Peri-ImplantitisNCT06166017
Lingual Keratinized Tissue in Fully Edentulous Patients and Its Impact on Implant Health
An observational study of Peri-Implantitis and Peri-implant Mucositis, run by George Eastman Dental Hospital, Italy.
Trial summary
Cross-sectional study involving the measurement of the width of lingual keratinized tissue (in the implant locations) in fully edentulous patients restored with dental implants. The width of KT will be correlated with the primary outcome, diagnosis of peri-implantitis, defined as Probing depth (PPD)>= 6 mm… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peri-Implantitis, Peri-implant Mucositis, Recession, Gingival
- What is being tested?
- Exposure to minimal amount of lingual keratinized tissue width
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Apr 2024to Jan 2025
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Volunteers presenting with integrated implants supporting a fixed or removable full-arch prosthesis. Minimum loading time of 12 months.
Who may be able to join
- Osseointegrated (non-mobile) and loaded dental implant
- Mandibular implants
- Full-arch implant-supported prostheses
- Removable full-arch prostheses
- Fixed full-arch prostheses
Who cannot join
- Implants loaded less than 12 months before examination
- Mobile (non integrated) implants
- Partially edentulous patients
About this study
Cross-sectional study involving the measurement of the width of lingual keratinized tissue (in the implant locations) in fully edentulous patients restored with dental implants. The width of KT will be correlated with the primary outcome, diagnosis of peri-implantitis, defined as Probing depth (PPD)>= 6 mm, inflammation/ bleeding on probing (BOP) and bone loss >= 3 mm from the implant platform.
Read the detailed description
The study will be conducted with a cross-sectional design. All clinical parameters (width of buccal and lingual keratinized tissue, probing depth, bleeding on probing, plaque, crestal bone loss, gingival index, suppuration) will be collected in mandibular implants in fully edentulous lower arches. The width of lingual band of keratinized tissue (KT) will be be correlated with diagnosis of peri-implantitis or peri-implant mucositis.
- Being tested
- Exposure to minimal amount of lingual keratinized tissue width
- Medical subject headings
- Peri-Implantitis, Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure to minimal amount of lingual keratinized tissue widthOther
measurement of clinical parameters
| Study group | Role | What they receive |
|---|---|---|
| Full-arch implant-supported restorations for fully edentulous patients | No interventions will be administered. Instead, clinical parameters will be collected (see detailed description) as well as radiographs of the implants. Receives: Other: Exposure to minimal amount of lingual keratinized tissue width |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of peri-implantitis (composite outcome made of different outcomes): yes or no (dichotomous)
dichotomous (yes or no) outcome composed by PPD (mm), BoP/SOP (yes or no dichotomous) and bone loss (mm, assessed on radiograph)
Measured: Day 1
Secondary outcomes (7)
Mucosal recession
Distance (mm) between the prosthetic margin/ locator and the mucosal margin
Measured: Day 1
Bleeding on probing (BOP)
dichotomous measure of mucosal inflammation detected via periodontal probe
Measured: Day 1
Probing pocket depth (PPD)
distance between the mucosal margin and the bottom of the sulcus/ pocket (mm)
Measured: Day 1
Self-assessed Brushing discomfort
Rated by patient on Visual analog score (100 mm) to define the amount of discomfort during brushing, with 0 being the minimum and 100 being maximum discomfort. The patient will be asked to rate their level of discomfort by placing an X over the line. The distance from 0 to the X will be measured and converted into a percentage of the entire length of the line.
Measured: Day 1
Crestal bone loss (mm)
Measured on radiograph (in mm) between the implant shoulder and the most coronal location of the crestal bone
Measured: Day 1
Suppuration on probing
measured dichotomously (yes/no) when probing an implant
Measured: Day 1
Diagnosis of mucositis
dichotomous (yes/no) presence of mucosal peri-implant inflammation in the absence of crestal bone loss
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study startApr 2024 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-ImplantitisStudies 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
- Cross-sectional
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- George Eastman Dental Hospital, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lucrezia Paternò Holtzman, George Eastman Dental Hospital, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06166017
- Sponsor's protocol ID
- GeorgeEastmanDH
- Status last verified
- Feb 2024
- First submitted
- 22 Nov 2023
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lingual Keratinized Tissue in Fully Edentulous Patients and Its Impact on Implant Health
- ClinicalTrials.gov ID
- NCT06166017
- Acronym / sponsor ID
- GeorgeEastmanDH
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- George Eastman Dental Hospital, ItalyUniversity, hospital or other
- Study start
- Apr 2024 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 12 Dec 2023 (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.
Cross-sectional study involving the measurement of the width of lingual keratinized tissue (in the implant locations) in fully edentulous patients restored with dental implants. The width of KT will be correlated with the primary outcome, diagnosis of peri-implantitis, defined as Probing depth (PPD)>= 6 mm, inflammation/ bleeding on probing (BOP) and bone loss >= 3 mm from the implant platform.
Detailed description
The study will be conducted with a cross-sectional design. All clinical parameters (width of buccal and lingual keratinized tissue, probing depth, bleeding on probing, plaque, crestal bone loss, gingival index, suppuration) will be collected in mandibular implants in fully edentulous lower arches. The width of lingual band of keratinized tissue (KT) will be be correlated with diagnosis of peri-implantitis or peri-implant mucositis.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Full-arch implant-supported restorations for fully edentulous patients | – | Other: Exposure to minimal amount of lingual keratinized tissue widthNo interventions will be administered. Instead, clinical parameters will be collected (see detailed description) as well as radiographs of the implants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Volunteers presenting with integrated implants supporting a fixed or removable full-arch prosthesis. Minimum loading time of 12 months.
Key inclusion criteria (5 listed)
- Osseointegrated (non-mobile) and loaded dental implant
- Mandibular implants
- Full-arch implant-supported prostheses
- Removable full-arch prostheses
- Fixed full-arch prostheses
Key exclusion criteria (3 listed)
- Implants loaded less than 12 months before examination
- Mobile (non integrated) implants
- Partially edentulous patients
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 |
|---|---|---|
| Exposure to minimal amount of lingual keratinized tissue widthmeasurement of clinical parameters | Other | Full-arch implant-supported restorations for fully edentulous patients |
Primary outcome
Diagnosis of peri-implantitis (composite outcome made of different outcomes): yes or no (dichotomous)
Time frame: Day 1
dichotomous (yes or no) outcome composed by PPD (mm), BoP/SOP (yes or no dichotomous) and bone loss (mm, assessed on radiograph)
7 secondary outcomes
Mucosal recession
Time frame: Day 1
Bleeding on probing (BOP)
Time frame: Day 1
Probing pocket depth (PPD)
Time frame: Day 1
Self-assessed Brushing discomfort
Time frame: Day 1
Crestal bone loss (mm)
Time frame: Day 1
Suppuration on probing
Time frame: Day 1
Diagnosis of mucositis
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Peri-Implantitis and Peri-implant Mucositis, run by George Eastman Dental Hospital, 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 5 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: status not confirmed, as of the sponsor's last update on 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Diagnosis of peri-implantitis (composite outcome made of different outcomes): yes or no (dichotomous) (time frame: Day 1). 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 22 Feb 2024.