Trial document




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  DRKS00012540

Trial Description

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Title

Efficacy of Fluor-Protector S fluoride varnish for preventing white-spot lesions and gingivitis in fixed orthodontic treatment of patients with high risk of caries - a randomized controlled trial

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Orthodontics is a part of dentistry and treats tooth and jaw misalignments. For the treatment of tooth misalignments, the use of a fixed multi-bracket appliance (MB) is generally necessary. These appliances frequently need to be in place 2 to 3 years. Initial caries and gingivitis are frequent undesired side effects during fixed orthodontic treatment (Zachrisson and Zachrisson 1971, Ogaard 1989). They are often caused by the limited oral hygiene ability due to the fixed appliance. Many studies have shown that fluorides can prevent tooth decay (Marinho 2009). For this reason, various fluoride-containing products have been developed to reduce the risk of caries development during orthodontic treatment with fixed appliances. Various studies report a positive effect of fluoride-containing oral hygiene products such as toothpastes, mouthwashes and gels. Orthodontists often use a fluoride varnish for bracket area sealing at the beginning of orthodontic therapy. Various studies have already demonstrated the protective efficacy of fluoride varnishes (Denes and Gabris 1991, Demito et al., 2011).
However, it is not yet known whether the fluoride concentration of FluorProtector S varnish for orthodontic bracket area sealing is sufficient to provide adequate or additional protection regarding initial caries, gum inflammation and dental plaque development in the recommended application interval (every 3 months) in patients with high caries risk compared to sufficient domestic oral hygiene with a fluoride-containing adult toothpaste. We therefore want to investigate in juvenile patients scheduled for fixed orthodontic therapy (buccal technique), whether an application of Fluor Protector S or a placebo varnish at the beginning of therapy and every 3 months on the tooth surfaces with bracket has an additional protective effect with respect to white-spot lesions, the accumulation of dental plaque and gum inflammation determined by means of established clinical indices, compared to adequate domestic oral hygiene by itself.

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Brief Summary in Scientific Language

Orthodontics is a part of dentistry and treats tooth and jaw misalignments. For the treatment of tooth misalignments, the use of a fixed multi-bracket appliances (MB) is generally necessary. The brackets are attached to the teeth by means of an adhesive gluing technique. The orthodontic archwires are fixed in the brackets and the teeth are guided and moved into their correct positions. These devices frequently need to be in place 2 to 3 years. White spot lesions (WSL) as a sign of initial enamel demineralization and consecutive caries (O'Reilly and Featherstone 1987), and accompanying gingivitis (LOE et al., 1965, Theilade et al., 1966) are frequent undesirable side effects during fixed orthodontic treatment (Zachrisson and Zachrisson, 1971, Ogaard, 1989).
Reasons for the high incidence are the limited oral hygiene ability due to the fixed appliance (Vivaldi-Rodrigues et al., 2006) and the increased adhesion of a pathogenic biofilm to the orthodontic brackets and synthetic bonding materials. As WSLs can not be fully restored therapeutically, the primary goal of the orthodontic practitioner must be to avoid such lesions (Sudjalim et al., 2006, Chambers et al., 2013).
The incidence and prevalence of enamel demineralizations and plaque-induced gingivitis are closely correlated with the patient's willingness to use adequate preventive measures (Julien et al., 2013). It is the responsibility of orthodontists to actively counteract their development by selecting a suitable prophylactic concept (Featherstone 2000, Derks et al., 2004, Bergstrand and Twetman 2011, Zabokova-Bilbilova et al., 2014). Preventive measures must be carried out in close cooperation between the orthodontist and the dentist, who often supports prophylaxis during orthodontic treatment (Helminen and Vehkalahti 2003).
Many studies have shown that fluorides can prevent enamel demineralizations and caries (Marinho 2009). For this reason, various fluoride-containing products have been developed to reduce the risk of WSL development in general as well as during orthodontic treatment with fixed appliances. Various studies report a positive effect of fluoride-containing oral hygiene products such as toothpastes, mouthwashes and gels. The effectiveness of the prevention of gingivitis has also been demonstrated for these products (Geiger et al 1992, Boyd 1993, 1994). However, since the effectiveness of the products is largely dependent on the cooperation of the patients (Geiger et al., 1992), orthodontists often use a varnish with high fluoride content at the beginning of orthodontic therapy. Various studies have shown a protective effect of fluoride varnishes (Denes and Gabris 1991, Demito et al., 2011). Regular use is particularly recommended in patients with high caries risk and limited access to fluoride-containing products (Autio-Gold 2008, Quock and Warren-Morris 2011).
The American Dental Association (ADA), the American Association of Pediatric Dentistry (AAPD), as well as the manufacturers of fluoride varnishes recommend the application of a fluoride varnish every 3 months in all patients between 6 and 18 years of age, if there is high risk of caries. According to this recommendation, a fluoride varnish is often applied adjacent to brackets in these patients at the beginning of the treatment by the orthodontist, and reapplied at intervals of 3 months.
Despite the probable preventive effect of fluorides (Marinho 2009) and fluoride varnishes (Denes and Gabris 1991), it is not yet known whether the fluoride concentration of FluorProtector S for orthodontic bracket area sealing is sufficiently effective in the recommended application interval (every 3 months) to develop a sufficient or additional protective effect with respect to the development of white spot lesions, plaque and gingivitis compared to a sufficient domestic oral hygiene with a fluoride-containing adult toothpaste. We therefore want to investigate in juvenile patients scheduled for fixed orthodontic therapy (buccal technique), whether an application of Fluor Protector S or a placebo varnish at the beginning of therapy and every 3 months on the tooth surfaces with bracket has an additional protective effect with respect to white-spot lesions, the accumulation of dental plaque and gum inflammation determined by means of established clinical indices, compared to adequate domestic oral hygiene by itself.

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Organizational Data

  •   DRKS00012540
  •   2017/06/08
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  •   yes
  •   Approved
  •   17-420-101, Ethikkommission an der Universität Regensburg
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Secondary IDs

  •   U1111-1196-9875 
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Health Condition or Problem studied

  •   K02.0 -  Caries limited to enamel
  •   K05.0 -  Acute gingivitis
  •   K05.1 -  Chronic gingivitis
  •   K03.6 -  Deposits [accretions] on teeth
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Interventions/Observational Groups

  •   Intervention 1: Instructions on home oral hygiene and nutrition
    Intervention 2: study-independent fixed orthodontic therapy in buccal technique
    Intervention 3: application of a placebo varnish at the beginning of fixed therapy and after 3 months (1x/3 months)
  •   Intervention 1: Instructions on home oral hygiene and nutrition
    Intervention 2: study-independent fixed orthodontic therapy in buccal technique
    Intervention 3: application of Fluor Protector S varnish at the beginning of fixed therapy and after 3 months (1x/3 months)
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, assessor, data analyst
  •   Placebo
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

ICDAS-II-INDEX - Measurement of white-spot / caries progression by clinical-visual assessment of the extent of the enamel / demineralization / initial caries on the buccal tooth surfaces with a score value (Likhert scale). Times: T-1, recruitment: appointment at least 30 days before the start of the fixed orthodontic therapy; T0, baseline: after bonding the brackets and removing the excess material; T1, 3 months: after 3 months of fixed therapy; T2, 6 months: after six months of fixed therapy (in case of a coincidence with the therapy end before debonding); T3: immediately after debonding


ENAMEL DECALCIFICATION INDEX (EDI) - Measurement of white-spot / caries-extension by visual assessment of the extent of enamel demineralization by means of intraoral images with a score value (Likhert scale). Times: T0, Baseline: after bonding the brackets and removing excess material; T1, 3 months: after 3 months of fixed therapy; T2, 6 months: after six months of fixed therapy (in case of a coincidence with the therapy end before debonding); T3: immediately after debonding

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Secondary Outcome

MODIFIED PLAQUE INDEX ACCORDING TO SILNESS / LOE (MPI) - Clinical-visual assessment of the extent of plaque accumulation on the buccal tooth surfaces with a score value (Likhert scale). Timing: T-1, recruitment: appointment at least 30 days before the start of the orthodontic therapy, at which the patient is selected as a potential paticipant; T0, baseline: before cleaning the teeth and bonding of the brackets (at the beginning of the session); T1, 3 months: after 3 months of fixed therapy; T2, 6 months: after 6 months of fixed therapy; T3: immediately after debonding


GINGIVAL INDEX ACCORDING TO SILNESS / LOE (1963) - Clinical-visual assessment of the extent of gingivitis per gingival margin / tooth with a score value (Likhert scale). Timing: T-1, recruitment: appointment at least 30 days before the start of the orthodontic therapy, at which the patient is selected as a potential participant; T0, baseline: before cleaning the tooth and bonding the brackets (at the beginning of the session); T1, 3 months: after 3 months of fixed therapy; T2, 6 months: after 6 months of fixed therapy; T3: immediately after debonding

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2017/06/12
  •   44
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   18   Years
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Additional Inclusion Criteria

• Patients before starting a fixed orthodontic therapy in buccal technique (in both dental arches) with a minimum expected treatment period of 6 months
• Bonding of brackets in the upper and lower arch on the same day (T0)
• no previous or paused fixed orthodontic therapy
• all permanent incisors, canines and premolars in both arches are present or erupted (5-5)
• All anterior teeth and premolars in both arches are intended to be fit with a bracket (20 tooth surfaces / participant).

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Exclusion Criteria

• Patients ≥ 18 years (adults)
• Pregnancy or lactation
• Application of a dental fluoride varnish or other caries-protective varnish preparations within the last 12 months
• Patients with a low to moderate caries risk (corresponding to 4 assessment parameters)
• Enamel changes (fluorosis, hypocalcification, etc.)
• Fillings and restorations in buccal tooth surfaces (with bracket)
• Syndrome patients and patients with reduced oral hygiene ability or ability to perform the study properly
• systemic, endocrine or oral diseases (diabetes, periodontitis, open oral wounds / ulcers, etc.), poor general condition
• alcohol / drug abuse, smoking (tobacco), long-term medications or antibiotics / antisialoga / steroids or other medicines affecting the saliva, biofilm or the tooth holding apparatus in the last 6 months
• local fluoride content in domestic drinking water> 0.2ppm F-
• Allergy / intolerance to fluorides or the preparations used
• Missing written consent
• Patients who are not prepared to comply with the protocol (no additional fluoride / PZR, dental treatment in consultation with orthodontists, oral hygiene, etc.)

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Addresses

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    • Poliklinik für Kieferorthopädie,Universitätsklinikum Regensburg
    • Franz-Josef-Strauß-Allee 11
    • 93053  Regensburg
    • Germany
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    • Poliklinik für Kieferorthopädie,Universitätsklinikum Regensburg
    • Mr.  PD Dr. Dr.  Christian  Kirschneck 
    • Franz-Josef-Strauß-Allee 11
    • 93053  Regensburg
    • Germany
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    • Poliklinik für Kieferorthopädie,Universitätsklinikum Regensburg
    • Mr.  PD Dr. Dr.  Christian  Kirschneck 
    • Franz-Josef-Strauß-Allee 11
    • 93053  Regensburg
    • Germany
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Sources of Monetary or Material Support

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    • Poliklinik für Kieferorthopädie,Universitätsklinikum Regensburg
    • Franz-Josef-Strauß-Allee 11
    • 93053  Regensburg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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