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Platelet Rich Fibrin in Soft Tissue Healing After Implant Uncovering

NCT ID: NCT05375357

Last Updated: 2022-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-20

Study Completion Date

2022-07-30

Brief Summary

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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.

Detailed Description

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Conditions

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Healing Surgical Wounds

Keywords

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Platelet Rich Fibrin Wound Healing Implant Uncovering

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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APF + L-PRF

Application of a layer of L-PRF to protect the donor area after uncovering implant procedure using Apically Positioned Flap (APF).

Group Type EXPERIMENTAL

Application of L-PRF on the donor area

Intervention Type PROCEDURE

After implant uncovering procedure with apically positioned flap, the donor area is covered with a layer of L-PRF

APF without L-PRF

The donor area is left to heal by secondary intention after APF in the implant uncovering procedure.

Group Type ACTIVE_COMPARATOR

Secondary intention healing of the donor area

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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G. d'Annunzio University

OTHER

Sponsor Role lead

Responsible Party

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Michele Paolantonio

Full time professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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G. D'Annunzio University

Chieti, , Italy

Site Status

Countries

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Italy

Other Identifiers

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19102021

Identifier Type: -

Identifier Source: org_study_id