Missing TeethRBFPDNCT05861921
Single-retainer Lithium Di-silicate Versus Zirconia Resin Bonded Bridge for Replacement of an Anterior Missing Tooth.
A study testing Single-retainer Lithium Di-silicate Resin Bonded Fixed Partial Denture in people with Missing Teeth, run by Cairo University at 1 site in Egypt.
Trial summary
First, Participants in this study will be recruit according to inclusion criteria. Proper examination for the participants (clinically and radiographically). Preparation for abutment tooth for Resin bonded fixed partial denture. Checking and verification for the restoration (trying). Read more about this study
- Who is it for?
- Ages 15 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Missing Teeth
- What is being tested?
- Single-retainer Lithium Di-silicate Resin Bonded Fixed Partial Denture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2023to 30 Oct 2024
- 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 15 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- All subjects are required to be:
- From 15-50 years old, to be able to read and sign the informed consent document.
- Have no active periodontal or pulpal diseases.
- Psychologically and physically able to withstand conventional dental procedures
- Maintenance of good oral hygiene.
- Able to return for follow-up examinations and evaluation
- Patients have missing upper incisor tooth.
Who cannot join
- Patient less than 15 or more than 50 years old
- Patient with active resistant periodontal diseases
- Patients with poor oral hygiene and uncooperative patients
- Pregnant women
- Patients in the growth stage with partially erupted teeth
- Psychiatric problems or unrealistic expectations
- Lack of opposing dentition in the area of interest
- More than one missing tooth in the area of interest
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Assessment of Single-retainer Lithium Di-silicate Versus Zirconia Resin Bonded Fixed Partial Denture for Replacement of an Anterior Missing Tooth. (Randomized Clinical Trial)
First, Participants in this study will be recruit according to inclusion criteria. Proper examination for the participants (clinically and radiographically). Preparation for abutment tooth for Resin bonded fixed partial denture. Checking and verification for the restoration (trying). Clinical assessment and survival evaluation of the final restoration on delivery and on follow-up every 12 weeks for 12 months.
Read the detailed description
Examination and diagnosis: Selection and examination of the patients according to inclusion and exclusion criteria. Diagnosis of the patient's chief complaint and teeth that will be involved in this study will be done.
Primary alginate impressions for diagnosis on primary casts and for mounting. The patients will be asked to maintain good oral hygiene measures by using tooth brush twice daily.
Taking a professional pre-operative photo.
Tooth preparation procedure:
- Preparation of abutment tooth for Resin bonded fixed partial denture according to specific standardized design for both types of final restorations.
- After tooth preparation, the final impression will be taken for each participant using the intraoral scanner.
- Fabrication of temporary restoration using composite resin temporary material and cemented using Zinc Oxide eugenol free temporary cement.
Fabrication of final restoration:
Lithium Di-silicate or Zirconia Resin bonded fixed partial denture will be fabricated according to group.
Clinical assessment and survival evaluation of the final restoration on delivery and on follow-up every 12 weeks for 12 months following outcome measures.
- Conditions
- Missing Teeth
- Being tested
- Single-retainer Lithium Di-silicate Resin Bonded Fixed Partial Denture
- Medical subject headings
- Anodontia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-retainer Lithium Di-silicate Resin Bonded Fixed Partial DentureOther
Lithium Di-silicate as final restorative material for resin bonded Fixed Partial Denture replacing missing upper anterior tooth.
| Study group | Role | What they receive |
|---|---|---|
| Single-retainer Lithium Di-silicate Resin Bonded Fixed Partial Denture | Experimental | Intervention will be the delivery of Lithium Di-silicate resin bonded fixed partial denture as final prosthetic restorative material for replacing missing upper anterior tooth. Receives: Other: Single-retainer Lithium Di-silicate Resin Bonded Fixed Partial Denture |
| Single-retainer Zirconia Resin Bonded Fixed Partial Denture | Active comparator | Comparator will be the delivery of Zirconia resin bonded fixed partial denture as final prosthetic restorative material for replacing missing upper anterior tooth. Receives: Other: Single-retainer Lithium Di-silicate Resin Bonded Fixed Partial Denture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical assessment in the term of fracture.
United States Public Health Service (USPHS) criteria index in Discrete scores
Measured: 1 year
Secondary outcomes (3)
Clinical assessment in the term of De-bonding.
United States Public Health Service (USPHS) criteria index in Discrete scores
Measured: 1 year
Success and survival rates
Binary as in failed or no failed
Measured: 1 year
Patient satisfaction
Questionnaire in discrete scores
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2023
- Study start1 Jul 2023
- Primary completion30 Jun 2024
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Missing TeethStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Catherine Attef Mounir Nasr, Cairo University
- Investigators
- Catherine A. Mounir, Asst. lect., Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05861921
- Sponsor's protocol ID
- 5223
- Acronym
- RBFPD
- Status last verified
- Mar 2025
- First submitted
- 7 May 2023
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment of Single-retainer Lithium Di-silicate Versus Zirconia Resin Bonded Fixed Partial Denture for Replacement of an Anterior Missing Tooth. (Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT05861921
- Acronym / sponsor ID
- RBFPD / 5223
- Conditions
- Missing Teeth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 17 May 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.
First, Participants in this study will be recruit according to inclusion criteria. Proper examination for the participants (clinically and radiographically). Preparation for abutment tooth for Resin bonded fixed partial denture. Checking and verification for the restoration (trying). Clinical assessment and survival evaluation of the final restoration on delivery and on follow-up every 12 weeks for 12 months.
Detailed description
Examination and diagnosis: Selection and examination of the patients according to inclusion and exclusion criteria. Diagnosis of the patient's chief complaint and teeth that will be involved in this study will be done.
Primary alginate impressions for diagnosis on primary casts and for mounting. The patients will be asked to maintain good oral hygiene measures by using tooth brush twice daily.
Taking a professional pre-operative photo.
Tooth preparation procedure:
- Preparation of abutment tooth for Resin bonded fixed partial denture according to specific standardized design for both types of final restorations.
- After tooth preparation, the final impression will be taken for each participant using the intraoral scanner.
- Fabrication of temporary restoration using composite resin temporary material and cemented using Zinc Oxide eugenol free temporary cement.
Fabrication of final restoration:
Lithium Di-silicate or Zirconia Resin bonded fixed partial denture will be fabricated according to group.
Clinical assessment and survival evaluation of the final restoration on delivery and on follow-up every 12 weeks for 12 months following outcome measures.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single-retainer Lithium Di-silicate Resin Bonded Fixed Partial Denture | Experimental | Other: Single-retainer Lithium Di-silicate Resin Bonded Fixed Partial DentureIntervention will be the delivery of Lithium Di-silicate resin bonded fixed partial denture as final prosthetic restorative material for replacing missing upper anterior tooth. |
| Single-retainer Zirconia Resin Bonded Fixed Partial Denture | Active comparator | Other: Single-retainer Lithium Di-silicate Resin Bonded Fixed Partial DentureComparator will be the delivery of Zirconia resin bonded fixed partial denture as final prosthetic restorative material for replacing missing upper anterior tooth. |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- All subjects are required to be:
Key exclusion criteria (8 listed)
- Patient less than 15 or more than 50 years old
- Patient with active resistant periodontal diseases
- Patients with poor oral hygiene and uncooperative patients
- Pregnant women
- Patients in the growth stage with partially erupted teeth
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 |
|---|---|---|
| Single-retainer Lithium Di-silicate Resin Bonded Fixed Partial DentureLithium Di-silicate as final restorative material for resin bonded Fixed Partial Denture replacing missing upper anterior tooth. | Other | Single-retainer Lithium Di-silicate Resin Bonded Fixed Partial Denture, Single-retainer Zirconia Resin Bonded Fixed Partial Denture |
Primary outcome
Clinical assessment in the term of fracture.
Time frame: 1 year
United States Public Health Service (USPHS) criteria index in Discrete scores
3 secondary outcomes
Clinical assessment in the term of De-bonding.
Time frame: 1 year
Success and survival rates
Time frame: 1 year
Patient satisfaction
Time frame: 1 year
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 10 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Missing Teeth
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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.
Catherine A. Mounir, Asst. lect. principal investigator
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 Single-retainer Lithium Di-silicate Resin Bonded Fixed Partial Denture in people with Missing Teeth, 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 7 inclusion and 8 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 10 Mar 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?
Clinical assessment in the term of fracture. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Mar 2025.