Experimental Gingivitis in Patients With Altered Passive Eruption

NCT03522571 | Completed DMC

• 1 other identifier: v. 01 02/12/2016
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Altered Passive Eruption of Teeth

Outcome Measures

Primary Outcomes (2)

• Change of Angulated bleeding score (AngBS)

  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 the value was assessed at T0, at day seven, fourteen, twenty-one, twenty-eight , thirty-five and at day forty-two

• Change of Gingival index (MGI)

  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.

  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 (3)

• Plaque index (PLI)

  Value was assessed at T0, at day seven, fourteen, twenty-one, twenty-eight , thirty-five and at day forty-two

• 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

• 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

Study Arms (2)

Patients with altered passive eruption - APE

EXPERIMENTAL

3 teeth of the patients with altered passive eruption that will undergo to experimental gingivitis

Behavioral: Experimental gingivitis

Patients with normal gingival anatomy - Non APE

ACTIVE COMPARATOR

3 teeth of the patients with normal gingival anatomy that will undergo to experimental gingivitis

Behavioral: Experimental gingivitis

Interventions

Experimental gingivitis BEHAVIORAL

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.

Patients with altered passive eruption - APE; Patients with normal gingival anatomy - Non APE

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• age ≥ 18 years
• probing depth ≤ 3 mm

You may not qualify if:

• 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

Sponsors & Collaborators

• Rustam Aghazada: lead

Study Sites (1)

Dipartimento di Scienze Odontostomatologiche e Maxillo Facciali

Roma, RM, 00161, Italy

Location

Study Officials

• Andrea Pilloni, MD, DDS, MSc

  University of Roma La Sapienza

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 27, 2018
• First Posted: May 11, 2018
• Study Start: February 21, 2017
• Primary Completion: July 19, 2017
• Study Completion: July 19, 2017
• Last Updated: June 6, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

IT (1)