- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03522571
Experimental Gingivitis in Patients With Altered Passive Eruption
Experimental Gingivitis in Patients With Altered Passive Eruption: A Case Control Study
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
RM
-
Roma, RM, Italy, 00161
- Dipartimento di Scienze Odontostomatologiche e Maxillo Facciali
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
|
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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;
|
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)
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:
|
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 Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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:
|
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)
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
|
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)
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.
|
Value was assessed at T0, at day seven, fourteen, twenty-one, twenty-eight , thirty-five and at day forty-two
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Andrea Pilloni, MD, DDS, MSc, Sapienza University of Rome
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- v. 01 02/12/2016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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