Evaluation of the anti-cariogenic effect of chitosan–nano amorphous calcium phosphate and chitosan-nano hydroxyapatite varnish

Phase 3

Recruiting

• Conditions: Dental caries.

• Registration Number: IRCT20220219054065N1
• Lead Sponsor: Shiraz University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 8 March 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Patients aged 14-29 years old who require fixed orthodontic therapy
All maxillary permanent teeth present up to at least first molars
Good overall health
Good oral hygiene ( with plaque score =20% )
No visible discontinuous band of plaque at the gingival margin of teeth and no bleeding on probing after 30 seconds
Normal stimulated salivary flow rate (>1.0 mL /min) and buffer capacity ( a final pH of 6.0 and 7.0)

Exclusion Criteria

History of any previous orthodontic treatments or extractions
History of using any bleaching agents or topical fluoridation within the last six months
Non-observence of oral hygiene instructions
Sever crowding of >6mm or severely rotated teeth , necessitating extraction of teeth
Blocked out teeth and high buccal teeth that ristricts the patient hygienic access also put limitation for vissual and diagnodent examinations
Any dental morphologic anomaly,intrinsic or extremly heavy extrinsic staining
Visible signs of caries or fluorosis or hypocalcification and also any developmental defects
Existence of dental crowns, amalgam or composite restorations which extended to buccal surface of teeth
Any systemic or endocrine problems ( such as diabetes or cardiovascular diseases), craniofacial anomalies and lip or palatal clefts and smoking habits
Any WSLs present on qualified teeth with and without frank cavitation, alterations of the enamel, e.g. hypoplasia, fluorosis
Chronic use of medication causing a dry mouth or known xerostomia; known pregnancy or breastfeeding during the course of the study
Professional administration or home use of highly concentrated fluoride products not related to the study during the whole study

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fluorescence assessment. Timepoint: every 3 months. Method of measurement: The teeth will be scanned carefully by the same dentist blinded as to group allocation of the subjects using probe tip B held in contact with the tooth surface and tilted around the measuring site rocking slowly in a pendulous motion so that fluorescence can be collected from all directions at 4 labial sites on the enamel (gingival, occlusal, mesial, and distal) around the brackets.The peak reading displayed on the panel of the DIAGNOdent pen during the scan will be recorded for each site of tooth surface. Then the mean of 4 sites for each tooth will be calculated and recorded. For each patient the mean scores of all 10 maxillary teeth that are included in the study will be calculated and a mean DD reading number for each patient will be recorded.