White Spot Lesions Prevention During Orthodontic Fixed Appliance Treatment: a Randomized Clinical Trial

Phase 3

• Conditions: White Spot Lesion of Tooth
• Interventions: Drug: nCaF2 primer; Drug: Control primer

• Registration Number: NCT04994314
• Lead Sponsor: University of Baghdad

Brief Summary

The aim of this study is to evaluate the effectiveness of calcium fluoride nanoparticles containing orthodontic primer in preventing or decreasing the incidence WSLs over a period of 6 months in patients with fixed orthodontic appliances.

This study proposed to be double blinded, split mouth, randomized clinical trial, with equal randomization (1:1 allocation ratio).

Detailed Description

The sample was selected and recruited from patients attending two centres (Orthodontic Department at Karbala Governmental Specialized Dental Center and Almina Dental Private Clinics/Karbala), but the bonding and follow up sessions were done in Almina Dental Private Clinics/Karbala. Patient recruitment was done according to specified inclusion and exclusion criteria.

Intervention procedure planned to be by bonding fixed orthodontic appliances to all patients. The four quadrants of the mouth will be divided into two groups (Group 1 and 2), with one group, the upper right and lower left quadrants bonded with nCaF2 resin, while the upper left and lower right quadrants bonded with control resin. For the other group, the reverse will be carried out. Then, by the use of a computer random number generator, the two groups will be randomly allocated, and each number in the random table will be given a study number in order to create the final Allocation Table for the participants in the study (which contained the study number and allocation group). the primary planned to be measured by DIAGNOdent Pen 2190 device to measure enamel demineralization objectively, while the secondary objective planned to be quantitative detection of Streptococcus mutans bacteria by using real-time PCR

Study Timeline

• Study Start: 2021-02-15
• Study First Submitted: 2021-07-27
• Status Verified: 2021-08
• Study First Submitted QC: 2021-08-05
• Last Update Submitted: 2021-08-05
• Study First Posted: 2021-08-06
• Last Update Posted: 2021-08-06
• Primary Completion: 2021-12-16
• Study Completion: 2022-02-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

• Patients have

  1. Fully erupted permanent teeth (regardless the third molar),
  2. Indication to have orthodontic treatment without extraction
  3. Fair or good oral hygiene before or after oral hygiene instruction

Exclusion Criteria

• Patients will be excluded if they had

  1. Previous orthodontic treatment or extractions
  2. Missing teeth
  3. Active enamel caries determined by clinical examination
  4. Patients with enamel hypoplasia, dental fluorosis or tetracycline pigmentation
  5. Labial restorations
  6. Severe periodontal diseases determined according to PDI index by Sigurd P. Ramfjord (Ramfjord, 1967)
  7. Craniofacial syndromes such as clefts
  8. Xerostomia determined from clinical history of the patient
  9. Severely rotated teeth (limiting the appearance of buccal surfaces)
  10. Heavy smokers determined by accounting the number of cigarettes per day and time to the first cigarette of the day (Heatherton et al., 1989) .

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
orthodontic primer containing calcium fluoride nanoparticles	nCaF2 primer	Fixed appliance for ten maxillary teeth and the contralateral mandibular teeth will be bonded using orthodontic primer containing calcium fluoride nanoparticles
Control primer	Control primer	Fixed appliance for ten maxillary teeth (contralateral to experimental ten side)and the contralateral mandibular teeth will be bonded using conventional primer (TransbondTM XT orthodontic primers (3M-Unitek, Monrovia, USA)

Primary Outcome Measures

Name	Time	Method
DIAGNOdent Pen scores change	Six months	assessing changes in the amount of enamel demineralization (DIAGNOdent Pen scores) between four time points:-; 1. baseline (before brackets bonding); 2. after one month of brackets bonding; 3. after three months of brackets bonding; 4. after six months of brackets bonding

Secondary Outcome Measures

Name	Time	Method
Streptococcus mutans load change	Six months	Quantitative detection of streptococcus mutans load changes (using real time PCR) between four time points:-; 1. baseline (before brackets bonding); 2. after one month of brackets bonding; 3. after three months of brackets bonding; 4. after six months of brackets bonding

Trial Locations

Locations (1)

Almina dental clinics; 🇮🇶 Karbala, Iraq