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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02797899
Other study ID # 285/254/1434
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2013
Est. completion date October 2015

Study information

Verified date March 2024
Source King Abdulaziz University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date October 2015
Est. primary completion date September 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Platelet Rich Fibrin
Native growth factors

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
King Abdulaziz University

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in Visual Analog scale (VAS) 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 1, 2, 3, 4 and 8 weeks
Secondary Changes in contour of the surgical area To check for wound healing; contour of the surgical area was examined and compared to preoperative records 1, 2, 3, 4 and 8 weeks
Secondary Changes in degree of color match To check for wound healing; degree of color match was examined and compared to preoperative records 1, 2, 3, 4 and 8 weeks
Secondary Changes in tissue texture To check for wound healing; tissue texture was examined and compared to preoperative records 1, 2, 3, 4 and 8 weeks
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