Periodontal DiseasesNCT06354972
Impact of SASP in the GCF on the Outcomes of Periodontal Regeneration
An observational study of Periodontal Diseases, run by University of Turin, Italy at 1 site in Italy.
Trial summary
Objectives: To test the impact of clinical inflammation and molecular expression profile (senescence-associated secretory phenotype; SASP) in the gingival crevicular fluid (GCF) on the outcomes of minimally-invasive periodontal regeneration in intra-bony defects. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- Minimally invasive surgical procedure
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 2 Jan 2022to 2 Jan 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Consecutive patients with a diagnosis of stage III or IV periodontitis who had undergone steps I-II of periodontal therapy were considered for inclusion.
Who may be able to join
- 1) diagnosis of stage III or IV periodontitis (Papapanou et al. 2018b); 2) full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) of <15%; 3) completion of steps I-II of periodontal treatment at least 2 months priorly; 4) tooth with residual PPD ≥ 6 mm, BoP+, and a radiographic intrabony component ≥ 3 mm, lacking furcation involvement (Aimetti et al. 2023), considered suitable for a minimally invasive procedure (Cortellini and Tonetti 2007) (Fig. 1A).
Who cannot join
- 1) age < 18 years; 2) current smokers; 3) contraindications to surgery; 4) systemic diseases that could impact periodontal healing; 5) pregnancy and lactation; 6) a history of periodontal surgery at the experimental teeth.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of the Senescence Associated Secretory Phenotype in the Gingival Crevicular Fluid on the Outcomes of Periodontal Regeneration
Objectives: To test the impact of clinical inflammation and molecular expression profile (senescence-associated secretory phenotype; SASP) in the gingival crevicular fluid (GCF) on the outcomes of minimally-invasive periodontal regeneration in intra-bony defects.
Methods: Sites associated with intrabony defects ≥ 3 mm requiring periodontal regeneration through minimally-invasive surgical technique were included. Pre-operatively, GCF was sampled for inflammatory biomarker analysis related to SASP [interleukin (IL)-1β, IL-6 and IL-12; matrix-metalloproteinases (MMP)-8 and -9]. Correlation analyses and logistic regression models were performed to assess the impact of predictors on clinical and radiographic outcomes.
- Conditions
- Periodontal Diseases
- Being tested
- Minimally invasive surgical procedure
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally invasive surgical procedureProcedure or surgery
All the experimental sites underwent a minimally-invasive surgical technique (MIST) procedure under magnification (Cortellini and Tonetti 2007). The full-thickness flap was minimally raised both on the buccal and oral side, avoiding vertical releasing incisions. Granulation tissue was scraped from the bony surfaces of the defect, and the root was debrided using minicurettes/ultrasonic device and chemically treated by EDTA. Regenerative procedure was carried out using a combination of enamel matrix derivatives and bone xenograft. The flaps were then repositioned and sutured in order to obtain passive primary closure.
| Study group | Role | What they receive |
|---|---|---|
| Minimally invasive periodontal regeneration | Minimally-invasive surgical technique (MIST) procedure using both biological inductors and bone xenograft. Receives: Procedure: Minimally invasive surgical procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical attachment level change
Clinical attachment level will be assessed on the experimental teeth using periodontal probe (PCP 15/11.5, Hu-Friedy, Chicago, IL, USA)
Measured: [Time Frame: 12 months]
Achievement of composite outcome measure
Composite outcome measure (COM) will be achieved by sites with probing pocket depth < 4 mm and relevant clinical attachment gain ≥ 3 mm at the 12-month re-evaluation
Measured: [Time Frame: 12 months]
Secondary outcomes (2)
Radiographic bone level change
Periapical standardized radiographs will be taken by a clinician masked to the clinical measurements using the paralleling technique and individually customized bite-blocks (RINN XCP Film Holding Instruments, Dentsply, York, USA)
Measured: [Time Frame: 12 months]
Probing pocket depth change
Probing depth will be assessed on the experimental teeth using periodontal probe (PCP 15/11.5, Hu-Friedy, Chicago, IL, USA)
Measured: [Time Frame: 12 months]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start2 Jan 2022
- Primary completion2 Nov 2022
- Study completion2 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06354972
- Sponsor's protocol ID
- SASP Turin
- Status last verified
- Apr 2024
- First submitted
- 3 Apr 2024
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Senescence Associated Secretory Phenotype in the Gingival Crevicular Fluid on the Outcomes of Periodontal Regeneration
- ClinicalTrials.gov ID
- NCT06354972
- Acronym / sponsor ID
- SASP Turin
- Conditions
- Periodontal Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- 2 Jan 2022 (actual)
- Primary completion
- 2 Nov 2022 (actual)
- Study completion
- 2 Jan 2024 (actual)
- First posted
- 9 Apr 2024 (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.
Objectives: To test the impact of clinical inflammation and molecular expression profile (senescence-associated secretory phenotype; SASP) in the gingival crevicular fluid (GCF) on the outcomes of minimally-invasive periodontal regeneration in intra-bony defects.
Methods: Sites associated with intrabony defects ≥ 3 mm requiring periodontal regeneration through minimally-invasive surgical technique were included. Pre-operatively, GCF was sampled for inflammatory biomarker analysis related to SASP [interleukin (IL)-1β, IL-6 and IL-12; matrix-metalloproteinases (MMP)-8 and -9]. Correlation analyses and logistic regression models were performed to assess the impact of predictors on clinical and radiographic outcomes.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Minimally invasive periodontal regeneration | – | Procedure: Minimally invasive surgical procedureMinimally-invasive surgical technique (MIST) procedure using both biological inductors and bone xenograft. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients with a diagnosis of stage III or IV periodontitis who had undergone steps I-II of periodontal therapy were considered for inclusion.
Key inclusion criteria (1 listed)
- 1) diagnosis of stage III or IV periodontitis (Papapanou et al. 2018b); 2) full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) of <15%; 3) completion of steps I-II of periodontal treatment at least 2 months priorly; 4) tooth with residual PPD ≥ 6 mm, BoP+, and a radiographic intrabony component ≥ 3 mm, lacking furcation involvement (Aimetti et al. 2023), considered suitable for a minimally invasive procedure (Cortellini and Tonetti 2007) (Fig. 1A).
Key exclusion criteria (1 listed)
- 1) age < 18 years; 2) current smokers; 3) contraindications to surgery; 4) systemic diseases that could impact periodontal healing; 5) pregnancy and lactation; 6) a history of periodontal surgery at the experimental teeth.
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 |
|---|---|---|
| Minimally invasive surgical procedureAll the experimental sites underwent a minimally-invasive surgical technique (MIST) procedure under magnification (Cortellini and Tonetti 2007). The full-thickness flap was minimally raised both on the buccal and oral side, avoiding vertical releasing incisions. Granulation tissue was scraped from the bony surfaces of the defect, and the root was debrided using minicurettes/ultrasonic device and chemically treated by EDTA. Regenerative procedure was carried out using a combination of enamel matrix derivatives and bone xenograft. The flaps were then repositioned and sutured in order to obtain passive primary closure. | Procedure or surgery | Minimally invasive periodontal regeneration |
Primary outcome
Clinical attachment level change
Time frame: [Time Frame: 12 months]
Clinical attachment level will be assessed on the experimental teeth using periodontal probe (PCP 15/11.5, Hu-Friedy, Chicago, IL, USA)
Achievement of composite outcome measure
Time frame: [Time Frame: 12 months]
Composite outcome measure (COM) will be achieved by sites with probing pocket depth < 4 mm and relevant clinical attachment gain ≥ 3 mm at the 12-month re-evaluation
2 secondary outcomes
Radiographic bone level change
Time frame: [Time Frame: 12 months]
Probing pocket depth change
Time frame: [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 9 Apr 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.
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 Periodontal Diseases, run by University of Turin, Italy 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 1 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 9 Apr 2024. 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?
Clinical attachment level change (time frame: [Time Frame: 12 months]). 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 9 Apr 2024.