Factors Influencing Postoperative Pain After Gingival Graft Harvesting
ConditionPostoperative Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversitat Internacional de Catalunya
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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%
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Gingival graft harvesting from the palate
Procedure/SurgeryAn epithelial gingival graft will be harvested from the palate of patients requiring mucogingival surgery.
Treatment groups
93 Participants
are divided into 1 treatment groupGroup A: Gingival graft harvesting from the palateOther 1 intervention
Trial outcomes
Primary outcomes
1
Postoperative pain
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)
Time frame
14 days post-surgery, recorded dailySecondary outcomes
1
Total operative time
Total operative time will be measured as the duration of the surgical procedure from the first incision to the completion of the final suture. Time will be recorded in minutes using a standard surgical timer. Longer times indicate longer procedures. Unit of Measure: Minutes
Time frame
At the time of surgery2
Duration of donor site preparation
Duration of donor site preparation will be measured as the time from the initial incision at the donor site to completion of tissue harvesting and hemostasis. Time will be recorded in minutes using a standard surgical timer. Longer times indicate longer donor site preparation. Unit of Measure: Minutes
Time frame
At the time of surgery3
Discomfort at eating
Discomfort while eating will be assessed using a 100-mm Visual Analog Scale for Discomfort (VAS). Patients will mark a point on a 100-mm horizontal line, where 0 mm indicates no discomfort and 100 mm indicates worst imaginable discomfort. Higher scores indicate greater discomfort while eating. Discomfort will be self-reported once daily for 14 days following surgery. Unit of Measure: Millimeters (0-100) on the Visual Analog Scale for Discomfort
Time frame
14 days post-surgery, recorded daily4
Oral Health Impact Profile - 5 items (OHIP5)
Oral health-related quality of life will be assessed using the Oral Health Impact Profile - 5 items (OHIP-5) questionnaire. The OHIP-5 consists of 5 items, each scored from 0 to 4, where 0 = never and 4 = very often, for a total score range of 0-20. Higher scores indicate worse oral health-related quality of life. The questionnaire will be completed preoperatively and at 14 days post-surgery. Unit of Measure: Points (0-20) on the OHIP-5 questionnaire
Time frame
Baseline and 2-weeks post-surgerySponsors and contacts
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Source ClinicalTrials.gov