Comparing tissue changes after gum grafts with and without donor site augmentation

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

This study is testing whether adding a collagen matrix at the donor site after gum graft surgery helps improve healing and tissue thickness compared to not using it.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Texas A&M University (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Dallas, Texas)
• Trial ID: NCT05961566 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effects of soft tissue augmentation on palatal volumetric changes following the harvesting of a connective tissue graft. Participants will be randomly assigned to receive either a collagen matrix at the donor site or no augmentation after gum graft harvesting. The study will assess tissue thickness and volumetric changes at various intervals post-surgery using clinical measurements and digital intraoral scans. A total of 40 participants will be involved, with 20 in each group, to determine the impact of the augmentation on healing and tissue characteristics.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 18-65 requiring mucogingival surgery involving connective tissue graft harvesting from the palate.

Not a fit: Patients with a history of smoking, contraindications for periodontal surgery, or previous surgical interventions in the palate may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve healing outcomes and tissue quality for patients undergoing gum graft procedures.

How similar studies have performed: While similar studies have explored soft tissue augmentation, this specific approach comparing augmented and non-augmented donor sites is relatively novel.

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

Where this trial is running

Dallas, Texas

• Texas A&M College of Dentistry — Dallas, Texas, United States (RECRUITING)

Study contacts

• Principal investigator: Ying S Wang, DDS, MS — Texas A&M School of Dentistry
• Study coordinator: Ying S Wang, DDS, MS

Conditions: Recession, Gingival, Subepithelial connective tissue graft, Collagen matrix, Collagen sponge, Soft tissue augmentation, Palatal volumetric change