Amelogenesis ImperfectaNCT02994862
E. Max Laminate Veneers With and Without Using Galla Chinnesis as Natural Cross Linking and Remineralizing Agent
A study testing Galla Chinnesis and Conventional Bonding in people with Amelogenesis Imperfecta, run by Cairo University.
Trial summary
In teeth requiring laminate veneers with amelogenesis imperfecta Will application of galla chinensis before Bonding of laminate veneers with adhesive resin cement provide better survival rate than conventional Bonding method Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Amelogenesis Imperfecta
- What is being tested?
- Galla Chinnesis and Conventional Bonding
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Dec 2017
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- All subjects are required to be:
- From 18-60 years old, and able to read and sign the informed consent document.
- Physically and psychologically able to tolerate conventional restorative procedures
- Have no active periodontal or pulpal diseases, have teeth with good restorations
- Patients with teeth problems indicated for laminate veneer (e.g. discoloration, fracture not involve more than 50% enamel loss, mild malposition, ….)
- Willing to return for follow-up examinations and evaluation
Who cannot join
- Patients in the growth stage with partially erupted teeth
- Patient with fractured teeth of more than 50% enamel loss
- Patients with poor oral hygiene and motivation
- Pregnant women
- Psychiatric problems or unrealistic expectations
- Lack of opposite occluding dentition in the area intended for restoration
Trial locations and contacts
No sites are listed yet.
Jylan Elguindy, Phd contact
About this study
Official title: One Year Clinical Evaluation of E. Max Laminate Veneers With and Without Using Galla Chinnesis as Natural Cross Linking and Remineralizing Agent Before Bonding to Teeth With Amelogenesis Imperfecta
In teeth requiring laminate veneers with amelogenesis imperfecta Will application of galla chinensis before Bonding of laminate veneers with adhesive resin cement provide better survival rate than conventional Bonding method
Read the detailed description
one year Clinical evaluation of laminate veneers with amelogenesis imperfecta Will application of galla chinensis before Bonding of laminate veneers with adhesive resin cement provide better survival rate than conventional Bonding method
- Conditions
- Amelogenesis Imperfecta
- Being tested
- Galla Chinnesis, Conventional Bonding
- Medical subject headings
- Amelogenesis Imperfecta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Galla ChinnesisOther
new Remineralizing Agent before Bonding to teeth with amelogenesis imperfecta
Conventional BondingOther
Normal Bonding Protocol
| Study group | Role | What they receive |
|---|---|---|
| Galla Chinnesis | Experimental | new Remineralizing Agent before Bonding to teeth with amelogenesis imperfecta Receives: Other: Galla Chinnesis |
| Conventional Bonding | Active comparator | Normal Bonding Method Receives: Other: Conventional Bonding |
What is being measured
The primary outcome is the main question the study is designed to answer.
marginal adaptation assessed by clinical evaluation using dental mirror and probe
clinical evaluation of marginal adaptation
Measured: 1 year
Secondary outcomes (1)
Patient satisfaction assessed using a Questionnaire
Questionnaire for patient satisfaction
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 posted16 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Amelogenesis ImperfectaStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Gamal Fahmy Mohammed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02994862
- Sponsor's protocol ID
- 1226500339
- Status last verified
- Dec 2016
- First submitted
- 8 Dec 2016
- Last updated
- 16 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Cheng L, ten Cate JM. Effect of Galla chinensis on the in vitro remineralization of advanced enamel lesions. Int J Oral Sci. 2010 Mar;2(1):15-20. doi: 10.4248/IJOS10019.
PubMed 20690414
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One Year Clinical Evaluation of E. Max Laminate Veneers With and Without Using Galla Chinnesis as Natural Cross Linking and Remineralizing Agent Before Bonding to Teeth With Amelogenesis Imperfecta
- ClinicalTrials.gov ID
- NCT02994862
- Acronym / sponsor ID
- 1226500339
- Conditions
- Amelogenesis Imperfecta
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 16 Dec 2016 (estimated)
- 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.
In teeth requiring laminate veneers with amelogenesis imperfecta Will application of galla chinensis before Bonding of laminate veneers with adhesive resin cement provide better survival rate than conventional Bonding method
Detailed description
one year Clinical evaluation of laminate veneers with amelogenesis imperfecta Will application of galla chinensis before Bonding of laminate veneers with adhesive resin cement provide better survival rate than conventional Bonding method
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Galla Chinnesis | Experimental | Other: Galla Chinnesisnew Remineralizing Agent before Bonding to teeth with amelogenesis imperfecta |
| Conventional Bonding | Active comparator | Other: Conventional BondingNormal Bonding Method |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- From 18-60 years old, and able to read and sign the informed consent document.
- Physically and psychologically able to tolerate conventional restorative procedures
- Have no active periodontal or pulpal diseases, have teeth with good restorations
- Patients with teeth problems indicated for laminate veneer (e.g. discoloration, fracture not involve more than 50% enamel loss, mild malposition, ….)
- Willing to return for follow-up examinations and evaluation
Key exclusion criteria (6 listed)
- Patients in the growth stage with partially erupted teeth
- Patient with fractured teeth of more than 50% enamel loss
- Patients with poor oral hygiene and motivation
- Pregnant women
- Psychiatric problems or unrealistic expectations
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 |
|---|---|---|
| Galla Chinnesisnew Remineralizing Agent before Bonding to teeth with amelogenesis imperfecta | Other | Galla Chinnesis |
| Conventional BondingNormal Bonding Protocol | Other | Conventional Bonding |
Primary outcome
marginal adaptation assessed by clinical evaluation using dental mirror and probe
Time frame: 1 year
clinical evaluation of marginal adaptation
1 secondary outcome
Patient satisfaction assessed using a Questionnaire
Time frame: 1 Year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2016.
- Background: PubMed 20690414Cheng L, ten Cate JM. Effect of Galla chinensis on the in vitro remineralization of advanced enamel lesions. Int J Oral Sci. 2010 Mar;2(1):15-20. doi: 10.4248/IJOS10019.
- Individual participant dataSharing planned: Undecided
Related trials for Amelogenesis Imperfecta
RecruitingObservational study
Oral Health Related Quality of Life of Children With Amelogenesis Imperfecta
Amelogenesis Imperfecta
Not yet recruiting
Renal and Vascular Phenotypic Characterization of Patients With Enamel Renal Syndrome Due to a Pathogenic Variant of the FAM20A Gene and Pathophysiological Study of Ectopic Calcifications
Enamel Renal Syndrome
RecruitingObservational study
Colorimetric, Ultra-structural and Elemental Comparison of Dental Enamel Defects
Amelogenesis Imperfecta, Dental Fluoroses
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.
Jylan Elguindy, Phd contact
Questions about this trial
What is this clinical trial studying?
A study testing Galla Chinnesis and Conventional Bonding in people with Amelogenesis Imperfecta, run by Cairo University.
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 6 inclusion and 6 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 16 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Mohammed mohammed, B.D.S (01226500339, mgamal400@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
marginal adaptation assessed by clinical evaluation using dental mirror and probe (time frame: 1 year). 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 NCT02994862, which also lists 1 linked publication.
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 16 Dec 2016.