Clinical trial NCT03200392: Er,Cr:YSGG Laser For Recipient Bed Bio-modification And Connective Tissue Harvesting in Treatment of Gingival Recession
Official 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Recession, Localized
Keywords: Er,Cr:YSGG laser
connective tissue graft
root coverage
mucogingival surgery
gingival recession
Lead sponsor: Misr International University
Sponsor class: OTHER
Collaborators: name: Ain Shams University
First posted: 2017-06-27
Enrollment: 24
Sex: ALL
Minimum age (years): 21
Maximum age (years): 58
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Recession depth
timeFrame: baseline-3-6-9 months
Secondary outcomes:
measure: Pain assessment at the donor site
timeFrame: 7 days
measure: number of analgesic pills consumed per day
timeFrame: 7 days
measure: Recession width
timeFrame: baseline-3-6-9 months
measure: Gingival thickness
timeFrame: baseline and at 9 months
measure: Height of keratinized tissue width
timeFrame: baseline and at 9 months
measure: Clinical attachment loss
timeFrame: baseline-3-6-9 months
measure: Probing pocket depth
timeFrame: baseline-3-6-9 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Misr International university
Study officials:
affiliation: Professor Department of Periodontology Ain Shams University
name: Ahmed Y Gamal, pHD
role: STUDY_CHAIR
affiliation: Doctor student Department of Periodontology Misr International University (MIU)
name: Tarek M Eltayeb, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Associate Professor Department of Periodontology MIU
name: Shahinaz G Elashiry, pHD
role: STUDY_DIRECTOR
affiliation: Professor Department of Prosthodontics Ain Shams University
name: Ramy M Ghali, pHD
role: STUDY_DIRECTOR
affiliation: Lecturer Department of Periodontology Ain Shams University
name: Fatma H Eldemerdash, pHD
role: STUDY_DIRECTOR
affiliation: Doctor student Department of Oral Radiology MIU
name: Islam S Shaker, MSc
role: STUDY_DIRECTOR
References:
citation: 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.