Evaluation of Remineralization Potential of Self Assembling Peptide Combined With Fluoride
1 other identifier
interventional
58
1 country
1
Brief Summary
Self-assembling peptide (P11-4) exhibited an outstanding ability for biomimetic re-mineralization of incipient enamel carious lesions. It creates a 3D matrix within the subsurface of carious lesions, allowing de novo formation of Hydroxyapatite crystals, thus enabling guided enamel regeneration of the demineralized enamel structure. Addition of fluoride to P11-4 may have a synergistic effect on the remineralization potential.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 13, 2021
CompletedFirst Posted
Study publicly available on registry
October 26, 2021
CompletedStudy Start
First participant enrolled
October 30, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2022
CompletedOctober 26, 2021
October 1, 2021
6 months
October 13, 2021
October 14, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Remineralization
measuring carious lesion development using DIAGNOdent laser fluorescence (scores from 0 to 99) according to progression of the carious lesion
6 months
Study Arms (2)
Self assembling peptide P11-4 with fluoride
EXPERIMENTALP11-4 forms a 3D matrix within subsurface of incipient carious lesions , allowing formation of new hydroxyapatite crystal facilitating guided regeneration of enamel lesions. Combination with fluoride will have a synergistic effect on remineralization potential
Fluoride varnish
ACTIVE COMPARATORGold standard agent for remineralization of incipient carious lesions.
Interventions
P11-4 self assembling peptide combined with fluoride
5% Sodium Fluoride varnish (equal to 22,600 ppm fluoride)
Eligibility Criteria
You may qualify if:
- Active carious white spot lesions.
- Patient compliance.
- Controlled oral hygiene condition.
You may not qualify if:
- Participant in another trial.
- Non carious lesions.
- Systemic diseases or concomitant medication affecting salivary flow.
- Cavitation of carious lesions.
- Parafunctional habits.
- Pregnancy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Faculty of Dentistry, Cairo University
Cairo, El Manial, 11553, Egypt
Study Officials
- PRINCIPAL INVESTIGATOR
Omar O Shaalan, PhD
Lecturer, Conservative Dentistry Department, Faculty of Dentistry, Cairo University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer, Conservative Dentistry Department, Faculty of Dentistry
Study Record Dates
First Submitted
October 13, 2021
First Posted
October 26, 2021
Study Start
October 30, 2021
Primary Completion
April 30, 2022
Study Completion
June 30, 2022
Last Updated
October 26, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share