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

Gingival Recession, Localized Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03200392
• Other study ID #: 121409
• Status: Completed
• Phase: N/A
• Start date: February 2015
• Est. completion date: February 2017

Study information

• Verified date: July 2017
• Source: Misr International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 58 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gingival Recession
• Gingival Recession, Localized

Intervention

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
• 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

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

Locations

Country	Name	City	State
Egypt	Misr International university	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Misr International University	Ain Shams University

Country where clinical trial is conducted

Egypt, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pain assessment at the donor site	Visual Analogue Scale	7 days
Secondary	number of analgesic pills consumed per day	counting number of analgesic pills per day	7 days
Secondary	Recession width	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
Secondary	Gingival thickness	determined 2mm apical to the gingival margin using standardised CBCT	baseline and at 9 months
Secondary	Height of keratinized tissue width	measured form the mid-buccal aspect of the gingival margin to the mucogingival line	baseline and at 9 months
Secondary	Clinical attachment loss	measured from the CEJ to the bottom of the periodontal pocket to the nearest mm.	baseline-3-6-9 months
Secondary	Probing pocket depth	measured from the gingival margin to the base of the periodontal pocket to the nearest mm	baseline-3-6-9 months