 6- Medically unfit for dental treatment and follow up.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: all ceramic single-retainer resin bonded fixed partial denture using the upper canine abutment
|
The intervention will be all ceramic single-retainer RBFPD using the upper canine as abutment with minimum preparation on the lingual surface within the enamel providing maximum area for the retainer bonding, to replace the upper lateral incisor and will be compared with the control/comparator group which is the all ceramic single-retainer RBFPD using the upper central incisor.
|
|
Active Comparator: all ceramic single-retainer resin bonded fixed partial denture using the upper central incisor
|
The intervention will be all ceramic single-retainer RBFPD using the upper canine as abutment with minimum preparation on the lingual surface within the enamel providing maximum area for the retainer bonding, to replace the upper lateral incisor and will be compared with the control/comparator group which is the all ceramic single-retainer RBFPD using the upper central incisor.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Survival rate in the term of retention and fracture
Time Frame: 12 months
|
The retention and fracture of the restoration of the two groups will be measured using the Modified United States Public Health Service (USPHS) criteria.
Regarging retention (Alpha= no debonding, Charlie= debonding), while fracture will scored as (Alpha= no fracture, Bravo=Small chipping, but clinically acceptable, Charlie= Failure due to bulk fracture).
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Abutment tooth mobility and patient's satisfaction
Time Frame: 12 months
|
the mobility of abutment teeth will be checked using Periotest while the patient's satisfaction will be examined using the questionnaire form containing 10 score ( number 10 denoting most satisfied while number 1 denote the least satisfied; where (1 to 2) highly dissatisfied, (3 to 4) dissatisfied, (5 to 6) neutral, (7 to 8) satisfied, and (9 to 10) highly satisfied
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Omaima S El Mahallawi, Professor, Cairo University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 15, 2023
Primary Completion (Actual)
February 13, 2025
Study Completion (Actual)
February 25, 2025
Study Registration Dates
First Submitted
March 31, 2023
First Submitted That Met QC Criteria
March 31, 2023
First Posted (Actual)
April 13, 2023
Study Record Updates
Last Update Posted (Actual)
July 20, 2025
Last Update Submitted That Met QC Criteria
July 16, 2025
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2-1-23
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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