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

• ClinicalTrials.gov Identifier: NCT05961566
• Recruitment Status: Recruiting
• First Posted: July 27, 2023
• Last Update Posted: January 19, 2024
• Sponsor: Hailey Bivens
• Information provided by (Responsible Party): Hailey Bivens, Texas A&M University

Tracking Information

• First Submitted Date: July 16, 2023
• First Posted Date: July 27, 2023
• Last Update Posted Date: January 19, 2024
• Actual Study Start Date: October 1, 2023
• Estimated Primary Completion Date: September 30, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 16, 2023)

• 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.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Palatal Volumetric Change Analysis Following Connective Tissue Graft With and Without Donor Site Augmentation
• Official Title: Palate Volumetric Change Analysis Following Connective Tissue Graft Harvesting With and Without Donor Site Augmentation: Randomized Controlled Trial

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.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Individuals will be randomly assigned to be in the control group of the intervention group (Collagen matrix soft tissue augmentation).

Masking: Single (Outcomes Assessor)
Masking Description:

Individuals computing the statistical analysis will be masked for which outcome was used. Surgeons and patients will only know which outcome will be used at time of surgery.

Primary Purpose: Supportive Care

• Condition: 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.

Other Names:

• Helistat - collagen matrix group
• Experimental

Study Arms

• No Intervention: Control
  Individuals with no addition of intervention (collagen matrix) after harvesting from the palate for a subepithelial connective tissue graft.
• Experimental: Collagen Matrix
  Individuals with the addition of the intervention (collagen matrix) after harvesting form the palate for a subepithelial connective tissue graft.
  Intervention: Device: Use of collagen matrix after subepithelial connective tissue graft harvest

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: July 16, 2023): 40
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 30, 2025
• Estimated Primary Completion Date: September 30, 2024 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Ying S Wang, DDS, MS; (214) 828-8282; yswang@tamu.edu

Contact: Hailey Bivens, DDS; heb2025@tamu.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05961566
• Other Study ID Numbers: IRB2023-0028
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Hailey Bivens, Texas A&M University
• Original Responsible Party: Same as current
• Current Study Sponsor: Hailey Bivens
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Ying S Wang, DDS, MS; Texas A&M School of Dentistry

• PRS Account: Texas A&M University
• Verification Date: July 2023