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Completed

NCT Number: NCT03844035

Impacts of Oral Irrigation in Patients With Periimplant Mucositis

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 TGF-β1, IL-1β, t-PA, and PAI-1 levels in periimplant crevicular fluid of patients with periimplant mucositis. The null hypothesis was that oral irrigators would be effective compared to interdental brush in the oral care of individuals who use implant-supported protheses.

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Key information

Conditions

Peri-implant Mucositis

Age range

45 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Detailed Description: Our aim was to evaluate efficacy of a manual tooth-brush with either interdental brush or oral irrigator in treatment of periimplant mucositis.

Material and Method: Forty-five patients with periimplant mucositis having at least one implant (age range:45-60) were included in study. Study was planned as randomized, single-blind, parallel-design. Patients were divided into 3 equal groups; i)toothbrush+oral irrigator ii)toothbrush+interdental brush, iii)only toothbrush. 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. Periimplant crevicular fluid(PCF) were taken from patents to assess levels of interleukin-1beta(IL-1β), Transforming growth factor-beta(TGF- β), tissue-type plasminogen activator(t-PA), plasminogen activator inhibitor-1(PAI-1). Clinical records were repeated at 2, 4 and 12 weeks.

The hypothesis of our study is that oral irrigators may be effective in oral care of individuals using an implant-supported prosthesis 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

  • subject with no systemic diseases that affect oral tissues and the nature of plaque,
  • with no professional cleaning for at least six months prior to baseline examination,
  • with one or more implants (Straumann, Waldenburg, Switzerland) functioning at least 24 months before the start of the study
  • having implants with BOP in at least two of the six regions
  • The people who agreed to refrain from the use of any nonstudy dental device or oral care product for the study duration were included in the study

Exclusion criteria

Exclusion criteria

  • subjects not cooperative,
  • having disease associated with bacteremia,
  • taking medication influencing gingival health (eg. dilantin, calcium channel blockers, cyclosporine, anticoagulants),
  • using long-term antibiotic and anti-inflammatory agents,
  • smokers and
  • women who were pregnant and in lactation period

Treatment and study plan

Periimplant crevicular fluid (PICF) collection

Diagnostic Test

Prior to PICF 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, New York, 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 PICF 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 -80⁰C. The readings were converted to an actual volume (µl) by reference to the standard curve.

Primary outcomes

  1. Periimplant 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 periimplant crevicular fluid have been associated with the destructive changes that occur in the inflamed human gingiva

  2. Periimplant crevicular fluid level of TGF-β1 as a marker both of inflammatory phase and proliferative phase

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

    TGF-β1 plays a role in the development and progression of periodontal diseases.

  3. Periimplant crevicular fluid level of t-PA as a marker for clinical evaluation and efficacy of periodontal treatment

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

    Higher levels of t-PA in periimplant crevicular fluid have been associated with gingivitis and periodontitis.

  4. Periimplant crevicular fluid level of PAI-1 as a marker for clinical evaluation and efficacy of periodontal treatment

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

    Higher levels of PAI-1 may be associated with progression of periodontitis

Sponsors and collaborators

Lead sponsor

Ondokuz Mayıs University

Other

Registry information

Official study title

Clinical and Biochemical Evaluation of Oral Irrigation in Patients With Periimplant Mucositis

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Feb 18, 2019
Registry last updated
Feb 18, 2019

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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