The healing process of palatal wounds
Conditions
Interventions
Group 1: Four 6mm mucosal samples are taken from the palate and then treated with the different wound dressings. Each of the wounds is then randomly treated with one of the four wound dressing protoco
Sponsors
University of Zürich Center of Dental Medicine Clinic of Reconstructive Dentistry
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Systemically healthy Good oral hygiene (Plaque index <30%) Absence of periodontal disease (Probing depth exceeding 3mm, except third molars) Sufficient space between the first molar and the canine for two 6mm biopsies with at least 3mm in between Sufficiently restored dentition Informed Consent as documented by signature
Exclusion criteria
Exclusion criteria: Previous surgeries at the palate within the last 3 months Uncontrolled diabetes Known coagulation disorders Blood coagulation-altering drugs Smoking of more than 10 cigarettes per day Self-declared pregnancy or breast feeding at the date of inclusion or intending to become pregnant during the course of the study Allergies against local anesthetics Allergies against collagen-based materials Concerns in terms of drawing blood or application of PRF/ PRGF membranes Known or suspected non-compliance, drug or alcohol abuse Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, etc. of the participant Participation in another study with investigational drug within the 30 days preceding and during the present study Previous enrolment into the current study Enrolment of the investigator, his/her family members, employees and other dependent persons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The evaluation of wound closure up to 14 days post-surgery. Patients come a total of eight times for a study visit. The first appointment (visit 1) involves the examination for participation in the study and photo documentation. At the second appointment (visit 2), the study intervention takes place, during which four mucosal samples are taken from the palate. The wound treatment of the four sites is randomized. The remaining appointments (visits 3-8) serve to document the healing process of the four mucosal wounds and take place on the 2nd, 5th, 7th, 9th, 12th and 14th day after the study intervention. During the second visit, the actual study intervention takes place and the following is carried out: - Venous blood sampling to prepare the wound dressings from autologous blood - Four circular palatal mucosal aspirates with a diameter of 6 mm - Wound dressings of the 4 resulting wounds + photo documentation At the remaining follow-up visits (visits 3-8), photos are taken to document wound healing. In addition, the patients fill out a questionnaire about their experiences/complaints during the treatment. The study will be completed within 14 days after the treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain perception over time assessed using an 11-point (i.e. 0-10) numerical rating scale (NRS) (0=no pain; 10=extremely painful) Painkiller consumption: Number of tablets taken after intervention. | — |
Countries
Switzerland
Contacts
Public ContactStefan Bienz
Center of Dental Medicine Clinic of Reconstructive Dentistry University of Zurich
Outcome results
None listed