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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.

Primary Purpose

Survival, Prosthesis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
all ceramic single-retainer resin bonded fixed partial denture
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Survival, Prosthesis focused on measuring survival, debonding, resin bonded retainer

Eligibility Criteria

14 Years - 30 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Faculty of Dentistry, Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

all ceramic single-retainer resin bonded fixed partial denture using the upper canine abutment

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

Arm Description

Outcomes

Primary Outcome Measures

Survival rate in the term of De-bonding and fracture
the de-bonding and fracture of the restoration of the two groups will be examined using Binary measurement ( de-bonding or fracture= Yes while no de-bonding and no fracture= No).

Secondary Outcome Measures

Abutment tooth mobility and patient's satisfaction
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 1 denoting most satisfied while number 10 denote the least satisfied; (from 1 to 5 will be considered as satisfied while from 6 to 10 will be considered as unsatisfied).

Full Information

First Posted
March 31, 2023
Last Updated
April 14, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05812066
Brief Title
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.
Official Title
Clinical Assessment of Distal Versus Mesial Single-Retainer Resin Bonded Fixed Partial Denture for Replacement of an Upper Lateral Incisor: (Randomized Clinical Trial).
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
February 28, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Survival, Prosthesis
Keywords
survival, debonding, resin bonded retainer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
all ceramic single-retainer resin bonded fixed partial denture using the upper canine abutment
Arm Type
Experimental
Arm Title
all ceramic single-retainer resin bonded fixed partial denture using the upper central incisor
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
all ceramic single-retainer resin bonded fixed partial denture
Intervention Description
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.
Primary Outcome Measure Information:
Title
Survival rate in the term of De-bonding and fracture
Description
the de-bonding and fracture of the restoration of the two groups will be examined using Binary measurement ( de-bonding or fracture= Yes while no de-bonding and no fracture= No).
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Abutment tooth mobility and patient's satisfaction
Description
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 1 denoting most satisfied while number 10 denote the least satisfied; (from 1 to 5 will be considered as satisfied while from 6 to 10 will be considered as unsatisfied).
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
mohamed A belead, master
Phone
01124741165
Ext
0020
Email
mohamed-belead@dentistry.cu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Omaima S El Mahallawi, Professor
Organizational Affiliation
Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Dentistry, Cairo University
City
Cairo
ZIP/Postal Code
35855
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
mohamed B Belead, Master
Phone
01124474116
Ext
0020
Email
mohamed-belead@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name & Degree
Mohamed A Belead, Master

12. IPD Sharing Statement

Learn more about this trial

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.

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