Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06510179
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-08
Brief Title:
Effectiveness of Different Types of Toothbrushes on Periodontal Health in Orthodontic Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effectiveness of Different Types of Toothbrushes on Periodontal Health in Orthodontic Patients With Gingivitis a Randomized Controlled Study
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
1 Is a single-tufted toothbrush as effective as orthodontic or conventional toothbrushes
2 What are the effects of these toothbrushes on dental biofilm removal and gingival inflammation Researchers will compare conventional toothbrushes orthodontic toothbrushes and single-tufted toothbrushes after professional mechanical debridement and oral hygiene instruction
Participants will
1 Receive nonsurgical periodontal therapy
2 According to the group they are involved they will receive an oral hygiene kit toothbrush and toothpaste and instruction
3 They will participate in the recalls in the first week sixth week and third month
1 Is a single-tufted toothbrush as effective as orthodontic or conventional toothbrushes
2 What are the effects of these toothbrushes on dental biofilm removal and gingival inflammation Researchers will compare conventional toothbrushes orthodontic toothbrushes and single-tufted toothbrushes after professional mechanical debridement and oral hygiene instruction
Participants will
1 Receive nonsurgical periodontal therapy
2 According to the group they are involved they will receive an oral hygiene kit toothbrush and toothpaste and instruction
3 They will participate in the recalls in the first week sixth week and third month
Detailed Description:
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 accumulation12 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 condition3 Previous animal studies on dentition with reduced periodontium have shown that orthodontic forces and tooth movements do not induce gingival inflammation without plaque4-7 However in the presence of plaque similar forces can result in vertical bone defects and attachment loss especially with tipping and intruding movements4 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 health8 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 devices9 Selecting oral hygiene instruments that are most appropriate for each patient39s 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 results810-12 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 teeth1314 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 area15 There are limited studies comparing the plaque removal efficacy of single-tufted brushes with conventional toothbrushes1516 and one study has investigated in orthodontic patients17 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
Orthodontic patients face challenges with mechanical plaque removal requiring various strategies to control plaque formation prevent gingivitis and maintain the periodontal health8 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 devices9 Selecting oral hygiene instruments that are most appropriate for each patient39s 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 results810-12 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 teeth1314 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 area15 There are limited studies comparing the plaque removal efficacy of single-tufted brushes with conventional toothbrushes1516 and one study has investigated in orthodontic patients17 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None