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Completed

NCT Number: NCT06510179

Effectiveness of Different Types of Toothbrushes on Periodontal Health in Orthodontic Patients

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.

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Okan University Dental Hospital

Istanbul, Tuzla, 34947, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients who had at least 22 teeth with brackets (excluding third molars)
  • 18-35 yo
  • had a diagnosis of dental plaque biofilm-induced gingivitis defined as ≥10% of --sites with bleeding on probing (BoP) and mean probing depth (PD) ≤3 mm
  • were systemically healthy, non-smokers, or smoked <10 cigarettes per day for at least five years
  • had not used antibiotics for the last three months
  • were not pregnant.

Exclusion criteria

  • patients who smoked ≥ 10 cigarettes per day for at least five years
  • who had less than 26 teeth with brackets
  • were younger than 18 years of age or older than 35 years of age
  • were periodontally healthy or had periodontitis
  • who had systemic disease
  • had used antibiotics in the last three months were pregnant

Treatment and study plan

Toothbrushing

Other

Patients brush their teeth using the technique instructed to them using the toothbrush provided.

Primary outcomes

  1. Gingival inflammation

    Time frame: at the baseline, first week, sixth week and third month

    Löe & Silnesss Gingival index

  2. bleeding on probing

    Time frame: at the baseline, first week, sixth week and third month

    bleeding on probing

Secondary outcomes

  1. Dental biofilm

    Time frame: at the baseline, first week, sixth week and third month

    Turesky modification of Quigley-Hein plaque Index

Other outcomes

  1. Pocket depth

    Time frame: at the baseline, first week, sixth week and third month

    Measuring probing pocket depth by a North Carolina periodontal probe

Sponsors and collaborators

Lead sponsor

Okan University

Other

Registry information

Official study title

Effectiveness of Different Types of Toothbrushes on Periodontal Health in Orthodontic Patients With Gingivitis: a Randomized Controlled Study

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 19, 2024
Registry last updated
Jul 19, 2024

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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