Treatment of Periodontitis Using Er:YAG Laser vs. Conventional Treatment Modalities

Chronic Periodontitis Clinical Trial

Official title:

Randomized Controlled Trial to Evaluate the Efficacy of Er:YAG Laser and Surgical Therapy in Treatment of Chronic Periodontitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00669253
• Other study ID #: 2008/189
• Status: Completed
• Phase: N/A
• First received: April 25, 2008
• Last updated: December 4, 2014
• Start date: June 2008
• Est. completion date: December 2012

Study information

• Verified date: December 2014
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Conventional non-surgical periodontal treatment, that is, root debridement using manual and ultrasonic means at baseline and surgery using the same means after 6 months in case of persistent deep pockets (Group 1)/ Er:YAG laser used in a non-surgical approach at baseline and surgery using the same laser after 6 months in case of persistent deep pockets (Group 2)/ Surgery at baseline using manual and ultrasonic means (Group 3). All patients will undergo supragingival maintenance on a yearly basis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2012
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years and older

Eligibility

Inclusion Criteria:

• at least 35 years of age

• at least 18 teeth present that can be retained by means of therapy among which 4 multirooted teeth or more(wisdom teeth excluded)

• presence of at least one deep pocket per quadrant (6 mm PPD or more) with radiographic evidence of bone loss (>= 30% of root length)

Exclusion Criteria:

• pregnancy

• removable prosthesis

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Intervention

Procedure:
• Er: YAG Laser
Scaling and root planing at baseline and surgery for remaining deep pockets after 6 months both using Er:YAG laser
• Conventional treatment 1(ultrasonic and manual means)
Scaling and root planing at baseline and surgery for remaining deep pockets after 6 months both using conventional methods : ultrasonic and manual means
• Conventional treatment 2 (ultrasonic and manual means)
Surgery at baseline for all deep pockets using conventional methods: ultrasonic and manual means

Locations

Country	Name	City	State
Belgium	University Hospital Ghent	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Probing pocket depth, Clinical attachment level and microbiological analysis		At baseline, 3, 6, 12, 24, 36, 48 and 60 months	No
Secondary	Gingivitis index, plaque index, bleeding on probing at the same time intervals + the number of interventions		After 5 years	Yes
Secondary	Consumed time per treatment/ Patient satisfaction/comfort ( Oral Health impact Profile : OHIP )/ The estimated financial costs based on average data delivered for instance by the Belgian Society of Periodontology		After 5 years	No
Secondary	Adverse effects described by the patient (number of painkillers taken, visual analogue scale to monitor post-operative pain, tooth sensitivity)		After 5 years	Yes

External Links

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