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

July 20, 2020 updated by: Tarek Mahmoud Nasser Eltayeb, Misr International University

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11218
        • Misr International University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 58 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 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.
  2. Controlled periodontal disease
  3. Full-mouth plaque score of <10%; full-mouth gingival score of <15%
  4. Patients available for 9 months follow-up period.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: L-DGG/LRB
laser root surface conditioning & laser DGG harvesting
Device: laser root surface conditioning & laser DGG harvesting
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
Experimental: B-DGG/LRB
laser root surface conditioning & blade DGG harvesting
Device: laser root surface conditioning & blade DGG harvesting
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
Active Comparator: B-DGG
blade DGG harvesting
Procedure: blade DGG harvesting
De-epithelialized palatal graft harvested using scalpel blade (Zucchelli et al. 2010) and coronal repositioned flap for gingival recession defect coverage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline-3-6-9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain assessment at the donor site
Time Frame: 7 days
Visual Analogue Scale
7 days
number of analgesic pills consumed per day
Time Frame: 7 days
counting number of analgesic pills per day
7 days
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
baseline-3-6-9 months
Gingival thickness
Time Frame: baseline and at 9 months
determined 2mm apical to the gingival margin using standardised CBCT
baseline and at 9 months
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
baseline and at 9 months
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.
baseline-3-6-9 months
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
baseline-3-6-9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Misr International University

Collaborators

Ain Shams University

Investigators

  • Study Chair: Ahmed Y Gamal, pHD, Professor Department of Periodontology Ain Shams University
  • Principal Investigator: Tarek M Eltayeb, MSc, Doctor student Department of Periodontology Misr International University (MIU)
  • Study Director: Shahinaz G Elashiry, pHD, Associate Professor Department of Periodontology MIU
  • Study Director: Ramy M Ghali, pHD, Professor Department of Prosthodontics Ain Shams University
  • Study Director: Fatma H Eldemerdash, pHD, Lecturer Department of Periodontology Ain Shams University
  • Study Director: Islam S Shaker, MSc, Doctor student Department of Oral Radiology MIU

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2015

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

June 20, 2017

First Submitted That Met QC Criteria

June 26, 2017

First Posted (Actual)

June 27, 2017

Study Record Updates

Last Update Posted (Actual)

July 22, 2020

Last Update Submitted That Met QC Criteria

July 20, 2020

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 121409

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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