Incidence Assessment of Gingival Fissures Associated with the Use of Manual and Electric Toothbrushes

NCT06651723 | Unknown

• 1 other identifier: 60844322.5.0000.5347
• Study Type: interventional
• Target: 34
• 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 of GF in young adults using manual and electric soft toothbrushes, in a cross-over randomized clinical trial along 2 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

  Clinical examination, under disclosing solution, will evaluate the presence of gingival fissures (GF) on the buccal surfaces of all teeth, except third molars. Additionally, the measurement of the GF will be performed with the aid of a North Carolina periodontal probe, positioned following the path of the GF from the gingival margin to the most apical portion of the lesion.

  From enrollment to the end of experimental time (2 months)

Secondary Outcomes (1)

• Toothbrush wear

  From enrollment to the end of experimental time (2 months)

Study Arms (2)

Electric brushes

EXPERIMENTAL

The participants will use an electric soft brush (test).

Device: Toothbrush type

Manual brushes

ACTIVE COMPARATOR

The participants will use a soft manual brush (control).

Device: Toothbrush type

Interventions

Toothbrush type DEVICE

The participants will use either an electric soft brush (test) and soft manual brush (control).

Electric brushes; Manual brushes

Eligibility Criteria

• Age: 14 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Good systemic health (ASA I and II); No history of periodontitis (no interproximal bone loss ≥ 3 mm); No gingival recession ≥ 3 mm; Minimum number of 20 teeth.

You may not qualify if:

• Use of medications that alter in some way the gingival and/or periodontal inflammatory response (phenytoin, sodium valproate, nifedipine, verapramil, diltiazem amlodipine, felodipine, cyclosporine \[Murakami et al., 2018\]); Having had antibiotic therapy in the last three months; Crowding; Presence of restorations and/or carious lesions in the cervical region on the buccal surfaces; Being under orthodontic treatment; Type 1 or 2 Diabetes Mellitus; Being a smoker; Being pregnant; Presence of full crowns and/or implants; Need for antibiotic prophylaxis for periodontal examination;

Sponsors & Collaborators

• Federal University of Rio Grande do Sul: lead

Study Sites (1)

Faculdade de Odontologia

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: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: The study will be blind randomized crossover clinical trial of 2 months' duration. The randomization will occur at day 0, followed by the 1st phase (30 days), a washout period of 21 days, and finally the 2nd phase (30 days).

Study Record Dates

• First Submitted: October 18, 2024
• First Posted: October 22, 2024
• Study Start: July 10, 2023
• Primary Completion: October 26, 2023
• Study Completion: October 30, 2024
• Last Updated: October 22, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)