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Completed

NCT Number: NCT06354972

Impact of SASP in the GCF 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.

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Key information

Conditions

Periodontal Diseases Mouth Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CIR Dental School

Turin, 10126, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

comprised:

  • 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:

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. 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)

  2. 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

Secondary outcomes

  1. Radiographic bone level change

    Time frame: [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)

  2. Probing pocket depth change

    Time frame: [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)

Sponsors and collaborators

Lead sponsor

University of Turin, Italy

Other

Registry information

Official study title

Impact of the Senescence Associated Secretory Phenotype in the Gingival Crevicular Fluid on the Outcomes of Periodontal Regeneration

Important dates

Study start
2022
Primary completion
2022
Study completion
2024
First posted
Apr 9, 2024
Registry last updated
Apr 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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