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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by University Hospital, Ghent.
Recruitment status was  Active, not recruiting
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 August 21, 2014