Jordan University of Science and Technology, Faculty of Dentistry
Irbid, Irbid Governorate, 22110, Jordan
NCT Number: NCT07240428
The goal of this clinical trial is to test the ability of water flosser to remove plaque and reduce gingival inflammation in patients undergoing fixed orthodontic treatment.
The main questions it aims to answer are:
Does water flosser remove plaque effectively in orthodontic patients? Does water flosser reduce gum inflammation in orthodontic patients?
Researchers compared water flosser to interdental brush to see if there is a difference in plaque and inflammation reduction.
Participants used interdental brush to clean between their teeth and around brackets in one side of their mouth, and they used water flosser to clean between the teeth and around brackets in the other side. The study lasted for 3 months.
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Notify Me18 year–35 year
All sexes
Interventional
Not applicable
Irbid, Irbid Governorate, 22110, Jordan
The study lasted for 3 months.
The following will be assessed
1- Plaque score using Rustogi modified navy plaque index for buccal and lingual surfaces, where the tooth was divided into multiple zones as the following :
The divided zones are:
Whole mouth: areas A,B,C,D,E,F,G and H. Marginal (gum line): areas A,B and C. Interproximal: areas D and F
0 score was given the area where there is no plaque.
1 score was given in the area where there is plaque Intraoral photos using professional camera were taken for all teeth and all surfaces to record the plaque score.
3.Visual Analog Scale (VAS) visual analog scale from 0 - 10 (0 - unsatisfied, uncomfortable, or difficult to use, 10 -very satisfied, comfortable, and easy to use) in each visit was taken.
Randomization and Blinding Independent of the clinical assessment, a third-party dentist used a computer-generated random number sequence to determine which side of each patient's mouth will be cleaned by interdental brush and which side will be cleaned by the oral irrigator. While participants were aware of which device they were using on each side, the examiner who performed the clinical examinations was blinded.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants used an interdental brush twice daily after toothbrushing on the assigned side. This method was compared to the use of water floss in the contralateral side (split-mouth design).
Participants used a water flosser twice daily after toothbrushing on the assigned side. Standard pressure setting and specialized tip were used. This method was compared to the use of an interdental brush in the contralateral quadrants (split-mouth design).
Time frame: Baseline, 2 weeks, 4 weeks, 2 month and 3 months
Plaque accumulation assessed using the Rustogi Modified Navy Plaque Index (RMNPI) on designated tooth surfaces in the sides assigned to interdental brush and water flosser. The tooth was divided into multiple zones as the following :
Whole mouth: areas A,B,C,D,E,F,G and H. Marginal (gum line): areas A,B and C. Interproximal: areas D and F
0 score was given the area where there is no plaque.
1 score was given in the area where there is plaque The minimum plaque score per surface (buccal or lingual) is zero, and the maximum plaque score per surface is 8 Intraoral photos using professional camera were taken for all teeth and all surfaces to record the plaque score.
Time frame: Baseline, 2 weeks, 4 weeks, 2 months ,and 3 months
Gingival inflammation was recorded using gingival index at six sites per tooth (distobuccal, midbuccal, mesiobuccal, distolingual/palatal, midlingual/palatal, mesiolingual/palatal) in each intervention side as follows :
0= Normal gingiva.
The minumn score is zero and the maximum score for one surface (buccal or lingual/palatal is 9.
Time frame: 2 Weeks, 4 weeks, 2months, and 3months
visual analog scale from 0 - 10 (0 - unsatisfied, uncomfortable, or difficult to use, 10 -very satisfied, comfortable, and easy to use)
King Abdullah University Hospital
Other
Comparison Between Interdental Brush and Water Floss on Plaque Accumulation and Gingival Inflammation in Patients Undergoing Fixed Orthodontic Treatment: A Single Blinded Split-Mouth Randomized Controlled Clinical Trial
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