Palatal Volumetric Change Analysis Following Connective Tissue Graft With and Without Donor Site Augmentation
Status unconfirmed · Not applicable
Conditions studied: Recession, Gingival
In brief
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.
Key facts
- Study ID
- NCT05961566
- Run by
- Hailey Bivens
- People needed
- 40
- Starts
- 2023-10-01
- Expected to finish
- 2025-03-30
- Last updated by the study team
- 2024-01-19
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Demographic
- 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
- Medical History
- Physically and mentally healthy with no contraindications for periodontal surgery
- American Society of Anesthesiologists: ASA-I or ASA-II
- Dental history
- Periodontally healthy
- No history of surgical interventions in the palate
- No history of cleft lip/palate
- No history of orthodontic treatment involving the palate (palatal expansion).
- Other
- Patients requiring mucogingival surgery involving connective tissue graft harvesting from the palate.
- Patients who are able and willing to provide informed consent
- Patients who are able and willing to follow study appointments
You may not qualify if…
- i. Medical History
- 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
- Medications affecting surgical or wound healing process and gingival tissues, such as phenytoin, cyclosporine, dihydropyridines, etc.
- Dental
- Patients with any history of palatal surgery
- Patients with inadequate donor site anatomy
- Poor oral hygiene
- Full-mouth plaque ≥ 20%
- Bleeding scores > 10%
- Untreated periodontitis
- Pocket depths > 3mm with BOP
- No active periodontal disease
Where it is running
- Texas A&M College of Dentistry — Dallas, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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