Pain, Wound Healing
Conditions
Brief summary
Background: Free gingival graft (FGG) is used to increase keratinized tissue dimensions. This prospective clinical trial was conducted aiming to determine whether the addition of an autologous platelet-rich fibrin (PRF) would improve soft tissue healing of donor sites and decrease pain scores. Methods: Twenty four patients were planned to receive FGG to augment keratinized tissue dimensions in the mandibular incisors area. Donor sites were assigned randomly to receive PRF or not by a flip of a coin during the screening visit. Patients were instructed to complete a pain study form. The palatal donor area were evaluated for complete wound healing records. These data were assessed and recorded before surgery, and 1,2,3,4 and 8 weeks postoperatively.
Detailed description
Background: Despite a relatively painful surgical procedure, free gingival graft (FGG) is still commonly used to increase keratinized tissue dimensions. This prospective clinical trial was conducted aiming to determine whether the addition of an autologous platelet-rich fibrin (PRF) after harvesting a FGG would improve soft tissue healing of donor sites and subsequently decrease pain scores. Methods: Twenty four patients were planned to receive FGG to augment keratinized tissue dimensions in the mandibular incisors area. Enrolled patients received periodontal examination, oral hygiene instructions and full-mouth debridement followed by standardized FGG of similar dimensions. Donor sites were assigned randomly to receive PRF or not by a flip of a coin during the screening visit. Patients were instructed to complete a pain study form to analyze pain scores including VAS, NRS-101, VRS-4 as well as three anxiety scales at base line. The palatal donor area were evaluated for complete wound healing based on the degree of color match, tissue texture, and contour of the surgical area compared to preoperative records. These data were assessed and recorded before surgery, and 1,2,3,4 and 8 weeks postoperatively.
Interventions
DEVICEPlatelet Rich Fibrin
Native growth factors
Sponsors
King Abdulaziz University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* lack of keratinized tissue in the mandibular central incisor region
Exclusion criteria
* smoking * uncontrolled systemic disease that might contraindicate periodontal surgery * severe gag reflex preventing maxillary surgical procedure * inability or unwillingness to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Visual Analog scale (VAS) | 1, 2, 3, 4 and 8 weeks | a visual analog scale (VAS) consisting a 10-cm line with two extremes at either end. no pain and pain that could not be more severe. Patients were asked to mark a point on the line that represent their level of perceived pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in contour of the surgical area | 1, 2, 3, 4 and 8 weeks | To check for wound healing; contour of the surgical area was examined and compared to preoperative records |
| Changes in degree of color match | 1, 2, 3, 4 and 8 weeks | To check for wound healing; degree of color match was examined and compared to preoperative records |
| Changes in tissue texture | 1, 2, 3, 4 and 8 weeks | To check for wound healing; tissue texture was examined and compared to preoperative records |
Outcome results
None listed