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The tolerance to RISA root canal fluid determined in an in-vivo study


- candidate number28041
- NTR NumberNTR6762
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR19-okt-2017
- Secondary IDs2017.015 
- Public TitleThe tolerance to RISA root canal fluid determined in an in-vivo study
- Scientific TitleThe toleance to RISA root canal fluid determined in an in-vivo study
- ACRONYMTIGRIS (Tolerance IrriGation RISa)
- hypothesisWell-being after root canal treatment with RISA irrigation. Frequency and intensity of postoperative pain.
- Healt Condition(s) or Problem(s) studiedParodontitis apicalis, Pain
- Inclusion criteria-- apical periodontitis has been diagnosed and confirmed with an intra-oral radiograph and appears on the radiograph as a radiolucent area around one or more root tips of the affected tooth. A root canal treatment has a reasonable/good prognosis (Sjögren et al. 1990) and the subject prefers NSRCT over tooth extraction or monitoring. The affected tooth has not previously received a complete root canal treatment.
- no spontaneous pre-operative pain or spontaneous pre-operative pain less than 36 (see fig. 1) (Heft & Parker 1984)
- no or mild swelling and no draining sinus tract on affected tooth.
- 18 – 75 years.
- completed the medical history questionnaire.
- 1st or 2nd molar, 1st or 2nd premolar
- DPSI of subject tooth is ≤3-
- tooth mobility ≤1
- signed the informed consent form
- Exclusion criteria- pain >36 on Heft-Parker VAS scale (fig. 1)
- subject tooth with a mobility score 2 or more
- subject tooth with a DPSI ≥3+
- subject tooth with open or incompletely formed root apices
- subject tooth that requires a post
- subject tooth with a vertical fracture or horizontal fracture extending below the cemento-enamel junction of the tooth
- teeth in the same quadrant requiring root canal therapy
- teeth with hypersensitive dentine in the same left or right facial half
- absence of a periapical
- previous (non)surgical (root-canal) treatment on subject tooth
- draining sinus tract or exacerbation originating from affected tooth

Current medication related criteria:
- chronic use of pain relief medication
- (par)enteral use of bisphosphonates
- systemic corticoid therapy

General-health related criteria:
- non-odontogenic facial pain
- any known infectious diseases (eg, human immunodeficiency virus, hepatitis B, hepatitis C, tuberculosis, or prion-induced disease)
- history of cancer in the oral-maxillofacial region
- history of cancer in the last two years
- history of head and/or neck radiation therapy
- diabetes mellitus type I/II,
- chronic inflammatory diseases like morbus Crohn or rheumatoid arthritis
- known sensitization to sorbic acid and its salts
- pain >36 on Heft-Parker VAS scale (fig. 1)
- subject tooth with a mobility score 2 or more
- subject tooth with a DPSI ≥3+
- subject tooth with open or incompletely formed root apices
- subject tooth that requires a post
- subject tooth with a vertical fracture or horizontal fracture extending below the cemento-enamel junction of the tooth
- teeth in the same quadrant requiring root canal therapy
- teeth with hypersensitive dentine in the same left or right facial half
- absence of a periapical
- previous (non)surgical (root-canal) treatment on subject tooth
- draining sinus tract or exacerbation originating from affected tooth  
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupFactorial
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-nov-2017
- planned closingdate1-nov-2019
- Target number of participants30
- Interventionsirrigation RISA
- Primary outcomepain / no pain
- Secondary outcomehealing apical periodontitis
- Timepointsintake, consultation, treatment, control after 1 year a total of 7 questionaires are filled out
- Trial web sitewww.acta.nl
- statusplanned
- CONTACT FOR PUBLIC QUERIES S.V. van der Waal
- CONTACT for SCIENTIFIC QUERIES S.V. van der Waal
- Sponsor/Initiator ACTA Dental Research BV
- Funding
(Source(s) of Monetary or Material Support)
Coltène / Whaledent GmbH + Co. KG
- Publications1: van der Waal SV, Scheres N, de Soet JJ, Wesselink PR, Crielaard W. Cytotoxicity, interaction with dentine and efficacy on multispecies biofilms of a modified salt solution intended for endodontic disinfection in a new in vitro biofilm model. Int Endod J. 2015; 48:153-61.

2: van der Waal SV, Jiang LM, de Soet JJ, van der Sluis LW, Wesselink PR, Crielaard W. Sodium chloride and potassium sorbate: a synergistic combination against Enterococcus faecalis biofilms: an in vitro study. Eur J Oral Sci. 2012
- Brief summaryRationale: After a series of laboratory tests, where RISA root-canal cleanser (RISA) showed good antimicrobial and biocompatible properties, the tolerance to the newly-devised compound is to be tested in the clinic in humans.
Primary objective: To assess the tolerance to RISA after its the application in the root-canal system during root canal treatment.
The secondary objective is to evaluate periapical radiolucency size on intra-oral radiographs of teeth treated with RISA.
- Main changes (audit trail)
- RECORD19-okt-2017 - 4-nov-2017


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