Carious DentinNCT03285022
Postoperative Hypersensitivity and Digital Radiographic Assessment of a Zinc Modified Versus a Conventional Glass Ionomer Cement in Deep Carious Lesion: Randomized Controlled Clinical Trial
A study testing Partial caries removel techniques in people with Carious Dentin, run by Cairo University.
Trial summary
The study aim to evaluate the difference between the effect of zinc modified glass ionomer and conventional glass ionomer on the success of partial caries removel technique Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Carious Dentin
- What is being tested?
- Partial caries removel techniques
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 20 Oct 2017to 20 Apr 2018
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female (>18 y)
- patient with At least 1 deep carious lesion
- Clinical symptoms of reversible pulpitis with positive pulp response
Who cannot join
- 1. Patient suffer from irreversible pulpitis (pain with hot or instant pain lasting for a while, resistant to analgesic) 2. Presence of any sign of periapical lesion (like sinus tract ) 3. Teeth with periodontal problem 4. Anterior teeth (material used for non aesthetic region) 5. Pregnant women, to avoid multiple exposure to x ray 6. Patients unable to give consent(mentally retarted, or refuse to right a consent)
Trial locations and contacts
No sites are listed yet.
About this study
The study aim to evaluate the difference between the effect of zinc modified glass ionomer and conventional glass ionomer on the success of partial caries removel technique
Read the detailed description
The zinc ion has an antibacterial effect which could increase the success of partial caries removel technique by decreasing the bactrial population .
- Conditions
- Carious Dentin
- Being tested
- Partial caries removel techniques
- Keywords
- Incomplete caries removel, Partial caries removel
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partial caries removel techniquesProcedure or surgery
Also called Partial caries removel
Removel of all superfacial dentin and leaving the inner affectted dentin
| Study group | Role | What they receive |
|---|---|---|
| Zinc modified glass ionomer | Experimental | Zinc modified glass ionomer (chemfill rock) galss ionomer used as restoration for posterior teeth in case of partial caries removel Receives: Procedure: Partial caries removel techniques |
| Conventionel glass ionomer | Active comparator | Conventional glass ionomer used as restoration for posterior teeth in case of partial caries removel Receives: Procedure: Partial caries removel techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
Digital radigraphic assessment
The presence of periapical change or change in lamina dura change after the procedure
Measured: At baseline ,3months and 6 months
Secondary outcomes (1)
Post opreative hypersenstivity
The presence or absence of pain with thermal
Measured: Baseline ,at 3 months and at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2017
- Study start20 Oct 2017 (estimated)
- Primary completion20 Apr 2018 (estimated)
- Study completion20 Apr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carious DentinStudies 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
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina mounir elkady, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03285022
- Sponsor's protocol ID
- CEBD-CU-2017-09-17
- Status last verified
- Sep 2017
- First submitted
- 14 Sep 2017
- Last updated
- 15 Sep 2017
- 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 15 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Hypersensitivity and Digital Radiographic Assessment of a Zinc Modified Versus a Conventional Glass Ionomer Cement in Deep Carious Lesion: Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03285022
- Acronym / sponsor ID
- CEBD-CU-2017-09-17
- Conditions
- Carious Dentin
- Keywords
- Incomplete caries removel, Partial caries removel
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Oct 2017 (estimated)
- Primary completion
- 20 Apr 2018 (estimated)
- Study completion
- 20 Apr 2018 (estimated)
- First posted
- 15 Sep 2017 (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.
The study aim to evaluate the difference between the effect of zinc modified glass ionomer and conventional glass ionomer on the success of partial caries removel technique
Detailed description
The zinc ion has an antibacterial effect which could increase the success of partial caries removel technique by decreasing the bactrial population .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zinc modified glass ionomer | Experimental | Procedure: Partial caries removel techniquesZinc modified glass ionomer (chemfill rock) galss ionomer used as restoration for posterior teeth in case of partial caries removel |
| Conventionel glass ionomer | Active comparator | Procedure: Partial caries removel techniquesConventional glass ionomer used as restoration for posterior teeth in case of partial caries removel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female (>18 y)
- patient with At least 1 deep carious lesion
- Clinical symptoms of reversible pulpitis with positive pulp response
Key exclusion criteria (1 listed)
- 1. Patient suffer from irreversible pulpitis (pain with hot or instant pain lasting for a while, resistant to analgesic) 2. Presence of any sign of periapical lesion (like sinus tract ) 3. Teeth with periodontal problem 4. Anterior teeth (material used for non aesthetic region) 5. Pregnant women, to avoid multiple exposure to x ray 6. Patients unable to give consent(mentally retarted, or refuse to right a consent)
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 |
|---|---|---|
| Partial caries removel techniquesAlso: Partial caries removelRemovel of all superfacial dentin and leaving the inner affectted dentin | Procedure or surgery | Conventionel glass ionomer, Zinc modified glass ionomer |
Primary outcome
Digital radigraphic assessment
Time frame: At baseline ,3months and 6 months
The presence of periapical change or change in lamina dura change after the procedure
1 secondary outcome
Post opreative hypersenstivity
Time frame: Baseline ,at 3 months and at 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2017.
- Individual participant dataSharing planned: No
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Clinical Investigation Measuring the Long Term Clinical Performance and Safety of Biodentine™ XP in Patients Treated for Coronal Restorative or Endodontic Dental Indications.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Partial caries removel techniques in people with Carious Dentin, 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 3 inclusion and 1 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 15 Sep 2017. 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 Dina Mounir Elkady, Assitant lecturer (01004297317, Dina.elkady@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Digital radigraphic assessment (time frame: At baseline ,3months and 6 months). 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 15 Sep 2017.