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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
  Purpose

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.


Condition Intervention
Chronic Periodontitis
 Procedure: Er: YAG Laser
Procedure: Conventional treatment 1(ultrasonic and manual means)
Procedure: Conventional treatment 2 (ultrasonic and manual means)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial to Evaluate the Efficacy of Er:YAG Laser and Surgical Therapy in Treatment of Chronic Periodontitis

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
Study Start Date: June 2008
Estimated Study Completion Date: December 2012
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Scaling and root planing at baseline and surgery for remaining deep pockets after 6 months both using Er:YAG laser
 Procedure: Er: YAG Laser
Scaling and root planing at baseline and surgery for remaining deep pockets after 6 months both using 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)
 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
Active Comparator: 3
Surgery at baseline for all deep pockets 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

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00669253

Locations
Belgium
University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Hugo De Bruyn, MD, Phd University Hospital, Ghent
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00669253     History of Changes
Other Study ID Numbers: 2008/189
Study First Received: April 25, 2008
Last Updated: June 15, 2012
Health Authority: Belgium: Institutional Review Board

Additional relevant MeSH terms:
Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on June 17, 2013