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Completed

NCT Number: NCT03200392

Er,Cr:YSGG Laser For Recipient Bed Bio-modification And Connective Tissue Harvesting in Treatment of Gingival Recession

A clinical and radiographic evaluation of using Erbium, Chromium, Scandium, Gallium and Garnet (Er,Cr:YSGG) laser in recipient site bio-modification and de-epithelialized connective tissue graft harvesting compared to conventional scalpel surgical technique in the treatment of class I and II Miller gingival recession.

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Key information

Age range

21 year–58 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Misr International university

Cairo, 11218, Egypt

About this study

Twenty four patients suffering from isolated Class I and II Miller gingival recession defects in anterior esthetic region were enrolled in this study. They were randomly assigned into three groups; de-epithelialized connective tissue graft harvesting technique or; conditioning the exposed root surfaces with Er,Cr:YSGG laser before connective tissue coverage using scalpel blade harvested de-epithelialized connective tissue graft harvesting technique, or; conditioning the exposed root surfaces with the Er,Cr:YSGG laser before Er,Cr:YSGG laser harvested connective tissue using de-epithelialized technique. Clinical and radiographic parameters were recorded at baseline and at 3, 6 and 9 months postoperatively.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Single class I, II Miller gingival recession defects (≥ 2mm in depth), presence of identifiable buccal cemento-enamel junction (CEJ) and presence of a step ≤ 1 mm at CEJ.
  • Controlled periodontal disease
  • Full-mouth plaque score of <10%; full-mouth gingival score of <15%
  • Patients available for 9 months follow-up period.

Exclusion criteria

  • Smokers.
  • Pregnant and lactating females.
  • Taking medications known to interfere with periodontal tissue health or healing.
  • Previous periodontal surgery on the involved sites.
  • Non-vital teeth.
  • Molar teeth.
  • Recession defects associated with caries or restoration.
  • Occlusal interferences.
  • Taking anti-inflammatory drugs or antibiotics in the past 6 months.

Treatment and study plan

laser root surface conditioning & laser DGG harvesting

Device

laser root surface bio-modification (single application) and placement of harvested de-epithelialized gingival graft (DGG) followed by coronal repositioned flap for gingival recession Miller's I, II defect coverage

Other names: erbium, chromium:YSGG laser

laser root surface conditioning & blade DGG harvesting

Device

laser root surface bio-modification (single application) and scalpel blade harvesting of de-epithelialized palatal graft (Zucchelli et al. 2010) and coronal repositioned flap for gingival recession Miller's I, II defect coverage

Other names: erbium, chromium:YSGG laser

blade DGG harvesting

Procedure

De-epithelialized palatal graft harvested using scalpel blade (Zucchelli et al. 2010) and coronal repositioned flap for gingival recession defect coverage

Primary outcomes

  1. Change in Recession depth

    Time frame: baseline-3-6-9 months

    measured from the gingival margin to the cemento-enamel junction at the mid-buccal aspect of the tooth using William's graduated periodontal probe to the nearest mm

Secondary outcomes

  1. Pain assessment at the donor site

    Time frame: 7 days

    Visual Analogue Scale

  2. number of analgesic pills consumed per day

    Time frame: 7 days

    counting number of analgesic pills per day

  3. Recession width

    Time frame: baseline-3-6-9 months

    distance between mesial and distal gingival margin of the tooth recorded on a horizontal line tangential at the CEJ to the nearest mm

  4. Gingival thickness

    Time frame: baseline and at 9 months

    determined 2mm apical to the gingival margin using standardised CBCT

  5. Height of keratinized tissue width

    Time frame: baseline and at 9 months

    measured form the mid-buccal aspect of the gingival margin to the mucogingival line

  6. Clinical attachment loss

    Time frame: baseline-3-6-9 months

    measured from the CEJ to the bottom of the periodontal pocket to the nearest mm.

  7. Probing pocket depth

    Time frame: baseline-3-6-9 months

    measured from the gingival margin to the base of the periodontal pocket to the nearest mm

Sponsors and collaborators

Lead sponsor

Misr International University

Other

Collaborators

  • Ain Shams University

Registry information

Official study title

The Use Of Er,Cr:YSGG Laser For Recipient Bed Bio-modification And De-epithelialized Palatal Graft Harvesting In The Treatment of Gingival Recession Defects -(Randomized Clinical Trial)

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jun 27, 2017
Registry last updated
Jul 22, 2020

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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