Healing Surgical Wounds Clinical Trial
Official title:
Evaluation of Healing Time and Postoperative Morbidity After Implant Uncovering With Vestibularly Repositioned Flap Associated With Leucocyte Platelet Rich Fibrin (L-PRF): a Randomized and Controlled Clinical Trial
NCT number | NCT05375357 |
Other study ID # | 19102021 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 20, 2021 |
Est. completion date | July 30, 2022 |
Verified date | May 2022 |
Source | G. d'Annunzio University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study represents a prospective, controlled and randomized clinical trial assessing the effects of L-PRF on the healing time of the donor area and on the patient's postoperative morbidity in the 4 weeks following the Apically Positioned Flap (APF) procedure in the uncovering phase of two-stage implants. A total of 40 patients were recruited and divided into two groups. The implant uncovering procedure in the test group was performed with APF and application of L-PRF on the donor area. Patients in the control group, on the other hand, were treated with APF alone, leaving the donor area to heal by secondary intention.
Status | Completed |
Enrollment | 40 |
Est. completion date | July 30, 2022 |
Est. primary completion date | July 30, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 19 Years to 80 Years |
Eligibility | Inclusion Criteria: - to have at least one implant in the maxilla with a quantity of vestibular keratinized gingiva < 2 mm - to be in good systemic health - to have a good oral hygiene (FMPS and FMBS < 20%) Exclusion Criteria: - systemic diseases: coagulation disorders; medications affecting periodontal status in the previous 6 months; pregnancy or lactation; - smoking habits; - peri-implant surgery on the experimental sites. |
Country | Name | City | State |
---|---|---|---|
Italy | G. D'Annunzio University | Chieti |
Lead Sponsor | Collaborator |
---|---|
G. d'Annunzio University |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Complete re-epithelialization of the wound of donor area (CWE) | Time needed to obtain a complete re-epithelialization of the wound of donor area | 4 weeks | |
Secondary | Post-Operative Discomfort (D) | Evaluation of post-operative discomfort using Visual Analogue Scale (VAS).The scale is represented by a straight horizontal line of fixed length, generally 10 cm. Extremities are defined as extreme limits of the parameter to be measured, oriented from left (worst) to right (best). | 4 weeks | |
Secondary | Changes in Feedind Habits (CFH) | Evaluation of changes in patients' feedind habits using Visual Analogue Scale (VAS).The scale is represented by a straight horizontal line of fixed length, generally 10 cm. Extremities are defined as extreme limits of the parameter to be measured, oriented from left (worst) to right (best). | 4 weeks | |
Secondary | Consumption of Analgesics (AU) | Assessment of postoperative pain by the number of analgesics taken | 4 weeks | |
Secondary | Alteration of Sensivity (AS) | Evaluation of alteration of sensivity on donor area | 4 weeks |
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