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Completed

NCT Number: NCT04018534

Effects Of Training On Brushing Behavior

This study is a single-blind randomized controlled trial on fixed orthodontic appliance candidates (n = 90) assigned into a control group (n = 30) and two different study groups (n = 30 in each). Patients who requiring non-extraction fixed orthodontic treatment, crowding under 5mm in the incisors and heaving at least 20 permanent teeth with healthy periodontal tissue and devoid of caries were included in the study. The control group received a standard printed educational material assisted with verbal information. The study groups either received video assisted or hands-on training about fixed orthodontic appliance and oral hygiene. The time requirements for all three educational interventions were recorded at the initial visit. The adequacy of oral hygiene is documented through plaque and gingival indices at the initial visit and 8th week of the treatment.

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Key information

Conditions

Orthodontic Appliances Oral Health Training Oral Hygiene

Age range

12 year–22 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Required non-extraction fixed orthodontic treatment, agree to use conventional stainless steel brackets (Gemini series; 3M Unitek, Monrovia, California, USA), at least 20 natural permanent teeth, crowding under 5 mm in the incisors and willing to participate in our research

Exclusion criteria

  • Dental caries, periodontal disease, systemic or chronic diseases such as diabetes, physical or mental disorders, smoking, previous orthodontic treatment, extensive dental restorations, antibiotic use during the previous 3 months, dental fluorosis and use of powered tooth brushes.

Treatment and study plan

Standard Verbal/Written Education

Behavioral

This patients as control group received a standard printed educational material assisted with verbal information in accordance with British Orthodontics Society (BOS) educational goals.

Video Assisted Education

Behavioral

The video training consisted of two separate sessions, each one lasting 5 minutes, one about the treatment materials and the other about the oral hygiene successively and in compliance with the British Orthodontics Society (BOS) educational obligations. All of the candidates were allowed to rewind and watch the video presentation until they reach all of the educational goals. The accomplishment of the educational goals was documented through a written examination form filled in by the candidates themselves. All of the candidates have rated fullscore in the written examinations on both topics.

Hands-on Training

Behavioral

The hands-on training consisting of two separate sessions was performed by one of the authors (E.A). The first is about the treatment materials and the second one is about the oral hygiene successively. They are in accordance with the British Orthodontics Society (BOS) educational obligations. All of the patients were allowed to ask questions freely until they reach all of the educational goals. The accomplishments of the educational goals were documented through a written examination form filled in by the candidates themselves. All of the candidates have rated fullscore in the written examinations on both topics. The time requirements for all three different educational interventions were recorded separately.

Primary outcomes

  1. Plaque index(PI) for oral health assessment.

    Time frame: PI was measured at the 8 weeks later in each patient.

    The brushing habits of the patients were checked at each appointment and were recorded with PI. This measurement of the state of oral hygiene by Silness-Löe plaque index is based on recording both soft debris and mineralized deposits on the following teeth.

  2. Gingival index(GI) for oral health assessment.

    Time frame: GI was measured at the 8 weeks later in each patient.

    This index was used to assess the severity and prevalence of gingivitis.Probe was used as a sensor for GI scoring and the mesial, distal, buccal and lingual surfaces of the teeth were evaluated in patients undergoing fixed orthodontic treatment.

Secondary outcomes

  1. Time duration spent for educational interventions

    Time frame: Average 30 minutes

    The time requirements for all three different educational interventions were recorded separately.These time durations consisted of the education time needed for both fixed appliance components and oral hygiene educations all together.

Sponsors and collaborators

Lead sponsor

Okan University

Other

Collaborators

  • Erol Aktunc
  • Ersan Ilsay Karadeniz
  • Fethiye Cakmak Ozlu

Registry information

Official study title

Effectiveness of Three Different Types Educational Methods on Implementation of Proper Oral Hygiene Behaviour Prior to Orthodontic Treatment

Important dates

Study start
2014
Primary completion
2016
Study completion
2018
First posted
Jul 12, 2019
Registry last updated
Jul 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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