RecruitingEarly Phase 1

Resin Infiltration Vs Self-Assembling Peptide (P11-4) in Treating White Spot Lesions

Egypt150 participantsStarted 2024-08-30

Plain-language summary

Clinical assessment of the effectiveness of two treatment modalities (self-assembling peptide (P11-4) (alone or combined with fluoride) and resin infiltration) for treating white spot lesions

Who can participate

Age range

7 Years – 14 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age (a range from 7-14 years of age was determined) * Good general health (absence of disease/no handicaps, to ensure oral care at home) * Preserved pulp vitality of the teeth. * Consolidated oral care daily. * Agreement by patient and parents (or guardians) to participate in the study Exclusion Criteria: * Patients with periodontal diseases (periodontal pockets or dental mobility) or radiologically identified pathologies (periapical radiolucency). * Teeth revealing any restorations were excluded from the current study. * Any previous or planned WSL treatment.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Esthetic Improvement of white spot lesion

Timeframe: 6 months

Tooth remineralization

Timeframe: 6 months

Trial details

NCT IDNCT06708481

SponsorOctober 6 University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-02

Contact for this trial

Dina El Kharadly, PHD

02 38355276 dina.yousry.dent@o6u.edu.eg

View on ClinicalTrials.gov More White Spot Lesion trials

Who can participate

Age range

7 Years – 14 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.