Palatal Volumetric Change Analysis Following Connective Tissue Graft With and Without Donor Site … (NCT05961566) | Clinical Trial Compass
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Palatal Volumetric Change Analysis Following Connective Tissue Graft With and Without Donor Site Augmentation
United States40 participantsStarted 2023-10-01
Plain-language summary
The goal of this randomized clinical trial is to compare whether soft tissue augmentation placed in the donor site following a gum graft harvesting leads to volumetric changes compared to non-augmented sites in the palate. The main questions it aims to answer are:
* Are there tissue thickness changes between the two groups (control group and augmentation group)?
* Are there volumetric changes in the donor site (palate) between the two groups in the short and long term? Participants will receive a gum graft and then based on what group they were randomly assigned, they will receive either a collagen matrix where the gum graft was taken (on the palate) or nothing will be placed.
Researchers will compare non-augmented sites with augmented sites to see if there is a change in tissue thickness and volume.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age: 18-65 years old
✓. Gender: Any
✓. Race: Any
✓. Non-smoker: no use of any tobacco product or nicotine-replacement products in the last 5 years
✓. Physically and mentally healthy with no contraindications for periodontal surgery
✓. American Society of Anesthesiologists: ASA-I or ASA-II
✓. Periodontally healthy
✓. No history of surgical interventions in the palate
Exclusion criteria
✕. Smokers or users of nicotine replacement products
✕. Patients with a contraindication, e.g., allergy, for any of the medications or materials used in the study (benzocaine, lidocaine, chlorhexidine rinse, ibuprofen, acetaminophen, Glycolon ® sutures, collagen sponge matrix)
. Patients with diabetes (glycemic level \> 110mg/l and HbA1c \> 6.5%)
✕. Drug or alcohol abuse history
✕. Pregnancy, lactation.
✕. Patients with a history of bisphosphonate therapy, radiotherapy in the head and neck region for malignancies, or chemotherapy for treatment of malignant tumors
✕. Coagulation disorders or other systemic conditions affecting surgical or wound healing process and gingival tissues, such as cancer, HIV, metabolic bone diseases etc.
✕. Medications affecting periodontal status in the previous 6 months