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

Completed

• Conditions: Periodontal Diseases
• Interventions: Procedure: Minimally invasive surgical procedure

• Registration Number: NCT06354972
• Lead Sponsor: University of Turin, Italy

Brief 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.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-02
• Primary Completion: 2022-11-02
• Study Completion: 2024-01-02
• Status Verified: 2024-04
• Study First Submitted: 2024-04-03
• Study First Submitted QC: 2024-04-03
• Last Update Submitted: 2024-04-03
• Study First Posted: 2024-04-09
• Last Update Posted: 2024-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Clinical attachment level change	[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: 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

Secondary Outcome Measures

Name	Time	Method
Radiographic bone level change	[Time Frame: 12 months]	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)
Probing pocket depth change	[Time Frame: 12 months]	Probing depth will be assessed on the experimental teeth using periodontal probe (PCP 15/11.5, Hu-Friedy, Chicago, IL, USA)

Trial Locations

Locations (1)

CIR Dental School; 🇮🇹 Turin, Italy