Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201909915338276 Date of Approval: 05/09/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Diode Laser and Red Complex Periodontal Bacteria
Official scientific title Diode Laser as an Additional Therapeutic Measure in Reducing Red Complex Bacteria in Chronic Periodontitis
Brief summary describing the background and objectives of the trial This study will assess whether a diode laser with a wavelength of 810 ± 10nm can be utilized as an adjunct to conventional management (i.e. scaling, root planing and polishing) of chronic periodontitis during initial phase therapy. A split mouth randomised control trial performed on 25 participants (who will present at the Oral Medicine and Periodontology Department of the University of the Western Cape) diagnosed with active, chronic periodontitis will be included in the study. In order to standardise the split mouth design the quadrants 1 & 4 were assessed together as a set and quadrants 2 & 3 were assessed as a set. A set of these quadrants were randomly assigned to either the test or control quadrants after conventional management was performed in all four quadrants. The base line bacterial colony collection (Micro-IDent®-11, Hain Lifescience GmbH, Nehren, Germany) and the clinical parameters assessed prior to the commencement of conventional management and were reassessed at the 6 week re-evaluation visit. The set of test quadrants were treated with the diode laser as an adjunct to the preceding conventional management. The control quadrant only received the conventional management. OBJECTIVES To compare the quantitative changes in the bacterial load of pathogens in the periodontal pocket after conventional management versus conventional management plus the diode laser. To compare the difference in the periodontal clinical parameters after conventional management versus conventional management plus the diode laser.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Oral Health
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Addition of the Diode laser application
Anticipated trial start date 05/01/2015
Actual trial start date 01/03/2015
Anticipated date of last follow up 01/12/2015
Actual Last follow-up date 01/08/2016
Anticipated target sample size (number of participants) 25
Actual target sample size (number of participants) 25
Recruitment status Completed
Publication URL http://hdl.handle.net/11394/5609
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Diode laser The treatment only with the laser on the test side of the mouth. The Picasso GaAlAs laser (AMD Lasers®, Indianapolis, Indiana, USA) with a wavelength of 810 ± 10 nm was used. The laser was used with a 400µm (0.4mm) optical fibre. The laser application in the test quadrant pockets occurred after the tip was initiated on articulation paper. The power setting of 1W continuous wave was selected. The Picasso GaAlAs laser (AMD Lasers®, Indianapolis, Indiana, USA) was set at continuous wave for the “decontamination” on 1W at a frequency of 50Hz. The laser tip was applied in the pocket for the extent of time that was needed to sweep the tip through the pocket. This time was maintained at 8 ± 2 seconds per buccal aspect of the tooth and about 8 ± 2 seconds per lingual/palatal aspect of the tooth. The tip was held parallel to the long axis of the tooth and 1mm coronally of the periodontal base of the pocket. Diode laser application in the periodontal pocket of patients diagnosed with chronic periodontitis. 25
Control Group Control side No laser No laser No laser, only conventional periodontal management i.e. scaling and polishing. 25 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The participants had to be adult patients (over the age of 18 years-64 years). For the purpose of this study the participants were diagnosed with chronic periodontitis and had to present with a minimum of four teeth present per quadrant. At least three teeth per quadrant had to present with periodontal probing pocket depths of 5mm or more in any of the six point probing areas namely mesio-buccal (MB), buccal (B), disto-buccal (DB), mesio-palatal (MP), palatal (P), disto-palatal (DP) per tooth were assessed. Clinical features defining a diagnosis of chronic periodontitis: Oedema and tissue erythema Moderate accumulations of plaque and calculus Bleeding on probing (BOP) Increased pocket depths (minimum probing pocket depth of 4mm) Radiographic evidence of bone loss (angular or horizontal) Tooth mobility Varying degrees of clinical attachment loss Slow to moderate rate of progression Amount of destruction consistent with the presence of local factors – such as plaque and calculus. The chronic periodontitis could have presented as localised (<30% of sites affected) or generalized (>30% of sites affected). The severity of the chronic periodontitis could have presented as mild (CAL= 1-2mm), moderate (CAL=3-4mm) or severe (CAL > 5mm) (Lindhe, 2015:129). All the above mentioned variants of chronic periodontitis were included in this study. Patients under 18 years and over 65 years. The only underlying medical conditions that were excluded were patients that were pregnant (or lactating) and patients undergoing radiation or chemotherapy. Patients with oral pigmentation of the attached gingiva in the study area of interest were also excluded from the study, as pigments (such as melanin) absorb laser energy at varying amounts which could potentially have an effect on the results. Patients who smoked more than 10 cigarettes per day were excluded.Patients that had taken antibiotics in the previous 6 months were excluded.Patients who had periodontal treatment in the previous 6 months were also excluded. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 64 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 24/10/2014 Senate Research committee and Dental Research Committee
Ethics Committee Address
Street address City Postal code Country
Fransie van Zijl Drive, Private Bag X1, Parow. Cape Town 7505 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Bacterial determination and the change in the colony forming units. Before any treatment. After 6 weeks from treatment date.
Secondary Outcome All patients receive the diode laser after 6 weeks if the diode laser adjuct reduced the red complex bacteria colony forming units. After 6 weeks from initial treatment date.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
The University of the Western Cape Tygerberg Oral Health Centre Fransie van Zijl street, Parow. Cape Town 7505 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
NHLS Fransie van Zijl Drive, Parow. Cape Town 7505 South Africa
Dr Sune mulder van Staden 43 Mauritius Crescent, Stellenberg, Durbanville Cape Town 7550 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor NHLS Fransie van Zijl Drive, Parow Cape Town 7505 South Africa Government body
Primary Sponsor Dr Sune Mulder van Staden 43 Maurtius Crescent, Stellenberg, Durbanville. Cape Town 7550 South Africa Individual
COLLABORATORS
Name Street address City Postal code Country
Dr H Holmes Oral medicine and periodontics, UWC Dental faculty, Fransie van Zijl Drive, Parow Cape Town 7505 South Africa
Prof J Hille NHLS, Tygerberg Hospital, Fransie van Zijl drive, Parow. Cape Town 7505 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sune Mulder van Staden drsunemulder@gmail.com +27614305870 43 Mauritius Crescent, Stellenberg, Durbanville
City Postal code Country Position/Affiliation
Cape Town 7550 South Africa Registrar
Role Name Email Phone Street address
Public Enquiries Sune Mulder van Staden drsunemulder@gmail.com +279373107 Office 2129, UWC dental faculty, Fransie van Zijl Drive, Parow
City Postal code Country Position/Affiliation
Cape Town 7505 South Africa Consultant
Role Name Email Phone Street address
Scientific Enquiries Sune Mulder van Staden drsunemulder@gmail.com +27219373107 Office 2129, UWC Dental faculty, Fransie van Zijl drive, Parow
City Postal code Country Position/Affiliation
Cape Town 7505 South Africa Consultant
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes http://hdl.handle.net/11394/5609 Evaluation of the results demonstrated that the diode laser produced no statistical decrease in the bacterial parameters in the periodontal pockets and resulted in a statistical increase of C. showae (Cs) and T. denticola (Td). The clinical parameters resulted in no statistical difference for any clinical parameter, with the exception of the reduction in BOP that was statistically significant (p< 0,05) with the laser as an adjunct. It is the recommendation that within the limitations of this study, that the utilization of the diode laser (810 ± 10nm) as an adjunct at the initial visit had no statistical effect in the reduction of the bacterial parameters nor resulted in an overall improvement of the clinical parameters. 01/11/2016 01/12/2019
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks http://hdl.handle.net/11394/5609
Changes to trial information