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NCT Number: NCT07683962

Influence of Early Wound Healing on the Outcomes of Regenerative Periodontal Surgery

This study investigates whether early post-surgical healing (1-2 weeks) affects the 12-month clinical and radiographic success of periodontal regenerative therapy, and identifies patient-related, site-specific, and technique-related factors associated with optimal early wound healing, in patients with Stage III-IV periodontitis.

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Key information

Conditions

Intrabony Periodontal Defect Wound Healing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sapienza University of Rome, Department of Oral and Maxillofacial Sciences, Section of Periodontology

Rome, 00161, Italy

Location status: Recruiting

Location contact

Andrea Pilloni

CONTACT

[email protected]

+39 3356409374

About this study

This single-center, prospective observational cohort study addresses two pre-specified aims: (1) the association between early wound healing at 1 and 2 weeks and 12-month clinical and radiographic outcomes; and (2) the identification of patient-related, site-related (e.g., intrabony defect depth, CEJ-to-bone-crest distance, defect configuration, intrabony defect classification), and technique-related (flap design, biomaterial) factors associated with optimal early wound healing.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of Stage III or IV Periodontitis.
  • Presence of at least one deep interproximal infrabony defect (Probing Pocket Depth [PPD] >= 6 mm, radiographic depth >= 3 mm).
  • Optimal oral hygiene: Full-Mouth Plaque Score (FMPS) and Full-Mouth Bleeding Score (FMBS) < 15% at the time of surgery.

Exclusion criteria

  • Systemic: ASA III-VI classification; uncontrolled diabetes; medications causing gingival overgrowth (e.g., nifedipine, cyclosporine, phenytoin); heavy smokers (>10 cigarettes/day); pregnancy or lactation.
  • Local: Third molars; Grade III tooth mobility; inadequate endodontic treatment; teeth undergoing orthodontic treatment; teeth supporting removable or implant-linked fixed prosthetics.

Treatment and study plan

Periodontal Regenerative Therapy

Procedure

All subjects undergo surgical debridement of the intrabony defect followed by a regenerative approach (biologics with or without bone grafts, or blood clot alone) using papilla preservation techniques (MIST, M-MIST, MPPT, SPPF, or SFA).

Primary outcomes

  1. Change in Clinical Attachment Level (CAL).

    Time frame: Baseline and 12 months.

Secondary outcomes

  1. Composite healing index (CHI)

    Time frame: 1 and 2 weeks

    CHI has two independent, dichotomous domains (wound closure and wound quality), each answering a single clinically distinct question, and reports the outcome as a two-digit composite code.

  2. Probing Pocket Depth (PPD) Change:

    Time frame: Baseline and 12 months.

  3. Early Wound Healing Index (EHI)

    Time frame: 1 and 2 weeks

    Assessed using the Early Wound Healing Index (EHI). The index ranges from a minimum score of 1 (complete tissue closure without fibrin) to a maximum score of 5 (incomplete tissue closure with partial/complete necrosis). Higher scores mean a worse clinical outcome.

  4. Change in Radiographic Parameters

    Time frame: Baseline and 12 months.

    Measured in millimeters (mm) or degrees (°) on standardized radiographs from baseline to 12 months. It calculates the distance from a fixed reference point (e.g., cementoenamel junction) to the bottom of the bony defect. A positive change (increase in mm) indicates bone gain (better outcome).

  5. Number of analgesic tablets

    Time frame: 1 and 2 weeks

  6. Percentage of Sites With Bleeding on Probing (BOP)

    Time frame: Baseline and 12 months

    Presence or absence of bleeding assessed within 30 seconds of probing at specific sites. The data will be aggregated and reported as the percentage of sites showing bleeding out of the total sites examined. Higher percentages indicate worse outcomes.

  7. Composite outcome measure (COM)

    Time frame: 12 months

    Proportion of sites achieving a combination of PPD ≤ 4 mm and CAL gain ≥ 3 mm

  8. Pocket closure

    Time frame: 12 months

    Proportion of sites achieving a combination of PPD ≤ 4 mm and absence of bleeding on probing

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea Pilloni

CONTACT

[email protected]

+39 3356409374

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Official study title

Influence of Early Wound Healing on the 12-month Clinical and Radiographic Outcomes of Regenerative Periodontal Surgery: a Prospective Observational Cohort Study

Acronym: EWH_reg

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 6, 2026
Registry last updated
Jul 31, 2026

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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