Sapienza University of Rome, Department of Oral and Maxillofacial Sciences, Section of Periodontology
Rome, 00161, Italy
Location status: Recruiting
NCT Number: NCT07683962
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Rome, 00161, Italy
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
Time frame: Baseline, 6 months, and 12 months.
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.
Time frame: Baseline, 6 months, and 12 months.
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.
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).
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).
Time frame: 1 and 2 weeks
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).
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.
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.
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.
Contact information is provided by the study sponsor or research team.
University of Roma La Sapienza
Other
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
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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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