Impact of SASP in the GCF on the Outcomes of Periodontal Regeneration

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.

Study Overview

• Status: Completed
• Conditions: Periodontal Diseases
• Intervention / Treatment: Procedure: Minimally invasive surgical procedure

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Italy
  • Turin, Italy, 10126
    • CIR Dental School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

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.

Description

Inclusion criteria comprised:

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).

Exclusion criteria encompassed:

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Minimally invasive periodontal regeneration; Minimally-invasive surgical technique (MIST) procedure using both biological inductors and bone xenograft.

Procedure: Minimally invasive surgical procedure; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	[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	[Time Frame: 12 months]

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	[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)	[Time Frame: 12 months]

Collaborators and Investigators

• Sponsor: University of Turin, Italy

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2022
• Primary Completion (Actual): November 2, 2022
• Study Completion (Actual): January 2, 2024

Study Registration Dates

• First Submitted: April 3, 2024
• First Submitted That Met QC Criteria: April 3, 2024
• First Posted (Actual): April 9, 2024

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Periodontal Diseases
• Other Study ID Numbers: SASP Turin

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No