Healing of gingival grafts Oral Health
Conditions
Interventions
The study investigates the healing of palatal grafts that have epithelium or are de-epithelialized.
Participants will be randomised via the side of the palate using the sealed envelope process. Follo
Sponsors
The Ohio State University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged between 21-38 years old 2. No systemic diseases; no coagulation disorders; no medications affecting wound healing or periodontal tissues in the previous 6 months; no pregnancy or lactation; no allergy or other contraindication to study medications 3. No tobacco or marijuana use; exhaled air carbon monoxide 1 on maxillary teeth; full-mouth plaque score [FMPS] and full-mouth bleeding score [FMBS] = 20% at study entry 5. No previous periodontal surgery on the palatal masticatory mucosa (donor area) 6. Adequate apico-coronal space (palatal vault height and upper arch shape) and mouth opening for required wound size and instrument use 7. Ability to tolerate maxillary impression making and use of palatal template, i.e., lack of strong gag reflex 8. No contraindication to receiving any study medications (anesthetics and analgesics), or gingival surgery
Exclusion criteria
Exclusion criteria: 1. Tobacco or marijuana user, or have used any tobacco products in the last 2 years 2. Unable or unwilling to refrain from drinking alcohol during the two weeks of the study 3. Unable or unwilling to refrain from consuming caffeine (in any form) for 3 hours before any of the study visits 4. Unable or unwilling to refrain from exercising for 3 hours before any of the study visits 5. Diagnosed with an uncontrolled systemic disease, such as high blood pressure (hypertension), seizures (epilepsy), high blood sugar (diabetes) 6. Disease or medication that affects blood clotting 7. History of systemic disease affecting healing, such as diabetes 8. Obese 9. Taking medications that can affect the gum tissues 10. Taking medications that can affect wound healing 11. Pregnant, or lactating, or using contraceptive medications 12. Allergic to any of the materials (impression materials, acrylic plastic) or medications (topical or local dental anesthetic; analgesic medication; cyanoacrylate) used in the study 13. Untreated periodontitis (gum) disease 14. Upper (maxillary) teeth that are loose (mobile), or have untreated cavities (caries), or poor or questionable root canal treatment 15. Inadequate oral hygiene or inflamed or swollen gums 16. History of surgery on the roof of the mouth 17. Conditions or diseases affecting the roof of your mouth 18. Use of any removable oral appliances for the upper jaw 19. Gag easily 20. The shape (steepness) of the roof of the mouth could prevent study procedures 21. Contraindication to receiving study medications or procedures 22. Unable or unwilling to adhere to the study visit schedule 23. Unable or unwilling to provide written informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in grafted tissue and wound dimensions measured using photographic image analysis at 2, 3, 7, and 14 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Soft tissue swelling measured using intraoral digital scanning on postoperative days 2, 3, 7, and 14 2. Wound area temperature measured using an infrared temperature camera on postoperative days 2, 3, 7, and 14 3. Wound healing scores measured using hyperspectral imaging (HSI) scoring on postoperative days 2, 3, 7, and 14 4. Color match, wound exudate biomarkers measured using clinical images (photographs) at postoperative days 2, 3, 7, and 14 5. Patient-reported outcomes measured using custom and Oral Health Impact Profile-14 (OHIP-14) questionnaires at baseline and on postoperative days 2, 3, 7, and 14 | — |
Countries
United States of America
Contacts
Public ContactDimitris Tatakis
Outcome results
None listed