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Clinical Trials/NCT03200392
NCT03200392CompletedNot Applicable

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)

Misr International University1 site in 1 country24 target enrollmentStarted: February 1, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
24
Locations
1
Primary Endpoint
Change in Recession depth

Study Overview

Brief Summary

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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Masking Description

Masking of investigator and participants was not applicable due to surgical procedure and use of laser either for root surface bio-modification or during connective tissue harvesting. The blinded outcome assessor performed the clinical measurements at each selected defect site during the study period. She was not involved in any other part of the study protocol.

Eligibility Criteria

Ages
21 Years to 58 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

  • •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.

Arms & Interventions

L-DGG/LRB

Experimental

laser root surface conditioning & laser DGG harvesting

Intervention: laser root surface conditioning & laser DGG harvesting (Device)

B-DGG/LRB

Experimental

laser root surface conditioning & blade DGG harvesting

Intervention: laser root surface conditioning & blade DGG harvesting (Device)

B-DGG

Active Comparator

blade DGG harvesting

Intervention: blade DGG harvesting (Procedure)

Outcomes

Primary Outcomes

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

  • Height of keratinized tissue width(baseline and at 9 months)
  • Pain assessment at the donor site(7 days)
  • number of analgesic pills consumed per day(7 days)
  • Recession width(baseline-3-6-9 months)
  • Gingival thickness(baseline and at 9 months)
  • Clinical attachment loss(baseline-3-6-9 months)
  • Probing pocket depth(baseline-3-6-9 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Tarek Mahmoud Nasser Eltayeb

laser certified from Aachen University (Germany) and Assistant Lecturer of Periodontology, Oral Medicine and Oral Diagnosis

Misr International University

Study Sites (1)

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