Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12607000129482
Ethics application status
Approved
Date submitted
13/02/2007
Date registered
14/02/2007
Date last updated
12/03/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
Laser therapy for the treatment of chronic periodontitis
Scientific title
A comparison of fluorescence-guided Er: YAG Laser (ERL) and mechanical scaling and root planing (SRP) for non-surgical sub-gingival debridement for the treatment of chronic periodontitis: a controlled prospective clinical study.
Universal Trial Number (UTN)
Trial acronym
No acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Moderate to advanced chronic periodontitis 1621 0
Condition category
Condition code
Oral and Gastrointestinal 1729 1729 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Using a split-mouth design each patient’s mouth will be divided into test and control quadrants.
The test quadrants will be debrided using an Er:YAG laser (KEY3®, Kavo, Biberach, Germany).The laser parameters are set at an energy level of 160mJ/pulse and a repetition rate of 10Hz. The Kavo periodontal P2061 handpiece will be used with water irrigation. The operator chooses the Kavo fibre tips as the situation dictates.

All treatments will be terminated when the operator is satisfied that the root surfaces are smooth and thoroughly debrided. An independent examiner will verify the clinical end point. There will be no time limit for instrumentation.
Intervention code [1] 1598 0
Treatment: Devices
Comparator / control treatment
The control quadrants will receive sub-gingival SRP using an ultrasonic scaler and Gracey hand instruments.
All treatments will be terminated when the operator is satisfied that the root surfaces are smooth and thoroughly debrided. An independent examiner will verify the clinical end point. There will be no time limit for instrumentation.
Control group
Active

Outcomes
Primary outcome [1] 2400 0
Bleeding on probing (BOP)
Timepoint [1] 2400 0
At baseline and at 6 and 12 weeks after intervention commencement
Primary outcome [2] 2401 0
Probing depth (PD)
Timepoint [2] 2401 0
At baseline and at 6 and 12 weeks after intervention commencement
Primary outcome [3] 2402 0
Clinical attachment level (CAL)
Timepoint [3] 2402 0
At baseline and at 6 and 12 weeks after intervention commencement
Secondary outcome [1] 4174 0
Patient perception of each treatment modality (Questionnaire format).
Timepoint [1] 4174 0
Immediately following each treatment. 24 hours following treatment and 1 week following treatment.
Secondary outcome [2] 4175 0
Visual analogue score (VAS) for discomfort
Timepoint [2] 4175 0
Immediately following each treatment.
Secondary outcome [3] 4176 0
Visual analogue score for pain
Timepoint [3] 4176 0
Immediately following each treatment.

Eligibility
Key inclusion criteria
All participants will have a minimum 16 teeth (4 per quadrant) and a diagnosis of moderate or advanced chronic periodontitis defined as PD =5mm, attachment loss of =2mm and bleeding on probing in 6 or more sites distributed throughout the mouth. They will be in good general health, and will have received no periodontal treatment within the previous 6 months. All patients must comprehend the visual analogue scale (VAS) and will sign informed consent forms.
Minimum age
30 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded from the study if they suffer from systemic diseases which could influence the outcome of therapy; require antibiotic coverage prior to dental treatment; use of medications such as antibiotics, steroids and anti-inflammatories in the 3 months prior to treatment; are pregnant; or are heavy smokers ( = 10 cigarettes per day).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
consecutively recruitment, concealed in sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random sequences
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
The assessor will be blinded
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment outside Australia
Country [1] 485 0
New Zealand
State/province [1] 485 0

Funding & Sponsors
Funding source category [1] 1878 0
Commercial sector/Industry
Name [1] 1878 0
KaVo Dental ASIA-PACIFIC Pte. Ltd
Country [1] 1878 0
Singapore
Primary sponsor type
University
Name
Department of Oral Sciences, School of Dentistry, University of Otago, New Zealand
Address
PO BOX 647
Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 1693 0
None
Name [1] 1693 0
Nil
Address [1] 1693 0
Country [1] 1693 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3503 0
Lower South Regional Ethics Committee
Ethics committee address [1] 3503 0
Ethics committee country [1] 3503 0
New Zealand
Date submitted for ethics approval [1] 3503 0
Approval date [1] 3503 0
16/11/2006
Ethics approval number [1] 3503 0
LRS/06/10/044

Summary
Brief summary
Patients often find having their teeth scaled an unpleasant experience.
The purpose of this research is to determine whether a laser is as effective as conventional instruments (powered and hand scalers) for the treatment of chronic periodontitis (gum disease). The effectiveness of each treatment method will be assessed using patient-centred outcomes such as clinical periodontal measurements and patients’ overall experience. The study design is such that it is as close to normal daily practice as possible.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27532 0
Address 27532 0
Country 27532 0
Phone 27532 0
Fax 27532 0
Email 27532 0
Contact person for public queries
Name 10787 0
Dr. Lingfeng Soo
Address 10787 0
Department of Oral Sciences
School of Dentistry
University of Otago
PO BOX 647
Dunedin 9016
Country 10787 0
New Zealand
Phone 10787 0
+64 3 4797036
Fax 10787 0
+64 3 4790673
Email 10787 0
[email protected]
Contact person for scientific queries
Name 1715 0
Dr. Lingfeng Soo
Address 1715 0
Department of Oral Sciences
School of Dentistry
University of Otago
PO BOX 647
Dunedin 9016
Country 1715 0
New Zealand
Phone 1715 0
+64 3 4797036
Fax 1715 0
+64 3 4790673
Email 1715 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.