Clinical trial NCT03844035: Impacts of Oral Irrigation in Patients With Periimplant Mucositis
Official title: Clinical and Biochemical Evaluation of Oral Irrigation in Patients With Periimplant Mucositis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peri-implant Mucositis
Keywords: periimplant mucositis
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2019-02-18
Enrollment: 45
Sex: ALL
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Periimplant crevicular fluid level of IL-1β as a marker of gingival inflammation
timeFrame: through study completion, an average of 1 year
measure: Periimplant crevicular fluid level of TGF-β1 as a marker both of inflammatory phase and proliferative phase
timeFrame: through study completion, an average of 1 year
measure: Periimplant crevicular fluid level of t-PA as a marker for clinical evaluation and efficacy of periodontal treatment
timeFrame: through study completion, an average of 1 year
measure: Periimplant crevicular fluid level of PAI-1 as a marker for clinical evaluation and efficacy of periodontal treatment
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ondokuzmayis University, Faculty of Dentistry, Department of Periodontology,
name: Burcu OZKAN CETINKAYA, Prof
role: STUDY_DIRECTOR
affiliation: Samsun Oral and Dental Health Hospital, Samsun, Turkey
name: Sema TUTUNCUOGLU, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Beykent University, Faculty of Dentistry, Department of Periodontology
name: Ferda PAMUK, Assoc. Prof.
role: STUDY_CHAIR
affiliation: Ondokuzmayis University, Faculty of Medicine Department of Biochemistry
name: Bahattin AVCI, Assoc. Prof.
role: STUDY_CHAIR
affiliation: Okan University, Faculty of Dentistry, Department of Periodontology
name: Gonca Cayir KELES, Prof
role: STUDY_CHAIR
affiliation: Ondokuzmayis University, Faculty of Dentistry, Department of Periodontology
name: Muge LUTFIOGLU, Assoc. Prof.
role: STUDY_CHAIR
affiliation: Izzet Baysal University, Faculty of Dentistry, Department of Periodontology
name: Şevki GULER, Assist.Prof.
role: STUDY_CHAIR
References:
citation: 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.