Er,Cr:YSGG Laser For Recipient Bed Bio-modification And Connective Tissue Harvesting in Treatment of Gingival Recession
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)
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedFirst Submitted
Initial submission to the registry
June 20, 2017
CompletedFirst Posted
Study publicly available on registry
June 27, 2017
CompletedJuly 22, 2020
July 1, 2017
1.9 years
June 20, 2017
July 20, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Recession depth
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 Outcomes (7)
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
Height of keratinized tissue width
baseline and at 9 months
- +2 more secondary outcomes
Study Arms (3)
L-DGG/LRB
EXPERIMENTALlaser root surface conditioning \& laser DGG harvesting
B-DGG/LRB
EXPERIMENTALlaser root surface conditioning \& blade DGG harvesting
B-DGG
ACTIVE COMPARATORblade DGG harvesting
Interventions
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
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
De-epithelialized palatal graft harvested using scalpel blade (Zucchelli et al. 2010) and coronal repositioned flap for gingival recession defect coverage
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Misr International Universitylead
- Ain Shams Universitycollaborator
Study Sites (1)
Misr International university
Cairo, 11218, Egypt
Related Publications (1)
Ozcelik O, Seydaoglu G, Haytac CM. Diode laser for harvesting de-epithelialized palatal graft in the treatment of gingival recession defects: a randomized clinical trial. J Clin Periodontol. 2016 Jan;43(1):63-71. doi: 10.1111/jcpe.12487. Epub 2016 Jan 21.
PMID: 26660000BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- laser certified from Aachen University (Germany) and Assistant Lecturer of Periodontology, Oral Medicine and Oral Diagnosis
Study Record Dates
First Submitted
June 20, 2017
First Posted
June 27, 2017
Study Start
February 1, 2015
Primary Completion
January 1, 2017
Study Completion
February 1, 2017
Last Updated
July 22, 2020
Record last verified: 2017-07
Data Sharing
- IPD Sharing
- Will not share