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Completed

NCT Number: NCT05562986

Impacts of Oral Irrigation in Orthodontic Patients

The present study aimed to investigate clinically the cleaning effectiveness of different treatment modalities, that is, oral irrigator or interdental brush usage addition to routine brushing and examine interleukin (IL)-1β, IL-10, matrix metalloproteinase (MMP)-1, MMP-8 levels in gingival crevicular fluid of orthodontic patients. The null hypothesis was that oral irrigators would be effective compared to interdental brush in the oral care of individuals who are orthodontic patients.

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Key information

Conditions

Oral Hygiene Mouth Diseases Orthodontics Periodontal Diseases Stomatognathic Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ondokuz Mayıs University, Faculty of Dentistry, Department of Periodontology

Samsun, 55270, Turkey (Türkiye)

About this study

The aim of this study is to compare the effectiveness of oral irrigator (OI) with interdental brush (IB) clinically and biochemically in orthodontic patients.

Thirty patients were randomly divided into two equal groups; patients using OI in addition to manuel brushing (OI-group), patients using IB in addition to manual brushing (IB-group). Study was planned as randomized, single-blind, parallel-design. Periodontal indexes were recorded clinically and interleukin (IL)-1β, IL-10, matrix metalloproteinase (MMP)-1, MMP-8 levels in gingival crevicular fluid were evaluated biochemically. After baseline examinations [Silness-Löe plaque index(PI), Löe-Silness gingival index(GI), probing pocket depth(PPD), clinical attachment level(CAL), bleeding on probing(BOP)], initial periodontal therapy was completed using full-mouth disinfection method. The data was collected in the baseline, 2nd, 4th and 8th weeks.

The hypothesis of our study is that oral irrigators may be effective in oral care of orthodontic patients because of the ease of use.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Being over 12 years old.
  • Having at least 20 permanent teeth with bands or brackets.
  • Finished phase I periodontal treatment.
  • Bleeding below 10% during probing.
  • No pocket depth of more than 5 mm.
  • Not receiving any treatment other than orthodontic treatment during the study.
  • Absence of removable or fixed prosthetic restorations.
  • Absence of any systemic disease (hepatic, renal, hematologic, cardiovascular).
  • Agreeing not to use any non-study mouthwash throughout the study.

Exclusion criteria

  • Performing poor cooperation.
  • Having diseases associated with bacteriemia.
  • Used antibiotics and anti-inflammatory drugs for any purpose for a long time.
  • Having diabetes.
  • Smoking habits.
  • Having a physical or mental problem that affects manual dexterity.
  • Using medication that could affect gingival health (such as dilantin, calcium channel blocker, cyclosporine, and anticoagulant).

Treatment and study plan

GCF (gingival crevicular fluid) collection

Diagnostic Test

Prior to GCF (gingival crevicular fluid) sampling, supragingival plaque was removed by sterile curets and, after air drying, the surfaces were isolated by cotton rolls. Filter paper strips (periopaper, proflow Inc., Amityville, NewYork, USA) were placed in sulcus for 30s. Care was taken not to avoid mechanical trauma and strips contaminated with blood or saliva were discarded. The absorbed GCF volume was estimated by a calibrated instrument (periotron 8000, proflow Inc., Amityville, NY, USA). Then, the strips were sealed into sterile tubes before freezing at -80 0C. The readings were converted to an actual volume (μl) by reference to the standard curve.

Primary outcomes

  1. GCF (gingival crevicular fluid) level of IL-1β as a marker of gingival inflammation

    Time frame: through study completion, an average of 1 year

    Elevated levels of IL-1β in GCF have been associated with the destructive changes that occur in the inflamed human gingiva, is a proinflammatory cytokine.

  2. GCF (gingival crevicular fluid) level of IL-10 as a marker of gingival inflammation

    Time frame: through study completion, an average of 1 year

    IL-10 plays an important role as a stop signal in suppressing the immune and inflammatory response by being released from periodontal tissues, thus trying to limit the spread and severity of the disease. It is an anti-inflammatory cytokine. It is reported that the level of GCF IL-10 is increased in inflamed areas.

  3. GCF (gingival crevicular fluid) level of MMP-1 as a marker of gingival inflammation

    Time frame: through study completion, an average of 1 year

    One of the MMPs, MMP-1, is generally expressed by fibroblasts, endothelial cells, keratinocytes, monocytes/macrophages, chondrocytes, and osteoblasts, and is a key regulator in connective tissue remodeling. In addition to gingivitis, there is a significant increase in MMP-1 levels in the GCF during the active periods of periodontitis.

  4. GCF (gingival crevicular fluid) level of MMP-8 as a marker of gingival inflammation

    Time frame: through study completion, an average of 1 year

    High concentration of MMP-8 is associated with tissue destruction and severity of periodontal disease. It is known to be secreted from inflammatory cells such as neutrophils and macrophages.

Sponsors and collaborators

Lead sponsor

Ondokuz Mayıs University

Other

Registry information

Official study title

Clinical and Biochemical Evaluation Oral Irrigator Effectiveness in Patients Under Orthodontic Treatment

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Oct 3, 2022
Registry last updated
Oct 3, 2022

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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