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

NCT ID: NCT06354972

Last Updated: 2024-04-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-02
• Study Completion Date: 2024-01-02

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.

Conditions

Periodontal Diseases

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Study Groups

Minimally invasive periodontal regeneration

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

Minimally invasive surgical procedure

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Turin, Italy

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CIR Dental School

Turin, , Italy

Countries

Italy

Other Identifiers

SASP Turin

Identifier Type: -

Identifier Source: org_study_id