Clinical trial NCT06408792: To Evaluate Postoperative Pain and Quality of Life After Taking a Deephethelized Gingival Graft and Covering it With Different Treatments
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain, Postoperative
Quality of Life
Palate; Wound
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
First posted: 2024-05-10
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective: To evaluate postoperative pain and quality of life in relation to oral health after obtaining a palatal de-epithelialized gingival graft and subsequent coverage of the surgical wound with an adhesive film of cellulose and fluid composite versus a palatal plate or covering with cyanoacrylate.

Study design: Randomized controlled study.

Patients: Patients who require a de-epithelialized gingival graft will be selected from two private clinics in the Community of Madrid.

Allocation: Patients will be randomly assigned to the study group (cellulose film and flowable composite), control group 1 (palatal plank) or control group 2 (cyanoacrylate coverage).

Variables: Postoperative pain will be recorded using a 10 cm visual analogue scale (VAS) and analgesic consumption will be noted. Quality of life in relation to oral health will be recorded using the Oral Health Impact Profile-14 (OHIP-14) questionnaire.

Analysis plan: Descriptive statistics will be used to describe patient characteristics. The possible differences between the 3 study groups will be evaluated using parametric or non-parametric tests depending on the distribution of the variables.


Eligibility 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.

Primary outcomes:
measure: Satisfaction assessed by the Visual Analog Scale in the palate
timeFrame: day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 10, day 14
measure: Satisfaction assessed by analgesic pills consumption
timeFrame: day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 10, day 14
Secondary outcomes:
measure: Satisfaction assessed by Oral Health Impact Profile 14 (OHIP-14)
timeFrame: day 0, day 3, day 7, day 14
measure: Hematoma assessed by the patient
timeFrame: Assessed day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10 after the surgery
measure: Swelling assessed by the patient
timeFrame: Assessed day 1, day 2, day 3,day 4, day 5, day 6, day 7, day 10,day 14 after the surgery
measure: Palate bleeding assessed by the patient
timeFrame: Assessed before and after 24 hours postoperatively
Other outcomes:
Locations:
city: Alcorcón
country: Spain
facility: Clinica Dental Doctores Garcia Ruiz e Iglesias Esquiroz
state: Madrid
Study officials:
affiliation: Universidad Complutense de Madrid
name: Rosa López-Pintor, Professor
role: PRINCIPAL_INVESTIGATOR
References: