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Completed

NCT Number: NCT01636830

The Incidence of Gingival Fissures _ a Crossover Single-blinded Randomized Clinical Trial

The objective of this study is to evaluate the incidence of gingival fissures according to the type of brush used, soft and medium.

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Key information

Conditions

Gingival Recession Gingival Diseases Mouth Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases Wounds and Injuries

Age range

14 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federal University of Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, 90035003, Brazil

About this study

Gingival recession constitute a functional and aesthetic problem that affects much of the population. One of the possible causes refers to a traumatic brushing. Individuals who have an excessive tooth brushing can cause injuries to your gums, such as abrasions and fissures. These lesions have been considered subrogated outcomes of gingival recession noninfectious. The literature only reports and case series showing the gingival fissures, which were once associated with traumatic occlusion.

This is the first clinical trial to evaluate the gingival fissures according to the type of brush used.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • good/ excellent health;
  • idade de 14 a 20 anos;
  • at least 20 teeth without a history of destructive periodontal disease, absence of gingival bleeding;
  • absence of loss of attachment/recession ≥2mm in molars and pre-molars in the buccal areas.

Exclusion criteria

  • were unable to provide consent or comply with the sudy protocol;
  • smokers;
  • pregnant women;
  • persons under orthodontic treatment or with dental or implant prosthesis, presence of cervical abrasions, restorations or caries;
  • need of antibiotic prophylaxis associated with dental procedures.

Treatment and study plan

Toothbrush type

Device

Evaluate the use of toothbrushes with bristles soft and medium

Primary outcomes

  1. Gingival Fissures associated with toothbrushing

    Time frame: 3 months

    This study took standardized photographs every 2 or 3 days during two periods of 28 days for evaluation of gingival fissures. These were measured by application of a disclosing solution of plaque on teeth and gums of the participants. The application developer board is safe, without contra-indications in the literature and facilitates visualization of gingival lesions and plaque.

Sponsors and collaborators

Lead sponsor

Federal University of Rio Grande do Sul

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil

Registry information

Official study title

The Incidence of Gingival Fissures _ a Crossover Single-blinded Randomized

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jul 10, 2012
Registry last updated
Jul 10, 2012

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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