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The goal of this clinical trial is to compare the effectiveness of different toothbrushes in patients with fixed orthodontic appliances who have gingival inflammation. The main questions it aims to answer are:
Participants will:
Fixed orthodontic treatment is often the preferred method for the treatment of malocclusion and involves using complex devices like brackets and arch wires. These devices create areas that retain plaque, making effective plaque removal more challenging. Studies have shown that patients with fixed orthodontic appliances tend to have increased plaque accumulation.1,2 These patients are more susceptible to gingival inflammation due to this plaque-accumulating environment. The essential role of dental biofilm in gingivitis is well-documented, and removing biofilm can reverse the condition.3 Previous animal studies on dentition with reduced periodontium have shown that orthodontic forces and tooth movements do not induce gingival inflammation without plaque.4-7 However, in the presence of plaque, similar forces can result in vertical bone defects and attachment loss, especially with tipping and intruding movements.4 Effective dental biofilm control is crucial for improving oral hygiene especially in orthodontic patients.
Orthodontic patients face challenges with mechanical plaque removal, requiring various strategies to control plaque formation, prevent gingivitis, and maintain the periodontal health.8 Mechanical plaque removal with toothbrushes and interdental devices is the most common method for controlling plaque at home. Most patients prefer manual toothbrushes, whether conventional or orthodontic, due to their lower cost and ease of use. Although powered toothbrushes are more effective than manual ones in reducing plaque and gingivitis both short and long term in non-orthodontic patients, the effectiveness of powered versus manual toothbrushes is still uncertain for the orthodontic patients. A recent systematic review and meta-analysis concluded that there was no significant difference between manual and powered toothbrushes in reducing plaque accumulation or gingivitis in patients with fixed orthodontic devices.9 Selecting oral hygiene instruments that are most appropriate for each patient's specific needs is crucial for motivating orthodontic patients. Manual orthodontic toothbrushes have undergone advancements in bristle design and material. Many types of toothbrush options have been promoted for orthodontic patients. The use of orthodontic toothbrushes is currently preferred over other types of toothbrushes due to their bristle design, which makes it easier to clean the area around the brackets. Since orthodontic toothbrushes typically feature a V-shaped groove, while the shorter bristles within the groove are designed to clean the middle bracket area, the longer bristles are intended to clean the surroundings of the brackets. Studies comparing the effectiveness of orthodontic and conventional toothbrushes in reducing plaque and gingivitis on teeth with fixed appliances have shown conflicting results.8,10-12 More recently, single-tufted brushes have been investigated for their effectiveness in plaque removal. Single-tufted toothbrushes are recommended as an adjunctive device for surfaces and areas of the teeth that are not easily reached with other oral hygiene devices, such as the distal surfaces of molars, furcation areas, irregular gingival margins and areas of crowded teeth.13,14 Hasegawa et al., who first compared the effectiveness of single-tufted toothbrushes with the golden standard conventional toothbrush in controlling newly formed biofilm in the dentogingival area of healthy individuals, found it effective at controlling short-term dental biofilm neoformation on the dentogingival area.15 There are limited studies comparing the plaque removal efficacy of single-tufted brushes with conventional toothbrushes15,16, and one study has investigated in orthodontic patients.17 However, none of them has monitored their periodontal health in the long term and have compared single-tufted toothbrushes with conventional and orthodontic toothbrushes together. It was hypothesized that single-tufted toothbrushes are more effective in plaque removal and the healing of gingival inflammation than conventional toothbrushes and as effective as orthodontic toothbrushes. Therefore, it was aimed to evaluate the long-term effectiveness of different toothbrushes in removing plaque and gingival inflammation in individuals under fixed orthodontic treatment for gingivitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional toothbrush group | Active Comparator | Patients are instructed with the modified Bass technique. In this technique, the toothbrush bristles are positioned 45° to the long axis of the tooth towards the base of the tooth at the gum line with a gentle back-and-forth rolling motion, then swept towards the occlusal surface of the teeth. To adapt to orthodontic braces, the same movement is repeated with the bristles positioned just occlusal to the brackets. |
|
| Orthodontic toothbrush group | Experimental | The patients in this group are instructed to brush with the Bass technique. In this technique, the toothbrush is placed on the gingival margin with its bristles at 45° to the long axis of the tooth. It is demonstrated by making back-and-forth movements and vibrating the brush at short intervals without lifting the bristles. |
|
| Single-tufted toothbrush group | Experimental | In this group, a single-tooth circular brushing technique first developed by Jiri Sedelmayer was explained, and dental plaque removal is demonstrated with circular movements around the brackets and following the gingival margin of each tooth. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Toothbrushing | Other | Patients brush their teeth using the technique instructed to them using the toothbrush provided. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gingival inflammation | Löe & Silnesss Gingival index | at the baseline, first week, sixth week and third month |
| bleeding on probing | bleeding on probing | at the baseline, first week, sixth week and third month |
| Measure | Description | Time Frame |
|---|---|---|
| Dental biofilm | Turesky modification of Quigley-Hein plaque Index | at the baseline, first week, sixth week and third month |
| Measure | Description | Time Frame |
|---|---|---|
| Pocket depth | Measuring probing pocket depth by a North Carolina periodontal probe | at the baseline, first week, sixth week and third month |
Inclusion criteria:
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul Okan University Dental Hospital | Istanbul | Tuzla | 34947 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21811688 | Result | Lee DW, Moon IS. The plaque-removing efficacy of a single-tufted brush on the lingual and buccal surfaces of the molars. J Periodontal Implant Sci. 2011 Jun;41(3):131-4. doi: 10.5051/jpis.2011.41.3.131. Epub 2011 Jun 30. | |
| 16849078 | Result | Rafe Z, Vardimon A, Ashkenazi M. Comparative study of 3 types of toothbrushes in patients with fixed orthodontic appliances. Am J Orthod Dentofacial Orthop. 2006 Jul;130(1):92-5. doi: 10.1016/j.ajodo.2006.01.018. |
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The authors have not yet decided on data sharing. Revisions will be made when it is determined on which website it can be published.
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| ID | Term |
|---|---|
| D005891 | Gingivitis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
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| ID | Term |
|---|---|
| D014099 | Toothbrushing |
| ID | Term |
|---|---|
| D009910 | Oral Hygiene |
| D011313 | Preventive Dentistry |
| D003813 | Dentistry |
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Patients will randomly allocate one of three groups (Conventional toothbrush group, orthodontic toothbrush group, or single-tufted toothbrush group).
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The researcher performing the clinical examination will not know the group in which the patients are included.
| 32951930 | Result | ElShehaby M, Mofti B, Montasser MA, Bearn D. Powered vs manual tooth brushing in patients with fixed orthodontic appliances: A systematic review and meta-analysis. Am J Orthod Dentofacial Orthop. 2020 Nov;158(5):639-649. doi: 10.1016/j.ajodo.2020.04.018. Epub 2020 Sep 17. |
| 280130 | Result | Ericsson I, Thilander B, Lindhe J. Periodontal conditions after orthodontic tooth movements in the dog. Angle Orthod. 1978 Jul;48(3):210-8. doi: 10.1043/0003-3219(1978)0482.0.CO;2. No abstract available. |
| 15312097 | Result | Axelsson P, Nystrom B, Lindhe J. The long-term effect of a plaque control program on tooth mortality, caries and periodontal disease in adults. Results after 30 years of maintenance. J Clin Periodontol. 2004 Sep;31(9):749-57. doi: 10.1111/j.1600-051X.2004.00563.x. |
| 3509967 | Result | Diamanti-Kipioti A, Gusberti FA, Lang NP. Clinical and microbiological effects of fixed orthodontic appliances. J Clin Periodontol. 1987 Jul;14(6):326-33. doi: 10.1111/j.1600-051x.1987.tb00979.x. |
| 4500561 | Result | Zachrisson S, Zachrisson BU. Gingival condition associated with orthodontic treatment. Angle Orthod. 1972 Jan;42(1):26-34. doi: 10.1043/0003-3219(1972)0422.0.CO;2. No abstract available. |
| 39455996 | Derived | Aykol-Sahin G, Ay-Kocabas B, Mert B, Usta H. Effectiveness of different types of toothbrushes on periodontal health in orthodontic patients with gingivitis: A randomized controlled study. BMC Oral Health. 2024 Oct 25;24(1):1289. doi: 10.1186/s12903-024-05084-x. |
| D009057 |
| Stomatognathic Diseases |