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Completed

NCT Number: NCT03053921

Placental Membrane for Root Coverage

Aim of the study was to evaluate the clinical efficacy of placental membrane with coronally advanced flap in covering single and multiple Miller's class I and II gingival recession defects.

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Key information

Conditions

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

Age range

23 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

STUDY DESIGN A total number of 60 teeth in 15 subjects were selected. Patients with bilateral Miller's class I and II gingival recession defects in the maxillary or mandibular anterior and premolar region were selected and divided into two groups using a split mouth design.

GroupI (Control) -30 recession defects treated with coronally advanced flap alone, using Zucchelli's technique.

Group II (Test) - 30 recession defects treated with coronally advanced flap, using Zucchelli's technique along with placental membrane.

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CLINICAL PARAMETERS:

  • Probing Pocket Depth(PPD)
  • Clinical Attachment Level(CAL)
  • Height of Gingival Recession(HGR)
  • Width of Gingival Recession(WGR)
  • Width of Keratinized Gingiva(WKG) The clinical parameters were assessed & recorded on 0 day, 90th day and 180th day

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients within the age group 23 to 55 years
  • Bilateral, upper or lower, Miller's class I and Class II gingival recession defects confined to the anterior and premolar region.
  • Presence of identifiable cemento-enamel junction
  • Presence of keratinized tissue apical to the exposed root

Exclusion criteria

  • Systemic complications
  • Occlusal interferences
  • Any contraindication for periodontal surgery and taking medication which are known to interfere with periodontal tissue health or healing
  • Previous periodontal surgery on the involved site
  • Smokers
  • Pregnant and lactating mothers

Treatment and study plan

recession coverage

Procedure

recession coverage done using Zuchellis technique

Other names: root coverage technique

recession coverage and membrane

Procedure

recession coverage done using Zuchellis technique with placental membrane

Other names: root coverage technique with membrane

Primary outcomes

  1. Height of Gingival recession

    Time frame: 6 months

    The height of gingival recession was measured from the cemento-enamel junction to the gingival margin using Williams periodontal probe

Secondary outcomes

  1. Clinical attachment level

    Time frame: Baseline and 6 months

    Clinical attachment level is measured as the distance between a fixed point on the crown such as cementoenamel junction to the base of the pocket using williams periodontal probe

  2. Width of Keratinized Gingiva

    Time frame: Baseline and 6 months

    It is measured as the distance from the gingival margin to the mucogingival junction using williams periodontal probe

Sponsors and collaborators

Lead sponsor

Meenakshi Ammal Dental College and Hospital

Other

Registry information

Official study title

Treatment of Gingival Recession Using a Coronally Advanced Flap Procedure With or Without Placental Membrane

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 15, 2017
Registry last updated
Feb 15, 2017

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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