NCT03028727

Brief Summary

Laser therapy has been proposed as a novel treatment option in controlling subgingival microorganisms. This randomized controlled clinical trial evaluates the effect of 980nm diode laser as an adjunct to scaling and root planing (SRP) in the management of chronic periodontitis (CP).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2013

Shorter than P25 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

March 1, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

January 7, 2017

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 23, 2017

Completed
Last Updated

January 23, 2017

Status Verified

January 1, 2017

Enrollment Period

6 months

First QC Date

January 7, 2017

Last Update Submit

January 19, 2017

Conditions

Chronic Periodontitis

Outcome Measures

Primary Outcomes (1)

  • Change in levels of P.gingivalis

    Microbial profile was assessed using PCR at baseline, 4-6 weeks and 12-14 weeks post treatment in both the study groups.

    14 weeks

Secondary Outcomes (4)

  • Change in gingival index

    14 weeks

  • Change in plaque index

    14 weeks

  • Change in probing pocket depth

    14 weeks

  • Change in clinical attachment level

    14 weeks

Study Arms (2)

Ultrasonic Scaling, Root planing

ACTIVE COMPARATOR

Ultrasonic Scaling and Root planing at day 0 and at 1 week.

Procedure: Ultrasonic Scaling and root planing

980 nm diode Laser irradiation

EXPERIMENTAL

Irradiation of periodontal pockets with with 980 nm diode Laser after scaling and root planing at day 0 and after 1 week.

Procedure: Ultrasonic Scaling and root planingProcedure: 980 nm diode laser irradiation

Interventions

Ultrasonic Scaling and root planingPROCEDURE

Procedure of scaling and root planing at day 0 and at 1 week

980 nm diode Laser irradiationUltrasonic Scaling, Root planing
980 nm diode laser irradiationPROCEDURE

Procedure of scaling and root planing and application of 980 nm diode laser at day 0 and at 1 week

980 nm diode Laser irradiation

Eligibility Criteria

Age30 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • systemically healthy subjects diagnosed with generalized moderate CP in the age group of 30 to 50 years.
  • Minimum of 20 teeth having atleast two non-adjacent sites per quadrant with probing pocket depth of ≥ 5mm and clinical attachment loss of 3- 4 mm

You may not qualify if:

  • Patients who had undergone periodontal therapy 6 months prior to the commencement of the study.
  • Subjects on antibiotics or immunosuppressants.
  • Chronic smokers, alcoholics, smokeless tobacco users.
  • Subjects with acute illnesses/acute intraoral lesions.
  • Pregnant women
  • Subjects who had undergone extensive restorative dental treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

Root Planing

Condition Hierarchy (Ancestors)

PeriodontitisPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dental ScalingDental ProphylaxisPeriodonticsDentistrySubgingival CurettagePreventive Dentistry

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Reader, Department of Periodontics

Study Record Dates

First Submitted

January 7, 2017

First Posted

January 23, 2017

Study Start

March 1, 2013

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

January 23, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share