Survival, ProsthesisNCT05812066

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.

A study testing all ceramic single-retainer resin bonded fixed partial denture in people with Survival, Prosthesis, run by Cairo University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 14 to 30 yearsHealthy volunteers can take part
Conditions the study is for: Survival, Prosthesis
What is being tested?: all ceramic single-retainer resin bonded fixed partial denture
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 54 participants
Where: 1 siteEgypt
Study dates: 15 Jul 2023to 25 Feb 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 14 to 30 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Faculty of Dentistry, Cairo University
Cairo, Cairo Governorate, 35855

Other trials in Egypt

About this study

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).

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.

Read the 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.

Conditions: Survival, Prosthesis
Being tested: all ceramic single-retainer resin bonded fixed partial denture
Keywords: survival, upper lateral incisor, single retainer RBFPD, resin bonded fixed partial denture
Medical subject headings: Prosthesis Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

all ceramic single-retainer resin bonded fixed partial dentureProcedure or surgery
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.

Study groups in NCT05812066
Study group	Role	What they receive
all ceramic single-retainer resin bonded fixed partial denture using the upper canine abutment	Experimental	Not described Receives: 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	Not described Receives: Procedure: all ceramic single-retainer resin bonded fixed partial denture

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 12 months

Secondary outcomes (1)

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 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
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jul 202325 Feb 2025

First posted13 Apr 2023
Study start15 Jul 2023
Primary completion13 Feb 2025
Study completion25 Feb 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Survival, ProsthesisStudies of the same condition, open and under way.
More trials run by Cairo UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 54 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05812066
Sponsor's protocol ID: 2-1-23
Status last verified: Apr 2023
First submitted: 31 Mar 2023
Last updated: 20 Jul 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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).
ClinicalTrials.gov ID: NCT05812066
Acronym / sponsor ID: 2-1-23
Conditions: Survival, Prosthesis
Keywords: survival, upper lateral incisor, single retainer RBFPD, resin bonded fixed partial denture
Study type: Interventional
Recruitment status: Completed
Enrolment: 54 participants (actual)
Lead sponsor: Cairo UniversityUniversity, hospital or other
Study start: 15 Jul 2023 (actual)
Primary completion: 13 Feb 2025 (actual)
Study completion: 25 Feb 2025 (actual)
First posted: 13 Apr 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
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

Who may qualify

Ages: 14 to 30 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (8 listed)

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.

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
all ceramic single-retainer resin bonded fixed partial dentureThe 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.	Procedure or surgery	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

Primary outcome

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).

1 secondary outcome

Abutment tooth mobility and patient's satisfaction
Time frame: 12 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
Individual participant dataSharing planned: No

Related trials for Survival, Prosthesis

Active, not recruiting
Survivorship of Attune Primary Total Knee Prosthesis
Noninflammatory Degenerative Joint Disease
RecruitingObservational study
Multicenter Mpact DM France
Total Hip Arthroplasty, Survival, Prosthesis
Active, not recruitingObservational study
Survival of Implant-Supported All-Ceramic Prostheses
Partial Edentulism, Disorder of Prostheses and Implants
Active, not recruitingObservational study
Local and Systemic Inflammatory Bone Alterations Related to Dental Implant Survival.
Peri Implant Mucositis, Peri Implant Bone Loss
Active, not recruitingObservational study
Transcatheter Aortic Valve Implantation Versus Standard Surgical Aortic Valve Replacement
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Omaima S El Mahallawi, Professor study director

Cairo University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing all ceramic single-retainer resin bonded fixed partial denture in people with Survival, Prosthesis, run by Cairo University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Survival rate in the term of retention and fracture (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05812066.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2025.