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

NCT00669253 | Completed

• 1 other identifier: 2008/189
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Periodontitis

Outcome Measures

Primary Outcomes (1)

• Probing pocket depth, Clinical attachment level and microbiological analysis

  At baseline, 3, 6, 12, 24, 36, 48 and 60 months

Secondary Outcomes (3)

• Gingivitis index, plaque index, bleeding on probing at the same time intervals + the number of interventions

  After 5 years

• 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

• Adverse effects described by the patient (number of painkillers taken, visual analogue scale to monitor post-operative pain, tooth sensitivity)

  After 5 years

Study Arms (3)

1

EXPERIMENTAL

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

Procedure: Er: YAG Laser

2

ACTIVE COMPARATOR

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)

3

ACTIVE COMPARATOR

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

Procedure: Conventional treatment 2 (ultrasonic and manual means)

Interventions

Er: YAG Laser PROCEDURE

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

1

Conventional treatment 1(ultrasonic and manual means) PROCEDURE

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

2

Conventional treatment 2 (ultrasonic and manual means) PROCEDURE

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

3

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• pregnancy
• removable prosthesis

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

Location

Related Links

• Related Info

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

Lasers, Solid-State; High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies; Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Hugo De Bruyn, MD, Phd

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2008
• First Posted: April 30, 2008
• Study Start: June 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2012
• Last Updated: December 5, 2014

Record last verified: 2014-12

Locations

BE (1)