Diode Laser Therapy As An Adjunct To Scaling And Root Planing

Chronic Periodontitis Clinical Trial

Official title:

Diode Laser Therapy As An Adjunct To Non-Surgical Management Of Chronic Periodontitis - A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03028727
• Other study ID #: KLESocietyIDS
• Status: Completed
• Phase: N/A
• First received: January 7, 2017
• Last updated: January 19, 2017
• Start date: March 2013
• Est. completion date: September 2013

Study information

• Verified date: January 2017
• Source: KLE Society's Institute of Dental Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

Conventional mechanical debridement can achieve a temporary decrease in the subgingival levels of Pg along with other pathogens. However, mechanical therapy alone may fail to eliminate pathogenic bacterial niches in inaccessible areas like deep pockets, root concavities, furcation areas etc. In search of more efficient and less traumatic techniques to improve periodontal healing, researchers proposed the use of lasers in periodontal therapy.

The adjunctive use of lasers with conventional tools may facilitate treatment and have the potential to improve healing. The diode laser is highly absorbed in hemoglobin and other pigments and is excellent for use in soft tissue surgical procedures.Laser application in improving clinical outcome in periodontal therapy, needs to be further investigated with well designed clinical trials. The investigators attempted to evaluate the efficacy of diode laser as an adjunct to SRP in the management of CP by evaluating clinical parameters coupled with quantitative estimation of P.gingivalis using Real-time Polymerase chain reaction (RT-PCR) assay.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 50 Years

Eligibility

Inclusion Criteria:

• 40 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Intervention

Procedure:
• Ultrasonic Scaling and root planing
Procedure of scaling and root planing at day 0 and at 1 week
• 980 nm diode laser irradiation
Procedure of scaling and root planing and application of 980 nm diode laser at day 0 and at 1 week

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
KLE Society's Institute of Dental Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in gingival index	Gingival index by Loe and Silness was assessed at baseline, 4-6 weeks and 12-14 weeks post treatment in both the groups	14 weeks
Secondary	Change in plaque index	Plaque index by Silness and Loe was assessed at baseline, 4-6 weeks and 12-14 weeks	14 weeks
Secondary	Change in probing pocket depth	Probing pocket depth was assessed at baseline, 4-6 weeks and 12-14 weeks	14 weeks
Secondary	Change in clinical attachment level	Clinical attachment level was assessed at baseline, 4-6 weeks and 12-14 weeks	14 weeks