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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 in patients with Stage III-IV periodontitis.

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Key information

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

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] >= 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 infrabony defect followed by a regenerative approach (biologics, 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, 6 months, and 12 months.

Secondary outcomes

  1. Early wound healing Classification

    Time frame: 1 and 2 weeks

    This system categorizes wounds into Classes (I-III) and Subclasses (A-C). The Classes define the wound closure status, with Class I indicating complete closure, Class II representing partial closure, and Class III denoting an open wound. The Subclasses assess the quality of healing by evaluating clinical signs during the hemostatic and inflammatory phase and the proliferative phase. Subclass A reflects optimal healing, Subclass B indicates sub-optimal healing, and Subclass C describes complicated healing.

  2. Probing Pocket Depth (PPD) Change:

    Time frame: Baseline, 6 months, 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 Linear Bone Fill

    Time frame: Baseline, 6 months, and 12 months.

    Measured in millimeters (mm) on standardized radiographs from baseline to 6 and 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. Oral Health Impact Profile-14 questionnaire

    Time frame: 1 and 2 weeks

    Evaluation of oral health-related quality of life using the unabbreviated Oral Health Impact Profile-14 (OHIP-14) questionnaire. The total score ranges from a minimum of 0 to a maximum of 56. Higher scores mean a worse outcome (greater negative impact on quality of life).

  6. Number of analgesic tablets

    Time frame: 1 and 2 weeks

  7. Patient-Reported Postoperative Swelling as Assessed by a Visual Analog Scale (VAS)

    Time frame: 1 and 2 weeks

    Postoperative swelling evaluated by the patient using a 100-mm Visual Analog Scale (VAS). The scale ranges from 0 mm (no swelling) to 100 mm (severe swelling). Higher scores indicate worse outcomes (greater swelling).

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

    Time frame: Baseline, 6 months 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.

  9. Postoperative Pain/Discomfort as Assessed by a Visual Analog Scale (VAS)

    Time frame: 1 and 2 weeks

    Patient's self-reported surgical discomfort/pain measured using a 100-mm Visual Analog Scale (VAS). The scale ranges from 0 mm (no pain/discomfort) to 100 mm (worst possible pain). Higher scores indicate worse outcomes.

  10. Patient-Reported Postoperative Estethics as Assessed by a Visual Analog Scale (VAS)

    Time frame: 1 and 2 weeks

    Patient's self-reported estethics measured using a 100-mm Visual Analog Scale (VAS). The scale ranges from 0 mm (worst possible estethics) to 100 mm (better possible estethics). Higher scores indicate better outcomes.

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 15, 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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