Missing TeethNCT05362591
Anterior Resin Bonded Restorations for Adolescent
A study testing resin bonded bridge with no preparation and resin bonded bridge with minimal preparation in people with Missing Teeth, run by October University for Modern Sciences and Arts at 1 site in Egypt.
Trial summary
a 24 Patients above 12 years old with missing upper incisor were divided into two groups, group 1: 12 patient will be treated by resin bonded bridge (RBB) with no preparation protocol, group 2: 12 patient will be treated by resin bonded bridge (RBB) with minimal preparation protocol. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Missing Teeth
- What is being tested?
- resin bonded bridge with no preparation and resin bonded bridge with minimal preparation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 8 May 2022to 1 Jun 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 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 12-18 years old
- Full set of permanent teeth.
- Missing upper incisor
- Controlled dental disease - no active caries or periodontal diseases
- Patients will be available to be clinically reviewed up to 1 year
Who cannot join
- Patients with uncontrolled active tooth decay or periodontal disease (i.e. 4+ mm probing depth and bleeding on probing).
- Patients with teeth missing opposite to the planned RBB
- Abutment tooth mobility of 2 or greater (Millers classification)
- Patients with debilitating illnesses or complicating medical conditions
- Heavily restored tooth abutment not suitable for an RBB
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Biomimetic Anterior Resin Bonded Restorations for Adolescent Patients
a 24 Patients above 12 years old with missing upper incisor were divided into two groups, group 1: 12 patient will be treated by resin bonded bridge (RBB) with no preparation protocol, group 2: 12 patient will be treated by resin bonded bridge (RBB) with minimal preparation protocol.
(RBB) retention/survival, patient's speech as well as thermal sensitivity and patient's satisfaction will be evaluated for 12 month at 3,6,9 and 12 month.
- Conditions
- Missing Teeth
- Being tested
- resin bonded bridge with no preparation, resin bonded bridge with minimal preparation
- Keywords
- missing incisors, resin bonded bridge
- Medical subject headings
- Anodontia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
resin bonded bridge with no preparationProcedure or surgery
resin bonded bridge without enamel preparation
resin bonded bridge with minimal preparationProcedure or surgery
resin bonded bridge with minimal preparation of tooth enamel
| Study group | Role | What they receive |
|---|---|---|
| resin bonded bridge with no preparation | Experimental | resin bonded bridge without enamel preparation Receives: Procedure: resin bonded bridge with no preparation |
| resin bonded bridge with minimal preparation | Active comparator | resin bonded bridge with minimal preparation on tooth enamel Receives: Procedure: resin bonded bridge with minimal preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
resin bonded bridge retention/survival
Presence of the prosthesis in patient's mouth (Yes/No) by clinical visual examination.
Measured: 12 month
Secondary outcomes (1)
Patient's satisfaction
Patient satisfaction outcome is including the following: comfort and stability, esthetics, ease of cleaning, ability to speak, self-esteem, and functionality. the outcome will be evaluated by a visual analogue scale ranging from 0 to 10, where 10 is the maximum (better outcome) and 0 is the minimum (worse outcome).
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study start8 May 2022
- Primary completion4 May 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
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.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- October University for Modern Sciences and Arts
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naglaa Ibrahim Ezz, October University for Modern Sciences and Arts
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05362591
- Sponsor's protocol ID
- REC-D124-2
- Status last verified
- Apr 2024
- First submitted
- 23 Apr 2022
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomimetic Anterior Resin Bonded Restorations for Adolescent Patients
- ClinicalTrials.gov ID
- NCT05362591
- Acronym / sponsor ID
- REC-D124-2
- Conditions
- Missing Teeth
- Keywords
- missing incisors, resin bonded bridge
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- October University for Modern Sciences and ArtsUniversity, hospital or other
- Study start
- 8 May 2022 (actual)
- Primary completion
- 4 May 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 5 May 2022 (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.
a 24 Patients above 12 years old with missing upper incisor were divided into two groups, group 1: 12 patient will be treated by resin bonded bridge (RBB) with no preparation protocol, group 2: 12 patient will be treated by resin bonded bridge (RBB) with minimal preparation protocol.
(RBB) retention/survival, patient's speech as well as thermal sensitivity and patient's satisfaction will be evaluated for 12 month at 3,6,9 and 12 month.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| resin bonded bridge with no preparation | Experimental | Procedure: resin bonded bridge with no preparationresin bonded bridge without enamel preparation |
| resin bonded bridge with minimal preparation | Active comparator | Procedure: resin bonded bridge with minimal preparationresin bonded bridge with minimal preparation on tooth enamel |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 12-18 years old
- Full set of permanent teeth.
- Missing upper incisor
- Controlled dental disease - no active caries or periodontal diseases
- Patients will be available to be clinically reviewed up to 1 year
Key exclusion criteria (5 listed)
- Patients with uncontrolled active tooth decay or periodontal disease (i.e. 4+ mm probing depth and bleeding on probing).
- Patients with teeth missing opposite to the planned RBB
- Abutment tooth mobility of 2 or greater (Millers classification)
- Patients with debilitating illnesses or complicating medical conditions
- Heavily restored tooth abutment not suitable for an RBB
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 |
|---|---|---|
| resin bonded bridge with no preparationresin bonded bridge without enamel preparation | Procedure or surgery | resin bonded bridge with no preparation |
| resin bonded bridge with minimal preparationresin bonded bridge with minimal preparation of tooth enamel | Procedure or surgery | resin bonded bridge with minimal preparation |
Primary outcome
resin bonded bridge retention/survival
Time frame: 12 month
Presence of the prosthesis in patient's mouth (Yes/No) by clinical visual examination.
1 secondary outcome
Patient's satisfaction
Time frame: 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing resin bonded bridge with no preparation and resin bonded bridge with minimal preparation in people with Missing Teeth, run by October University for Modern Sciences and Arts 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 5 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: status not confirmed, as of the sponsor's last update on 3 Apr 2024. 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?
Results are not available in the source record.
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?
resin bonded bridge retention/survival (time frame: 12 month). 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 3 Apr 2024.