Recruiting

Connective Tissue Graft

Sponsor:

Hailey Bivens

Code:

NCT05961566

Conditions

Recession, Gingival

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Use of collagen matrix after subepithelial connective tissue graft harvest

Study Details

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

Study ID

NCT05961566

Start date

Oct 1, 2023

Status verified date

Jul, 2023

Completion date

Mar 30, 2025

Anticipated

Primary completion date

Sep 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

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.

Primary outcome measure

  • Palatal Thickness Change [ Time Frame: 2 months, 4 months, 6 months ]
  • Palatal Volume Change [ Time Frame: 2 months, 4 months, 6 months ]

Central Contacts and Locations

Central contacts

Ying S Wang, DDS, MS

(214) 828-8282yswang@tamu.edu

Hailey Bivens, DDS

heb2025@tamu.edu

Locations

Texas A&M College of Dentistry

Recruiting

Dallas, Texas, United States, 75226

Contacts

Ying S Wang, DDS, MS

214-828-8282yswang@tamu.edu

More Information

Sponsor

Hailey Bivens

Last update posted

Jan 19, 2024

Last verified

Jul, 2023

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Hailey Bivens on 2024-01-19.