RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-10-01
Study Completion:2025-03-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05961566

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.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Demographic
  2. 1. Age: 18-65 years old
  3. 2. Gender: Any
  4. 3. Race: Any
  5. 4. Non-smoker: no use of any tobacco product or nicotine-replacement products in the last 5 years
  6. * Medical History
  7. 1. Physically and mentally healthy with no contraindications for periodontal surgery
  8. 2. American Society of Anesthesiologists: ASA-I or ASA-II
  9. * Dental history
  10. 1. Periodontally healthy
  11. 2. No history of surgical interventions in the palate
  12. 3. No history of cleft lip/palate
  13. 4. No history of orthodontic treatment involving the palate (palatal expansion).
  14. * Other
  15. 1. Patients requiring mucogingival surgery involving connective tissue graft harvesting from the palate.
  16. 2. Patients who are able and willing to provide informed consent
  17. 3. Patients who are able and willing to follow study appointments
  1. * i. Medical History
  2. 1. Smokers or users of nicotine replacement products
  3. 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)
  4. 3. Patients with diabetes (glycemic level \> 110mg/l and HbA1c \> 6.5%)
  5. 4. Drug or alcohol abuse history
  6. 5. Pregnancy, lactation.
  7. 6. Patients with a history of bisphosphonate therapy, radiotherapy in the head and neck region for malignancies, or chemotherapy for treatment of malignant tumors
  8. 7. Coagulation disorders or other systemic conditions affecting surgical or wound healing process and gingival tissues, such as cancer, HIV, metabolic bone diseases etc.
  9. 8. Medications affecting periodontal status in the previous 6 months
  10. 9. Medications affecting surgical or wound healing process and gingival tissues, such as phenytoin, cyclosporine, dihydropyridines, etc.
  11. * Dental
  12. 1. Patients with any history of palatal surgery
  13. 2. Patients with inadequate donor site anatomy
  14. 3. Poor oral hygiene
  15. 1. Full-mouth plaque ≥ 20%
  16. 2. Bleeding scores \> 10%
  17. 4. Untreated periodontitis
  18. 1. Pocket depths \> 3mm with BOP
  19. 2. No active periodontal disease

Contacts and Locations

Study Contact

Ying S Wang, DDS, MS
CONTACT
(214) 828-8282
yswang@tamu.edu
Hailey Bivens, DDS
CONTACT
heb2025@tamu.edu

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Hailey Bivens

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-01
Study Completion Date2025-03-30

Study Record Updates

Study Start Date2023-10-01
Study Completion Date2025-03-30

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Recession, Gingival