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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date May 2022
Source G. d'Annunzio University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Application of L-PRF on the donor area
After implant uncovering procedure with apically positioned flap, the donor area is covered with a layer of L-PRF
Secondary intention healing of the donor area
After implant uncovering procedure with apically positioned flap, the donor area is left to heal by secondary intention

Locations

Country Name City State
Italy G. D'Annunzio University Chieti

Sponsors (1)

Lead Sponsor Collaborator
G. d'Annunzio University

Country where clinical trial is conducted

Italy, 

Outcome

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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