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

Primary Purpose

Gingival Recession, Localized

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

laser root surface conditioning & laser DGG harvesting

laser root surface conditioning & blade DGG harvesting

blade DGG harvesting

About this trial

This is an interventional treatment trial for Gingival Recession, Localized focused on measuring Er,Cr:YSGG laser, connective tissue graft, root coverage, mucogingival surgery, gingival recession

Eligibility Criteria

21 Years - 58 Years (Adult)All SexesAccepts Healthy Volunteers

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:

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.

Sites / Locations

Misr International university

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

L-DGG/LRB

B-DGG/LRB

B-DGG

Arm Description

laser root surface conditioning & laser DGG harvesting

laser root surface conditioning & blade DGG harvesting

blade DGG harvesting

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pain assessment at the donor site

Visual Analogue Scale

number of analgesic pills consumed per day

counting number of analgesic pills per day

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

Gingival thickness

determined 2mm apical to the gingival margin using standardised CBCT

Height of keratinized tissue width

measured form the mid-buccal aspect of the gingival margin to the mucogingival line

Clinical attachment loss

measured from the CEJ to the bottom of the periodontal pocket to the nearest mm.

Probing pocket depth

measured from the gingival margin to the base of the periodontal pocket to the nearest mm

Full Information

NCT ID

NCT03200392

First Posted

June 20, 2017

Last Updated

July 20, 2020

Sponsor

Misr International University

Collaborators

Ain Shams University

1. Study Identification

Unique Protocol Identification Number

NCT03200392

Brief Title

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

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Completed

Study Start Date

February 2015 (Actual)

Primary Completion Date

January 2017 (Actual)

Study Completion Date

February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Misr International University

Collaborators

Ain Shams University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gingival Recession, Localized

Keywords

Er,Cr:YSGG laser, connective tissue graft, root coverage, mucogingival surgery, gingival recession

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

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.

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

L-DGG/LRB

Arm Type

Experimental

Arm Description

laser root surface conditioning & laser DGG harvesting

Arm Title

B-DGG/LRB

Arm Type

Experimental

Arm Description

laser root surface conditioning & blade DGG harvesting

Arm Title

B-DGG

Arm Type

Active Comparator

Arm Description

blade DGG harvesting

Intervention Type

Device

Intervention Name(s)

laser root surface conditioning & laser DGG harvesting

Other Intervention Name(s)

erbium, chromium:YSGG laser

Intervention Description

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

Intervention Name(s)

laser root surface conditioning & blade DGG harvesting

Other Intervention Name(s)

erbium, chromium:YSGG laser

Intervention Description

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

Procedure

Intervention Name(s)

blade DGG harvesting

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in Recession depth

Description

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

Time Frame

baseline-3-6-9 months

Secondary Outcome Measure Information:

Title

Pain assessment at the donor site

Description

Visual Analogue Scale

Time Frame

7 days

Title

number of analgesic pills consumed per day

Description

counting number of analgesic pills per day

Time Frame

7 days

Title

Recession width

Description

distance between mesial and distal gingival margin of the tooth recorded on a horizontal line tangential at the CEJ to the nearest mm

Time Frame

baseline-3-6-9 months

Title

Gingival thickness

Description

determined 2mm apical to the gingival margin using standardised CBCT

Time Frame

baseline and at 9 months

Title

Height of keratinized tissue width

Description

measured form the mid-buccal aspect of the gingival margin to the mucogingival line

Time Frame

baseline and at 9 months

Title

Clinical attachment loss

Description

measured from the CEJ to the bottom of the periodontal pocket to the nearest mm.

Time Frame

baseline-3-6-9 months

Title

Probing pocket depth

Description

measured from the gingival margin to the base of the periodontal pocket to the nearest mm

Time Frame

baseline-3-6-9 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

58 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: 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.

Overall Study Officials: