Evaluating pain and quality of life after gingival graft surgery with different treatments
Randomized Controlled Tiral to Evaluate Postoperative Pain and Quality of Life in Relation to Oral Health After Taking a Deephethelized Gingival Graft and Covering it With an Adhesive Film of Cellulose and Fluid Composite in Comparison With a Palate Plate or Cyanocrylate.
This study is testing which of three different treatments can help reduce pain and improve quality of life for patients after gum surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 33 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universidad Complutense de Madrid Academic / other |
| Drugs / interventions | denosumab, romosozumab, bevacizumab, sunitinib, chemotherapy, immunotherapy |
| Locations | 1 site (Alcorcón, Madrid) |
| Trial ID | NCT06408792 on ClinicalTrials.gov |
What this trial studies
This study aims to assess postoperative pain and quality of life related to oral health following a palatal de-epithelialized gingival graft. Patients will be randomly assigned to receive one of three treatments: an adhesive film of cellulose and fluid composite, a palatal plate, or cyanoacrylate coverage. Pain levels will be measured using a visual analogue scale, while quality of life will be evaluated through the Oral Health Impact Profile-14 questionnaire. The study will take place in two private clinics in the Community of Madrid.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who require soft tissue augmentation for dental implants and meet specific anatomical criteria.
Not a fit: Patients with a history of previous palatal graft extraction or those unable to comply with study procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved postoperative pain management and enhanced quality of life for patients undergoing gingival graft procedures.
How similar studies have performed: While similar studies have explored postoperative pain management in dental procedures, this specific approach using different coverage techniques is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients aged ≥18 years. 2. Need for soft tissue augmentation in an edentulous space to increase gingival volume simultaneously with placing a dental implant. 3. Patients with a palatal thickness of at least 4mm. This will be measured by overlaying a DICOM file of the CBCT with an STL file of the intraoral scan (Shining 3D). It will be measured at the height of the maxillary 2nd premolar, 5mm from the gingival margin. 4. Patients in whom a de-epithelialized palatal graft measuring 12x5mm can be obtained and which is between 1.5-2mm thick. The thickness will be measured with a digital caliper once it has been de-epithelialized. 5. Patients with no history of previous palatal graft extraction. 6. Patients with the ability to comply with the procedures related to the study, such as maintaining good oral hygiene, filling out the questionnaires and attending follow-up appointments. 7. Patients with the ability to fully understand the nature of the proposed surgery and the ability to understand and sign the informed consent form. Exclusion Criteria: 1. Presence of vertical bone dehiscence of \>3mm in the buccal area of the edentulous space where the implant will be placed (assessed at the time of surgery). 2. Smokers of more than 10 cigarettes/day 3. Presence of untreated periodontitis. 4. Diabetics 5. Patients being treated with oral anticoagulants or antiplatelet agents. 6. Patients with a history of malignant tumors, head and neck radiotherapy, chemotherapy or immunotherapy treatment in the last 5 years. 7. Patients with a history of previous or current medication that affects wound healing or promotes the appearance of infections, such as the use of corticosteroids, immunosuppressants or immunomodulators. 8. Patients with diseases that affect the metabolism of connective tissue, autoimmune or chronic inflammatory diseases with oral involvement (oral lichen planus, mucosal pemphigoid, pemphigus...), alterations in vascularization in the donor or recipient area, metabolic bone diseases or abuse of alcohol. 9. Patients receiving antiresorptive drugs such as bisphosphonates, denosumab, romosozumab or other drugs associated with osteonecrosis due to drugs such as m-TOR inhibitors, bevacizumab and sunitinib. 10. Pregnant or breastfeeding women. 11. Presence of oral lesions on the palate such as recurrent lesions due to herpes simplex virus. 12. Patients who use removable dental prosthesis that covers the palate. 13. Patients with a history of hypersensitivity to any of the materials used in the study.
Where this trial is running
Alcorcón, Madrid
- Clinica Dental Doctores Garcia Ruiz e Iglesias Esquiroz — Alcorcón, Madrid, Spain (Recruiting)
Study contacts
- Principal investigator: Rosa López-Pintor, Professor — Universidad Complutense de Madrid
- Study coordinator: José González Serrano, PhD
- Email: josego09@ucm.es
- Phone: +34662293482
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.