Experimental Gingivitis in Patients With Altered Passive Eruption

NCT ID: NCT03522571

Last Updated: 2019-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-21
• Study Completion Date: 2017-07-19

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.

Conditions

Altered Passive Eruption of Teeth

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Patients with altered passive eruption - APE

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

Group Type: EXPERIMENTAL

Experimental gingivitis

Intervention Type: 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 normal gingival anatomy - Non APE

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

Group Type: ACTIVE_COMPARATOR

Experimental gingivitis

Intervention Type: 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.

Interventions

Experimental gingivitis

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 Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rustam Aghazada

OTHER

Sponsor Role: lead

Responsible Party

Rustam Aghazada

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Andrea Pilloni, MD, DDS, MSc

Role: STUDY_CHAIR

University of Roma La Sapienza

Locations

Dipartimento di Scienze Odontostomatologiche e Maxillo Facciali

Roma, RM, Italy

Countries

Italy

Other Identifiers

v. 01 02/12/2016

Identifier Type: -

Identifier Source: org_study_id