CClinicalTrials.gg
CompletedNCT03844035Updated Feb 18, 2019

Impacts of Oral Irrigation in Patients With Periimplant Mucositis

An interventional study of Periimplant crevicular fluid (PICF) collection in Peri-implant Mucositis, sponsored by Ondokuz Mayıs University. Completed. Open to participants aged 45 Years to 60 Years. Per ClinicalTrials.gov, last updated 2019-02-18.

Sponsored by Ondokuz Mayıs University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 4 years 3 months after the study started (first participant enrolled Nov 2014, registered Feb 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
45 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Peri-implant Mucositis

Browse trials for

Keywords

  • periimplant mucositis
03

In context

Mucositis

488 studies on the registry are indexed under Mucositis; 70 are open to participants now.

This study's enrollment of 45 is close to the median of 50 across 394 interventional studies indexed under Mucositis.

Browse Mucositis studies →

Lead sponsor

Ondokuz Mayıs University is the lead sponsor of 262 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
45 participants (actual)

Study arms

  • Experimental
    Oral irrigator group

    Fifteen 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.

    Diagnostic Test: Periimplant crevicular fluid (PICF) collection

  • Experimental
    Interdental brush group

    Fifteen 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.

    Diagnostic Test: Periimplant crevicular fluid (PICF) collection

  • Active comparator
    Control group

    Fifteen 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.

    Diagnostic Test: Periimplant crevicular fluid (PICF) collection

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.

06

What researchers measure

Primary outcomes

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

    Elevated levels of IL-1β in periimplant crevicular fluid have been associated with the destructive changes that occur in the inflamed human gingiva

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

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

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

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

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

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

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

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

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

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

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Tutuncuoglu S, Cetinkaya BO, Pamuk F, Avci B, Keles GC, Kurt-Bayrakdar S, Lutfioglu M. Clinical and biochemical evaluation of oral irrigation in patients with peri-implant mucositis: a randomized clinical trial. Clin Oral Investig. 2022 Jan;26(1):659-671. doi: 10.1007/s00784-021-04044-x. Epub 2021 Jul 12. PubMed 34251534 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 18, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03844035
Lead sponsor
Ondokuz Mayıs University
Responsible party
Burcu Ozkan Cetinkaya (Professor in Periodontology, Ondokuz Mayıs University) — Principal investigator
First posted
Feb 18, 2019
Start date
Nov 6, 2014
Primary completion
May 4, 2015
Completion
Jun 5, 2015
Last update
Feb 18, 2019

Study contacts

Burcu OZKAN CETINKAYA, Prof
study director · Ondokuzmayis University, Faculty of Dentistry, Department of Periodontology,
Sema TUTUNCUOGLU, Dr
principal investigator · Samsun Oral and Dental Health Hospital, Samsun, Turkey
Ferda PAMUK, Assoc. Prof.
study chair · Beykent University, Faculty of Dentistry, Department of Periodontology
Bahattin AVCI, Assoc. Prof.
study chair · Ondokuzmayis University, Faculty of Medicine Department of Biochemistry
Gonca Cayir KELES, Prof
study chair · Okan University, Faculty of Dentistry, Department of Periodontology
Muge LUTFIOGLU, Assoc. Prof.
study chair · Ondokuzmayis University, Faculty of Dentistry, Department of Periodontology
Şevki GULER, Assist.Prof.
study chair · Izzet Baysal University, Faculty of Dentistry, Department of Periodontology

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion