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

Description

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Recession, Gingival
Intervention / Treatment

-

Contacts and Locations

Dallas

Texas A&M College of Dentistry, Dallas, Texas, United States, 75226

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Hailey Bivens,

Ying S Wang, DDS, MS, PRINCIPAL_INVESTIGATOR, Texas A&M School of Dentistry

Study Record Dates

2025-03-30