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OpenTrials
Completed

NCT Number: NCT05375357

Platelet Rich Fibrin in Soft Tissue Healing After Implant Uncovering

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.

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Key information

Conditions

Healing Surgical Wounds

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

G. D'Annunzio University

Chieti, 66100, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Application of L-PRF on the donor area

Procedure

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

Procedure

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

Primary outcomes

  1. Complete re-epithelialization of the wound of donor area (CWE)

    Time frame: 4 weeks

    Time needed to obtain a complete re-epithelialization of the wound of donor area

Secondary outcomes

  1. Post-Operative Discomfort (D)

    Time frame: 4 weeks

    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).

  2. Changes in Feedind Habits (CFH)

    Time frame: 4 weeks

    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).

  3. Consumption of Analgesics (AU)

    Time frame: 4 weeks

    Assessment of postoperative pain by the number of analgesics taken

  4. Alteration of Sensivity (AS)

    Time frame: 4 weeks

    Evaluation of alteration of sensivity on donor area

Sponsors and collaborators

Lead sponsor

G. d'Annunzio University

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 16, 2022
Registry last updated
Dec 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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