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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

University Hospital, Ghent

ClinicalTrials.gov Identifier:

NCT00669253

First received: April 25, 2008

Last updated: June 15, 2012

Last verified: June 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

April 25, 2008

Last Updated Date

June 15, 2012

Start Date ^ICMJE

June 2008

Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Probing pocket depth, Clinical attachment level and microbiological analysis [ Time Frame: At baseline, 3, 6, 12, 24, 36, 48 and 60 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00669253 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Gingivitis index, plaque index, bleeding on probing at the same time intervals + the number of interventions [ Time Frame: After 5 years ] [ Designated as safety issue: Yes ]
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 [ Time Frame: After 5 years ] [ Designated as safety issue: No ]
Adverse effects described by the patient (number of painkillers taken, visual analogue scale to monitor post-operative pain, tooth sensitivity) [ Time Frame: After 5 years ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Chronic Periodontitis

Intervention ^ICMJE

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

Study Arm (s)

Experimental: 1
Scaling and root planing at baseline and surgery for remaining deep pockets after 6 months both using Er:YAG laser

Intervention: Procedure: Er: YAG Laser
Active Comparator: 2
Scaling and root planing at baseline and surgery for remaining deep pockets after 6 months both using conventional methods (ultrasonic and manual means)

Intervention: Procedure: Conventional treatment 1(ultrasonic and manual means)
Active Comparator: 3
Surgery at baseline for all deep pockets using conventional methods (ultrasonic and manual means)

Intervention: Procedure: Conventional treatment 2 (ultrasonic and manual means)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2012

Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

35 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Belgium

Administrative Information

NCT Number ^ICMJE

NCT00669253

Other Study ID Numbers ^ICMJE

2008/189

Has Data Monitoring Committee

Responsible Party

University Hospital, Ghent

Study Sponsor ^ICMJE

University Hospital, Ghent

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Hugo De Bruyn, MD, Phd

University Hospital, Ghent

Information Provided By

University Hospital, Ghent

Verification Date

June 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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