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.
Clinical Assessment of Distal Versus Mesial Single-Retainer Resin Bonded Fixed Partial Denture for Replacement of an Upper Lateral Incisor: (Randomized Clinical Trial).
1 other identifier
interventional
54
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 31, 2023
CompletedFirst Posted
Study publicly available on registry
April 13, 2023
CompletedStudy Start
First participant enrolled
July 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 13, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 25, 2025
CompletedJuly 20, 2025
April 1, 2023
1.6 years
March 31, 2023
July 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Survival rate in the term of retention and fracture
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 Outcomes (1)
Abutment tooth mobility and patient's satisfaction
12 months
Study Arms (2)
all ceramic single-retainer resin bonded fixed partial denture using the upper canine abutment
EXPERIMENTALall ceramic single-retainer resin bonded fixed partial denture using the upper central incisor
ACTIVE COMPARATORInterventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Faculty of Dentistry, Cairo University
Cairo, Cairo Governorate, 35855, Egypt
Related Publications (1)
Belead MA, El Mahallawi OSED, Soliman GA, Badran AR. Clinical Assessment of Distal Versus Mesial Single-Retainer Resin Bonded Fixed Partial Denture for Replacement of an Upper Lateral Incisor: Randomized Clinical Trial. Int J Prosthodont. 2026 Jan 16;0(0):1-20. doi: 10.11607/ijp.9613. Online ahead of print.
PMID: 41544224DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Omaima S El Mahallawi, Professor
Cairo University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Statistician
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principle investigator
Study Record Dates
First Submitted
March 31, 2023
First Posted
April 13, 2023
Study Start
July 15, 2023
Primary Completion
February 13, 2025
Study Completion
February 25, 2025
Last Updated
July 20, 2025
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share