Clinical trial NCT03522571: Experimental Gingivitis in Patients With Altered Passive Eruption
Official title: Experimental Gingivitis in Patients With Altered Passive Eruption: A Case Control Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Altered Passive Eruption of Teeth
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2018-05-11
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief 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.

Eligibility criteria: Inclusion Criteria:

* age ≥ 18 years
* probing depth ≤ 3 mm

Exclusion Criteria:

* Smoking
* 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

Primary outcomes:
measure: Change of Angulated bleeding score (AngBS)
timeFrame: Change of the value was assessed at T0, at day seven, fourteen, twenty-one, twenty-eight , thirty-five and at day forty-two
measure: Change of Gingival index (MGI)
timeFrame: Change of the value was assessed at T0, at day seven, fourteen, twenty-one, twenty-eight , thirty-five and at day forty-two
Secondary outcomes:
measure: Plaque index (PLI)
timeFrame: Value was assessed at T0, at day seven, fourteen, twenty-one, twenty-eight , thirty-five and at day forty-two
measure: Quigley Hein Plaque Index (QH)
timeFrame: Value was assessed at T0, at day seven, fourteen, twenty-one, twenty-eight , thirty-five and at day forty-two
measure: Gingival crevicular fluid volume (GCF)
timeFrame: Value was assessed at T0, at day seven, fourteen, twenty-one, twenty-eight , thirty-five and at day forty-two
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Dipartimento di Scienze Odontostomatologiche e Maxillo Facciali
state: RM
Study officials:
affiliation: University of Roma La Sapienza
name: Andrea Pilloni, MD, DDS, MSc
role: STUDY_CHAIR
References: