Skip to content

Evaluation of caries control effect of a varnish containing combined nanohydroxyapatite and galla chinensis

Evaluation of the antibacterial and caries prevention effects of a varnish containing combined nanohydroxyapatite and galla chinensis in fixed orthodontic patients

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20220907055913N1
Enrollment
72
Registered
2022-09-16
Start date
2022-10-07
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

dental caries.

Interventions

Intervention 1: Control group: Placebo Varnish. Intervention 2: Intervention group: varnish combined galla chinensis(GCE) and nano hydroxyapatite(HA). HA ( Ca10(Po4) 6(OH)2 , white powder , size of na

Sponsors

Shiraz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
14 Years to 29 Years

Inclusion criteria

Inclusion criteria: The age range of 14 to 29 years Absence of any systemic disease Periodontal health, absence of current caries or enamel demineralization. All permanent dentition is present up to the first molar No history of prior orthodontic or periodontal therapy No smoking habit No use of antibiotics or antibacterial mouthwash in the previous month

Exclusion criteria

Exclusion criteria: Visible sign of dental hypo-calcification Craniofacial anomalies History of cleft lip and palate deformities History of dental restorative treatment on the buccal surface History of long term use of anti-inflammatory drugs History of glass ionomer dental restorative treatment

Design outcomes

Primary

MeasureTime frame
Caries assessment(florescent and visual assesment). Timepoint: Initial values (T?) ,? months(T?), ? months(T?) , ? months(T?) of use of various anti-demineralizing agents. Method of measurement: 1. Visual assessment: All measures will be taken by the same examiner, who is calibrated before the research. Before bonding, the initial visual assessment will be done. The international caries detection and assessment system II (ICDAS II) will be used to inspect and record the buccal surfaces of the test subjects' teeth at each visit. After ? seconds of compressed air drying on the tooth surfaces, the examination will be done. The evaluation will be conducted with the use of a mouth mirror and a blunt probe under clinical illumination in accordance with the ICDAS II index criteria. The mean scores of all ?? maxillary teeth involved in the research will be computed for each patient, and a mean reading number will be recorded. 2. Florescent assessment: 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 the 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 included in the study will be calculated and a mean Diagnodent reading number for each patient will be recorded.

Secondary

MeasureTime frame
Bactreial colony count. Timepoint: plaque sampling and bacterial culturing will be done at the following time intervals: Initial values (T0) ,1 months(T1), 4 months(T2) , 7 months(T3) of use of various anti-demineralizing agents. Method of measurement: On the day of the appointment, the patient will be refrained from eating or brushing their teeth. Ligatures and archwires will be carefully removed at each appointment. The collecting sites will be gently air dried after being isolated of the excess water and saliva with cotton rolls. Plaque samples will be collected using a sterile cotton swab from the labial surfaces of the considered teeth.By moving the tip of the sterile cotton swab along the occlusal, mesial, gingival, and distal edges of the bracket base, and while holding the tip in constant contact with the tooth surface adjacent to the base of bracket, dental plaque will be collected. Sterile cotton swabs will be rapidly transferred to the samples transport media (thioglycolate broth carrier medium) and to anaerobic bacteria culture media. Microbial samples will be cultivated and analyzed by the same examiner in the Department of Clinical Microbiology of Shiraz University of Medical Sciences. According to G. WESTERGREN AND B. KRASSE, the sample will be cultured.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactShabnam Ajami

Shiraz University of Medical Sciences

dr.ajami.sh@gmail.com+98 71 3626 3193

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026