Altered Passive Eruption of TeethNCT03522571
Experimental Gingivitis in Patients With Altered Passive Eruption
A study testing Experimental gingivitis in people with Altered Passive Eruption of Teeth, run by Rustam Aghazada at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Altered Passive Eruption of Teeth
- What is being tested?
- Experimental gingivitis
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteItaly
- Study dates
- 21 Feb 2017to 19 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age ≥ 18 years
- probing depth ≤ 3 mm
Who cannot join
- Smoking
- Periodontitis
- Systemic diseases
- Immunosuppressed or immunocompromised patients
- Use of medications affecting periodontal status
- Uncontrolled diabetes
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site
Dipartimento di Scienze Odontostomatologiche e Maxillo Facciali
Roma, RM, 00161
About this study
Official title: Experimental Gingivitis in Patients With Altered Passive Eruption: A Case Control Study
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.
Read the 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
- Being tested
- Experimental gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental gingivitisBehavioural
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 group | Role | What they receive |
|---|---|---|
| Patients with altered passive eruption - APE | Experimental | 3 teeth of the patients with altered passive eruption that will undergo to experimental gingivitis Receives: 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 Receives: Behavioral: Experimental gingivitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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:
- - 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.
Measured: 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)
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.
Measured: 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)
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
Measured: 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)
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.
Measured: Value was assessed at T0, at day seven, fourteen, twenty-one, twenty-eight , thirty-five and at day forty-two
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study start21 Feb 2017
- Primary completion19 Jul 2017
- Study completion19 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Altered Passive Eruption of TeethStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rustam Aghazada
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rustam Aghazada, University of Roma La Sapienza
- Investigators
- Andrea Pilloni, MD, DDS, MSc, Study chair, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03522571
- Sponsor's protocol ID
- v. 01 02/12/2016
- Status last verified
- Jun 2019
- First submitted
- 27 Apr 2018
- Last updated
- 6 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experimental Gingivitis in Patients With Altered Passive Eruption: A Case Control Study
- ClinicalTrials.gov ID
- NCT03522571
- Acronym / sponsor ID
- v. 01 02/12/2016
- Conditions
- Altered Passive Eruption of Teeth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Rustam AghazadaUniversity, hospital or other
- Study start
- 21 Feb 2017 (actual)
- Primary completion
- 19 Jul 2017 (actual)
- Study completion
- 19 Jul 2017 (actual)
- First posted
- 11 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with altered passive eruption - APE | Experimental | Behavioral: Experimental gingivitis3 teeth of the patients with altered passive eruption that will undergo to experimental gingivitis |
| Patients with normal gingival anatomy - Non APE | Active comparator | Behavioral: Experimental gingivitis3 teeth of the patients with normal gingival anatomy that will undergo to experimental gingivitis |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- age ≥ 18 years
- probing depth ≤ 3 mm
Key exclusion criteria (13 listed)
- Smoking
- Periodontitis
- Systemic diseases
- Immunosuppressed or immunocompromised patients
- Use of medications affecting periodontal status
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental gingivitisIndividual 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. | Behavioural | Patients with altered passive eruption - APE, Patients with normal gingival anatomy - Non APE |
Primary outcome
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.
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.
3 secondary outcomes
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2019.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Pilloni, MD, DDS, MSc study chair
University of Roma La Sapienza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental gingivitis in people with Altered Passive Eruption of Teeth, run by Rustam Aghazada at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2019.