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Идёт набор NCT07377370

Factors Influencing Postoperative Pain After Gingival Graft Harvesting

Без фазы С лечением Postoperative Pain

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Gingival graft harvesting from the palate.
Кому может быть актуально
Состояния в реестре: Postoperative Pain. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Испания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Patient-Related Factors Influencing Postoperative Pain After Gingival Graft Harvesting From the Palate: A Prospective Study

Обзор

This prospective cohort study aims to evaluate patient-related, psychological, and clinical factors influencing postoperative pain following gingival graft harvesting from the palate. Consecutive adult patients requiring mucogingival surgery for root coverage or soft tissue augmentation around teeth or dental implants will be recruited at the Clínica Universitària d'Odontologia of Universitat Internacional de Catalunya (Barcelona, Spain). All participants will undergo standardized pre-surgical periodontal care and oral hygiene instruction prior to surgery. Gingival grafts will be harvested from the palate under local anesthesia using a standardized surgical technique. Postoperative management will include analgesic medication, antiseptic rinses, and standardized postoperative instructions. Patient-reported outcomes will be collected using validated questionnaires to assess anticipated pain, postoperative pain, stress, dental anxiety, psychological profile, personality traits, pain catastrophizing, coping strategies, oral health-related quality of life, and analgesic consumption. Postoperative pain and discomfort during eating will be recorded daily for two weeks. Clinical variables, including palatal thickness, graft dimensions, operative time, operator experience, and donor-site wound healing, will also be assessed. The primary outcome is postoperative pain intensity following palatal graft harvesting. Secondary outcomes include operative time, donor-site discomfort, oral health-related quality of life, analgesic consumption, psychological and behavioral factors, and donor-site healing. The results of this study aim to improve understanding of factors associated with postoperative pain and to support individualized patient management in mucogingival surgery.

Подробное описание

This prospective cohort study is designed to investigate patient-related, psychological, and clinical factors influencing postoperative pain following gingival graft harvesting from the palate. The study will be conducted at the Clínica Universitària d'Odontologia of Universitat Internacional de Catalunya (UIC), Barcelona, Spain, in accordance with the Declaration of Helsinki (October 2024 revision). The study protocol and informed consent will be reviewed and approved by the Ethical Committee of Universitat Internacional de Catalunya.

Consecutive adult patients requiring mucogingival surgery for root coverage or soft tissue augmentation around teeth or dental implants will be screened for eligibility. Inclusion criteria include systemically healthy individuals aged 18 years or older, a healthy periodontal status according to the AAP/EFP definition, and full-mouth plaque and bleeding scores ≤20%. Exclusion criteria include pregnancy or lactation, smoking ≥10 cigarettes per day, systemic or metabolic diseases affecting wound healing, use of medications interfering with healing, chronic pain disorders, psychiatric diagnoses, regular use of analgesics or psychotropic medications, allergy to ibuprofen, recent grafting procedures, and ongoing orthodontic treatment.

Prior to surgery, all patients will complete initial periodontal therapy when indicated, followed by professional prophylaxis and individualized oral hygiene instruction at least two weeks before the surgical procedure. On the day of surgery, gingival graft harvesting will be performed under local anesthesia using 4% articaine with epinephrine (1:100,000). An epithelialized gingival graft will be harvested from the palate using a standardized technique. Graft dimensions will be determined based on clinical requirements. In cases of bilaminar techniques, the graft will be de-epithelialized extra-orally, whereas the epithelium will be preserved for free gingival graft procedures. Donor-site management will include placement of collagen sponges and hemostatic sutures using non-resorbable suspensory mattress sutures.

All surgical procedures will be performed by postgraduate students enrolled in the Master's Degree in Periodontology at UIC. Operator experience will be recorded based on the year of residency. Postoperative care will be standardized for all participants and will include instructions to avoid mechanical trauma at the surgical site, prescription of ibuprofen 600 mg three times daily for five days, chlorhexidine mouth rinses for two weeks, and rescue medication with paracetamol if needed. Sutures will be removed after two weeks.

Sociodemographic data will be collected during the pre-surgical visit, including age, sex, education level, occupation, smoking habits, alcohol consumption, and body mass index. Patient-reported outcomes will be assessed using validated questionnaires evaluating anticipated pain, stress levels, dental anxiety, psychological profile, personality traits, pain catastrophizing, coping strategies, and previous grafting experience. Postoperative pain intensity and discomfort during eating will be recorded daily for two weeks using visual analog scales. Oral health-related quality of life will be assessed at baseline, one week, and two weeks postoperatively using the OHIP-5 questionnaire. Analgesic consumption during the first postoperative week will also be recorded.

Clinical variables will include palatal thickness measured by transgingival probing, graft dimensions recorded at the time of harvesting, total operative time, and duration of donor-site preparation. Donor-site wound healing will be evaluated at one and two weeks postoperatively using standardized clinical photographs assessed independently by two blinded examiners. A modified wound healing score will be applied, and inter-rater reliability will be calculated.

The primary outcome of the study is postoperative pain intensity following palatal gingival graft harvesting. Secondary outcomes include operative time, donor-site discomfort, oral health-related quality of life, analgesic consumption, psychological and behavioral factors, palatal thickness, graft dimensions, operator experience, and donor-site wound healing. The findings of this study aim to identify factors associated with postoperative pain and to support improved patient-centered management strategies in mucogingival surgery.

Вмешательства

  • Процедура Gingival graft harvesting from the palate
    An epithelial gingival graft will be harvested from the palate of patients requiring mucogingival surgery.

Первичные конечные точки

  • Postoperative pain [Срок оценки: 14 days post-surgery, recorded daily]
Вторичные конечные точки (12)
  • Total operative time [Срок оценки: At the time of surgery]
  • Duration of donor site preparation [Срок оценки: At the time of surgery]
  • Discomfort at eating [Срок оценки: 14 days post-surgery, recorded daily]
  • Oral Health Impact Profile - 5 items (OHIP5) [Срок оценки: Baseline and 2-weeks post-surgery]
  • Analgesic consumption [Срок оценки: During the first week]
  • Anticipated pain [Срок оценки: Baseline]
  • Stress level (PSS-4) [Срок оценки: Baseline]
  • Dental Anxiety (IDAF-4C) [Срок оценки: Baseline]
  • Psychological profile (SCL-90-R) [Срок оценки: Baseline]
  • Personality traits (BFI-10) [Срок оценки: Baseline]
  • Pain Catastrophizing Scale (PCS) [Срок оценки: Baseline]
  • Coping strategies (Brief COPE) [Срок оценки: Baseline]

Критерии участия

Критерии включения

  • Patients requiring mucogingival surgery for gingival augmentation or root coverage purposes
  • Systemically healthy individuals aged 18 years or older
  • Healthy periodontal status according to the AAP/EFP definition
  • Full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) ≤ 20%

Критерии исключения

  • Pregnancy or lactation
  • Self-reported smoking ≥10 cigarettes/day
  • Presence of metabolic or systemic diseases that negatively affect soft tissue healing
  • Use of medications that may interfere with wound healing
  • Chronic pain disorders (e.g., fibromyalgia)
  • Psychiatric diagnoses
  • Regular use of analgesics, antidepressants, anxiolytics, or opioids
  • Allergy to the study medication (Ibuprofen)
  • History of grafting within the past 6 months
  • Ongoing orthodontic therapy

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Испания · 1 центр
  • Clínica Universitària d'Odontologia - UIC Barcelona — Barcelona

Идентификаторы

NCT: NCT07377370 · PER-ECL-2025-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗