Palatal Volumetric Change Analysis Following Connective Tissue Graft With and Without Donor Site Augmentation
- Conditions
- Recession, Gingival
- Registration Number
- NCT05961566
- Lead Sponsor
- Hailey Bivens
- Brief 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.
- Detailed Description
The randomized controlled trial aims to investigate the potential effect of post-harvesting donor site augmentation on palatal volumetric changes following connective tissue graft harvesting.
The study investigation is a randomized controlled trial (RCT) that aims to have 20 participants in each group. The palatal thickness will be clinically assessed and a digital intraoral scan of the palate will be performed pre-operatively. A subepithelial connect tissue graft will then be harvested from the palate. Patients will then be randomly assigned to receive/not receive augmentation of the donor site, using a collagen sponge. Palatal thickness measurements and intraoral scans will be repeated at 2-, 4-, and 6-months postoperatively.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
-
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
-
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
-
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Palatal Thickness Change 2 months, 4 months, 6 months Initial palatal thickness of first and second surgery will be measured prior to each surgical incision with an endodontic reamer
Palatal Volume Change 2 months, 4 months, 6 months Palatal volume change will be compared using an intraoral scan where the scans will be overlayed to compare differences is volume change.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Texas A&M College of Dentistry
🇺🇸Dallas, Texas, United States
Texas A&M College of Dentistry🇺🇸Dallas, Texas, United StatesYing S Wang, DDS, MSContact214-828-8282yswang@tamu.eduHailey Bivens, DDSSub Investigator