The Remineralization of Early Enamel Caries in Permanent Teeth

White Spot Lesion Clinical Trial

Official title:

Clinical Evaluation of Biomimetic Self -Assembling Peptide (p11-4) in The Remineralization of Early Enamel Caries in Permanent Teeth

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06358066
• Other study ID #: self assembling peptides
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: April 6, 2024
• Est. completion date: December 6, 2024

Study information

• Verified date: April 2024
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluate clinically the remineralizing potential of self-assembling peptide ( P11-4) fluoride plus in early enamel carious lesions of permanent anterior teeth.

Description:

Study design This study will be conducted as a randomized controlled clinical trial. Study setting The study will be carried out in the clinic of Pediatric Dentistry Department, Faculty of Dentistry, Tanta University. Group assignment: Fifty children will be randomly allocated using simple random table into two groups as follows: - Group I (study group): Teeth will be treated with self-assembling peptide (P11-4) fluoride plus varnish. - Group II (control group): Teeth will be treated with fluoride varnish. Ethical consideration The purpose of the present study will be explained to both the parents and children and informed consents will be obtained as well as ascents from children .The researcher will be obligated to do dental treatment for every child according to his-her condition as compensation according to the guidelines on human research adopted by the Research Ethics Committee, Faculty of Dentistry, Tanta University. Materials to be used in the study: Materials Composition Manufacture Trade names Fluoride varnish 5% sodium fluoride (22.600ppm) Dentkist-korea Charm varnish R Self-assembling peptide p11-4 Sodium Fluoride 0.05% Water,Chlorhexidine digluconate,Tromethamine, Trehalose Dihydrate, Oligopeptide-104, HydroxyPropyl MethylCellulose,Citric Acid,Sodium Hydroxide Credentis AG, Windisch, Switzerland CURODONT Repair ™ fluoride plus Polishing paste fluoride free Titanium Oxide Crosstex- Chicago,US Sparkle Free Prophy Paste Methods 1. Clinical examination and assessments: - Full dental and medical history for the children will be recorded in the child chart. - Children will be examined under reflector light conditions using sterile mirrors and blunt end probes with compressed air. - Labial surface of one anterior tooth in each child will be cleaned and plaque debris will be removed using a prophylaxis paste fluoride free and a polishing brush 20,21,. - Early enamel carious Lesions will be assessed according to the International Caries Detection and Assessment System (ICDAS II; ranging between 1-3) and Laser fluorescence (LF) measurements DIAGNOdent* will be conducted and values will be recorded as baseline data22,23. 2. Clinical procedure: - The selected teeth will be isolated with rubber dam. - The labile surface of the teeth will be gently cleaned and dried with air syringe. - In Group I: Self-assembling peptide (P11-4) fluoride plus will be applied according to the manufacturer's instructions by pushing the two cylinders together and will left for 5 min till the tooth surface appears dry to insure its diffusion 15. - In Group II: Fluoride varnish will be applied under manufacturer instructions by applying thin layer of varnish with a brush in strokes 24. In all groups children will be advised to: - Not to rinse his or her mouth, eat, or drink for at least 30 minutes after the treatment, only soft food and drink can be consumed in the day of treatment 22. - The children use a soft toothbrush and fluoridated toothpaste as an oral hygiene regimen23. 3. Evaluation: The remineralizing process of the early enamel carious lesions will be assessed qualitatively using ICDAS II scoring system (table 1) and quantitatively using the laser fluorescence DIAGNOdent measuring at baseline 1, 3, 6 months post-treatment

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 6, 2024
• Est. primary completion date: October 6, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 14 Years

Eligibility

Inclusion Criteria:

• • Presence of active non-cavitated carious white spot lesions with DIAGNO/dent reading from 5 to 17 ,on labial surfaces of permanent anterior teeth and International Caries Detection And Assessment System II (ICDAS II) ranging between 1 and 3.
• The children' age range between 10 to14 years old.
• Children had completed fixed orthodontic treatment within the past week.
• Good oral hygiene with a plaque index score 0 or 1.
• No systemic diseases or medication affecting salivary flow.

Exclusion Criteria:

• Children with tetracycline pigmentation, dental fluorosis, or enamel hypoplasia.
• Children had fluoride application less than 3 months before the study.
• Presence of restoration and cavitation on the surface to be treated.

Related Conditions & MeSH terms

• White Spot Lesion

Intervention

Device:
• diagnodent
The remineralizing process of the early enamel carious lesions will be assessed quantitatively using the laser fluorescence DIAGNOdent measuring at baseline 1, 3, 6 months post-treatment

Diagnostic Test:
• ICDAS 2
The remineralizing process of the early enamel carious lesions will be assessed qualitatively using ICDAS II scoring system

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	measurement of mineral contents of teeth with early carious lesions among 2 arms. quantitatively using the laser fluorescence DIAGNOdent and qualitatively using ICDAS II scoring system	95% confidence limit; 80% power of the study; Successful rate of re-mineralizing effect at 60% among least treatment group compared with 95% in the most favorable treatment groups. 16 The sample size based on the previously mentioned criteria was found at N=23 in each group. The researcher will increase the sample size to 25 patients in each group to compensate for incomplete results and default rate diagnodent scale : Score 1: 0-4 (healthy tooth structure) Score 2: 5-10 (outer half enamel caries) Score 3: 11-20 (inner half enamel caries) scoring criteria of the ICDAS II system for coronal smooth surface caries: 0 Sound tooth surface; Enamel first visual change; Enamel distinct visual change; Enamel initial breakdown; Underlying dark shadow from dentine; Distinct cavity with visible dentine; Extensive (more than half the surface) distinct cavity	1 month
Secondary	measurement of mineral contents of teeth with early carious lesions among 2 arms. quantitatively using the laser fluorescence DIAGNOdent and qualitatively using ICDAS II scoring system	Diagnodent scale Score 1: 0-4 (healthy tooth structure) Score 2: 5-10 (outer half enamel caries) Score 3: 11-20 (inner half enamel caries) scoring criteria of the ICDAS II system for coronal smooth surface caries: 0 Sound tooth surface; Enamel first visual change; Enamel distinct visual change; Enamel initial breakdown; Underlying dark shadow from dentine; Distinct cavity with visible dentine; Extensive (more than half the surface) distinct cavity	3 months