NCT05812066

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 13, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

July 15, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 13, 2025

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2025

Completed
Last Updated

July 20, 2025

Status Verified

April 1, 2023

Enrollment Period

1.6 years

First QC Date

March 31, 2023

Last Update Submit

July 16, 2025

Conditions

Keywords

survivalupper lateral incisorsingle retainer RBFPDresin bonded fixed partial denture

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

EXPERIMENTAL
Procedure: all ceramic single-retainer resin bonded fixed partial denture

all ceramic single-retainer resin bonded fixed partial denture using the upper central incisor

ACTIVE COMPARATOR
Procedure: all ceramic single-retainer resin bonded fixed partial denture

Interventions

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.

all ceramic single-retainer resin bonded fixed partial denture using the upper canine abutmentall ceramic single-retainer resin bonded fixed partial denture using the upper central incisor

Eligibility Criteria

Age14 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

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

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, Cairo Governorate, 35855, Egypt

Location

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.

MeSH Terms

Conditions

Prosthesis Failure

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Omaima S El Mahallawi, Professor

    Cairo University

    STUDY DIRECTOR

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

Locations