Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04018534
Other study ID # 11022014
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 5, 2014
Est. completion date November 24, 2018

Study information

Verified date July 2019
Source Okan University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date November 24, 2018
Est. primary completion date June 6, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years to 22 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Standard Verbal/Written Education
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
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
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.

Locations

Country Name City State
n/a

Sponsors (4)

Lead Sponsor Collaborator
Okan University Erol Aktunc, Ersan Ilsay Karadeniz, Fethiye Cakmak Ozlu

Outcome

Type Measure Description Time frame Safety issue
Primary Plaque index(PI) for oral health assessment. 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. PI was measured at the 8 weeks later in each patient.
Primary Gingival index(GI) for oral health assessment. 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. GI was measured at the 8 weeks later in each patient.
Secondary Time duration spent for educational interventions 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. Average 30 minutes
See also
  Status Clinical Trial Phase
Completed NCT04025684 - Efficacy of Manual Toothbrushes in Removing Dental Plaque N/A
Completed NCT05644236 - Safety and Efficacy Evaluation of Mouth Wash(Glister Mouth Wash): Pilot Study N/A
Completed NCT03267511 - A Study to Investigate the Stain and Plaque Removal Capability of Two Experimental Potassium Nitrate Dentifrices Phase 2
Completed NCT01962493 - An Efficacy Study of Stain Control of a 67% Sodium Bicarbonate Containing Toothpaste on Chlorhexidine Tooth Staining Phase 4
Completed NCT01237782 - Efficacy of a Propolis-based Denture Cleanser N/A
Completed NCT05459558 - Clinical Study to Investigate the Tooth Stain Removal Efficacy of Two Experimental Toothpastes Compared to a Standard Toothpaste When Used Twice Daily for 8 Weeks N/A
Completed NCT03390452 - Mobile Phone Messaging To Improve Oral Hygiene Among Primary School Children in Pakistan N/A
Withdrawn NCT03947203 - Oral Health Promotion: Youth as Agents Of Change N/A
Completed NCT01954212 - Stroke Oral healthCare pLan Evaluation Phase 2
Completed NCT01948349 - Impact of Bracket Design and Oral Hygiene Maintenance on Halitosis in the Orthodontic Patient N/A
Completed NCT00103493 - Oral Health Education Program Phase 3
Not yet recruiting NCT05527613 - Evaluation of the Efficacy of a Messaging Application to Improve Oral Hygiene in Orthodontic Patients.ECA N/A
Completed NCT05304338 - Evaluation of the Effect of Oil Pulling N/A
Recruiting NCT06080321 - Oral Hygiene Compliance in Orthodontic Patients Using Active Reminders N/A
Completed NCT05515510 - Acceptance and Efficacy of a Digital Application Among Parents to Control Early Childhood Caries N/A
Active, not recruiting NCT06150573 - A Study Assessing the Effects of an Experimental Dentifrice in Maintaining Tooth Color Following Tooth Bleaching N/A
Recruiting NCT06164496 - Evaluation of the Effectiveness of Different Toothbrushes in Children N/A
Recruiting NCT05697432 - Orodental Hygiene in Children With Special Needs N/A
Recruiting NCT04410250 - Effect of Oral Hygienization in Newborn on Candida Spp Colonization N/A
Completed NCT04095780 - The Effectiveness of Oral Health Promotion on Pneumonia Complicating Stroke N/A