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

NCT06354972 | Completed

• 1 other identifier: SASP Turin
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Radiographic bone level change

  [Time Frame: 12 months]

• Probing pocket depth change

  [Time Frame: 12 months]

Study Arms (1)

Minimally invasive periodontal regeneration

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

Procedure: Minimally invasive surgical procedure

Interventions

Minimally invasive surgical procedure 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.

Minimally invasive periodontal regeneration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \) 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).

You may not qualify if:

• \) 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.

Sponsors & Collaborators

• University of Turin, Italy: lead

Study Sites (1)

CIR Dental School

Turin, 10126, Italy

Location

MeSH Terms

Conditions

Periodontal Diseases

Interventions

Minimally Invasive Surgical Procedures

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2024
• First Posted: April 9, 2024
• Study Start: January 2, 2022
• Primary Completion: November 2, 2022
• Study Completion: January 2, 2024
• Last Updated: April 9, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)