Fluoride Varnish, Ozone, Octenidin and WSLs in Orthodontic Patients

NCT04992481 | Completed DMC

• 1 other identifier: KB-0012/124/12
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

Objectives: to assess the efficiency of four prophylactic protocols on white spot lesions during orthodontic treatment: 1. professional mechanical tooth cleaning (PMTC)+fluoride varnish, 2. PMTC+fluoride varnish+gaseous ozone therapy 3. PMTC+fluoride varnish+domestic octenidin mouth rinse, 4. PMTC+fluoride varnish+domestic octenidin mouth rinse+ gaseous ozone therapy versus a control group not subjected to any prophylactic program. Materials and Methods: Patients (n=150, 111 women and 39 men, age 16-50y,) who began orthodontic treatment with fixed appliances bonded to both dental arches have been provided with detailed initial oral hygiene instruction recommendations. The hygienic recommendations comprised: toothbrushing every surface after every meal (4 minutes) with a fluoridated toothpaste (1450 ppm) using the roll and Bass methods with a soft toothbrush recommended for fixed appliance, interdental toothbrushes, single-tufted brushes and dental floss recommended for fixed appliance. An instruction leaflet has been delivered to every subject, as well. A reinstruction was made during every control visit referring to the results of the oral hygiene assessment. Subsequently, the patients were randomly allocated (using number random generator) into five groups (n=30), including four study groups (I, II, III, IV) and one control group (K). Group I: professional mechanical tooth cleaning (PMTC)+fluoride varnish, group II: PMTC+fluoride varnish+gaseous ozone therapy, group III: PMTC+fluoride varnish+domestic octenidin mouth rinse, group IV: PMTC+fluoride varnish+domestic octenidin mouth rinse+ gaseous ozone therapy, control group (K) not subjected to any prophylactic program. The period of observation was 12 months, with prophylactic visits every four weeks and examinations every 12 weeks. The assessment of white spot lesions was proceeded on the labial surfaces of upper and lower teeth, with patient on the dental chair in proper dental lighting, after cleaning and drying the assessed surfaces.

Conditions

White Spot Lesion of Tooth

Keywords

white spot; orthodontic treatment; caries prophylaxis

Outcome Measures

Primary Outcomes (1)

• WSLs presence on teeth

  The assessment of white spot lesions was proceeded on the labial surfaces of upper and lower teeth, with patient on the dental chair in proper dental lighting, after cleaning and drying the assessed surfaces. WSL index according to Gorelick et al. \[28\] was used as follows: 0 - no visible WSL or surface disruption (no demineralization) * visible WSL, covering less than 1/3 of surface, without surface disruption (mild demineralization) * visible WSL, covering more than 1/3 of the surface, with a roughened surface, but not requiring restoration (moderate demineralization) * visible cavitation, requiring restoration (severe demineralization) Every dental surface was subjected to visual-tactile examination performed on a dental chair with proper dental lighting, using dental probe and a mirror. Caries was diagnosed on the level of cavitation, the presence of fillings has been noted as well.

  12 months

Study Arms (5)

1. professional mechanical tooth cleaning (PMTC)+fluoride varnish

EXPERIMENTAL

This arm constituted of randomly selected 30 participants. In this group professional mechanical tooth cleaning (PMTC)+fluoride varnish were performed.

Procedure: PMTC; Procedure: fluoride varnish

2. PMTC+fluoride varnish+gaseous ozone therapy

EXPERIMENTAL

This arm constituted of randomly selected 30 participants. In this group PMTC+fluoride varnish+gaseous ozone therapy were performed.

Procedure: PMTC; Procedure: fluoride varnish; Procedure: gaseous ozone therapy

3. PMTC+fluoride varnish+domestic octenidin mouth rinse

EXPERIMENTAL

This arm contituted of randomly selected 30 participants. In this group PMTC+fluoride varnish+domestic octenidin mouth rinse were applied.

Procedure: PMTC; Procedure: fluoride varnish; Procedure: domestic octenidin mouth rinse

4. PMTC+fluoride varnish+domestic octenidin mouth rinse+ gaseous ozone therapy

EXPERIMENTAL

This arm constituted of randomly selected 30 participants. In this group PMTC+fluoride varnish+domestic octenidin mouth rinse+ gaseous ozone therapy were performed.

Procedure: PMTC; Procedure: fluoride varnish; Procedure: gaseous ozone therapy; Procedure: domestic octenidin mouth rinse

Control group

NO INTERVENTION

Control group not subjected to any prophylactic program constituted of randomly selected 30 participants.

Interventions

PMTC PROCEDURE

In patients from the study groups I, II, III, IV a professional mechanical tooth cleaning (PMTC) including air-polishing was proceeded on every visit using a glycine-based prophylaxis powder (Air-Flow Soft, EMS, Switzerland).

1. professional mechanical tooth cleaning (PMTC)+fluoride varnish; 2. PMTC+fluoride varnish+gaseous ozone therapy; 3. PMTC+fluoride varnish+domestic octenidin mouth rinse; 4. PMTC+fluoride varnish+domestic octenidin mouth rinse+ gaseous ozone therapy

fluoride varnish PROCEDURE

In patients from groups I, II, III, IV a fluoride varnish of 5% NaF (Profluorid Varnish, Voco, Germany) was applied with a microbrush. Every patient was instructed to stop from drinking and eating for the next two hours (as recommended by the manufacturer).

1. professional mechanical tooth cleaning (PMTC)+fluoride varnish; 2. PMTC+fluoride varnish+gaseous ozone therapy; 3. PMTC+fluoride varnish+domestic octenidin mouth rinse; 4. PMTC+fluoride varnish+domestic octenidin mouth rinse+ gaseous ozone therapy

gaseous ozone therapy PROCEDURE

Patients from groups II and IV were additionally subjected to in-office ozone therapy using OzonyTron-OZ (Mymed, Germany). Ozone was applied on a silicone double-jaw tray of a proper size (allowing even ozone distribution in the oral cavity) following professional mechanical tooth cleaning. A Full Mouth Desinfection program lasting 5 minutes was used.

2. PMTC+fluoride varnish+gaseous ozone therapy; 4. PMTC+fluoride varnish+domestic octenidin mouth rinse+ gaseous ozone therapy

domestic octenidin mouth rinse PROCEDURE

Patients from groups III and IV received a domestic mouthrinse (Octenidol MD, Schülke, Germany) and were recommended to use 15 ml of the liquid for 30 seconds after evening toothbrushing.

3. PMTC+fluoride varnish+domestic octenidin mouth rinse; 4. PMTC+fluoride varnish+domestic octenidin mouth rinse+ gaseous ozone therapy

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• permanent dentition
• fixed appliances bonded to both dental arches (no more than 4 weeks prior to the study)

You may not qualify if:

• inborn tooth anormalities
• prosthetics restorations

Sponsors & Collaborators

• Pomeranian Medical University Szczecin: lead

Related Publications (22)

• Øgaard B: White spot lesions during orthodontic treatment: mechanisms and fluoride preventive aspects. Semin Orthod. 2008;14:183-193

  RESULT

• Scheie AA, Arneberg P, Krogstad O. Effect of orthodontic treatment on prevalence of Streptococcus mutans in plaque and saliva. Scand J Dent Res. 1984 Jun;92(3):211-7. doi: 10.1111/j.1600-0722.1984.tb00881.x.

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• Fejerskov O, Nyvad B, Kidd E: Clinical and histological manifestations of dental caries. In: Fejerskov O, Kidd E, editors. Dental caries: the disease and its clinical management. Copenhagen, Denmark: Blackwell Munksgaard; 2003, p. 71-99.

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• Tufekci E, Dixon JS, Gunsolley JC, Lindauer SJ. Prevalence of white spot lesions during orthodontic treatment with fixed appliances. Angle Orthod. 2011 Mar;81(2):206-10. doi: 10.2319/051710-262.1.

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• Kozak U, Sekowska A, Chalas R. The Effect of Regime Oral-Hygiene Intervention on the Incidence of New White Spot Lesions in Teenagers Treated with Fixed Orthodontic Appliances. Int J Environ Res Public Health. 2020 Dec 17;17(24):9460. doi: 10.3390/ijerph17249460.

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  PMID: 20691360 RESULT

• Maxfield BJ, Hamdan AM, Tufekci E, Shroff B, Best AM, Lindauer SJ. Development of white spot lesions during orthodontic treatment: perceptions of patients, parents, orthodontists, and general dentists. Am J Orthod Dentofacial Orthop. 2012 Mar;141(3):337-344. doi: 10.1016/j.ajodo.2011.08.024.

  PMID: 22381494 RESULT

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  PMID: 17693365 RESULT

• Stecksen-Blicks C, Renfors G, Oscarson ND, Bergstrand F, Twetman S. Caries-preventive effectiveness of a fluoride varnish: a randomized controlled trial in adolescents with fixed orthodontic appliances. Caries Res. 2007;41(6):455-9. doi: 10.1159/000107932. Epub 2007 Sep 7.

  PMID: 17827963 RESULT

• Ogaard B, Larsson E, Henriksson T, Birkhed D, Bishara SE. Effects of combined application of antimicrobial and fluoride varnishes in orthodontic patients. Am J Orthod Dentofacial Orthop. 2001 Jul;120(1):28-35. doi: 10.1067/mod.2001.114644.

  PMID: 11455374 RESULT

• Geiger AM, Gorelick L, Gwinnett AJ, Benson BJ. Reducing white spot lesions in orthodontic populations with fluoride rinsing. Am J Orthod Dentofacial Orthop. 1992 May;101(5):403-7. doi: 10.1016/0889-5406(92)70112-N.

  PMID: 1590288 RESULT

• Demito CF, Vivaldi-Rodrigues G, Ramos AL, Bowman SJ. The efficacy of a fluoride varnish in reducing enamel demineralization adjacent to orthodontic brackets: an in vitro study. Orthod Craniofac Res. 2004 Nov;7(4):205-10. doi: 10.1111/j.1601-6343.2004.00305.x.

  PMID: 15562583 RESULT

• Msallam FA, Grawish ME, Hafez AM, Abdelnaby YL. Decalcification prevention around orthodontic brackets bonded to bleached enamel using different topical agents. Prog Orthod. 2017 Dec;18(1):15. doi: 10.1186/s40510-017-0170-4. Epub 2017 Jun 12.

  PMID: 28580541 RESULT

• Sharda S, Gupta A, Goyal A, Gauba K. Remineralization potential and caries preventive efficacy of CPP-ACP/Xylitol/Ozone/Bioactive glass and topical fluoride combined therapy versus fluoride mono-therapy - a systematic review and meta-analysis. Acta Odontol Scand. 2021 Aug;79(6):402-417. doi: 10.1080/00016357.2020.1869827. Epub 2021 Jan 16.

  PMID: 33459095 RESULT

• Hochli D, Hersberger-Zurfluh M, Papageorgiou SN, Eliades T. Interventions for orthodontically induced white spot lesions: a systematic review and meta-analysis. Eur J Orthod. 2017 Apr 1;39(2):122-133. doi: 10.1093/ejo/cjw065.

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• Tahmasbi S, Mousavi S, Behroozibakhsh M, Badiee M. Prevention of white spot lesions using three remineralizing agents: An in vitro comparative study. J Dent Res Dent Clin Dent Prospects. 2019 Winter;13(1):36-42. doi: 10.15171/joddd.2019.006. Epub 2019 Apr 24.

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• Lale S, Solak H, Hincal E, Vahdettin L. In Vitro Comparison of Fluoride, Magnesium, and Calcium Phosphate Materials on Prevention of White Spot Lesions around Orthodontic Brackets. Biomed Res Int. 2020 Mar 30;2020:1989817. doi: 10.1155/2020/1989817. eCollection 2020.

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• Hu H, Feng C, Jiang Z, Wang L, Shrestha S, Yan J, Shu Y, Ge L, Lai W, Hua F, Long H. Effectiveness of remineralizing agents in the prevention and reversal of orthodontically induced white spot lesions: a systematic review and network meta-analysis. Clin Oral Investig. 2020 Dec;24(12):4153-4167. doi: 10.1007/s00784-020-03610-z. Epub 2020 Oct 15.

  PMID: 33057826 RESULT

• Gorelick L, Geiger AM, Gwinnett AJ. Incidence of white spot formation after bonding and banding. Am J Orthod. 1982 Feb;81(2):93-8. doi: 10.1016/0002-9416(82)90032-x.

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• Grocholewicz K, Miklasz P, Zawislak A, Sobolewska E, Janiszewska-Olszowska J. Fluoride varnish, ozone and octenidine reduce the incidence of white spot lesions and caries during orthodontic treatment: randomized controlled trial. Sci Rep. 2022 Aug 17;12(1):13985. doi: 10.1038/s41598-022-18107-w.

  PMID: 35978074 DERIVED

Study Officials

• Katarzyna Grocholewicz, DDS, PhD

  Pomeranian Medical University, Szczecin, Poland

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The patients have been randomly divided (using number random generator) into five groups (n=30), including four study groups (I, II, III, IV) and one control group (K).
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: To participate in the study 167 healthy adults (16-50 years) who began orthodontic treatment with fixed appliances bonded to both dental arches were eligible and consecutively invited. Informed consent was obtained from 150 patients (111 women and 39 men). The patients have been randomly divided (using number random generator) into five groups (n=30), including four study groups (I, II, III, IV) and one control group (K).

Study Record Dates

• First Submitted: July 19, 2021
• First Posted: August 5, 2021
• Study Start: February 1, 2013
• Primary Completion: June 30, 2016
• Study Completion: June 30, 2016
• Last Updated: August 12, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share