NCT05217823

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2012

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
7.9 years until next milestone

First Submitted

Initial submission to the registry

January 4, 2022

Completed
28 days until next milestone

First Posted

Study publicly available on registry

February 1, 2022

Completed
Last Updated

February 23, 2022

Status Verified

February 1, 2022

Enrollment Period

2.1 years

First QC Date

January 4, 2022

Last Update Submit

February 7, 2022

Conditions

Keywords

LasersPeriodontitisRoot planingTreatment outcome

Outcome Measures

Primary Outcomes (1)

  • Probing pocket depth

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

    1 year

Secondary Outcomes (4)

  • Gingival recession

    1 year

  • Clinical attachment level

    1 year

  • Bleeding on probing

    1 year

  • Plaque level

    1 year

Study Arms (2)

Er:YAG laser

EXPERIMENTAL

Teeth treated with Er:YAG laser

Device: Er:YAG laser

Hand instruments

ACTIVE COMPARATOR

Teeth treated with Gracey curettes

Other: hand instruments

Interventions

Also known as: Er:YAG laser, LiteTouch, Light Instruments, Israel
Er:YAG laser
Also known as: Gracey curettes
Hand instruments

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Chronic PeriodontitisLymphoma, FollicularPeriodontitis

Interventions

Lasers, Solid-State

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

LasersOptical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

January 4, 2022

First Posted

February 1, 2022

Study Start

January 1, 2012

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

February 23, 2022

Record last verified: 2022-02