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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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TCTR |
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Last refreshed on:
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1 April 2024 |
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Main ID: |
TCTR20140703002 |
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Date of registration:
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03/07/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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EFFECT OF ACEMANNAN SPONGES ON OSSEOUS HEALING OF PERIAPICAL LESION
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Scientific title:
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Acemannan sponges induce bone formation of osseous defect after periapical surgery: clinical and radiographic examinations |
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Date of first enrolment:
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23/01/2015 |
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Target sample size:
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45 |
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Recruitment status: |
Enrolling by invitation |
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URL:
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https://www.thaiclinicaltrials.org/show/TCTR20140703002 |
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Study type:
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Interventional |
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Study design:
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Randomized
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Phase:
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Phase 2
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Countries of recruitment
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Vietnam
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Contacts
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Name:
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Van Hong
Le |
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Address:
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40A, Trang Thi street, Hoan Kiem district, Hanoi, Vietnam
10000
N/a
Vietnam |
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Telephone:
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+84 913096888 |
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Email:
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vanlh_1010@yahoo.com |
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Affiliation:
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40A, Trang Thi street, Hoan Kiem district, Hanoi, Vietnam |
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Name:
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Pasutha
Thunyakitpsial |
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Address:
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Department of Anatomy, Faculty of Dentistry, Chulalongkorn Universiity, Henri-Dunant Rd, Patumwan
10330
N/a
Thailand |
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Telephone:
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+6622188885 |
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Email:
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pthunyak@yahoo.com |
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Affiliation:
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Chulalongkorn University |
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Key inclusion & exclusion criteria
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Inclusion criteria: Patient presents a radiolucency periapical lesion with 5 to 15 mm diameter size of anterior teeth
Abnormalities of dental pulp and root shape
Restoration considerations such as crown or post in the root canals
Horizontal fractures
Breakage instruments or extrument of filling materials
Referance from endodontist to do periapical surgery
Exclusion criteria: Allergy to anesthetics or herbal medicines
pregnant women
Smoker addition
Alcohol drinkers
Enable teeth for root canal retreatment
Compromise of crown root ratio
Lesions close to the mental forament or nasal cavities
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Acemannan
Bone healing
Radiographic
Periapical surgery
Phase 2 clinical trial
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The bone defect healing after periapical surgery
Acemannan
Bone healing
Radiographic
Periapical surgery
Phase 2 clinical trial
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Intervention(s)
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10 mg acemannan sponges will be inserted into bone defect,0.5cc DBM putty (DBX, Synthes, USA) is used in each bone defect.
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Acemannan sponges,Demineralized bone matrix
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Experimental Other,Active Comparator Other
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Primary Outcome(s)
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Bone healing 3 and 6 months postoperation Radiographic density
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Secondary Outcome(s)
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Clinical signs 1 and 7 days Pain scale, swelling scale
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Secondary ID(s)
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Chulalongkorn Univer
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Source(s) of Monetary Support
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Research Unit of Herbal Medicine and Natural Product for Dental Application
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Ethics review
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Status: Submitted, approved
Approval date:
Contact:
ranghammat@hotmail.com
The Ethics Committee, Hanoi National Hospital of Odonto - Stomatology, Hanoi, Vietnam
+84439285172 Ext.
ranghammat@hotmail.com
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Results
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Results available:
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Date Posted:
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Date Completed:
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26/03/2015 |
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URL:
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