GingivitisNCT04299347
Influence of the Restorative Cervical Margin Placement on the Supracrestal Tissue Attachment
An observational study of Gingivitis, run by University of Siena at 1 site in Italy.
Trial summary
The aim of the present study is to understand the influence that marginal/subgingival restorations exert on the surrounding periodontal tissues. Even though proximal restorations are routine in everyday clinical practice, few information is available as to whether or not they may have a detrimental effect on the… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 29 Nov 2018to 3 Mar 2020
- Phase
- Observational
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients coming to the Endodontic and Restorative department of Policlinico le Scotte- Siena, when eligible, were included in the study.
Who may be able to join
- an age range 18-70 years
- a good general health
- the ability to understand the phases of the trial and to stick to them for the whole length of the study
- the ability of will to release a written informed consent
- presence of a marginal cavity or a 2mm subgingival cavity
- presence of a cavity subgingival > 2mm
Who cannot join
- PPD>4mm
- patients affected by active periodontal disease
- patients smoking more than 10 cigarettes/pipes per day
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of the Restorative Cervical Margin Placement on the Supracrestal Tissue Attachment. A Longitudinal Study
The aim of the present study is to understand the influence that marginal/subgingival restorations exert on the surrounding periodontal tissues. Even though proximal restorations are routine in everyday clinical practice, few information is available as to whether or not they may have a detrimental effect on the supracrestal tissue attachment.
- Conditions
- Gingivitis
- Keywords
- subgingival restorations, proximal restorations, cytokine, biomarkers, GCF sampling
- Medical subject headings
- Gingivitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding on Probing
bleeding from the gingival sulcus when probing
Measured: 12 months
Secondary outcomes (1)
radiographic distance from the caries/margin of the restoration to the bone crest
LInear measurement between the most apical level of the restoration to the bone crest
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start29 Nov 2018
- Primary completion29 Jun 2019
- Study completion3 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Siena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicola Discepoli, University of Siena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04299347
- Sponsor's protocol ID
- PR001
- Status last verified
- Mar 2020
- First submitted
- 4 Mar 2020
- Last updated
- 6 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of the Restorative Cervical Margin Placement on the Supracrestal Tissue Attachment. A Longitudinal Study
- ClinicalTrials.gov ID
- NCT04299347
- Acronym / sponsor ID
- PR001
- Conditions
- Gingivitis
- Keywords
- subgingival restorations, proximal restorations, cytokine, biomarkers, GCF sampling
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of SienaUniversity, hospital or other
- Study start
- 29 Nov 2018 (actual)
- Primary completion
- 29 Jun 2019 (actual)
- Study completion
- 3 Mar 2020 (actual)
- First posted
- 6 Mar 2020 (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.
The aim of the present study is to understand the influence that marginal/subgingival restorations exert on the surrounding periodontal tissues. Even though proximal restorations are routine in everyday clinical practice, few information is available as to whether or not they may have a detrimental effect on the supracrestal tissue attachment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients coming to the Endodontic and Restorative department of Policlinico le Scotte- Siena, when eligible, were included in the study.
Key inclusion criteria (6 listed)
- an age range 18-70 years
- a good general health
- the ability to understand the phases of the trial and to stick to them for the whole length of the study
- the ability of will to release a written informed consent
- presence of a marginal cavity or a 2mm subgingival cavity
Key exclusion criteria (3 listed)
- PPD>4mm
- patients affected by active periodontal disease
- patients smoking more than 10 cigarettes/pipes per day
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bleeding on Probing
Time frame: 12 months
bleeding from the gingival sulcus when probing
1 secondary outcome
radiographic distance from the caries/margin of the restoration to the bone crest
Time frame: 12 months
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 Mar 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gingivitis, run by University of Siena 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 6 inclusion and 3 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 Mar 2020. 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?
Bleeding on Probing (time frame: 12 months). 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 Mar 2020.