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.

Not Applicable

Not yet recruiting

• Conditions: Survival, Prosthesis
• Interventions: Procedure: all ceramic single-retainer resin bonded fixed partial denture

• Registration Number: NCT05812066
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study First Submitted: 2023-03-31
• Study First Submitted QC: 2023-03-31
• Status Verified: 2023-04
• Study First Posted: 2023-04-13
• Last Update Submitted: 2023-04-14
• Last Update Posted: 2023-04-18
• Study Start: 2023-08-01
• Primary Completion: 2024-12-31
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 54

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
all ceramic single-retainer resin bonded fixed partial denture using the upper central incisor	all ceramic single-retainer resin bonded fixed partial denture	-
all ceramic single-retainer resin bonded fixed partial denture using the upper canine abutment	all ceramic single-retainer resin bonded fixed partial denture	-

Primary Outcome Measures

Name	Time	Method
Survival rate in the term of De-bonding and fracture	12 months	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

Name	Time	Method
Abutment tooth mobility and patient's satisfaction	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 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).

Trial Locations

Locations (1)

Faculty of Dentistry, Cairo University; 🇪🇬 Cairo, Egypt