PeriodontitisNCT05061511
Expression of Inflammasomes in Peri-implantitis and Periodontitis
An observational study of Periodontitis and Peri-Implantitis, run by University of Parma at 1 site in Italy.
Trial summary
This is a laboratory-based study and it aims to evaluate the expression of inflammasomes in healthy gingiva and in the presence of peri-implantitis and periodontitis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontitis, Peri-Implantitis, Inflammation
- What is being tested?
- Analysis of inflammasome expression and Histological analysis
- Type of treatment
- Injection or infusion
- How many people
- 48 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2021to 30 Jun 2024
- 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
- Adult, Older adult
Study population: The definition of the 3 groups will be based on the features described by the 2017 World Workshop on the classification of periodontal and peri-implant conditions (Berglundh et al., 2018, Papapanou et al., 2018).
Who may be able to join
- ≥18 years old
Who cannot join
- <18 years old
- Medical history that includes uncontrolled diabetes or hepatic or renal failure, or other serious medical conditions or transmittable diseases e.g. serious cardiovascular disease or AIDS.
- History of rheumatic fever, heart murmur, mitral valve prolapse, artificial heart valve or other conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures.
- Antibiotic, anti-inflammatory or anticoagulant therapy during the 2 weeks preceding the baseline exam.
- History of alcohol or drug abuse.
- In treatment with medications causing gingival overgrowth
Show all 9Show fewer
- Smoking ≥10 cigarettes a day
- Self-reported pregnancy or lactation (this criterion is due to oral tissue changes related to pregnancy and nursing which can affect interpretation of study results).
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgement of the investigator, would make the subject inappropriate for entry into this study.
Trial locations and contacts
1 site in 1 country.
About this study
This is a laboratory-based study and it aims to evaluate the expression of inflammasomes in healthy gingiva and in the presence of peri-implantitis and periodontitis
Read the detailed description
This is a laboratory-based study involving 48 systemically healthy patients divided into: healthy (H) (n=16), periodontitis stage III-IV (n=16) (PE) and peri-implantitis (n=16) (PI).
Patients will be recruited at the Centro di Odontoiatria, Dipartimento di Medicina e Chirurgia, Università di Parma.
Only 1 study visit will be performed, which coincides with the day in which the patient will receive the dental/gingival surgery.
After signing an informed consent form, all participants will undergo a full-mouth periodontal and peri-implant examination, including plaque index (FMPS), probing pocket depth (PPD), clinical attachment level (CAL), bleeding on probing (FMBS) recorded by a calibrated examiner from six sites per tooth/implant (mesiobuccal, midbuccal, distobuccal, distolingual, midlingual and mesiolingual) excluding third molars and using a manual University of North Carolina (UNC-15) periodontal probe. This is a routine examination done as part of dental assessments that allows to place a diagnosis of health, periodontitis or peri-implantitis.
Gingival tissue samples will be collected during surgical procedures such as gingivectomy, crown lengthening and resective surgery. In order to minimise the influence of bacteria from dental plaque as a source of local inflammation and preferentially evaluate the influence of systemic inflammatory conditions on the periodontal tissues, and following the standard of practice in periodontal and peri-implant treatment, patients belonging to the PE and PI group would have received non-surgical therapy and practical and theoretical sessions on general oral hygiene within 3 months before collecting the biopsy (Sanz et al., 2020).
Samples of the H group will be obtained from sites with gingival index (GI) <1 (Loe, 1967), no clinical attachment loss and without bleeding on probing. For PE and PI groups, tissue samples will be selected from the areas involved in the surgical procedure presenting the greatest level of inflammation and with the deepest PPD.
Each patient will contribute to one gingival tissue sample only, which may include up to 3 neighboring teeth/implants.
- Conditions
- Periodontitis, Peri-Implantitis, Inflammation
- Being tested
- Analysis of inflammasome expression, Histological analysis
- Medical subject headings
- Periodontitis, Peri-Implantitis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analysis of inflammasome expressionOther
RNA isolation, spectrophotometric quantification, reverse transcription to cDNA and relative quantification of gene expression using a quantitative reverse transcription polymerase chain reaction (qRT-PCR). Specific inflammasome-related transcripts will be investigated, including ASC, caspase-1, IL-1beta, IL-18, NLRP3, NLRP2, AIM2, POP1, POP2, CARD16, CARD18, TRIM16, and TRIM20. A qRT-PCR System (e.g. StepOne Plus, Applied Biosystems) will be used for the amplification and analysis of the PCR products. Expression data will be reported as the ratio between each investigated target gene and GAPDH (used as housekeeping endogenous control).
Histological analysisOther
gingival tissue samples will be prepared for paraffin inclusion and different stains will be used to evaluate the histological features of the tissues, distribution of inflammatory cells and alignment of collagen fibers.
Moreover, a trained examiner will assess semi-quantitatively the inflammatory infiltrate under light microscopy.
The expression of inflammatory/immune-related proteins such as NLRP3, ASC-2, IL-1beta and IL-18 protein expressions will be compared among the three groups by immunodetection methods
| Study group | Role | What they receive |
|---|---|---|
| Healthy gingival tissue | healthy patients with absence of gingivitis (full-mouth bleeding score <10%), no history of periodontal disease, having ≥20 teeth, and ≤1 tooth with interdental clinical attachment loss. Receives: Other: Analysis of inflammasome expression; Other: Histological analysis | |
| Periodontitis patients | patients with stage III or IV periodontitis, which means that these patients would have deep periodontal lesions that extend at least to the mid portion of the roots and whose management is complicated by the presence of intrabony defects, furcation involvement, history of periodontal tooth loss and localized ridge defects. Receives: Other: Analysis of inflammasome expression; Other: Histological analysis | |
| Peri-implantitis patients | patients affected by peri-implantitis, defined as radiographic evidence of bone loss ≥3 mm and probing pocket depth ≥6 mm around implants in conjunction with bleeding on probing; or defined as bleeding and/or suppuration on probing, increased probing pocket depth from a previous examination and loss of peri-implant bone. Receives: Other: Analysis of inflammasome expression; Other: Histological analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference in expression of inflammasome-related transcripts ASC, caspase-1, IL-1beta, IL-18, NLRP3, NLRP2, AIM2, POP1, POP2, CARD16, CARD18, TRIM16, and TRIM20 between the 3 groups
Measured: at the time of tissue collection (cross-sectional)
Secondary outcomes (3)
Qualitative histological description of gingival tissue in the 3 groups
Measured: at the time of tissue collection (cross-sectional)
Semi-quantitative assessment of inflammatory score within histology sections
Measured: at the time of tissue collection (cross-sectional)
Differences in the expression of inflammatory-immune related proteins, such as NLRP3, ASC-2, IL-1beta and IL-18 proteins, as assessed by immunodetection methods in the 3 groups
Measured: at the time of tissue collection (cross-sectional)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2021
- Study start1 May 2021
- Primary completion14 Dec 2023
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Parma
- Sponsor type
- University, hospital or other
- Collaborators
- ITI International Team for Implantology, Switzerland
- Responsible party
- Principal investigator, Prof Elena Calciolari, University of Parma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05061511
- Sponsor's protocol ID
- P-003
- Status last verified
- Apr 2025
- First submitted
- 27 May 2021
- Last updated
- 22 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Centro di Odontoiatria is the sponsor for this study. We will be using patient information in order to undertake this study and will act as the data controller for this study. This means that we are responsible for looking after patient information and using it properly. We will keep identifiable information for 20 years after the study has finished. The only people within the Centro di Odontoiatria who will have access to information that identifies the patients will be people who need to contact them about the research study, and make sure that relevant information about the study is recorded for their care, and to oversee the quality of the study or audit the data collection process. The people who analyse the information will not be able to identify patients and will not be able to find out their name or contact details.
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expression of Inflammasomes in Peri-implantitis and Periodontitis
- ClinicalTrials.gov ID
- NCT05061511
- Acronym / sponsor ID
- P-003
- Conditions
- Periodontitis, Peri-Implantitis, Inflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of ParmaUniversity, hospital or other
- Collaborators
- ITI International Team for Implantology, Switzerland
- Study start
- 1 May 2021 (actual)
- Primary completion
- 14 Dec 2023 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 29 Sep 2021 (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.
This is a laboratory-based study and it aims to evaluate the expression of inflammasomes in healthy gingiva and in the presence of peri-implantitis and periodontitis
Detailed description
This is a laboratory-based study involving 48 systemically healthy patients divided into: healthy (H) (n=16), periodontitis stage III-IV (n=16) (PE) and peri-implantitis (n=16) (PI).
Patients will be recruited at the Centro di Odontoiatria, Dipartimento di Medicina e Chirurgia, Università di Parma.
Only 1 study visit will be performed, which coincides with the day in which the patient will receive the dental/gingival surgery.
After signing an informed consent form, all participants will undergo a full-mouth periodontal and peri-implant examination, including plaque index (FMPS), probing pocket depth (PPD), clinical attachment level (CAL), bleeding on probing (FMBS) recorded by a calibrated examiner from six sites per tooth/implant (mesiobuccal, midbuccal, distobuccal, distolingual, midlingual and mesiolingual) excluding third molars and using a manual University of North Carolina (UNC-15) periodontal probe. This is a routine examination done as part of dental assessments that allows to place a diagnosis of health, periodontitis or peri-implantitis.
Gingival tissue samples will be collected during surgical procedures such as gingivectomy, crown lengthening and resective surgery. In order to minimise the influence of bacteria from dental plaque as a source of local inflammation and preferentially evaluate the influence of systemic inflammatory conditions on the periodontal tissues, and following the standard of practice in periodontal and peri-implant treatment, patients belonging to the PE and PI group would have received non-surgical therapy and practical and theoretical sessions on general oral hygiene within 3 months before collecting the biopsy (Sanz et al., 2020).
Samples of the H group will be obtained from sites with gingival index (GI) <1 (Loe, 1967), no clinical attachment loss and without bleeding on probing. For PE and PI groups, tissue samples will be selected from the areas involved in the surgical procedure presenting the greatest level of inflammation and with the deepest PPD.
Each patient will contribute to one gingival tissue sample only, which may include up to 3 neighboring teeth/implants.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy gingival tissue | – | Other: Analysis of inflammasome expression, Other: Histological analysishealthy patients with absence of gingivitis (full-mouth bleeding score <10%), no history of periodontal disease, having ≥20 teeth, and ≤1 tooth with interdental clinical attachment loss. |
| Periodontitis patients | – | Other: Analysis of inflammasome expression, Other: Histological analysispatients with stage III or IV periodontitis, which means that these patients would have deep periodontal lesions that extend at least to the mid portion of the roots and whose management is complicated by the presence of intrabony defects, furcation involvement, history of periodontal tooth loss and localized ridge defects. |
| Peri-implantitis patients | – | Other: Analysis of inflammasome expression, Other: Histological analysispatients affected by peri-implantitis, defined as radiographic evidence of bone loss ≥3 mm and probing pocket depth ≥6 mm around implants in conjunction with bleeding on probing; or defined as bleeding and/or suppuration on probing, increased probing pocket depth from a previous examination and loss of peri-implant bone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The definition of the 3 groups will be based on the features described by the 2017 World Workshop on the classification of periodontal and peri-implant conditions (Berglundh et al., 2018, Papapanou et al., 2018).
Key inclusion criteria (1 listed)
- ≥18 years old
Key exclusion criteria (9 listed)
- <18 years old
- Medical history that includes uncontrolled diabetes or hepatic or renal failure, or other serious medical conditions or transmittable diseases e.g. serious cardiovascular disease or AIDS.
- History of rheumatic fever, heart murmur, mitral valve prolapse, artificial heart valve or other conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures.
- Antibiotic, anti-inflammatory or anticoagulant therapy during the 2 weeks preceding the baseline exam.
- History of alcohol or drug abuse.
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 |
|---|---|---|
| Analysis of inflammasome expressionRNA isolation, spectrophotometric quantification, reverse transcription to cDNA and relative quantification of gene expression using a quantitative reverse transcription polymerase chain reaction (qRT-PCR). Specific inflammasome-related transcripts will be investigated, including ASC, caspase-1, IL-1beta, IL-18, NLRP3, NLRP2, AIM2, POP1, POP2, CARD16, CARD18, TRIM16, and TRIM20. A qRT-PCR System (e.g. StepOne Plus, Applied Biosystems) will be used for the amplification and analysis of the PCR products. Expression data will be reported as the ratio between each investigated target gene and GAPDH (used as housekeeping endogenous control). | Other | Healthy gingival tissue, Peri-implantitis patients, Periodontitis patients |
| Histological analysisgingival tissue samples will be prepared for paraffin inclusion and different stains will be used to evaluate the histological features of the tissues, distribution of inflammatory cells and alignment of collagen fibers. Moreover, a trained examiner will assess semi-quantitatively the inflammatory infiltrate under light microscopy. The expression of inflammatory/immune-related proteins such as NLRP3, ASC-2, IL-1beta and IL-18 protein expressions will be compared among the three groups by immunodetection methods | Other | Healthy gingival tissue, Peri-implantitis patients, Periodontitis patients |
Primary outcome
difference in expression of inflammasome-related transcripts ASC, caspase-1, IL-1beta, IL-18, NLRP3, NLRP2, AIM2, POP1, POP2, CARD16, CARD18, TRIM16, and TRIM20 between the 3 groups
Time frame: at the time of tissue collection (cross-sectional)
3 secondary outcomes
Qualitative histological description of gingival tissue in the 3 groups
Time frame: at the time of tissue collection (cross-sectional)
Semi-quantitative assessment of inflammatory score within histology sections
Time frame: at the time of tissue collection (cross-sectional)
Differences in the expression of inflammatory-immune related proteins, such as NLRP3, ASC-2, IL-1beta and IL-18 proteins, as assessed by immunodetection methods in the 3 groups
Time frame: at the time of tissue collection (cross-sectional)
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 22 Apr 2025.
- Individual participant dataSharing planned: No. Centro di Odontoiatria is the sponsor for this study. We will be using patient information in order to undertake this study and will act as the data controller for this study. This means that we are responsible for looking after patient information and using it properly. We will keep identifiable information for 20 years after the study has finished. The only people within the Centro di Odontoiatria who will have access to information that identifies the patients will be people who need to contact them about the research study, and make sure that relevant information about the study is recorded for their care, and to oversee the quality of the study or audit the data collection process. The people who analyse the information will not be able to identify patients and will not be able to find out their name or contact details.
Related trials for Periodontitis
Active, not recruitingObservational study
A Retrospective Comparative Evaluation of Omega-3 and Resveratrol Supplementation in Patients With Periodontitis
Periodontitis
Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
Recruiting
Probiotics Versus Antibiotics as an Adjuvant to Non-surgical Periodontal Treatment Among Smokers With Stage II, Grade B Periodontitis
Probiotics, Antibiotics
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 Periodontitis and Peri-Implantitis, run by University of Parma 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 1 inclusion and 9 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 22 Apr 2025. 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?
difference in expression of inflammasome-related transcripts ASC, caspase-1, IL-1beta, IL-18, NLRP3, NLRP2, AIM2, POP1, POP2, CARD16, CARD18, TRIM16, and TRIM20 between the 3 groups (time frame: at the time of tissue collection (cross-sectional)). 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 Apr 2025; AzTrials last refreshed its copy on 8 Nov 2026.