Dental CariesPhase 1NCT05667545
Evaluation of the Effect of Self-Assembling Peptide P11-4
A Phase 1 study testing Peptide in people with Dental Caries, run by Egymedicalpedia at 1 site in Egypt.
Trial summary
Dental caries is a biofilm-mediated, sugar-driven, multifactorial, dynamic disease that results in the phasic demineralization and remineralization of dental hard tissues. These tissues have poor regeneration capability because of the lack of both regenerative cells and vascularization. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Dental Caries
- What is being tested?
- Peptide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2021to 30 Oct 2021
- Phase
- Phase 1
- 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 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients included in the study will be required to present at least one permanent molar with an active deep carious lesion without pulpal involvement.
- Age of patient: 18 -30 years
- Carious lesions will be standardized by means of clinical and radiographic examinations performed before the procedures
Who cannot join
- Teeth with deep dentinal lesions with pulpal involvement, abscess, pain or swelling
- Developmental disorders and adjacent soft tissue lesions
- Patients with systemic illness will be excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Remineralizing Effect of Self-assembling Peptide P11-4 on Caries Affected Dentin.
Dental caries is a biofilm-mediated, sugar-driven, multifactorial, dynamic disease that results in the phasic demineralization and remineralization of dental hard tissues.
These tissues have poor regeneration capability because of the lack of both regenerative cells and vascularization.
In the complex caries progression process involving dietary sugars, bacterial metabolism and demineralization, the collagenous organic matrix becomes exposed and destroyed by resident and bacterial proteases, allowing the lesion to expand
Read the detailed description
It is possible to find numerous noninvasive or minimally invasive therapies for caries such as hygiene education, fluorides, Phosphopeptide compounds, xylitol and infiltrative resins.
However, when caries progresses to the point of breaking down the dental tissues, composite restorations are imperative to preserve the tooth functionality.
During the execution of routine dental restorations, the hybrid structure formed by the dental bonding procedure occurs through the interaction and subsequent polymerization of monomers around the demineralized collagen matrix.
The oral cavity is a severe environment for the resin-dental bond to survive for a reasonable length of time, with thermomechanical changes, chemical attacks by acids and enzymes and other factors posing routine daily challenges. Therefore to achieve effective and stable bonding, the preservation of dentin collagen is critical, since collagen represents the major organic component of the dentin matrix.
Based on today's understanding of the dental biomineralization process, new efforts have been made to develop synthetic analogues of non-collagenous proteins (NCPs), which are involved in the events of nucleation and growth of hydroxyapatite crystals in hard tissues Such analogues have been designed mirroring the amphiphilic characteristics of NCPs, with polar groups complexing inorganic ions and non-polar side chains governing the matrix-matrix interactions.
- Conditions
- Dental Caries
- Being tested
- Peptide
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PeptideDrug
Also called peptide P11-4
it is about synthetic protein acting on tooth structure help information apatite crystals
| Study group | Role | What they receive |
|---|---|---|
| Negative control group (A1) | Active comparator | A1: cavities will be sealed directly by restorative material (conventional glass ionomer) without any treatment. Receives: Drug: Peptide |
| Treatment group (A2) | Active comparator | A2: cavities will be treated by Self-Assembling peptide P11-4 then sealed by conventional glass ionomer. Receives: Drug: Peptide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remineralization
Assessment of the remineralizing effect of self-assembling peptide P11-4 on affected-caries dentin. Remineralization will be assessed by radiodensity using digital radiography
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2022
- Study start1 Jul 2021
- Primary completion1 Oct 2021
- Study completion30 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- To study the effect of self assembling-peptide P11-4 treatment on dentine remineralization, after removal of all infected dentine (Remineralization of caries affected dentin),
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Egymedicalpedia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Asmaa Mosleh, Lecturer, Principal investigator, Al-Azhar Faculty of Dentistary for girls
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05667545
- Sponsor's protocol ID
- Nafesa Mostafa
- Status last verified
- Jan 2023
- First submitted
- 12 Dec 2022
- Last updated
- 6 Jan 2023
- 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 6 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Remineralizing Effect of Self-assembling Peptide P11-4 on Caries Affected Dentin.
- ClinicalTrials.gov ID
- NCT05667545
- Acronym / sponsor ID
- Nafesa Mostafa
- Conditions
- Dental Caries
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- EgymedicalpediaIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 30 Oct 2021 (actual)
- First posted
- 28 Dec 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.
Dental caries is a biofilm-mediated, sugar-driven, multifactorial, dynamic disease that results in the phasic demineralization and remineralization of dental hard tissues.
These tissues have poor regeneration capability because of the lack of both regenerative cells and vascularization.
In the complex caries progression process involving dietary sugars, bacterial metabolism and demineralization, the collagenous organic matrix becomes exposed and destroyed by resident and bacterial proteases, allowing the lesion to expand
Detailed description
It is possible to find numerous noninvasive or minimally invasive therapies for caries such as hygiene education, fluorides, Phosphopeptide compounds, xylitol and infiltrative resins.
However, when caries progresses to the point of breaking down the dental tissues, composite restorations are imperative to preserve the tooth functionality.
During the execution of routine dental restorations, the hybrid structure formed by the dental bonding procedure occurs through the interaction and subsequent polymerization of monomers around the demineralized collagen matrix.
The oral cavity is a severe environment for the resin-dental bond to survive for a reasonable length of time, with thermomechanical changes, chemical attacks by acids and enzymes and other factors posing routine daily challenges. Therefore to achieve effective and stable bonding, the preservation of dentin collagen is critical, since collagen represents the major organic component of the dentin matrix.
Based on today's understanding of the dental biomineralization process, new efforts have been made to develop synthetic analogues of non-collagenous proteins (NCPs), which are involved in the events of nucleation and growth of hydroxyapatite crystals in hard tissues Such analogues have been designed mirroring the amphiphilic characteristics of NCPs, with polar groups complexing inorganic ions and non-polar side chains governing the matrix-matrix interactions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- To study the effect of self assembling-peptide P11-4 treatment on dentine remineralization, after removal of all infected dentine (Remineralization of caries affected dentin),
| Arm | Type | Receives |
|---|---|---|
| Negative control group (A1) | Active comparator | Drug: PeptideA1: cavities will be sealed directly by restorative material (conventional glass ionomer) without any treatment. |
| Treatment group (A2) | Active comparator | Drug: PeptideA2: cavities will be treated by Self-Assembling peptide P11-4 then sealed by conventional glass ionomer. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients included in the study will be required to present at least one permanent molar with an active deep carious lesion without pulpal involvement.
- Age of patient: 18 -30 years
- Carious lesions will be standardized by means of clinical and radiographic examinations performed before the procedures
Key exclusion criteria (3 listed)
- Teeth with deep dentinal lesions with pulpal involvement, abscess, pain or swelling
- Developmental disorders and adjacent soft tissue lesions
- Patients with systemic illness will be excluded
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 |
|---|---|---|
| PeptideAlso: peptide P11-4it is about synthetic protein acting on tooth structure help information apatite crystals | Drug | Negative control group (A1), Treatment group (A2) |
Primary outcome
Remineralization
Time frame: 3 months
Assessment of the remineralizing effect of self-assembling peptide P11-4 on affected-caries dentin. Remineralization will be assessed by radiodensity using digital radiography
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 6 Jan 2023.
- 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.
Asmaa Mosleh, Lecturer principal investigator
Al-Azhar Faculty of Dentistary for girls
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Peptide in people with Dental Caries, run by Egymedicalpedia 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 3 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 6 Jan 2023. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 (time frame: 3 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 6 Jan 2023.