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Experimental Gingivitis in Patients With Altered Passive Eruption

Primary Purpose

Altered Passive Eruption of Teeth

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Experimental gingivitis
Sponsored by
Rustam Aghazada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Altered Passive Eruption of Teeth

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Dipartimento di Scienze Odontostomatologiche e Maxillo Facciali

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Patients with altered passive eruption - APE

Patients with normal gingival anatomy - Non APE

Arm Description

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

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

Outcomes

Primary Outcome Measures

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; bleeding upon probe stimulation; spontaneous bleeding.
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: - Normal gingiva; - Mild inflammation - slight change in color and slight edema - Moderate inflammation - redness, edema and glazing, - Severe inflammation - marked redness and edema, ulceration with tendency to spontaneous bleeding.

Secondary Outcome Measures

Plaque index (PLI)
Plaque index (PLI), according to Silness & Loe was scored as: - No plaque ; - A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only after application of disclosing solution - Moderate accumulation of soft deposit s within the gingival pocket, or the tooth and gingival margin which can be seen with the naked eye. - Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.
Quigley Hein Plaque Index (QH)
Quigley Hein Plaque Index - QH (Modified by Turesky et al.) was registered after using disclosing solution as: 0 - No plaque - Separate flecks of plaque at the cervical margin of the tooth - A thin continuous band of plaque (up to one mm) at the cervical margin of the tooth - A band of plaque wider than one mm but covering less than one-third of the crown of the tooth - Plaque covering at least one-third but less than two-thirds of the crown of the tooth - Plaque covering two-thirds or more of the crown of the tooth
Gingival crevicular fluid volume (GCF)
Gingival crevicular fluid volume (GCF), collected as previously described and measured according to Periotron 8.000 manufacturer's (OraFlow Inc., Plainview, New York, USA) instructions. The individual site was gently air dried in an apico-coronal direction without removal of any visible supragingival plaque. The area was carefully isolated with cotton rolls, to avoid salivary contamination. A sterile paper strip (Periopaper; OraFlow Inc.) was introduced into the crevice until mild resistance was felt. Attention was paid to avoid any mechanical injury to marginal tissues. The strip was left in place for 5 s and immediately transferred, for volume determination, to the calibrated, chair-side located Periotron 8,000 (OraFlow Inc.). Paper strips contaminated by gingival bleeding during gingival crevicular fluid (GCF) determination were discarded and corresponding data were recorded as missing.

Full Information

First Posted
April 27, 2018
Last Updated
June 5, 2019
Sponsor
Rustam Aghazada
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1. Study Identification

Unique Protocol Identification Number
NCT03522571
Brief Title
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

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
February 21, 2017 (Actual)
Primary Completion Date
July 19, 2017 (Actual)
Study Completion Date
July 19, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Rustam Aghazada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Altered Passive Eruption of Teeth

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with altered passive eruption - APE
Arm Type
Experimental
Arm Description
3 teeth of the patients with altered passive eruption that will undergo to experimental gingivitis
Arm Title
Patients with normal gingival anatomy - Non APE
Arm Type
Active Comparator
Arm Description
3 teeth of the patients with normal gingival anatomy that will undergo to experimental gingivitis
Intervention Type
Behavioral
Intervention Name(s)
Experimental gingivitis
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of Angulated bleeding score (AngBS)
Description
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; bleeding upon probe stimulation; spontaneous bleeding.
Time Frame
Change of the value was assessed at T0, at day seven, fourteen, twenty-one, twenty-eight , thirty-five and at day forty-two
Title
Change of Gingival index (MGI)
Description
Gingival index (MGI) according to Silness & Loe, but without probing component, due to not disturb plaque accumulation, was registered as: - Normal gingiva; - Mild inflammation - slight change in color and slight edema - Moderate inflammation - redness, edema and glazing, - Severe inflammation - marked redness and edema, ulceration with tendency to spontaneous bleeding.
Time Frame
Change of the value was assessed at T0, at day seven, fourteen, twenty-one, twenty-eight , thirty-five and at day forty-two
Secondary Outcome Measure Information:
Title
Plaque index (PLI)
Description
Plaque index (PLI), according to Silness & Loe was scored as: - No plaque ; - A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only after application of disclosing solution - Moderate accumulation of soft deposit s within the gingival pocket, or the tooth and gingival margin which can be seen with the naked eye. - Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.
Time Frame
Value was assessed at T0, at day seven, fourteen, twenty-one, twenty-eight , thirty-five and at day forty-two
Title
Quigley Hein Plaque Index (QH)
Description
Quigley Hein Plaque Index - QH (Modified by Turesky et al.) was registered after using disclosing solution as: 0 - No plaque - Separate flecks of plaque at the cervical margin of the tooth - A thin continuous band of plaque (up to one mm) at the cervical margin of the tooth - A band of plaque wider than one mm but covering less than one-third of the crown of the tooth - Plaque covering at least one-third but less than two-thirds of the crown of the tooth - Plaque covering two-thirds or more of the crown of the tooth
Time Frame
Value was assessed at T0, at day seven, fourteen, twenty-one, twenty-eight , thirty-five and at day forty-two
Title
Gingival crevicular fluid volume (GCF)
Description
Gingival crevicular fluid volume (GCF), collected as previously described and measured according to Periotron 8.000 manufacturer's (OraFlow Inc., Plainview, New York, USA) instructions. The individual site was gently air dried in an apico-coronal direction without removal of any visible supragingival plaque. The area was carefully isolated with cotton rolls, to avoid salivary contamination. A sterile paper strip (Periopaper; OraFlow Inc.) was introduced into the crevice until mild resistance was felt. Attention was paid to avoid any mechanical injury to marginal tissues. The strip was left in place for 5 s and immediately transferred, for volume determination, to the calibrated, chair-side located Periotron 8,000 (OraFlow Inc.). Paper strips contaminated by gingival bleeding during gingival crevicular fluid (GCF) determination were discarded and corresponding data were recorded as missing.
Time Frame
Value was assessed at T0, at day seven, fourteen, twenty-one, twenty-eight , thirty-five and at day forty-two

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Pilloni, MD, DDS, MSc
Organizational Affiliation
University of Roma La Sapienza
Official's Role
Study Chair
Facility Information:
Facility Name
Dipartimento di Scienze Odontostomatologiche e Maxillo Facciali
City
Roma
State/Province
RM
ZIP/Postal Code
00161
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Yes

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Experimental Gingivitis in Patients With Altered Passive Eruption

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