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Platelet Rich Fibrin in Soft Tissue Healing After Implant Uncovering

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05375357
Enrollment
40
Registered
2022-05-16
Start date
2021-04-20
Completion date
2022-07-30
Last updated
2022-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healing Surgical Wounds

Keywords

Platelet Rich Fibrin, Wound Healing, Implant Uncovering

Brief 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.

Interventions

PROCEDUREApplication 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

PROCEDURESecondary intention healing of the donor area

After implant uncovering procedure with apically positioned flap, the donor area is left to heal by secondary intention

Sponsors

G. d'Annunzio University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Complete re-epithelialization of the wound of donor area (CWE)4 weeksTime needed to obtain a complete re-epithelialization of the wound of donor area

Secondary

MeasureTime frameDescription
Post-Operative Discomfort (D)4 weeksEvaluation 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).
Changes in Feedind Habits (CFH)4 weeksEvaluation 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).
Consumption of Analgesics (AU)4 weeksAssessment of postoperative pain by the number of analgesics taken
Alteration of Sensivity (AS)4 weeksEvaluation of alteration of sensivity on donor area

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026