Deep CariesNCT04262076
Remineralization of Caries Affected Dentin
A study testing Pulpine with Polyamidoamine Dendrimer in people with Deep Caries, run by Al-Azhar University at 1 site in Egypt.
Trial summary
Remineralization of carious affected dentin Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Deep Caries
- What is being tested?
- Pulpine with Polyamidoamine Dendrimer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2018to 1 Jan 2020
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Presence of at least one class one carious posterior teeth in both left and right side.
- Absence of spontaneous pain, Mobility and tenderness on percussion.
- Radiographically, the preoperative inclusion criteria are, no internal or external resorption and no widening of the periodontal membrane space.
Who cannot join
- Patients with poor oral Hygiene.
- Evidence of Rampant Caries.
- Teeth with periodontal involvement.
- Poor general health condition.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Pulpine and Combination of Pulpine With Polyamidoamine Dendrimer on Remineralization of Carious Affected Human Dentin
Remineralization of carious affected dentin
Read the detailed description
Remineralization of Carious affected dentin by using Pulpine alone and combination of Pulpine with Polyamidoamine Dendrimer.
- Conditions
- Deep Caries
- Being tested
- Pulpine with Polyamidoamine Dendrimer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulpine with Polyamidoamine DendrimerOther
Removal of infected dentin in class I Cavities followed by application of Polyamidoamine Denrimer on caries affected Dentin that is washed out of the cavity after 30 secs then finally place Pulpine .
| Study group | Role | What they receive |
|---|---|---|
| Combination of pulpine with Polyamidoamine Dendrimer | Experimental | Removal of Caries infected dentin from the walls and floor of the cavity and then apply polyamidoamine Denrimer for 30 secs ,then washed out of the cavity followed by placement of Pulpine over affected Dentin. Receives: Other: Pulpine with Polyamidoamine Dendrimer |
| Pulpine | Active comparator | Removal of Caries infected dentin from the walls and the floor of the cavity followed by application of Pulpine over affected Dentin. Receives: Other: Pulpine with Polyamidoamine Dendrimer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remineralization & increase dentin density that is measured by using Vista Scan Radiography.
Vista scan Radiography used to measure pixel grey value after 6 months.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start1 Jun 2018
- Primary completion1 Dec 2019
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep CariesStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Model description
- split mouth design
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Rizk Abo El Wafa Ahmed, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04262076
- Sponsor's protocol ID
- REC17-01123
- Status last verified
- Jan 2020
- First submitted
- 26 Jan 2020
- Last updated
- 11 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pulpine and Combination of Pulpine With Polyamidoamine Dendrimer on Remineralization of Carious Affected Human Dentin
- ClinicalTrials.gov ID
- NCT04262076
- Acronym / sponsor ID
- REC17-01123
- Conditions
- Deep Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 10 Feb 2020 (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.
Remineralization of carious affected dentin
Detailed description
Remineralization of Carious affected dentin by using Pulpine alone and combination of Pulpine with Polyamidoamine Dendrimer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- split mouth design
| Arm | Type | Receives |
|---|---|---|
| Combination of pulpine with Polyamidoamine Dendrimer | Experimental | Other: Pulpine with Polyamidoamine DendrimerRemoval of Caries infected dentin from the walls and floor of the cavity and then apply polyamidoamine Denrimer for 30 secs ,then washed out of the cavity followed by placement of Pulpine over affected Dentin. |
| Pulpine | Active comparator | Other: Pulpine with Polyamidoamine DendrimerRemoval of Caries infected dentin from the walls and the floor of the cavity followed by application of Pulpine over affected Dentin. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Presence of at least one class one carious posterior teeth in both left and right side.
- Absence of spontaneous pain, Mobility and tenderness on percussion.
- Radiographically, the preoperative inclusion criteria are, no internal or external resorption and no widening of the periodontal membrane space.
Key exclusion criteria (4 listed)
- Patients with poor oral Hygiene.
- Evidence of Rampant Caries.
- Teeth with periodontal involvement.
- Poor general health condition.
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 |
|---|---|---|
| Pulpine with Polyamidoamine DendrimerRemoval of infected dentin in class I Cavities followed by application of Polyamidoamine Denrimer on caries affected Dentin that is washed out of the cavity after 30 secs then finally place Pulpine . | Other | Combination of pulpine with Polyamidoamine Dendrimer, Pulpine |
Primary outcome
Remineralization & increase dentin density that is measured by using Vista Scan Radiography.
Time frame: 6 months
Vista scan Radiography used to measure pixel grey value after 6 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 11 Feb 2020.
- Individual participant dataSharing planned: Yes
Related trials for Deep Caries
RecruitingPhase 2
Clinical and Radiographic Success Rate of Pulpotomy Versus Pulpectomy for Management of Primary Teeth With Deep Caries
Deep Caries
Recruiting
"The Relationship Between Pulpal Inflammatory Marker Levels in Moderate and Severe Pulpitis and Outcome of Full Pulpotomy in Mandibular Molars With Extremely Deep Caries: A Prospective Cohort Study."
Moderate Severe Pulpitis, Extremely Deep Caries
Recruiting
Outcome of Partial Pulpotomy in Permanent Mandibular Molars With Symptomatic Irreversible Pulpitis After Wound Lavage With Calcium Hypochlorite or Sodium Hypochlorite
Symptomatic Irreversible Pulpitis (SIP), Extremely Deep Caries
Active, not recruiting
Outcome of Selective Caries Removal Performed by Undergraduate Students
Deep Caries Lesion of Pemanent Teeth
Enrolling by invitation
Evaluation of Selective and Stepwise Excavation in Young Permanent Teeth With Deep Caries Lesions.
Dental Caries, Dental Cavities
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 Pulpine with Polyamidoamine Dendrimer in people with Deep Caries, run by Al-Azhar 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 3 inclusion and 4 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 11 Feb 2020. 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?
Remineralization & increase dentin density that is measured by using Vista Scan Radiography. (time frame: 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 11 Feb 2020.