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ISRCTN
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ISRCTN29742423
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DOI
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10.1186/ISRCTN29742423
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Formulation and evaluation of new biodegradable periodontal chip containing Selvadora Persica in chitosan base for the management of chronic periodontitis
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Scientific title
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Formulation and evaluation of new biodegradable periodontal chip containing Selvadora Persica in chitosan base for the management of chronic periodontitis: a randomized single-blind split mouth study
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Acronym
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N/A
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Serial number at source
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5/1/6/01
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Study hypothesis
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Therapeutic uses of Salvadora Persica have been found in toothpaste, mouth rinses and endodontic irrigation solution. This newly formulated periodontal chips containing Salvadora persica can be utilized as adjuncts to scaling and root planning in the managements of chronic periodontitis.
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Lay summary
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Lay summary under review 2
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Ethics approval
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Research Management institute, Universiti Teknologi MARA, 20 April 2011, ref: 600-RMI(5/1/6/01)
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Study design
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Two month randomized single-blind split mouth study
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Countries of recruitment
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Malaysia
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Disease/condition/study domain
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Chronic periodontitis
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Participants - inclusion criteria
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1. Twelve chronic periodontitis male aged between 35 and 56 years (mean age 41.8 ± 5.6)
2. Has at least 4 non adjacent teeth with periodontal pocket measuring ≥5mm
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Participants - exclusion criteria
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1. History of systemic disease that might impact the course of periodontal disease or would require prophylactic antibiotics before dental treatment
2. Antibiotics or any modality of periodontal treatment in the past 3 months
3. Presence of overhanging restorations
4. Pregnancy, smoking habits, allergy to Selvadora Persica (Miswak)
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Anticipated start date
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25/04/2011
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Anticipated end date
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30/12/2011
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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12
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Interventions
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At baseline, all patients were treated with full mouth scaling and root planning. Periodontal pockets were divided into four groups. One of which is the control group, while group two received plain Chitosan chip. Group three received chips containing Salvadora persica extract and group four received chips containing Benzylisothiocyanate.
Plaque index, bleeding on probing, periodontal probing pocket depth and clinical attachment levels using acrylic stents were recorded at day 0 and 60.
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Primary outcome measure(s)
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The result showed reductions in Probing Pocket Depth (PPD) in all 4 groups and these reductions are statistically significant in all 4 groups (p=0.01). The effects of the treatments were evident post treatment recording. At 2 months, PPD was reduced to 4.52 mm in the SRP alone group, to 5.27 in SRP plus chitosan, to 5.60 mm in the SRP plus Salvadora Persica chip group and to 4.63 mm in the SRP plus BITC chip group contrasted with pre-treatment records.
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Secondary outcome measure(s)
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For bleeding on probing, the outcome shows that there was significant improvement in bleeding on probing in all groups post treatment. The enhancements in BOP were comparatively similar for all groups following 2 months (p=0.05).
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Sources of funding
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Universiti Teknologi MARA (Malaysia) ref: 600- RM I/ST/DANA5/3/ Dst (198/2009)
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Trial website
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Publications
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Contact name
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Prof
Fouad
Al- Bayaty
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Address
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Universiti Teknologi MARA
Centre for Periodontology
Faculty of Dentistry
Selangor Darul Ehsan
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City/town
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Shah Alam
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Zip/Postcode
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40450
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Country
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Malaysia
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Email
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fouad@salam.uitm.edu.my
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Sponsor
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University of Malaya (Malaysia)
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Address
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c/o Professor Mahmood Ameen Abdulla
Department of Molecular Medicine
Faculty of Medicine
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City/town
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Kuala Lumpur
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Zip/Postcode
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50603
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Country
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Malaysia
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Email
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mahmood955@yahoo.com
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Sponsor website:
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http://www.um.edu.my/
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Date applied
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02/12/2012
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Last edited
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26/02/2013
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Date ISRCTN assigned
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26/02/2013
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