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

NCT ID: NCT05961566

Last Updated: 2024-01-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2025-03-30

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.

Conditions

Recession, Gingival

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Control

Individuals with no addition of intervention (collagen matrix) after harvesting from the palate for a subepithelial connective tissue graft.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Collagen Matrix

Individuals with the addition of the intervention (collagen matrix) after harvesting form the palate for a subepithelial connective tissue graft.

Group Type: EXPERIMENTAL

Use of collagen matrix after subepithelial connective tissue graft harvest

Intervention Type: DEVICE

A collagen matrix is placed under the overlying flap after the subepithelial connective tissue graft harvesting.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Helistat - collagen matrix group; Experimental

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hailey Bivens

OTHER

Sponsor Role: lead

Responsible Party

Hailey Bivens

Co-Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ying S Wang, DDS, MS

Role: PRINCIPAL_INVESTIGATOR

Texas A&M School of Dentistry

Locations

Texas A&M College of Dentistry

Dallas, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ying S Wang, DDS, MS

Role: CONTACT

yswang@tamu.edu

(214) 828-8282

Hailey Bivens, DDS

Role: CONTACT

heb2025@tamu.edu

Facility Contacts

Ying S Wang, DDS, MS

Role: primary

yswang@tamu.edu

214-828-8282

Other Identifiers

IRB2023-0028

Identifier Type: -

Identifier Source: org_study_id