Healing of palatal grafts with and without epithelium
| ISRCTN | ISRCTN56435384 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN56435384 |
| Secondary identifying numbers | 2024H0052 |
- Submission date
- 13/04/2024
- Registration date
- 16/04/2024
- Last edited
- 16/04/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Oral Health
Plain English Summary
Background and Study Aims
Gingival (gum) grafting surgery, also known as periodontal plastic surgery, is a common and effective procedure often used to treat receding gums or thin gums and other conditions around a tooth, a dental implant, or a space where a tooth is missing. The gum graft is typically taken from the roof of the mouth (palate). One thing that is thought to affect the healing of the graft after it is placed is de-epithelialization, which is to remove the epithelial cell layer from the graft before placement. The purpose of this study is to evaluate how the healing of gingival grafts is affected depending on whether or not the grafts are de-epithelialized before placement.
Who can participate?
Healthy volunteers aged 21-38 years old
What does the study involve?
This study involves detaching a small piece of gingival tissue from each side of the roof of the mouth and then placing it back into the mouth as a graft. The piece of tissue from one side will be de-epithelialized before it is placed back, and the other one will not. Various aspects of wound healing, for example, swelling and redness in the wound area, will be assessed at the postoperative visits.
What are the possible benefits and risks of participating?
There are no benefits to participation. Possible risks include minor discomfort from receiving local anesthesia and the potential post-operative discomfort and/or pain at the wound area; bleeding from the wound site; mild localized swelling; rarely, infection after the procedure; very rarely, may experience transient numbness or altered sensation at the roof of the mouth; rarely, side effects of the pain pills; rarely, allergic reactions to the study materials and drugs.
Where is the study run from?
The Ohio State University College of Dentistry
When is the study starting and how long is it expected to run for?
January 2024 to June 2025
Who is funding the study?
Intramural funding at The Ohio State University College of Dentistry
Who is the main contact?
Dimitris Tatakis, tatakis.1@osu.edu
Contact information
Public, Scientific, Principal Investigator
305 W. 12th Avenue
Columbus
43210
United States of America
 ORCID ID |
0000-0001-6327-3610 |
|---|---|
| Phone | +1 614-292-0371 |
| tatakis.1@osu.edu |
Study information
| Study design | Longitudinal randomized split-mouth study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised split-mouth study |
| Study setting(s) | University/medical school/dental school |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | The effects of de-epithelialization on palatal gingival graft healing |
| Study hypothesis | Removal of epithelium affects the healing of palatal gingival grafts |
| Ethics approval(s) |
Approved 04/04/2024, Ohio State Biomedical Sciences IRB (130C Mount Hall 1050 Carmack Road, Columbus, Ohio, 43210-1002, United States of America; +1 614-292-1582; irbinfo@osu.edu), ref: 2024H0052 |
| Condition | Healing of gingival grafts |
| Intervention | 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. Following the harvesting of two free gingival grafts of standardized size from opposite sides of the palate and the subsequent placement of the grafts onto ipsilateral standardized palatal recipient sites (each recipient site being the donor site of the ipsilaterally-placed graft), clinical and patient-centered outcomes will be assessed on postoperative Days 2, 3, 7, and 14. One of the grafts will be harvested and left intact before being placed onto the recipient bed and the other graft will be placed onto its designated recipient bed after being de-epithelialized. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Changes in grafted tissue and wound dimensions measured using photographic image analysis at 2, 3, 7, and 14 days |
| Secondary outcome measures | 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 |
| Overall study start date | 14/01/2024 |
| Overall study end date | 30/06/2025 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 21 Years |
| Upper age limit | 38 Years |
| Sex | Both |
| Target number of participants | 25 |
| Participant 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 <8 ppm 4. Absence of untreated caries lesions, extensive caries history, untreated periodontitis, history of cleft palate, inadequate endodontic therapy or tooth mobility >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 |
| Participant 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 |
| Recruitment start date | 25/04/2024 |
| Recruitment end date | 31/03/2025 |
Locations
Countries of recruitment
- United States of America
Study participating centre
Columbus, Ohio
43210
United States of America
Sponsor information
University/education
The Ohio State University Office of Research, Compliance office, 305 W. 12th Avenue
Columbus
43210
United States of America
| Phone | +1 (614) 292-6446 |
|---|---|
| carruthers.39@osu.edu | |
| Website | https://www.osu.edu/ |
"ROR" |
https://ror.org/00rs6vg23 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- The Ohio State University, Ohio State, Ohio Agricultural and Mechanical College, OSU, tOSU
- Location
- United States of America
Results and Publications
| Intention to publish date | 30/06/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Dimitris Tatakis (tatakis.1@osu.edu) |
Editorial Notes
15/04/2024: Study's existence confirmed by the Biomedical Sciences Institutional Review Board of The Ohio State University.
