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Completed

NCT Number: NCT05812066

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.

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.

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Key information

Age range

14 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Cairo University

Cairo, Cairo Governorate, 35855, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

all ceramic single-retainer resin bonded fixed partial denture

Procedure

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 outcomes

  1. Survival rate in the term of retention and fracture

    Time frame: 12 months

    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).

Secondary outcomes

  1. Abutment tooth mobility and patient's satisfaction

    Time frame: 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 10 denoting most satisfied while number 1 denote the least satisfied; where (1 to 2) highly dissatisfied, (3 to 4) dissatisfied, (5 to 6) neutral, (7 to 8) satisfied, and (9 to 10) highly satisfied

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Clinical Assessment of Distal Versus Mesial Single-Retainer Resin Bonded Fixed Partial Denture for Replacement of an Upper Lateral Incisor: (Randomized Clinical Trial).

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 13, 2023
Registry last updated
Jul 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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