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

NCT06510179 | Completed

• 1 other identifier: 2023/30 Rev-1/ 681
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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. 1.Is a single-tufted toothbrush as effective as orthodontic or conventional toothbrushes?
2. 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.
3. 3.Receive nonsurgical periodontal therapy
4. 4.According to the group they are involved, they will receive an oral hygiene kit (toothbrush and toothpaste) and instruction
5. 5.They will participate in the recalls in the first week, sixth week, and third month.

Conditions

Gingivitis; Orthodontics

Keywords

orthodontic appliances; oral hygiene; toothbrushing; gingivitis

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• Dental biofilm

  at the baseline, first week, sixth week and third month

Other Outcomes (1)

• Pocket depth

  at the baseline, first week, sixth week and third month

Study Arms (3)

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.

Other: Toothbrushing

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.

Other: Toothbrushing

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.

Other: Toothbrushing

Interventions

Toothbrushing OTHER

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

Conventional toothbrush group; Orthodontic toothbrush group; Single-tufted toothbrush group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• patients who had at least 22 teeth with brackets (excluding third molars)
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Okan University: lead

Study Sites (1)

Istanbul Okan University Dental Hospital

Istanbul, Tuzla, 34947, Turkey (Türkiye)

Location

Related Publications (8)

• 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.

  PMID: 21811688 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.

  PMID: 16849078 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.

  PMID: 32951930 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.

  PMID: 280130 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.

  PMID: 15312097 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.

  PMID: 3509967 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.

  PMID: 4500561 RESULT

• 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.

  PMID: 39455996 DERIVED

MeSH Terms

Conditions

Gingivitis

Interventions

Toothbrushing

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Oral Hygiene; Preventive Dentistry; Dentistry

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The researcher performing the clinical examination will not know the group in which the patients are included.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: Patients will randomly allocate one of three groups (Conventional toothbrush group, orthodontic toothbrush group, or single-tufted toothbrush group).

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 19, 2024
• Study Start: August 1, 2023
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: July 19, 2024

Record last verified: 2024-07

Locations

TU (1)