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Impacts of Oral Irrigation in Patients With Periimplant Mucositis

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03844035
Enrollment
45
Registered
2019-02-18
Start date
2014-11-06
Completion date
2015-06-05
Last updated
2019-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peri-implant Mucositis

Keywords

periimplant mucositis

Brief summary

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.

Detailed description

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.

Interventions

DIAGNOSTIC_TESTPeriimplant crevicular fluid (PICF) collection

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.

Sponsors

Ondokuz Mayıs University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
45 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Periimplant crevicular fluid level of IL-1β as a marker of gingival inflammationthrough study completion, an average of 1 yearElevated levels of IL-1β in periimplant crevicular fluid have been associated with the destructive changes that occur in the inflamed human gingiva
Periimplant crevicular fluid level of TGF-β1 as a marker both of inflammatory phase and proliferative phasethrough study completion, an average of 1 yearTGF-β1 plays a role in the development and progression of periodontal diseases.
Periimplant crevicular fluid level of t-PA as a marker for clinical evaluation and efficacy of periodontal treatmentthrough study completion, an average of 1 yearHigher levels of t-PA in periimplant crevicular fluid have been associated with gingivitis and periodontitis.
Periimplant crevicular fluid level of PAI-1 as a marker for clinical evaluation and efficacy of periodontal treatmentthrough study completion, an average of 1 yearHigher levels of PAI-1 may be associated with progression of periodontitis

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026