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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON25853
Enrollment
30
Registered
2017-10-19
Start date
2017-11-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Apical periodontitis, pain

Interventions

irrigation RISA

Sponsors

ACTA Dental Research B.V.
Lead Sponsor

Eligibility

Inclusion criteria

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

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  

Design outcomes

Primary

MeasureTime frame
pain / no pain

Secondary

MeasureTime frame
healing apical periodontitis

Contacts

Public ContactS.V. van der Waal

Academisch Centrum Tandheelkunde Amsterdam,

s.vd.waal@acta.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)