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Experimental Gingivitis in Patients With Altered Passive Eruption

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ClinicalTrials.gov Identifier: NCT03522571
Recruitment Status : Completed
First Posted : May 11, 2018
Last Update Posted : May 17, 2018
Sponsor:
Information provided by (Responsible Party):
Rustam Aghazada, University of Roma La Sapienza

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.

Condition or disease Intervention/treatment Phase
Altered Passive Eruption of Teeth Behavioral: Experimental gingivitis Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Experimental Gingivitis in Patients With Altered Passive Eruption: A Case Control Study
Actual Study Start Date : December 15, 2015
Actual Primary Completion Date : April 7, 2017
Actual Study Completion Date : April 7, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rashes

Arm Intervention/treatment
Experimental: Patients with altered passive eruption - APE
3 teeth of the patients with altered passive eruption that will undergo to experimental gingivitis
Behavioral: 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.

Active Comparator: Patients with normal gingival anatomy - Non APE
3 teeth of the patients with normal gingival anatomy that will undergo to experimental gingivitis
Behavioral: 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.




Primary Outcome Measures :
  1. Change of Angulated bleeding score (AngBS) [ 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 ]

    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.

  2. Change of Gingival index (MGI) [ 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 ]

    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.


Secondary Outcome Measures :
  1. Plaque index (PLI) [ Time Frame: Value was assessed at T0, at day seven, fourteen, twenty-one, twenty-eight , thirty-five and at day forty-two ]

    Plaque index (PLI), according to Silness & Loe was scored as:

    1. - No plaque ;
    2. - 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
    3. - Moderate accumulation of soft deposit s within the gingival pocket, or the tooth and gingival margin which can be seen with the naked eye.
    4. - Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.

  2. Quigley Hein Plaque Index (QH) [ Time Frame: 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 (Modified by Turesky et al.) was registered after using disclosing solution as:

    0 - No plaque

    1. - Separate flecks of plaque at the cervical margin of the tooth
    2. - A thin continuous band of plaque (up to one mm) at the cervical margin of the tooth
    3. - A band of plaque wider than one mm but covering less than one-third of the crown of the tooth
    4. - Plaque covering at least one-third but less than two-thirds of the crown of the tooth
    5. - Plaque covering two-thirds or more of the crown of the tooth

  3. Gingival crevicular fluid volume (GCF) [ Time Frame: 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), 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.



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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03522571


Sponsors and Collaborators
Rustam Aghazada
Investigators
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Study Chair: Andrea Pilloni, MD, DDS, MSc Sapienza University of Rome

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Responsible Party: Rustam Aghazada, Principal Investigator, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT03522571     History of Changes
Other Study ID Numbers: v. 01 02/12/2016
First Posted: May 11, 2018    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Gingivitis
Exanthema
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Skin Diseases