Clinical Evaluation of Remineralizing Potential of Remineralizing Agents on WSLs Managment

NCT07111403 | Recruiting

• 1 other identifier: A0108024CD
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate and compare the clinical effect of four different remineralizing agents on initial enamel caries after a two years follow up.

Conditions

Initial Dental Caries; White Spot Lesion of Tooth

Outcome Measures

Primary Outcomes (1)

• ICDAS II scores

  Remineralization will be assessed using visual tactile assessment of white spot lesions based on change in ICDAS II scores (reduction from score 2 to 1, or from score 1 to 0).

  assessment will be done at baseline and after 3, 6, 12 and 24 months.

Secondary Outcomes (1)

• DIAGNOdent score

  assessment will be done at baseline and after 3, 6, 12 and 24 months.

Study Arms (4)

SAP fluoride plus

ACTIVE COMPARATOR

Participants in this group received P11-4 (Curodont Repair™, Biomedical products for tooth preservation) only at baseline. First, the tooth was completely isolated using rubber dam followed by cleaning of the tooth surface with sodium hypochlorite 2% for 20 s, acid etching with phosphoric acid gel 35-37% for 20 s, rinsing and drying.

Procedure: SAP fluoride plus

10% n-HAp

ACTIVE COMPARATOR

A Low-speed handpiece was used to clean the tooth surface with fluoride-free pumice (Pumice powder extra fine, SSWhite, Rio de Janeiro, Brazil) after tooth isolation, rinsing, and drying. after that the material was applied

Procedure: 10% n-HAp.

10% n-BAG.

ACTIVE COMPARATOR

A Low-speed handpiece was used to clean the tooth surface with fluoride-free pumice (Pumice powder extra fine, SSWhite, Rio de Janeiro, Brazil) after tooth isolation, rinsing, and drying. after that the material was applied

Procedure: 10% n-BAG.

Flour Protector S

ACTIVE COMPARATOR

The teeth were dried and a very thin coat of the varnish was applied and allowed to dry for 20 s.

Procedure: Flour Protector S

Interventions

SAP fluoride plus PROCEDURE

The agent was applied by removing the safety clip, activating the applicator and squeezing out the sponge above the lesion and the solution was left to diffuse for 5 min.the patients were instructed to eat only soft foods and avoid hot liquids for two hours. Also, they were educated and motivated about the importance of oral hygiene.

SAP fluoride plus

10% n-HAp. PROCEDURE

the pastes were applied using micro brushes. The excess was removed after four minutes with a cotton swab. The subjects were advised not to drink or eat for 30 minutes after the treatment. The treatment was applied once every week for a period of four weeks.they instructed to adhere to oral hygiene measures.

10% n-HAp

10% n-BAG. PROCEDURE

the pastes were applied using micro brushes. The excess was removed after four minutes with a cotton swab. The subjects were advised not to drink or eat for 30 minutes after the treatment. The treatment was applied once every week for a period of four weeks. patients instructed to adhere to oral hygiene measures.

10% n-BAG.

Flour Protector S PROCEDURE

After application of varnish, the patient was instructed to avoid abrasive diet for the rest of the day and not brush or floss until the next morning. The treatment was done at baseline and after 6 months.

Flour Protector S

Eligibility Criteria

• Age: 14 Years - 26 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Participants should have at least one visible initial enamel caries in the permanent teeth
• Only lesions with ICDAS II score of 1 or 2 could be included
• The patients must have good oral hygiene

You may not qualify if:

• patients receiving tetracyclines, any other medication known to stain teeth - Patients had fluoride application less than 3 months before the study
• Teeth which have microcavities or dentinal involvement due to loss of enamel - Teeth that have discoloration, enamel hypoplasia or fluorosis.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Faculty of Dentistry, Mansoura University, Egypt

Al Mansurah, Egypt

RECRUITING

Study Officials

• Tarek A Arisha, Ass Lecturer

  Faculty of Dentistry, Mansoura University, Egypt

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tarek A Arisha, Ass Lecturer

CONTACT

01063912693; tarekadel@mans.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double (Participant, Investigator) Double (Participant, Investigator)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants in each group received one remineralizing material according to manufacture's instructions or previous studies' recommendations after tooth isolation.

Study Record Dates

• First Submitted: August 1, 2025
• First Posted: August 8, 2025
• Study Start: September 10, 2024
• Primary Completion (Estimated): September 10, 2026
• Study Completion (Estimated): September 17, 2026
• Last Updated: August 13, 2025

Record last verified: 2024-09

Locations

EG (1)