Evaluation of Gingival Fissures Associated With Soft and Medium Toothbrushes

NCT03367481 | Completed

• 1 other identifier: Gingival fissures study
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Gingival fissures (GF) have been suggested as risk indicators for clinical attachment loss (CAL) and gingival recession, especially in free surfaces and in patients with low plaque scores. The major factors related to the GF occurrence are high daily brushing frequencies, excessive force to brush, malpositioned teeth, use of abrasive dentifrices, and stiffness of the toothbrushes bristles. Thus, in order to better understand the pathogenesis and progression of GF, this study aim to evaluate the incidence and behavior of GF in young adults using soft and medium brushes, in a cross-over randomized clinical trial along 6 months.

Conditions

Gingival Recession; Gingival Abrasion; Wounds and Injuries

Keywords

Gingival fissures; Gingival recession; Risk factors; Traumatic toothbrushing

Outcome Measures

Primary Outcomes (1)

• Gingival fissures associated with toothbrushing

  Standardized photographs, under disclosing solution (2Tone®) from 1st and 2nd premolars and 1st molar area in all quadrants, will be taken at baseline and at days 30, 60, 90, 100, 130, 160 and 190 for evaluation of gingival fissures. The disclosing solution is safe, without contra-indications in the literature and facilitates visualization of gingival lesions and plaque. After, the photographs will be analyzed in an image software in order to determine the mean number of new fissures, fissures that decreased, and those that stabilized over time. If, at any time during the study a gingival fissure become greater than 3mm, the patients will stop the use of the specific toothbrush and will be follow until the regression of the lesion.

  6 months

Secondary Outcomes (1)

• Toothbrush wear

  6 months

Study Arms (2)

Control toothbrush

ACTIVE COMPARATOR

The participants will use a toothbrush with soft bristles.

Device: Toothbrush type

Test toothbrush

EXPERIMENTAL

The participants will use a toothbrush with medium bristles.

Device: Toothbrush type

Interventions

Toothbrush type DEVICE

In this cross-over study, the participants will use either a soft brush (control) and the medium brush (test).

Control toothbrush; Test toothbrush

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• have at least 20 teeth,
• negative history of periodontitis (CAL ≥ 3mm),
• good systemic health.

You may not qualify if:

• do not have orthodontic appliances or dental implants,
• absence of dental caries or restorations at cervical buccal surface.

Sponsors & Collaborators

• Federal University of Rio Grande do Sul: lead

Study Sites (1)

Federal University of Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

Location

MeSH Terms

Conditions

Gingival Recession; Wounds and Injuries

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Officials

• Rui V Oppermann, PhD

  Federal University of Rio Grande do Sul

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head Professor

Study Record Dates

• First Submitted: December 1, 2017
• First Posted: December 8, 2017
• Study Start: February 22, 2019
• Primary Completion: December 16, 2019
• Study Completion: December 16, 2019
• Last Updated: May 14, 2021

Record last verified: 2021-05

Locations

BR (1)