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Completed

NCT Number: NCT02018120

Platelet Rich Fibrin in the Treatment of Multiple Gingival Recessions

The aim of this randomized controlled clinical study is to evaluate and compare the effectiveness of platelet rich fibrin (PRF) and connective tissue grafts in the treatment of multiple gingival recessions.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ege University School of Dentistry Department of Periodontology

Izmir, Bornova, 35100, Turkey (Türkiye)

About this study

The aim of this randomized controlled clinical study is to evaluate and compare the effectiveness of platelet rich fibrin (PRF) and connective tissue grafts in the treatment of multiple gingival recessions.

Primary outcome variables were percentage of complete root coverage and mean root coverage percentages at 6 months follow up. The secondary outcome variables include keratinized tissue and gingival thickness gain.

Sample size has been estimated as 13 in each treatment arm. All recessions are treated with modified coronally advanced flap. On test sites PRF membrane and on control sites connective tissue grafts will be placed under modified coronally advanced flaps. Random allocation of the treatment sites to test and control groups were performed using a computer software designed for randomization.

Clinical parameters such as gingival index, plaque index, keratinized tissue width, gingival recession depth and width were measured at 1, 3 and 6 months. Probing pocket depth, clinical attachment level, gingival thickness and gingival recession area were measure at baseline and 6 months. All gingival recession-related parameters such as recession height, recession width and recession area and keratinized tissue width along with mean root coverage and complete root coverage were assessed on standardized clinical photographs using an image analysis software.

Clinical photographs were obtained at baseline and 1, 3 and 6 months after surgical intervention. 4 mm length wire was placed on gingiva to check reproducibility and to obtain standardized pictures.

Gingival tissue thickness were measured with an #15 endodontic reamer attached to rubber stopper inserted perpendicularly into the gingival tissue 2 mm below the gingival margin; thickness of the reamer will be measured with a digital caliper.

Mean root coverage percentage was calculated as percentage of covered root surface area at 6 months.

Follow up of subjects was 6 months.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Two or more adjacent teeth with at least 2 mm Miller Class I gingival recessions at non-molar teeth
  • Identifiable CEJ on all teeth
  • Age ≥ 18
  • Presence of tooth vitality and absence of restorations and superficial caries in the treatment area
  • No past surgical treatment history of affected area.
  • Gingival thickness ≥ 0,8 mm for recession areas.
  • Sufficient palatal donor tissue for connective tissue harvesting.

Exclusion criteria

  • Smoking
  • Pregnancy or lactation
  • Systematic diseases that may affect outcomes of periodontal therapy
  • Self-reported antibiotic medication within three months
  • Occlusal trauma in treatment site

Treatment and study plan

connective tissue graft

Procedure

Platelet Rich Fibrin

Procedure

Primary outcomes

  1. Mean root coverage percentage

    Time frame: 6 months

    mean area of root coverage achieved by surgical root coverage therapy.

  2. complete root coverage percentage

    Time frame: 6 months

    percentage of gingival recession defects completely covered by flaps after 6 months

Secondary outcomes

  1. keratinized tissue width

    Time frame: 6 months

    changes in keratinized tissue width at 6 months

  2. gingival tissue thickness

    Time frame: 6 months

    changes from baseline in gingival tissue thickness at 6 months

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Official study title

Comparison of Platelet Rich Fibrin and Connective Tissue Graft in Treatment of Multiple Gingival Recessions

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 23, 2013
Registry last updated
Dec 23, 2013

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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