Clinical Efficacy Of 810 Nanometer Diode Laser As An Adjunct To Mechanical Periodontal Treatment Of Residual Periodontal Pockets

NCT02531555 | Completed

• 1 other identifier: Meseli et al.
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Aim of this randomized controlled parallel-designed study was to evaluate the effects of diode laser as an adjunct to mechanical periodontal treatment on clinical parameters and gingival crevicular fluid (GCF) volume of the residual pockets diagnosed following initial periodontal treatment in chronic periodontitis (CP) patients. Methods: A total of 84 residual pockets on single-rooted teeth in 11 CP patients were included and randomly assigned into 3 groups. Residual pockets were treated either only by mechanical treatment (Group M) (n=28), only by diode laser disinfection (Group L) (n=28) or by combination of these techniques (Group M+L) (n=28). Plaque index, gingival index (GI), bleeding on probing (BoP), probing depth (PD), clinical attachment level and gingival recession were assessed at baseline and 8 weeks after treatment of residual pockets. GCF samples were collected at baseline, 1 and 8 weeks after treatment.

Conditions

Chronic Periodontitis

Keywords

chronic periodontitis; dental scaling; gingival crevicular fluid; lasers; periodontal pocket; root planing

Outcome Measures

Primary Outcomes (1)

• Probing depth

  Probing depth is defined as the distance from the free gingival margin to the bottom of the periodontal pocket.

  8 week

Secondary Outcomes (5)

• Plaque index

  8 week

• Gingival index

  8 week

• Clinical attachment level

  8 week

• Bleeding on probing via periodontal probe

  8 week

• Change of gingival crevicular fluid volume

  Baseline, 8 weeks

Study Arms (3)

Group M

ACTIVE COMPARATOR

Mechanical periodontal treatment (Group M): Scaling and root planing were performed with Gracey curettes until the operator feels that root surface is clean, hard and smooth.

Device: Gracey curettes

Group L

EXPERIMENTAL

Pocket disinfection with diode laser (Group L): Subgingival irradiation with a GaAlAs diode laser (CHEESE®, Gigaa Laser, China) was applied to residual pockets each for 20 sec in continious mode. The diode laser had a wavelenght of 810 nm and power output of 1 W for subgingival irradiation (Maximum output power of device was 7 W). Diode laser application was performed parallel to root surface by a 200 µm fiber tip inserted at the bottom of periodontal pocket and slowly moved from apical to coronal direction in a sweeping motion without local anesthesia.

Device: 810 Nanometer Wavelenght GaAlAs Diode Laser

Group M+L

EXPERIMENTAL

Combined treatment (Group M+L): Following mechanical periodontal treatment, pocket irradiation with diode laser was performed as mentioned above.

Device: 810 Nanometer Wavelenght GaAlAs Diode Laser; Device: Gracey curettes

Interventions

810 Nanometer Wavelenght GaAlAs Diode Laser DEVICE

FDA approved 810 nanometer GaAlAs Diode Laser

Also known as: CHEESE®, Gigaa Laser, China

Group L; Group M+L

Gracey curettes DEVICE

Also known as: Hu-Friedy, SG 5/6, 7/8, 11/12, 13/14, Hu-Friedy Ins. Co., USA

Group M; Group M+L

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Systemically healthy,
• Non-smoker,
• Chronic periodontitis diagnosed according to Armitage 1,
• Aged between 35 and 65,
• Not received any periodontal treatment within the last 3 months,
• Have horizontal bone loss radiographically,
• Presence at least 20 natural teeth except third molars
• Consent to participate in the study.

You may not qualify if:

• Any systemic disease that might interfere with the prognosis of periodontal disease (i.e. diabetes mellitus, HIV infection),
• Smoking,
• Antibiotics, anti-inflammatory drugs or any other medication taken within the previous 6 months that may affect the outcome of the study,
• Any physical limitations or restrictions that might preclude normal oral hygiene procedures.

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University, Faculty of Dentistry

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Chronic Periodontitis; Periodontal Pocket

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2015
• First Posted: August 24, 2015
• Study Start: January 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: August 24, 2015

Record last verified: 2015-08

Locations

TU (1)