Clinical and Biochemical Evaluation of Oral Irrigation in Patients With Periimplant Mucositis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 主要终点
- Periimplant crevicular fluid level of TGF-β1 as a marker both of inflammatory phase and proliferative phase
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Periimplant crevicular fluid (PICF) collection (Diagnostic Test)
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.
干预措施: Periimplant crevicular fluid (PICF) collection (Diagnostic Test)
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.
干预措施: Periimplant crevicular fluid (PICF) collection (Diagnostic Test)
结局指标
主要结局
Periimplant crevicular fluid level of TGF-β1 as a marker both of inflammatory phase and proliferative phase
时间窗: through 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 treatment
时间窗: through 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 treatment
时间窗: through 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 inflammation
时间窗: 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
次要结局
未报告次要终点
研究者
Burcu Ozkan Cetinkaya
Professor in Periodontology
Ondokuz Mayıs University