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.

Survival, Prosthesis Clinical Trial

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).

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05812066
• Other study ID #: 2-1-23
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: February 28, 2025

Study information

• Verified date: April 2023
• Source: Cairo University
• Contact: mohamed A belead, master
• Phone: 01124741165
• Email: mohamed-belead[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 54
• Est. completion date: February 28, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prosthesis Failure
• Survival, Prosthesis

Intervention

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

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	12 months
Secondary	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).	12 months