Palate Volumetric Change Analysis Following Connective Tissue Graft Harvesting With and Without Donor Site Augmentation: Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Recession, Gingival
- Sponsor
- Hailey Bivens
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Palatal Thickness Change
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Hailey Bivens
Co-Investigator
Texas A&M University
Eligibility Criteria
Inclusion Criteria
- •Demographic
- •Age: 18-65 years old
- •Gender: 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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Palatal Thickness Change
Time Frame: 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
Time Frame: 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.