Experimental Gingivitis in Patients With Altered Passive Eruption
Condition: Altered Passive Eruption of Teeth
MeSH terms: Gingivitis; Exanthema
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Experimental gingivitis
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening