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

Primary Purpose

Chronic Periodontitis

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Er: YAG Laser
Conventional treatment 1(ultrasonic and manual means)
Conventional treatment 2 (ultrasonic and manual means)
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Periodontitis

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Ghent

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

1

2

3

Arm Description

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

Scaling and root planing at baseline and surgery for remaining deep pockets after 6 months both using conventional methods (ultrasonic and manual means)

Surgery at baseline for all deep pockets using conventional methods (ultrasonic and manual means)

Outcomes

Primary Outcome Measures

Probing pocket depth, Clinical attachment level and microbiological analysis

Secondary Outcome Measures

Gingivitis index, plaque index, bleeding on probing at the same time intervals + the number of interventions
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
Adverse effects described by the patient (number of painkillers taken, visual analogue scale to monitor post-operative pain, tooth sensitivity)

Full Information

First Posted
April 25, 2008
Last Updated
December 4, 2014
Sponsor
University Hospital, Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT00669253
Brief Title
Treatment of Periodontitis Using Er:YAG Laser vs. Conventional Treatment Modalities
Official Title
Randomized Controlled Trial to Evaluate the Efficacy of Er:YAG Laser and Surgical Therapy in Treatment of Chronic Periodontitis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Scaling and root planing at baseline and surgery for remaining deep pockets after 6 months both using Er:YAG laser
Arm Title
2
Arm Type
Active Comparator
Arm Description
Scaling and root planing at baseline and surgery for remaining deep pockets after 6 months both using conventional methods (ultrasonic and manual means)
Arm Title
3
Arm Type
Active Comparator
Arm Description
Surgery at baseline for all deep pockets using conventional methods (ultrasonic and manual means)
Intervention Type
Procedure
Intervention Name(s)
Er: YAG Laser
Intervention Description
Scaling and root planing at baseline and surgery for remaining deep pockets after 6 months both using Er:YAG laser
Intervention Type
Procedure
Intervention Name(s)
Conventional treatment 1(ultrasonic and manual means)
Intervention Description
Scaling and root planing at baseline and surgery for remaining deep pockets after 6 months both using conventional methods : ultrasonic and manual means
Intervention Type
Procedure
Intervention Name(s)
Conventional treatment 2 (ultrasonic and manual means)
Intervention Description
Surgery at baseline for all deep pockets using conventional methods: ultrasonic and manual means
Primary Outcome Measure Information:
Title
Probing pocket depth, Clinical attachment level and microbiological analysis
Time Frame
At baseline, 3, 6, 12, 24, 36, 48 and 60 months
Secondary Outcome Measure Information:
Title
Gingivitis index, plaque index, bleeding on probing at the same time intervals + the number of interventions
Time Frame
After 5 years
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hugo De Bruyn, MD, Phd
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

Links:
URL
http://www.uzgent.be
Description
Related Info

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

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