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Completed

NCT Number: NCT05267015

PRF for Treating Maxillary Gingival Recession

This is a split-mouth, randomized, controlled clinical trial that aims to evaluate the clinical efficacy of platelet-rich fibrin (PRF) membranes in conjunction with coronally advanced flap (CAF) in treating maxillary gingival recession defects.

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Key information

Conditions

Gingival Recession Gingival Diseases Mouth Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arab American University

Ramallah, 240, Palestinian Territories

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Greater than 18 years old
  • Bilateral Miller class I + II recession in the upper jaw

Exclusion criteria

  • Smokers
  • Patients with systemic diseases that could interfere with the healing
  • Patients undergoing bisphosphonate therap .Patients who previously received radiation therapy of the jaws.

Treatment and study plan

Gingival coverage using coronally advanced flap and a connective tissue graft

Procedure

A coronally advanced flap is applied for recession coverage in the maxilla in a split-mouth randomized trial using a subepithelial connective tissue graft

Gingival coverage using coronally advanced flap and platelet rich fibrin membranes

Procedure

A coronally advanced flap is applied for recession coverage in the maxilla in a split-mouth randomized trial using platelet rich fibrin membranes

Primary outcomes

  1. Increase in gingival height (recession coverage)

    Time frame: six weeks

    The measurements of the increase in gingival height (recession coverage) using a linear evaluation (corono-apical direction) with a periodontal probe (Merrit-B; Hu-Friedy, Chicago, IL, USA) at the interventions sites to the nearest 0.5 mm. Registration of the recession height was done before treatment and after 6 weeks.

  2. Shrinkage in gingival height

    Time frame: six months

    To assess the shrinkage of the gingival height, the amount of gingival height vestibular to the treated teeth in a corono-apical direction was measured after the surgery and after six months.

Secondary outcomes

  1. Postoperative pain visual analog scores (VAS) and surgery time

    Time frame: two weeks

    This questionnaire used 100 mm visual analog scores VAS to evaluate the amount of pain, ranging from 0 (no pain) to 10 (worst pain imaginable), and the amount of swelling. Patients were asked to fill in the VAS scales at day 7 and day 14 at suture removal. The time of surgery was measured of both treatment options. Timing started at the moment of first incision until the last suture.

Sponsors and collaborators

Lead sponsor

Arab American University (Palestine)

Other

Registry information

Official study title

PRF for Treating Maxillary Gingival Recessions: A Split-mouth, Randomized, Controlled Clinical Trial

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 4, 2022
Registry last updated
Mar 4, 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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