Experimental Gingivitis in Patients With Altered Passive Eruption: A Case Control Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Change of Angulated bleeding score (AngBS)
研究概览
简要总结
Altered passive eruption (APE) is an anatomical condition that is frequently diagnosed in periodontal clinical practice, especially for the ever-increasing demand of patients for the aesthetic improvement of their smile. In addition to its aesthetic value, however, altered passive eruption could also affect gingival and periodontal health. In fact, in the case of plaque accumulation, the altered passive eruption (APE) is likely to be a predisposing factor for a more rapid progression of gingivitis with higher inflammation indexes (Angulated Bleeding Score - AngBs and Modified Gingival Index - mGI). Notwithstanding, even if gingivitis in patients with altered passive eruption is developed much more rapidly, thorough home oral hygiene and plaque control conduces to complete clinical recovery. Further studies with a large number of patients are required to confirm the correlation between altered passive eruption and periodontal diseases.
详细描述
Study hypothesis
Despite the fact that many authors suggest that the patients with altered passive eruption are more susceptible to gingivitis and periodontitis due to the excess of gingiva, which impedes the correct oral hygiene procedure, there is to-date no clinical study confirming this assumption. The aim of the present study is therefore to examine the onset, progress and the healing of experimental gingivitis in patients with altered passive eruption when compared to patients with normal gingival anatomy.
Study design This is single centre interventional non randomised case-control study.
Interventions To achieve optimum gingival health and to standardize gingival baseline conditions all subjects participated in a pretrial period 7 days before T0. On day 7(T0), after professional scaling and polishing a powered toothbrush (Oral-B pro 3000, Braun, Procter and Gamble, USA), individually chosen interdental brush (Tepe, Sweden), and standard toothpaste (AZ - pro expert, Procter and Gamble, USA), along with oral hygiene instructions, were provided. Subjects were instructed to brush the teeth by using powered toothbrush.
Individual cast models were prepared on alginate impressions. A 2-mm thick film of technical wax was set on the supra gingival area at buccal and proximal surfaces of study teeth on test quadrant. The stent were delivered at day 0. Subjects were instructed to wear the stent prior to the oral hygiene session throughout the experimental gingivitis period to prevent plaque removal during brushing of the remaining dentition. On Day 42 (T6): After recording of clinical parameters, oral hygiene instruction and an additional session of supragingival scaling, as needed, and polishing were given.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age ≥ 18 years
- •probing depth ≤ 3 mm
排除标准
- •Periodontitis
- •Systemic diseases
- •Immunosuppressed or immunocompromised patients
- •Use of medications affecting periodontal status
- •Uncontrolled diabetes
- •Pregnancy or lactation
- •Addiction to alcohol or drugs
- •Psychiatric problems
- •Presence of any restorations on the examined quadrant
- •Presence of periapical and endo-perio lesions
- •Teeth with malposition and alteration in crown morphology
- •Patients with an acute infection (abscess) in the site intended for treatment
研究组 & 干预措施
Patients with altered passive eruption - APE
3 teeth of the patients with altered passive eruption that will undergo to experimental gingivitis
干预措施: Experimental gingivitis (Behavioral)
Patients with normal gingival anatomy - Non APE
3 teeth of the patients with normal gingival anatomy that will undergo to experimental gingivitis
干预措施: Experimental gingivitis (Behavioral)
结局指标
主要结局
Change of Angulated bleeding score (AngBS)
时间窗: Change of the value was assessed at T0, at day seven, fourteen, twenty-one, twenty-eight , thirty-five and at day forty-two
Angulated bleeding score (AngBS) was introduced by Trombelli et al, which is a modification of the angulated bleeding index as reported by van der Weijden. After lightly drying the gingiva with compressed air, a periodontal probe (PCP 15 University of North Carolina(UNC), Hu Friedy, Chicago, Illinois, USA) was held at an angle of approximately 60° to the longitudinal axis of the tooth and in contact with the sulcular gingival tissues. Angulated bleeding score (AngBS) was scored as: 0: no bleeding; 1. bleeding upon probe stimulation; 2. spontaneous bleeding.
Change of Gingival index (MGI)
时间窗: Change of the value was assessed at T0, at day seven, fourteen, twenty-one, twenty-eight , thirty-five and at day forty-two
Gingival index (MGI) according to Silness \& Loe, but without probing component, due to not disturb plaque accumulation, was registered as: 1. - Normal gingiva; 2. - Mild inflammation - slight change in color and slight edema 3. - Moderate inflammation - redness, edema and glazing, 4. - Severe inflammation - marked redness and edema, ulceration with tendency to spontaneous bleeding.
次要结局
- Quigley Hein Plaque Index (QH)(Value was assessed at T0, at day seven, fourteen, twenty-one, twenty-eight , thirty-five and at day forty-two)
- Plaque index (PLI)(Value was assessed at T0, at day seven, fourteen, twenty-one, twenty-eight , thirty-five and at day forty-two)
- Gingival crevicular fluid volume (GCF)(Value was assessed at T0, at day seven, fourteen, twenty-one, twenty-eight , thirty-five and at day forty-two)
研究者
Rustam Aghazada
Principal Investigator
University of Roma La Sapienza