Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06358066
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-23
First Post:
2024-03-29
Brief Title:
The Remineralization of Early Enamel Caries in Permanent Teeth
Sponsor:
Tanta University
Organization:
Tanta University
Study Overview
Official Title:
Clinical Evaluation of Biomimetic Self -Assembling Peptide p11-4 in The Remineralization of Early Enamel Caries in Permanent Teeth
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Evaluate clinically the remineralizing potential of self-assembling peptide P11-4 fluoride plus in early enamel carious lesions of permanent anterior teeth
Detailed 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 22600ppm Dentkist-korea Charm varnish R
Self-assembling peptide p11-4 Sodium Fluoride 005 WaterChlorhexidine digluconateTromethamine Trehalose Dihydrate Oligopeptide-104 HydroxyPropyl MethylCelluloseCitric AcidSodium Hydroxide Credentis AG Windisch Switzerland CURODONT Repair fluoride plus Polishing paste fluoride free Titanium Oxide Crosstex- ChicagoUS 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 2021
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 data2223
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 manufacturers 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
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 22600ppm Dentkist-korea Charm varnish R
Self-assembling peptide p11-4 Sodium Fluoride 005 WaterChlorhexidine digluconateTromethamine Trehalose Dihydrate Oligopeptide-104 HydroxyPropyl MethylCelluloseCitric AcidSodium Hydroxide Credentis AG Windisch Switzerland CURODONT Repair fluoride plus Polishing paste fluoride free Titanium Oxide Crosstex- ChicagoUS 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 2021
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 data2223
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 manufacturers 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None