Palatal Volumetric Change Analysis Following Connective Tissue Graft With and Without Donor Site Augmentation

Recession, Gingival Clinical Trial

Official title:

Palate Volumetric Change Analysis Following Connective Tissue Graft Harvesting With and Without Donor Site Augmentation: Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05961566
• Other study ID #: IRB2023-0028
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: March 30, 2025

Study information

• Verified date: July 2023
• Source: Texas A&M University
• Contact: Ying S Wang, DDS, MS
• Phone: (214) 828-8282
• Email: yswang[@]tamu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 30, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Demographic

1. Age: 18-65 years old

2. Gender: Any

3. Race: Any

4. Non-smoker: no use of any tobacco product or nicotine-replacement products in the last 5 years

• Medical History

1. Physically and mentally healthy with no contraindications for periodontal surgery

2. American Society of Anesthesiologists: ASA-I or ASA-II

• Dental history

1. Periodontally healthy

2. No history of surgical interventions in the palate

3. No history of cleft lip/palate

4. No history of orthodontic treatment involving the palate (palatal expansion).

• Other

1. Patients requiring mucogingival surgery involving connective tissue graft harvesting from the palate.

2. Patients who are able and willing to provide informed consent

3. Patients who are able and willing to follow study appointments

Exclusion Criteria:

• i. Medical History

1. Smokers or users of nicotine replacement products

2. 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)

3. Patients with diabetes (glycemic level > 110mg/l and HbA1c > 6.5%)

4. Drug or alcohol abuse history

5. Pregnancy, lactation.

6. Patients with a history of bisphosphonate therapy, radiotherapy in the head and neck region for malignancies, or chemotherapy for treatment of malignant tumors

7. Coagulation disorders or other systemic conditions affecting surgical or wound healing process and gingival tissues, such as cancer, HIV, metabolic bone diseases etc.

8. Medications affecting periodontal status in the previous 6 months

9. Medications affecting surgical or wound healing process and gingival tissues, such as phenytoin, cyclosporine, dihydropyridines, etc.

• Dental

1. Patients with any history of palatal surgery

2. Patients with inadequate donor site anatomy

3. Poor oral hygiene

1. Full-mouth plaque = 20%

2. Bleeding scores > 10%

4. Untreated periodontitis

1. Pocket depths > 3mm with BOP

2. No active periodontal disease

Related Conditions & MeSH terms

• Gingival Recession
• Recession, Gingival

Intervention

Device:
• Use of collagen matrix after subepithelial connective tissue graft harvest
A collagen matrix is placed under the overlying flap after the subepithelial connective tissue graft harvesting.

Locations

Country	Name	City	State
United States	Texas A&M College of Dentistry	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Hailey Bivens

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Palatal Thickness Change	Initial palatal thickness of first and second surgery will be measured prior to each surgical incision with an endodontic reamer	2 months, 4 months, 6 months
Primary	Palatal Volume Change	Palatal volume change will be compared using an intraoral scan where the scans will be overlayed to compare differences is volume change.	2 months, 4 months, 6 months