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

NCT ID: NCT03200392

Last Updated: 2020-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2017-02-28

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.

Conditions

Gingival Recession, Localized

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

L-DGG/LRB

laser root surface conditioning \& laser DGG harvesting

Group Type: EXPERIMENTAL

laser root surface conditioning & laser DGG harvesting

Intervention Type: DEVICE

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

B-DGG/LRB

laser root surface conditioning \& blade DGG harvesting

Group Type: EXPERIMENTAL

laser root surface conditioning & blade DGG harvesting

Intervention Type: DEVICE

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

B-DGG

blade DGG harvesting

Group Type: ACTIVE_COMPARATOR

blade DGG harvesting

Intervention Type: PROCEDURE

De-epithelialized palatal graft harvested using scalpel blade (Zucchelli et al. 2010) and coronal repositioned flap for gingival recession defect coverage

Interventions

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

Intervention Type: 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

Intervention Type: DEVICE

blade DGG harvesting

De-epithelialized palatal graft harvested using scalpel blade (Zucchelli et al. 2010) and coronal repositioned flap for gingival recession defect coverage

Intervention Type: PROCEDURE

Other Intervention Names

erbium, chromium:YSGG laser; erbium, chromium:YSGG laser

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 58 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: collaborator

Misr International University

OTHER

Sponsor Role: lead

Responsible Party

Tarek Mahmoud Nasser Eltayeb

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed Y Gamal, pHD

Role: STUDY_CHAIR

Professor Department of Periodontology Ain Shams University

Tarek M Eltayeb, MSc

Role: PRINCIPAL_INVESTIGATOR

Doctor student Department of Periodontology Misr International University (MIU)

Shahinaz G Elashiry, pHD

Role: STUDY_DIRECTOR

Associate Professor Department of Periodontology MIU

Ramy M Ghali, pHD

Role: STUDY_DIRECTOR

Professor Department of Prosthodontics Ain Shams University

Fatma H Eldemerdash, pHD

Role: STUDY_DIRECTOR

Lecturer Department of Periodontology Ain Shams University

Islam S Shaker, MSc

Role: STUDY_DIRECTOR

Doctor student Department of Oral Radiology MIU

Locations

Misr International university

Cairo, , Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 26660000 (View on PubMed)

Other Identifiers

121409

Identifier Type: -

Identifier Source: org_study_id