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临床试验/NCT07377370
NCT07377370招募中不适用

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

Universitat Internacional de Catalunya1 个研究点 分布在 1 个国家目标入组 93 人开始时间: 2026年2月2日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
93
试验地点
1
主要终点
Postoperative pain

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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%

排除标准

  • 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

研究组 & 干预措施

Gingival graft harvesting from the palate

Other

Participants undergoing epithelial graft harvesting from the palate as part of mucogingival surgery. The palatal wound will be treated by placing collagen sponges and hemostatic sutures.

干预措施: Gingival graft harvesting from the palate (Procedure)

结局指标

主要结局

Postoperative pain

时间窗: 14 days post-surgery, recorded daily

Postoperative pain will be assessed as pain intensity measured using a Visual Analog Scale (VAS). The VAS consists of a 100-mm horizontal line, where 0 mm indicates no pain and 100 mm indicates worst imaginable pain. Pain will be self-reported by patients once daily during the 14-day postoperative period. Unit of Measure: Pain intensity (millimeters on a 0-100 mm Visual Analog Scale)

次要结局

  • Total operative time(At the time of surgery)
  • Duration of donor site preparation(At the time of surgery)
  • Discomfort at eating(14 days post-surgery, recorded daily)
  • Oral Health Impact Profile - 5 items (OHIP5)(Baseline and 2-weeks post-surgery)
  • Analgesic consumption(During the first week)
  • Anticipated pain(Baseline)
  • Stress level (PSS-4)(Baseline)
  • Dental Anxiety (IDAF-4C)(Baseline)
  • Psychological profile (SCL-90-R)(Baseline)
  • Personality traits (BFI-10)(Baseline)
  • Pain Catastrophizing Scale (PCS)(Baseline)
  • Coping strategies (Brief COPE)(Baseline)
  • Past grafting experience(Baseline)
  • Palatal thickness(Baseline)
  • Graft dimensions(At the time of surgery)
  • Operator experience(At the time of surgery)
  • Healing of the donor site(1-week and 2-weeks post-surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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