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Impacts of Oral Irrigation in Patients With Periimplant Mucositis

Not Applicable
Completed
Conditions
Peri-implant Mucositis
Interventions
Diagnostic Test: Periimplant crevicular fluid (PICF) collection
Registration Number
NCT03844035
Lead Sponsor
Ondokuz Mayıs University
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
45
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Oral irrigator groupPeriimplant crevicular fluid (PICF) collectionFifteen patients using toothbrush and oral irrigator(oxytet oral irrigatör).All patients were told to use Modified Bass method of tooth brushing technique. PI, GI, PPD and CAL values were measured with William's probe (Hu-Fried, Chicago, IL, A.B.D) around the teeth and with plastic probe around the implants. All clinical parameters were evaluated on each of the six regions of the implant (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual).PICF was collected one day after the clinical examination from buccal aspects of the mesial and distal surfaces at the interproximal sites.Following the initial clinical records, all patients were performed full mouth instrumentation and described oral hygiene procedure according to their groups.
Interdental brush groupPeriimplant crevicular fluid (PICF) collectionFifteen patients using toothbrush and interdental brush.All patients were told to use Modified Bass method of tooth brushing technique. PI, GI, PPD and CAL values were measured with William's probe (Hu-Fried, Chicago, IL, A.B.D) around the teeth and with plastic probe around the implants. All clinical parameters were evaluated on each of the six regions of the implant (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual). PICF was collected one day after the clinical examination from buccal aspects of the mesial and distal surfaces at the interproximal sites. Following the initial clinical records, all patients were performed full mouth instrumentation and described oral hygiene procedure according to their groups.
Control groupPeriimplant crevicular fluid (PICF) collectionFifteen patients using only toothbrush.All patients were told to use Modified Bass method of tooth brushing technique. PI, GI, PPD and CAL values were measured with William's probe (Hu-Fried, Chicago, IL, A.B.D) around the teeth and with plastic probe around the implants. All clinical parameters were evaluated on each of the six regions of the implant (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual). PICF was collected one day after the clinical examination from buccal aspects of the mesial and distal surfaces at the interproximal sites. Following the initial clinical records, all patients were performed full mouth instrumentation and described oral hygiene procedure according to their groups.
Primary Outcome Measures
NameTimeMethod
Periimplant crevicular fluid level of TGF-β1 as a marker both of inflammatory phase and proliferative phasethrough study completion, an average of 1 year

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

Periimplant crevicular fluid level of PAI-1 as a marker for clinical evaluation and efficacy of periodontal treatmentthrough study completion, an average of 1 year

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

Periimplant crevicular fluid level of t-PA as a marker for clinical evaluation and efficacy of periodontal treatmentthrough study completion, an average of 1 year

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

Periimplant crevicular fluid level of IL-1β as a marker of gingival inflammationthrough 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

Secondary Outcome Measures
NameTimeMethod
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