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Postoperative PainNCT07377370

Factors Influencing Postoperative Pain After Gingival Graft Harvesting

A study testing Gingival graft harvesting from the palate in people with Postoperative Pain, run by Universitat Internacional de Catalunya at 1 site in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This prospective cohort study aims to evaluate patient-related, psychological, and clinical factors influencing postoperative pain following gingival graft harvesting from the palate. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Postoperative Pain
What is being tested?
Gingival graft harvesting from the palate
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
93 participants
Where
1 siteSpain
Study dates
2 Feb 2026to Sep 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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%

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Lory Abrahamian, DDS, MSc, PhD Candidate contact

+34722528012

lory.abrahamian@uic.es

Spain1 site, 1 recruiting
  • Clínica Universitària d'Odontologia - UIC Barcelona

    Barcelona, Sant Cugat Del Valles, 08195

    Lory Abrahamian, +34935042000, lory.abrahamian@uic.es

    Recruiting

Other trials in Spain

About this study

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

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.

Read more

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.

Read the detailed description

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.

Being tested
Gingival graft harvesting from the palate
Keywords
postoperative pain, gingival graft, patient-related factors, palatal wound healing, psychological profile
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gingival graft harvesting from the palateProcedure or surgery

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

Study groups in NCT07377370
Study groupRoleWhat they receive
Gingival graft harvesting from the palateOtherParticipants 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.
Receives: Procedure: Gingival graft harvesting from the palate

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 14 days post-surgery, recorded daily

Secondary outcomes (17)
  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

    Measured: At the time of surgery

  2. 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

    Measured: At the time of surgery

  3. 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

    Measured: 14 days post-surgery, recorded daily

  4. 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

    Measured: Baseline and 2-weeks post-surgery

  5. Analgesic consumption

    Postoperative analgesic consumption will be measured as the number of standard doses of pain medication taken by the patient during the 7-day postoperative period. Patients will record each dose taken in a daily diary, including the type and amount of analgesic. Higher numbers indicate greater analgesic use.

    Unit of Measure: Number of doses (or tablets/capsules)

    Measured: During the first week

  6. Anticipated pain

    Anticipated postoperative pain will be assessed using the Visual Analog Scale for Pain (VAS). Patients will mark a point on a 100-mm horizontal line, where 0 mm indicates no expected pain and 100 mm indicates worst imaginable expected pain. Higher scores indicate greater anticipated pain. This assessment will be completed preoperatively, immediately before surgery.

    Unit of Measure: Millimeters (0-100) on the Visual Analog Scale for Pain

    Measured: Baseline

  7. Stress level (PSS-4)

    Perceived stress will be assessed using the Perceived Stress Scale - 4 item version (PSS-4). The PSS-4 consists of 4 items, each scored from 0 to 4, where 0 = never and 4 = very often, for a total score range of 0-16. Higher scores indicate higher perceived stress. The questionnaire will be completed preoperatively, immediately before surgery.

    Unit of Measure: Points (0-16) on the Perceived Stress Scale - 4 item version (PSS-4)

    Measured: Baseline

  8. Dental Anxiety (IDAF-4C)

    Dental anxiety will be assessed using the Index of Dental Anxiety and Fear - Core 4 items (IDAF-4C). The IDAF-4C consists of 4 items, each scored from 1 to 5, where 1 = no anxiety and 5 = extreme anxiety, for a mean score range of 1-5. Higher scores indicate greater dental anxiety. The questionnaire will be completed preoperatively, immediately before surgery.

    Unit of Measure: Mean score (1-5) on the Index of Dental Anxiety and Fear - Core 4 items (IDAF-4C)

    Measured: Baseline

  9. Psychological profile (SCL-90-R)

    Psychological symptoms will be assessed using the Symptom Checklist - 90 Revised (SCL-90-R). The SCL-90-R consists of 90 items, each scored from 0 to 4, where 0 = not at all and 4 = extremely, for a Global Severity Index (GSI) score range of 0-4. Higher scores indicate greater psychological symptom severity. The questionnaire will be completed preoperatively, immediately before surgery.

    Unit of Measure: Mean score (0-4) on the Global Severity Index of the Symptom Checklist - 90 Revised (SCL-90-R)

    Measured: Baseline

  10. Personality traits (BFI-10)

    Personality traits will be assessed using the Big Five Inventory - 10 items (BFI-10). The BFI-10 consists of 10 items, each scored from 1 to 5, where 1 = disagree strongly and 5 = agree strongly, for a mean score range of 1-5 on each of the five personality domains (Extraversion, Agreeableness, Conscientiousness, Neuroticism, Openness). Higher scores indicate stronger expression of the respective personality trait. The questionnaire will be completed preoperatively, immediately before surgery.

    Unit of Measure: Mean score (1-5) for each domain on the Big Five Inventory - 10 items (BFI-10)

    Measured: Baseline

  11. Pain Catastrophizing Scale (PCS)

    Pain catastrophizing will be assessed using the Pain Catastrophizing Scale (PCS). The PCS consists of 13 items, each scored from 0 to 4, where 0 = not at all and 4 = all the time, for a total score range of 0-52. Higher scores indicate greater levels of pain catastrophizing. The questionnaire will be completed preoperatively, immediately before surgery.

    Unit of Measure: Total score (0-52) on the Pain Catastrophizing Scale (PCS)

    Measured: Baseline

  12. Coping strategies (Brief COPE)

    Coping strategies will be assessed using the Brief COPE questionnaire. The Brief COPE consists of 28 items across 14 subscales, each scored from 1 to 4, where 1 = I haven't been doing this at all and 4 = I've been doing this a lot. Higher scores indicate greater use of the respective coping strategy. The questionnaire will be completed preoperatively, immediately before surgery.

    Unit of Measure: Score (1-4) for each subscale on the Brief COPE questionnaire

    Measured: Baseline

  13. Past grafting experience

    Past grafting experience will be assessed by asking patients whether they have previously undergone gingival or soft tissue grafting procedures. Responses will be recorded as Yes or No.

    Unit of Measure: Categorical (Yes/No)

    Measured: Baseline

  14. Palatal thickness

    Palatal thickness will be measured at the donor site using an endodontic spreader with a stop. The measurement will be recorded in millimeters (mm) at the level of the premolars on the hard palate. Higher values indicate a thicker palatal tissue.

    Unit of Measure: Millimeters (mm)

    Measured: Baseline

  15. Graft dimensions

    Graft dimensions will be measured immediately after harvesting. Length, width, and thickness of the graft will be recorded in millimeters (mm) using a periodontal probe (PCP15). Higher values indicate larger graft size.

    Unit of Measure: Millimeters (mm) for length, width, and thickness

    Measured: At the time of surgery

  16. Operator experience

    Operator experience will be assessed as the number of years of clinical experience performing periodontal or soft tissue grafting procedures. Higher numbers indicate greater operator experience.

    Unit of Measure: Years of clinical experience

    Measured: At the time of surgery

  17. Healing of the donor site

    Healing of the donor site will be assessed using a modified wound healing score with four variables: Necrosis, Fibrin/Granulation Tissue, Bleeding on Palpation, and Texture, each scored 0-2:

    Variable: 0 1 2 Necrosis: Complete Incomplete Absent Fibrin/Granulation Tissue: Fibrin > granulation tissue Fibrin = granulation tissue Fibrin < granulation tissue Bleeding on Palpation: Present Slight Absent Texture: Obvious difference Moderate difference No difference

    Two blinded clinical examiners will independently evaluate standardized photographs at 1 week and 2 weeks postoperatively. Higher total scores indicate better wound healing. Inter-rater reliability will be calculated.

    Unit of Measure: Score (0-8), sum of four variables on the modified wound healing score

    Measured: 1-week and 2-weeks post-surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2026
  2. Study start2 Feb 2026
  3. Primary completionJul 2027 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
93 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07377370
Sponsor's protocol ID
PER-ECL-2025-01
Status last verified
Jan 2026
First submitted
12 Jan 2026
Last updated
4 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Gingival graft harvesting from the palate in people with Postoperative Pain, run by Universitat Internacional de Catalunya at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lory Abrahamian, DDS, MSc, PhD Candidate (+34722528012, lory.abrahamian@uic.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative pain (time frame: 14 days post-surgery, recorded daily). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.

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