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

NCT05961566 | Unknown

• 1 other identifier: IRB2023-0028
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Recession, Gingival

Keywords

Subepithelial connective tissue graft; Collagen matrix; Collagen sponge; Soft tissue augmentation; Palatal volumetric change

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Control

NO INTERVENTION

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

Collagen Matrix

EXPERIMENTAL

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

Device: Use of collagen matrix after subepithelial connective tissue graft harvest

Interventions

Use of collagen matrix after subepithelial connective tissue graft harvest DEVICE

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

Also known as: Helistat - collagen matrix group, Experimental

Collagen Matrix

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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%

Sponsors & Collaborators

• Hailey Bivens: lead

Study Sites (1)

Texas A&M College of Dentistry

Dallas, Texas, 75226, United States

RECRUITING

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Officials

• Ying S Wang, DDS, MS

  Texas A&M School of Dentistry

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ying S Wang, DDS, MS

CONTACT

(214) 828-8282; yswang@tamu.edu

Hailey Bivens, DDS

CONTACT

heb2025@tamu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Co-Investigator

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

Study Record Dates

• First Submitted: July 16, 2023
• First Posted: July 27, 2023
• Study Start: October 1, 2023
• Primary Completion: September 30, 2024
• Study Completion: March 30, 2025
• Last Updated: January 19, 2024

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)