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Completed

NCT Number: NCT02335866

Platelet-Rich Fibrin in the Treatment of Multiple Gingival Recessions

The main objective of this study was to evaluate the clinical effectiveness of platelet-rich fibrin membrane used in combination with a coronally advanced flap and to compare it with the use of a subepitelial connective tissue graft in combination with a coronally advanced flap in Miller class I-II bilateral gingival recession treatment

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

NEU Dental School

Konya, 42060, Turkey (Türkiye)

About this study

Purpose

The main objective of this study was to evaluate the clinical effectiveness of platelet-rich fibrin (PRF) in combination with modified coronally advanced flap (MCAF) in the treatment of multiple gingival recessions. Furthermore the second aim of the present study was to compare plastic periodontal surgical procedure, with PRF membrane and connective tissue graft, by a randomized splitmouth controlled study.

Clinical effectiveness of platelet-rich fibrin (PRF) in combination with modified coronally advanced flap (MCAF) as measured by Clinical measurements.

Material and Methods

Twenty patients with multiple gingival recession defects (Miller I, II) participated in this split-mouth trial. Sixty defects received either MCAF+PRF (test) or MCAF with subepithelial connective tissue graft (SCTG) (control). Gingival recession depth (RD), gingival recession width (RW), keratinized tissue width (KTW), recession area (RA), probing depth (PD), clinical attachment level (CAL) and gingival thickness (GT) were evaluated at baseline and 6 months. Additionally post-surgery patient satisfaction and pain status were measured by comparing visual analogue scale (VAS) scores.

Clinical measurements were taken at starting point and 6 months postoperatively. The measurements comprised an assessment of probing depth (PD),clinical attachment level (CAL) and gingival recession parameters including recession depth (RD), recession width (RW), keratinized tissue width (KTW) and gingival thickness (GT) were assessed by a calibrated examiner (E. Ö.). PD, CAL, RD, RW and KTW values were recorded by a Williams probe graduated in 1-mm increments and rounded up to the nearest millimeter (Hu Friedy, Chicago, IL, USA). To standardize the clinical measurements acrylic stents were prepared on patients' casts. The following measurements were recorded at the mid-buccal point of the teeth at baseline and6 months after surgery. GT was evaluated using endodontic reamer attached to a rubber stopper inserted perpendicularly into the gingival tissue 3 mm below the gingival margin under local anesthesia, and then the thickness was measured to the nearest 0.1 mm using a caliper.RD was measured from the CEJ to the gingival margin, RW was measured tangentially at the mid-facial CEJ and RA was calculated as the area within the contour of denuded root. KTW recorded as the distance from the mucogingival junction to the gingival margin. Duplicate measurements were made for RD, RW, RA and KTW with an interval of 24 hours and the average value of two measurements was used for the assessment. The postoperative pain was evaluated with a visual analog score (VAS).

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • non smoking,
  • similar bilateral Miller Class I or II20 localized gingival recessions at least ≥3 mm, located on incisors, canines or premolars on both jaws,
  • identifiable cemento-enamel junction (CEJ),
  • age ≥18 years,
  • presence of tooth vitality and absence of restorations and superficial caries in the area to be treated,
  • no periodontal surgical treatment on the involved sites,
  • sufficient palatal donor tissue at least ≥2.5 mm thickness for the indicated SCTG

Exclusion criteria

  • Patients in a pregnancy or lactation period or with self-reported history of antibiotic medication within 6 months
  • Molar, mobile or fully restorated teeth

Treatment and study plan

test groups

Procedure

At the test sites, the previously prepared PRF was positioned over the recession defects, the coronal margin of the PRF was placed at the CEJ

Other names: PRF groups

Control groups

Procedure

Split-full-split thickness flap incisions were performed in a coronal-apical direction. The papillae adjacent to the involved tooth were de-epithelialized to create a connective tissue bed. The gingival flap was repositioned without tension, with its margin located on the enamel, on the test and control sides. It was held in that position with 5-0 resoble sutures

Other names: Connective tissue graft groups

Primary outcomes

  1. Complete root coverage

    Time frame: 6 months

    Change from baseline in gingival recession will be assessed at 1, 3 and 6 months.

  2. Gingival recession depth

    Time frame: 6 months

    Change from baseline in gingival recession will be assessed at 6 months

Secondary outcomes

  1. Keratinized tissue width

    Time frame: 6 months

    Change from baseline in keratinized tissue at 6 months.

  2. Pain scores

    Time frame: first week after operations

    Pain level evaluated on visual analog scale

Sponsors and collaborators

Lead sponsor

Necmettin Erbakan University

Other

Registry information

Official study title

Platelet Rich Fibrin Against Connective Tissue Graft in Treatment of Gingival Recessions

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jan 12, 2015
Registry last updated
Jan 12, 2015

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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