NCT06436664

Brief Summary

The aim of this study is to investigate the effects of tooth brushing training methods on orthodontic patients and to determine the most effective oral hygiene methods for individuals receiving orthodontic treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 31, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2024

Completed
Last Updated

July 31, 2024

Status Verified

July 1, 2024

Enrollment Period

2 months

First QC Date

May 24, 2024

Last Update Submit

July 29, 2024

Conditions

Keywords

tooth brushingfixed orthodontic treatmentmicrobial dental plaque

Outcome Measures

Primary Outcomes (2)

  • The Turesky modified index

    The Turesky modified index, plaque on the buccal and lingual surfaces of all teeth. TMQHI scores were recorded as follows: 0, no dental plaque present, 1. isolated areas of dental plaque, 2. A thin dental plaque tape of ≤1 mm, 3. dental plaque covered up to 1/3 of the tooth surface, 4. dental plaque covered between 1/3 and 2/3 of the tooth surface, 5. dental plaque covers ≥2/3 of the tooth surface.

    Baseline, 1st month, 3rd month

  • Orthodontic plaque index

    Score 0: No plaque accumulation Score 1: There is plaque accumulation covering one side of the bracket base Score 2: There is plaque accumulation covering two sides of the bracket base Score 3: There is plaque accumulation covering three sides of the bracket base Score 4: There is plaque accumulation covering all four sides of the bracket base. and/or the presence of gingival inflammation

    Baseline, 1st month, 3rd month

Secondary Outcomes (1)

  • Gingival Index

    Baseline, 1st month, 3rd month

Study Arms (4)

Control group

OTHER

In patients receiving fixed orthodontic treatment, the orthodontic plaque index, Turesky modified index and gingival index will be recorded at the beginning, 1st and 3rd months. No special instructions will be given to these patients regarding the tooth brushing process.

Other: Tooth brushing

Group 1

EXPERIMENTAL

Patients will receive a standard brochure and oral presentation on tooth brushing in the Group 1. The orthodontic plaque index, Turesky modified index and gingival index will be recorded at the beginning, 1st and 3rd months. These patients will receive a standardized brochure for tooth brushing.

Other: Tooth brushing

Group 2

EXPERIMENTAL

Patients will receive a standard tooth brushing on a dental model in the Group 2. The orthodontic plaque index, Turesky modified index and gingival index will be recorded at the beginning, 1st and 3rd months.

Other: Tooth brushing

Group 3

EXPERIMENTAL

In patients undergoing fixed orthodontic treatment, the orthodontic plaque index, Turesky modified index and gingival index will be recorded at the beginning, 1st and 3rd months. Patients will be taught standard tooth brushing with a video in Group 3.

Other: Tooth brushing

Interventions

Firstly, the toothbrush must be positioned at a 45° angle to the gingival margin. Secondly, the brush should be moved back and forth in small horizontal jerks. Thirdly, with a vertical movement, the brush should be moved in the occlusal direction, i.e. upwards in the lower jaw and downwards in the upper jaw to remove debris.

Control groupGroup 1Group 2Group 3

Eligibility Criteria

Age14 Years - 20 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • The patient with orthodontic attachments at least 4 months
  • with permanent dentition

You may not qualify if:

  • impacted or atypically erupted teeth
  • with prosthetic restorations such as crowns or implants
  • open bite
  • deep bite
  • crowding more than 7 mm or polydiastema cases
  • Individuals diagnosed with periodontitis
  • ndividuals with cleft lip and palate or other craniofacial anomalies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yasemin TUNCA

Van, 65080, Turkey (Türkiye)

Location

Related Publications (3)

  • Cozzani M, Ragazzini G, Delucchi A, Mutinelli S, Barreca C, Rinchuse DJ, Servetto R, Piras V. Oral hygiene compliance in orthodontic patients: a randomized controlled study on the effects of a post-treatment communication. Prog Orthod. 2016 Dec;17(1):41. doi: 10.1186/s40510-016-0154-9. Epub 2016 Dec 19.

  • Renton-Harper P, Addy M, Newcombe RG. Video instruction to establish a panel of experts to compare tooth cleaning by 4 electric toothbrushes. J Clin Periodontol. 2001 Oct;28(10):917-22. doi: 10.1034/j.1600-051x.2001.028010917.x.

  • 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.

MeSH Terms

Interventions

Toothbrushing

Intervention Hierarchy (Ancestors)

Oral HygienePreventive DentistryDentistry

Study Officials

  • Yasemin TUNCA, PhD

    Yuzuncu Yil University

    PRINCIPAL INVESTIGATOR
  • Dicle ALTINDAL, DDS

    Yuzuncu Yil University

    STUDY DIRECTOR
  • Nihal FAHRZADEH, PhD

    Yuzuncu Yil University

    STUDY CHAIR
  • Murat Tunca, PhD

    Yuzuncu Yil University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, DDS, Assistant Professor

Study Record Dates

First Submitted

May 24, 2024

First Posted

May 31, 2024

Study Start

January 15, 2024

Primary Completion

March 4, 2024

Study Completion

July 15, 2024

Last Updated

July 31, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations