Factors Influencing Postoperative Pain After Gingival Graft Harvesting

NCT07377370 | Recruiting

• 1 other identifier: PER-ECL-2025-01
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Pain

Keywords

postoperative pain; gingival graft; patient-related factors; palatal wound healing; psychological profile

Outcome Measures

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)

  14 days post-surgery, recorded daily

Secondary Outcomes (17)

• 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

Study Arms (1)

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.

Procedure: Gingival graft harvesting from the palate

Interventions

Gingival graft harvesting from the palate PROCEDURE

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

Gingival graft harvesting from the palate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitat Internacional de Catalunya: lead

Study Sites (1)

Clínica Universitària d'Odontologia - UIC Barcelona

Barcelona, Sant Cugat Del Valles, 08195, Spain

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Lory Abrahamian, DDS, MSc, PhD Candidate

CONTACT

+34722528012; lory.abrahamian@uic.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: January 29, 2026
• Study Start: February 2, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: February 4, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)