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Er:YAG Laser Treatment of Moderate Chronic Periodontitis

Primary Purpose

Chronic Periodontitis, Generalized, Moderate

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Er:YAG laser

hand instruments

About this trial

This is an interventional treatment trial for Chronic Periodontitis, Generalized, Moderate focused on measuring Lasers, Periodontitis, Root planing, Treatment outcome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

at least two teeth per quadrant with PPD between 3,6 mm and 6,4 mm;
loss of clinical attachment up to 4 mm
bleeding on probing

Exclusion Criteria:

periodontal treatment in the last 12 months;
systemic diseases;
systemic medication

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Er:YAG laser

Hand instruments

Arm Description

Teeth treated with Er:YAG laser

Teeth treated with Gracey curettes

Outcomes

Primary Outcome Measures

Probing pocket depth

Change in PPD (measured as a distance between the gingival margin and the depth of the pocket) using computerised periodontal probe

Secondary Outcome Measures

Gingival recession

Change in GR (measured as a distance between the gingival margin and the cement-enamel junction) using computerised periodontal probe

Clinical attachment level

Change of CAL (measured as a distance between the cement-enamel junction and the depth of the pocket) using computerised periodontal probe

Bleeding on probing

Change in BoP

Plaque level

Change of Plaque index

Full Information

NCT ID

NCT05217823

First Posted

January 4, 2022

Last Updated

February 7, 2022

Sponsor

Plovdiv Medical University

1. Study Identification

Unique Protocol Identification Number

NCT05217823

Brief Title

Er:YAG Laser Treatment of Moderate Chronic Periodontitis

Official Title

Long-term Stability of Er:YAG Laser Non-surgical Periodontal Treatment

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Completed

Study Start Date

January 2012 (Actual)

Primary Completion Date

February 2014 (Actual)

Study Completion Date

February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Plovdiv Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The Er:YAG laser possesses specific characteristics allowing to be used in non-surgical periodontal treatment. The aim of the resent study was to evaluate the long-term clinical effectiveness of Er:YAG laser monotherapy in the treatment of moderate chronic periodontitis and to compare it with conventional hand instrumentation. MATERIALS AND METHODS: 451 teeth (1,099 periodontal pockets) from 30 patients with moderate chronic periodontitis (initial probing pocket depth 4 to 6 mm) were allocated for subgingival scaling and root planing in two groups - hand instrumentation (control) and Er:YAG laser instrumentation with 100mJ/15Hz (test). Using a computerized periodontal probe, patients were examined for probing pocket depth (PPD), gingival recession (GR), clinical attachment level (CAL), bleeding on probing (BOP), plaque presence (FMPS) at baseline, one, three, six and 12 months after instrumentation.

6. Conditions and Keywords

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

Chronic Periodontitis, Generalized, Moderate

Keywords

Lasers, Periodontitis, Root planing, Treatment outcome

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Er:YAG laser

Arm Type

Experimental

Arm Description

Teeth treated with Er:YAG laser

Arm Title

Hand instruments

Arm Type

Active Comparator

Arm Description

Teeth treated with Gracey curettes

Intervention Type

Device

Intervention Name(s)

Er:YAG laser

Other Intervention Name(s)

Er:YAG laser, LiteTouch, Light Instruments, Israel

Intervention Type

Other

Intervention Name(s)

hand instruments

Other Intervention Name(s)

Gracey curettes

Primary Outcome Measure Information:

Title

Probing pocket depth

Description

Change in PPD (measured as a distance between the gingival margin and the depth of the pocket) using computerised periodontal probe

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Gingival recession

Description

Change in GR (measured as a distance between the gingival margin and the cement-enamel junction) using computerised periodontal probe

Time Frame

1 year

Title

Clinical attachment level

Description

Change of CAL (measured as a distance between the cement-enamel junction and the depth of the pocket) using computerised periodontal probe

Time Frame

1 year

Title

Bleeding on probing

Description

Change in BoP

Time Frame

1 year

Title

Plaque level

Description

Change of Plaque index

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: at least two teeth per quadrant with PPD between 3,6 mm and 6,4 mm; loss of clinical attachment up to 4 mm bleeding on probing Exclusion Criteria: periodontal treatment in the last 12 months; systemic diseases; systemic medication

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Er:YAG Laser Treatment of Moderate Chronic Periodontitis

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