Diode Laser Study for Periodontal Maintenance Patients

NCT01215201 | Completed DMC

• 1 other identifier: 0452-09-EP
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

This study tries to determine whether the additional use of laser with "cleaning" (known as scaling and root planning) will result in the reduction of inflammation, reduction of bleeding upon examination and reduction of pocket depth in patients who are being maintained on a regular basis but have pocket depths that are ≥5mm with bleeding. When a pocket is bleeding, it is inflamed. It is usually "cleaned" with periodontal instruments (root-planed) to establish health. Some research also advocates using laser therapy to treat a bleeding pocket. Laser therapy is presently being performed in some dental offices and dental colleges. This research is trying to see if the additional laser therapy is beneficial.

Conditions

Periodontal Diseases; Periodontitis, Apical, Chronic Nonsuppurative; Suppuration of Gingival Crevice

Keywords

Periodontal maintenance; ≥5mm probing depth; bleeding on probing and/or suppuration

Outcome Measures

Primary Outcomes (1)

• Periodontal clinical parameters

  Reduction in Probing Depth, Gaining of clinical attachment level, Reduction of Bleeding upon Probing, Reduction of Plaque accumulation, reduction of IL-1B inflammatory marker.

  3 months

Study Arms (2)

Scaling and Root Planing Alone

OTHER

Control group

Procedure: Scaling and Root Planing

Diode Laser plus Scaling and Root Planing

EXPERIMENTAL

Diode Laser is used in addition to Scaling and root planing procedure.

Procedure: Diode Laser + Scaling and Root Planing

Interventions

Scaling and Root Planing PROCEDURE

Use periodontal hand instruments (curettes) to remove plaque, bacteria, and deposits on the root's surfaces.

Scaling and Root Planing Alone

Diode Laser + Scaling and Root Planing PROCEDURE

First: Periodontal hand instruments (curettes) were used to remove plaque, bacteria, and deposits on the root's surfaces (within a periodontal pocket) Then: Biolase 940 nm Ezlase diode laser was used to sterilize a periodontal pocket. Power: 0.80 Watts Wavelength: 940 nm Energy level: 0.80 Joules/second Mode of beam delivery: continuous

Diode Laser plus Scaling and Root Planing

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any adult periodontal maintenance patient having had chronic periodontitis with last active therapy at least 3 months prior and with 1 or more sites/subject with ≥5mm probing depth that have bleeding on probing and/or suppuration. They have signed an informed consent form to participate in the study.

You may not qualify if:

• Subjects who are un-controlled diabetics, use NSAIDS regularly for chronic disease/pain, used antibiotics for the last 3 months, require antibiotic coverage for therapy, are pregnant and below age 30.

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska Medical Center, College of Dentistry

Lincoln, Nebraska, 68583, United States

Location

MeSH Terms

Conditions

Periodontal Diseases; Periapical Granuloma

Interventions

Tooth Exfoliation; Root Planing; Lasers, Semiconductor

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Periapical Periodontitis; Periapical Diseases; Jaw Diseases; Periodontitis

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry; Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Naomi-Trang Nguyen, DDS

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2010
• First Posted: October 6, 2010
• Study Start: May 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: July 1, 2011
• Last Updated: September 15, 2023

Record last verified: 2023-09

Locations

US (1)